Prop 65 FAQ for Dentists
What is Proposition 65?
Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement Act of 1986, prohibits businesses with ten or more employees from knowingly discharging any chemical listed as "known to the State of California to cause cancer or reproductive toxicity" to a source of drinking water, and requires that such businesses provide a "clear and reasonable warning" prior to exposing any person to a listed chemical.
Under Proposition 65, the Governor is required to publish a list of chemicals known to be carcinogens and/or reproductive toxicants, as determined by the State of California. This list must be updated annually. Over 700 chemicals have been listed as of January 2003. The State Office of Environmental Health Hazard Assessment (OEHHA) administers the listing process. The list and additional information are available at www.oehha.ca.gov.
Does the law apply to all dentists?
The law applies to dental businesses, including dental offices in California which utilize listed chemicals in the scope of dentistry and employ ten or more employees.
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. Private enforcers, however, must first provide a 60-day notice to targeted businesses, the Attorney General, district attorneys, and city attorneys that set forth the alleged violations before any lawsuit is formally initiated. 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.
What does Proposition 65 mean to dentists?
Dentistry was first affected by Proposition 65 back in 1993 when a consumer group, the Environmental Law Foundation served violation notices on several dental amalgam manufacturers for not providing proper notices to customers and the public. Most manufacturers banded together and began legal challenges. On behalf of all members, CDA participated in settlement discussions between the Environmental Law Foundation and amalgam manufacturers. On two separate occasions during negotiations, CDA submitted proposed warnings to the Attorney General’s Office requesting approval, but the Attorney General’s Office declined, stating that the warnings did not meet the Proposition 65 requirements.
The Environmental Law Foundation and another organization called Consumer Cause served additional notices of violation to other dental supply manufacturers for failing to post warnings of mercury, nickel, and hexavalent chromium exposure. In late 2000, the amalgam suppliers and manufacturers, collectively known as the Committee of Dental Amalgam Manufacturers and Distributors, settled with the private enforcers, which resulted in the dissemination of warning signs and educational mailings to their customers.
In 2001, individual dental offices became involved when another environmental group, As You Sow, served 80 offices in Southern California with violation notices. Beginning in 2002, through meetings and other communications between As You Sow, CDA, and the Attorney General, a settlement was negotiated to devise an appropriate Proposition 65 notice for distribution to dentists for posting. After more than a year of negotiations, in January 2003, CDA entered into a formal Consent Judgment with As You Sow and the Attorney General’s Office on acceptable language, to be incorporated into the notice signs. The Consent Judgment is not an admission of any violation, and no civil penalties were assessed. This settlement is expected to eliminate further piecemeal litigation brought by private enforcers against dental offices.
Who is affected by the Settlement Agreement?
All privately operated dental practices in California, and other dental health businesses such as dental schools, allied dental schools, dental laboratories, and dental clinics within hospitals which employ ten or more persons are affected by the settlement; they will be receiving a Proposition 65 mailing from CDA. The CDA is required to prepare and distribute the mailing, to include the new notice sign, to those groups by March 2003. However, only dental businesses with more than nine employees are required to comply with Proposition 65 and post the notice sign. However, because the definition of "employee" is liberal (part-time and even certain contractors are included), the settlement establishes a procedure whereby compliance with Proposition 65 and its regulatory requirements can be fully achieved by dental offices and other dental health businesses within two years. Non-member dentists and allied groups can participate in the settlement through a buy-in provision that is part of the Consent Judgment.
What does the Settlement Agreement Require?
The Settlement Agreement requires CDA to prepare and distribute a mailing, which will include the new notice sign and other information, to dental businesses in California by March 2003. CDA members with more than nine employees who receive this mailing are required to comply with Proposition 65 and post the notice sign within 30 days. Non-members and allied dental service businesses including dental schools and training programs, dental laboratories and dental clinics will have up until January 9, 2005, to post the Notice To Patients, complete the opt-in agreement form, and submit it with a payment check to As You Sow’s attorney. The fee for the opt-in agreement is $603 if paid from now through January 9, 2004, and increases to $1206 if paid from January 10, 2004, through January 9, 2005. Any dental business which does not join in the settlement may be held liable for failure to comply with Proposition 65 if it cannot prove full compliance independent of the settlement.
What will be included in the CDA mailing?
