Prop. 65
Proposition 65 in the Dental Office
Teresa J. Pichay and Linda J. Seifert
Copyright 2001 Journal of the California Dental Association.
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In the mid-90s, dentistry became included in enforcement activity for Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. This year, 80 dental offices were served with 60-day notices for failing to post Prop. 65 warnings. The California Dental Association has been inundated with inquiries on what dental offices should be doing with regard to Prop. 65 requirements. This article provides a brief history of Prop. 65 and answers the questions most frequently asked of CDA.
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Several events occurring this year have accelerated organized dentistry’s actions with respect to California’s Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986. This initiative, adopted by a two-thirds majority, was portrayed as consumer legislation to ensure safety of the state’s drinking water. It prohibits businesses with 10 or more employees from knowingly discharging or releasing any chemical "known to the state to cause cancer or reproductive toxicity" into any source of drinking water. It also requires that businesses give any individual a "clear and reasonable warning" prior to exposing an individual to a chemical "known to the state to cause cancer or reproductive toxicity."
Dentistry became a target of the statute in the mid-1990s when the Environmental Law Foundation served a number of dental amalgam manufacturers with violation notices. Ever since, the dental "industry" has figured into Proposition 65 enforcement activity. This year, dental offices have received requests to post amalgam warning signs from more than one dental supply company, and several settlements involving dental manufacturers or supply companies have been finalized. In addition, as of early spring, 80 dental offices have been served with 60-day notices for failing to post Proposition 65 warnings. The California Dental Association has been inundated with inquiries on how and why dental offices should respond to these activities. This article provides a brief history of the Proposition 65 initiative and its impact on the dental industry. The article includes the questions most frequently asked of CDA.
Does the law apply to me?
The law applies to business with 10 or more employees. The historical framework shows the process by which dental manufacturers, suppliers, distributors, and dental offices became objects for Proposition 65 compliance. Dentistry’s first inclination that the law would affect it occurred in 1993 when the Environmental Law Foundation served violation notices on several amalgam manufacturers. Most manufacturers banded together and began legal challenges. One manufacturer settled in 1995 with the Environmental Law Foundation and distributed amalgam warning signs to its customers. Another manufacturer petitioned the state’s Office of Environmental Health Hazard Assessment to remove "mercury and mercury compounds" from the Proposition 65 list of chemicals. CDA, with the assistance of the American Dental Association, supported the petition with scientific information. The petition was nevertheless denied.
On behalf of all members, CDA participated in settlement discussions between the Environmental Law Foundation and amalgam manufacturers. CDA wanted to ensure that any warning a dental office provides would also preclude further Proposition 65 action against that dental office. Since mercury is not the only Proposition 65-listed chemical used in dentistry, during settlement discussions CDA proposed language that would generally include other dental materials in a warning. After reaching agreement with the Environmental Law Foundation and manufacturers, CDA’s proposal was submitted to the Attorney General’s Office for review in early 1999. The Attorney General’s Office did not approve the warning on the grounds that the source or cause of exposure was not specific and accordingly did not meet the Proposition 65 requirements. CDA submitted additional information to the Attorney General’s Office, detailing the dental products and chemicals to which the public could be exposed. This information was developed based upon the review of one dental office’s material safety data sheets. Again, the Attorney General’s Office indicated that an appropriate Proposition 65 warning must clearly state the source of the exposure. The Environmental Law Foundation and amalgam manufacturers then continued with settlement discussions without CDA and reached an agreement in late 2000. CDA continued to consider options to provide dental offices with the maximum protection from Proposition 65 actions.
In October 1999, another environmental group, Consumer Cause, served violation notices on Western Dental Centers and, later, on Smilecare and Community Dental Services, Inc. The notices allege exposures to nickel, nickel compounds, nickel carbonyl, and chromium (hexavalent compounds) from orthodontic appliances and dental crowns, and exposure to mercury and mercury compounds from dental amalgam. Western Dental then took the unusual step of serving 60-day notices on its suppliers: Lancer Orthodontics; American Orthodontics Corp.; JB Dental Supply, Inc.; and Southern Dental Industries, Inc. These suppliers have now reached settlement agreements with Western Dental, with the result including a cash settlement plus the distribution of amalgam warning signs.