The following materials will be included in the March 2003 CDA mailing, as required by the Consent Judgment:
- A cover letter
- A sample notice sign
- A 60-day Notice of Violation
- Summary of the Consent Judgment, and a link to CDA’s public website for a complete copy of the Consent Judgment – www.cda.org
- An opt-in agreement form
CDA members with more than nine employees must post the notice sign within 30 days of receipt. Non-member dentists must follow the provisions outlined in the opt-in agreement in order to be protected by the Settlement Agreement. The remaining documents enclosed in the mailer are included for reference.
How is employee defined?
All full-time and part-time staff members are counted. The definition of employee is broad, and encompasses part-time employees who provide only limited services in the office including janitors, gardeners, delivery staff, and even bookkeepers. When in doubt, an office should err on the side of inclusion to be certain.
If a dentist has two offices or businesses, by statutory definition, signage could be required for each location, even if one location has fewer than ten employees. If each location is a different business, in a legal context, and the number of employees does not exceed nine in either one, then no signage would be required under the law.
I received a Proposition 65 mailing notification from a non-CDA entity. What am I supposed to do with this?
As long as dentists are following CDA’s procedures as described in the mailer, then they can choose not to take action on the notification. In 2001 and 2002, several CDA member dentists received a mailing from the Committee of Dental Amalgam Manufacturers and Distributors. The mailings are part of a different settlement agreement of earlier Proposition 65 legal actions. Included in the mailing was a postcard to be returned to the organization.
If dental offices receive a similar mailing in 2003, they are not required to return the postcard, but may do so voluntarily. If the postcard is returned, dental offices may choose to send one of the following responses:
1. The sign is not posted because this office has less than ten employees.
2. The sign is not posted because this office does not use products with chemicals on the Prop 65 lists. (This may apply to specialty offices, such as oral surgery clinics).
3. The sign is not posted because this office uses the notice language agreed to by the California Dental Association, As You Sow, and the Attorney General.
CDA, with the support of the Attorney General’s Office, will be communicating with the other parties responsible for providing Proposition 65 notices to dental offices to devise a uniform notice consistent with the Consent Judgment negotiated by CDA, As You Sow and the Attorney General.
What do I tell patients who ask about the notice?
First, note that the notice does not state that the dental products or procedures cause cancer or reproductive harm. It states only that the products or procedures may expose the patient to "chemicals known to the state" to cause cancer or reproductive harm. The revised notice makes it clear that all restorative materials have been approved by the U.S. Food and Drug Administration. That agency has concluded "there is overwhelming agreement among major health authorities that have assessed these risks that there is no evidence of a serious threat to the general population whose dental caries are treated with amalgam." In addition, the U.S. Food and Drug Administration, the National Institutes of Health, the U.S. Public Health Service, the Centers for Disease Control and Prevention, the World Health Organization, the Agency for Toxic Substances and Disease Registry, and other respected U.S. and international health agencies, continue to review and monitor scientific evidence with regard to the use of restorative (filling) materials and, to date, have determined that they are safe and effective to use in dental patients. The California Dental Association always encourages dentists to discuss patient options before beginning dental treatment.
Are dentists required to post a notice sign in their offices?
All dentists employing more than nine employees must post the required notice sign, the language of which is provided for consumers at the end of this document. CDA strongly encourages offices with less than ten employees to post the notice sign, because, as mentioned above, the definition of employee is broad, and dentists should err on the safe side by posting the sign.
Currently, the Dental Materials Fact Sheet published by the Dental Board of California describes the contents of the various restorative (filling) materials used today, and must be provided to patients the first time they seek restorative treatment. CDA encourages dentists to communicate with patients on all aspects of dental treatment, including options for selecting dental materials best suited for the patients’ dental needs.
What chemicals used in dentistry require Proposition 65 warnings?
Out of the approximately 700 chemicals currently listed as known to the state to cause cancer or reproductive harm, several dozen have been identified that are used in dental materials and treatments. Proposition 65 states that warnings are required prior to any detectable exposure, unless it can be shown that the exposure poses no significant risk. However, as defined in the law, "no significant risk" is conservatively defined as an exposure usually about a thousand times less than is generally regarded as a safe exposure. Therefore, the settlement arbitrated by the Attorney General’s Office focused the warning on those chemicals which could not be shown to present no significant risk, and eliminated warnings about chemicals used in dentistry which clearly are not significant. This approach avoided what could have been expensive and counterproductive litigation given Proposition 65’s conservative definition of significant risk. The list of dental materials currently considered to be included in the warning is at the end of this paper.