Consumer Cause in 2000 further proceeded to challenge dentistry’s compliance with Proposition 65 by serving notices on several dental suppliers for failing to warn of the danger of nickel in orthodontic products. The Environmental Law Foundation served additional notices to several dental suppliers for mercury in dental amalgam. The amalgam suppliers and manufacturers, collectively known as the Committee of Dental Amalgam Manufacturers and Distributors, settled with the Environmental Law Foundation, which resulted in the dissemination of more warning signs. Individual dental offices became directly involved in Proposition 65 early this year when even another environmental group, As You Sow, served 80 offices in the Los Angeles area with 60-day notices.
How is the law enforced?
The attorney general, any district attorney, or any city attorney of a city with a population in excess of 750,000 may enforce Proposition 65. In addition, Proposition 65 has a "private enforcement" provision that allows individuals and organizations "acting in the public’s interest" to initiate cases. Before private enforcement actions can occur, several preliminary conditions must be satisfied. One condition is that private enforcers must provide a "60-day notice" to a targeted business, the attorney general, district attorneys, and city attorneys that set forth the alleged Proposition 65 violations before any lawsuit is formally initiated. If resolved in this manner, private enforcers may recover from the defendants the costs incurred in pursing the Proposition 65 action and a percentage of any penalties levied against the defendants. The law specifies that any business found in violation is liable for a civil penalty not to exceed $2,500 per day for each violation.
Should dentists post a notice?
Dentists are encouraged to post the statutorily mandated notices. The association is in continual communication with the Attorney General’s Office regarding the language to be incorporated into a warning sign. The difficulty arises in crafting warning language acceptable to both the regulators and CDA because the number of dental products that contain chemicals included in the Proposition 65 list is extensive.
Those charged with enforcing the statute want to avoid "over warning" or, in their view, warning of exposures that are "insignificant." CDA, on the other hand, wants any warning to be inclusive enough that it warns of all the exposures that may subject an office to violation notices while not alarming the patient into refusing needed dental treatment. In addition, the statute makes a distinction between chemicals that cause cancer (carcinogens) and those that cause birth defects or other reproductive harm (reproductive toxicants). The "perfect" warning language remains elusive because of a continuing dispute over the enforcer’s preference for singling out amalgam -- or mercury -- in any approved warning.
Three alternative proposed warning methods have been submitted for the attorney general’s review. If the alternative warning systems are approved, each dentist will have several options available, and each dentist can select the warning most suitable for the practice. The first warning method is a sign as shown in Figure 1.
The warning should be printed on approximately 8 ½-by-11-inch paper of durable quality and have large, easy-to-read print. The word "warning" should be typed in letters at least one-inch high, and the remaining letters should be at least one-half-inch tall. The warning should be posted in a location or locations that provide a "clear and reasonable" warning prior to exposure.
The second alternative warning method would consist of the above warning sign and an explanatory brochure directly adjacent to the sign. The brochure would list a number of additional specific products and describes the statute in greater detail. The third warning option would consist of a brochure only. The brochure would be provided to a patient at undetermined intervals calculated to give the patient clear and reasonable notice prior to exposure. The dental office would be required to retain proof that the patient received the notice.
How is "employee" defined?
Only businesses with 10 or more employees are required to comply with the warning requirements. Of course, all full-time staff members are counted. The definition of an employee, however, is broad and encompasses part-time employees who provide only limited services for the office. Part-time janitors, delivery staff, and even bookkeepers may fit the statutory definition and will need to be counted among the total. When in doubt, one should err on the side of inclusion rather than exclusion to be absolutely safe.
I have two offices with fewer than 10 employees at each office, but the combined number of employees is more than 10. Must a Proposition 65 sign be placed at each office?
The operative word in this situation is "office." If the dentist has two offices or "businesses," by statutory definition, then signage could be required for each location. If each location is a different "business," in a legal context, and the number of employees -- full- and part-time -- does not exceed nine in either one, then no signage is required under the statute. Alternatively, if one of the offices employs more than 10 people, signage will be required for that office.
I have had a warning posted. Can I still be liable for damages under the statute?
It is possible. If an office has a clear and reasonable sign posted, however, that warns of the exposures occurring in the office, the dentist should be free from liability from the first posting day forward. The environmental groups and CDA disagree regarding the date on which dentists were first required to post notices; and until the issue is resolved, dentists are urged to post notices.
Liability for damages also depends upon the sign’s language, size, and location. It should provide the patient clear and reasonable notice, in a place where people to be exposed can see it, of the names of chemicals utilized in the office that are known to the state of California to be a cause of cancer, birth defects, or reproductive harm. Recent settlements require that the warning identify which chemicals are reproductive toxicants and which are carcinogens. The notice requirements for the former are more stringent than for the latter.
The warning language may change in the future. It is not a static process. New chemicals can be added, and scientific evidence validating the significance or insignificance of risk of various substances can transpire and result in additions or deletions from the list. Also, external forces such as litigation can result in alterations to the warning signage. Although a one-year compliance window is given to newly added chemicals, failure to comply with changes in warning requirements could result in violations subject to penalty.
Must I adhere to the warning language distributed by CDA?
No. But we would encourage you to do so until this matter is resolved through negotiation and settlement. The signage that CDA has submitted is intended to satisfy the statutory and regulatory scheme, but it has not been approved by the attorney general’s staff. CDA’s interest is in devising a warning that will be sufficiently broad to cover all materials in the dental office but specific enough to encompass the specific products that appear to be of paramount interest to the private enforcers. We expect that the sign verbiage that is included in this article will not be the final wording as we continue with iteration after iteration to identify the wording that will satisfy the state of California, the environmental groups pressing for enforcement of the statute, and the dental profession. Accordingly, a dentist can post a warning that is different from what CDA has suggested, but challenges may prove more difficult to defend. Any warning, no matter who the author, must be "clear and reasonable" and warn of exposures to chemicals on the state’s list that are used in a particular dental office.
I don’t use some of the products or chemicals included in the recommended warning -- do I have to include them in my Proposition 65 warning system?
No. The statute requires only that a warning be provided for the chemicals that are used in the business. The chemicals that have been the subject of violation notices to dental offices and manufacturers include amalgam (mercury, methylmercury) and orthodontic wires and braces (nickel, nickel compounds, chromium or hexavalent compounds, nickel carbonyl). While there are other chemicals on the list that are used in the dental office, most -- if not all -- are perceived to provide "no significant risk" to the public as that term is defined in the statute.
Where does the Proposition 65 sign have to be posted?
Other than that the warning be clear, reasonable and provided to the consumer prior to the exposure, no mandate regarding the method for providing the notice is included in the statute. In fact, the notice does not necessarily need to be posted. Posting, however, is the most frequently utilized method to warn consumers of Proposition 65 exposures.
Settlements in other Proposition 65 challenges are unambiguous, though, in their mandate that the consumer receive clear notice of the exposure. Under the precedents set by other industries as a result of their settlements, the dental office should determine what location in the office will afford the patient a reasonable opportunity to receive notice of the exposure.
Does my liability insurance cover Proposition 65-related claims?
Only the insurance company can provide a definitive answer to that question. One carrier advises, however, that failure to post a warning required by state statute is not the type of risk anticipated by a general liability policy. It is regulatory in nature and accordingly not covered. Dentists should check with their own carriers if they have questions.
How has the law been challenged?