In addition, the Settlement Agreement includes a provision which provides that, if initially within 180 days of the Consent Judgment and thereafter if new scientific information becomes available, any dental material or chemical, except for amalgam or mercury which may be reviewed under other circumstances, may be eliminated if scientific data warrants an exemption. Within the 180-day time period, CDA will work diligently to have any chemical which qualifies for an exemption eliminated from the warning requirement.
I don’t use some of the chemicals included in the newly mandated notice sign – do I have to include them in my Proposition 65 notice?
Yes, the Consent Judgment with As You Sow requires that the notice given below be posted in dental facilities employing more than nine employees. Some of the chemicals on the list commonly used in dentistry include mercury, nickel compounds, hexavalent chromium, and formaldehyde; refer to the table provided on the next page. However, while there are other chemicals on the list that are used in dentistry, most, if not all, are perceived to provide "no significant risk" to the public, as that term is defined in the statute. Until scientific data is introduced which warrants a qualification for exemption, the warning requirements for those chemicals other than amalgam must remain. CDA will be working diligently within the 180-day time period to have these chemicals eliminated from the warning requirements.
Are specialty clinics that do not utilize any chemicals on the list, such as oral surgery clinics, required to post a notice sign?
Dental businesses that do not utilize any chemicals on the Proposition 65 list are not subject to the requirements of Proposition 65 and are not required to post the notice sign.
What if I have over nine employee and decide not to post the notice sign?
Offices with over nine employees who decide not to follow CDA’s guidelines will not be protected under CDA’s Consent Judgment with As You Sow and the Attorney General, and could be subject to additional Proposition 65 violation enforcement.
If I post the Proposition 65 notice sign, does this mean I must continue distributing the Dental Materials Fact Sheet to each patient undergoing restorative treatment?
Yes. The two documents are separate but equal entities, necessary for dental offices to comply with two separate laws. The governing agency responsible for administering Proposition 65 is OEHHA, the Office of Environmental Health Hazard Assessment, which is a division of the California Environmental Protection Agency.
The Dental Board of California is responsible for developing and distributing the Dental Materials Fact Sheet, which describes and compares the risks and efficacy of the various types of dental restorative materials that may be used to repair a dental patient’s oral condition or defect. The Dental Board is required to develop, distribute, and administer the Fact Sheet to licensed dentists in California. In turn, each licensed dentist must provide a copy of the Fact Sheet at least once to patients of record and to new patients prior to commencing any dental restorative work.
Must I adhere to the notice language distributed by CDA?
Yes. In order to be protected by the Consent Judgment, dental offices with ten or more employees must post the notice sign given below.
The sign should be posted as provided in the CDA mailer, which will be sent to all dental businesses in California by March 2003. The notice sign must be prominently placed in a location which will afford the patient a reasonable opportunity to receive notice of the exposure and which provides a "clear and reasonable warning" to all patients and visitors prior to exposure. There is sufficient leeway in the Consent Judgment to allow dental offices to determine whether the signs should be posted at the entrance, in the waiting room, in the operatory, or in more than one of these locations. However, a single sign prominently displayed in the waiting room is deemed to be in compliance.
NOTICE TO PATIENTS
Proposition 65 WARNING: Dental Amalgam , used in many dental fillings, causes exposure to mercury, a chemical known to the State of California to cause birth defects or other reproductive harm.
Root canal treatment and restorations, including fillings, crowns, and bridges, use chemicals known to the State of California to cause cancer.
The US Food and Drug Administration has studied the situation and approved all dental restorative materials for use.
Consult your dentist to determine which materials are appropriate for your treatment.
If you have additional questions or concerns about the Proposition 65 notice requirements, please call the Contact Center, 800.CDA SMILE or 800.232.7645, or visit CDA Online at cda.org.
Proposition 65 chemicals in dental offices listed in the settlement agreement
| Material/Use | Proposition 65 Chemicals |
| Amalgam fillings | Mercury Mercury compounds |
| Materials associated with non-amalgam restorations, including but not limited to crowns, bridges, composite fillings, and orthodontics | Beryllium Ceramic Fibers Chloroform Chromium (Hexavalent) Crystalline Silica Formaldehyde Methylene chloride Nickel |
| Materials used in other dental treatments, including but not limited to root canal treatments, dental impressioning, and dental sealant applications | Chloroform Methylene chloride Toluene |