Since its passage in 1986, many -- predominately unsuccessful -- challenges have been made. Some have argued that U.S. Food and Drug Administration approval of a drug or product preempts state statute, and warnings should not be required for chemicals determined safe by the FDA. Dental amalgam is one of the chemicals that falls within that category. The exposure threshold mandating a warning under Proposition 65 is far more stringent than required by the FDA. The courts have ruled, therefore, that FDA approval does not preempt Proposition 65 and that warnings are required for certain exposures in spite of the FDA’s determinations. Challenges to the statutory methodology to obtain an exemption under the statute have been futile. Other challenges -- for instance, that informed consent laws supercede Proposition 65 warning requirements -- have proven unsuccessful so far; but at least one case on this issue is still in the courts.
Very recently, though, the attorney general announced an intention to introduce legislation to "clarify" the statute. In particular, that office seeks limitation on private enforcement provisions and procedures adopted to prevent "over" warning. Comment is invited of interested parties, and CDA expects to make recommendations.
How are chemicals added to the Proposition 65 list?
The list began with a few chemicals and now includes more than 700. According to the law, chemicals may be added to the list in one of three ways. The first method described in the statute is "if in the opinion of the state’s qualified experts it has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity." There is no definition of "state’s qualified experts." The second method is "if a body considered to be authoritative by such experts has formally identified it as causing cancer or reproductive toxicity." The third method is "if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity." Authoritative bodies include the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, the National Toxicology Program, and the National Institute of Occupational Safety and Health. The list must be updated once a year.
An up-to-date list of chemicals is available at the Office of Environmental Health Hazard Assessment Web site: http://www.oehha.org/prop65/prop65_list/Newlist.html.
The dental products with Proposition 65 chemicals are considered safe, and there is no evidence to show they cause cancer or reproductive toxicity. Why must a Proposition 65 warning be provided?
The law sets stringent standards for determining if a product is "safe." To be exempt from the warning requirement, a business would have to show for a chemical listed as a carcinogen that the level of exposure is below the "no significant risk" level. The "no significant risk level" is defined as the level of exposure calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime. In the case of chemicals listed as reproductive toxicants, the category in which dental amalgam falls, a business would have to demonstrate that the level of exposure is one-thousandth the level known to cause birth defects or reproductive harm.
While the amount of research on the safety of amalgam could fill a tall building, little research has been done to examine the relationship between cancer and orthodontic appliances, stainless steel crowns, composites, root canal treatment, and other dental products. Also, the Office of Environmental Health Hazard Assessment has not yet determined the "no significant risk level" for nickel or the "maximum allowable daily level" for mercury and is not likely to do so for at least three years. Since these levels are not set, an application for a safe use determination for dental products with these chemicals may require extensive scientific review.
What do I tell patients who ask about the warning?
First, note that the warning does not state that the dental products or procedures cause cancer or reproductive harm. It states that the products or procedures "may expose" the patient to "chemicals known to the state" to cause cancer or reproductive harm. Dentists, as health care providers, are obligated to inform their patients of the risks and benefits of the care provided. The information the dentist provides should be within his or her area of training, experience, knowledge, and scope of practice. Educational materials from several sources are available to dentists to provide to patients. The Dental Board of California is developing a "Dental Materials Fact Sheet" for use in discussions with patients.
What is the current status?
CDA’s interest is in resolving the Proposition 65 warning issue for all members and to achieve a level of confidence that once an acceptable warning is crafted and properly displayed, a dentist’s warning obligation will be satisfied. To date, CDA has proposed to the Attorney General’s Office three methods by which dental offices can provide a Proposition 65 warning: sign only, brochure only, or a combination of a sign and brochure. Although meetings have been held, the parties are yet to agree on appropriate language. In addition, CDA continues to monitor other settlements and litigation under Proposition 65 and to evaluate CDA’s position on this issue. Further, CDA met with many of the dentists served with violation notices and with representatives of the environmental group that served them. CDA continues to work toward an expeditious solution to all issues related to Proposition 65.
Authors
Teresa J. Pichay is the coordinator of the California Dental Association's Council on Dental Research and Developments.
Linda J. Seifert is CDA’s general counsel.
References
1. Health and Saf. Code Sec. 25249.5, et. seq.
2. Health and Saf. Code Secs. 25249.6, 25249.11, subd. (b)
3. Health and Saf. Code Secs. 25249.6
4. The Committee on Dental Manufacturers and JB Dental distributed warning signs to dental offices in early 2001.
5. Consumer Cause v. Western Dental Centers, Inc. and the resulting cross-complaints resulted in consent judgments between Western and Southern Dental Industries, Inc.; JB Dental supply Company, Southern Dental Industries, and Lancer Orthodontics, among others. Angress Dental Supply Co., Inc., Burkhardt Dental Supply and 19 other suppliers entered into consent decrees with Environmental Law Foundation.
6. On Jan. 25, 2001, the consumer group As You Sow caused 39 dental offices in the Los Angeles area to be served with 60-day notices of violations under the statute. On Feb. 13, 2001, another 41 offices were served with the identical notice.
7. Angress Dental Supply Co., Inc., Burkhardt Dental Supply Co., Inc. Derby Dental Supply Co., Inc., Degussa-Hals Corporation, Dentsply International, Inc., Henry Schein, Inc., IDE Interstate, Inc., and Patterson Dental Supply are among the manufacturers who participated in the challenges.
8. Kerr Corporation filed the petition in 1996.
9. OEHHA denied the petition in April 1998.
10. See Reference 5, ante.
11. Health and Saf. Code Sec. 25249.7, subd. (c).; see also 22 Cal. Code of Regs., Sec 12903
12. Health and Saf. Code Sec. 25249, subd. (d)
13. Health and Saf. Code Sec. 25249.7, subd. (b)
14. Health and Saf. Code Sec. 25249.6
15. Over the several months immediately preceding the publication of this article, several warning iterations have been submitted to the Attorney General’s office for review. While the case law is clear that the statute does not required the "best" warning method available to comply with the statute, a "reasonable" method is required. See People ex.rel. Lundgren v. Cotter & Co. (1997) 53 Cal. App. 4th 1373, rev. den., cert. den., 118 S.Ct. 601, rehg. den. 118 S.Ct. 900. Agreement has been difficult to achieve. In the interim, CDA believes that the good faith effort on the part of the profession to comply with the statute by posting the notice provided in this article should protect the dentist from noncompliance penalties.
16. Recommendations regarding the paper and size of lettering are based on review of other consent judgments.
17. Labor Code Sec. 3351.
18. Health and Saf. Code Sec. 25249.10, subd. (b)
19. Ibid., see Reference 18
20. A recent settlement involving several orthodontic manufactures concludes that the nickel as used in orthodontic materials poses "no significant risk" within the meaning of the statute and that no warning is required.
21. Health and Saf. Code Sec. 25249.10, subd. (c)
22. People v. Lundgren, supra.
23. Industrial Truck Assn. V. Henry (9th Cir. 1997) 125 F.3d 1305, Committee on Dental Amalgam Mftrs. And Distributors v. Stratton (9th Cir. 1996) 92 F.3d 807, cert. Den. 117 S.Ct. 754.
24. Health and Saf. Code Sec. 25249.8
25. Health and Saf. Code Sec. 25249.10
26. Required by enactment of SB 934 in 1992, the fact sheet will compare various types of dental restorative materials that can be used to repair a patient’s oral condition. The "draft" fact sheet states that dental amalgam is "generally safe."
To request a printed copy of this article, please contact/CDA Legal Department, (916) 443-3382, Ext. 4020.
Figure 1. The sign opposite may be photocopied onto cardstock for display in the dental office.
WARNING
Restorative materials such as composite and amalgam fillings and crowns, orthodontic appliances such as brackets and wires, and other materials used in dental treatment contain chemicals known to the State of California to cause cancer, birth defects, and other reproductive harm.
