Frequently Asked Questions about Prop. 65
What is Proposition 65?
Proposition 65 is the "Safe Drinking Water and Toxic Enforcement Act of 1986," a ballot initiative passed by the voters in November 1986. It is administered by the Office of Environmental Health Hazard Assessment (OEHHA), which is part of the California Environmental Protection Agency (Cal/EPA).
What does Proposition 65 do?
Proposition 65 provides that persons doing business in California may not expose individuals to chemicals known to cause cancer or reproductive toxicity without first giving clear and reasonable warning, nor discharge such chemicals into drinking water.
How do I know which chemicals cause cancer or reproductive toxicity?
The state publishes a list of "chemicals" known to cause cancer or birth defects or other reproductive harm, which is updated at least once a year. This is known as the "Proposition 65 list" of chemicals.
The list now contains about 750 substances. The chemicals include both individual chemicals and categories of chemicals. The chemical may be present, for example, in common household products such as food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust.
How do chemicals get on the list?
A chemical can be placed on the list in any of the following three ways:
In addition to these three listing methods, chemicals meeting certain scientific criteria and identified by the state's Labor Code as causing cancer or birth defects or other reproductive harm are placed on the list. This method was used to establish the initial list of chemicals.
How does a business know when to give a warning?
The warning requirement states that "No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual."
"Knowingly" means aware that the chemical was present. The courts have interpreted this very phrase very broadly.
"Intentionally" means intending to sell a product or perform some other act, with the requisite knowledge.
How much of the chemical needs to be present before a company must provide a warning?
For carcinogens, the "no significant risk level (NSRL)" is the level of exposure that would result in no more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime.
For developmental toxins, the "no observable effect level (NOEL)" is determined by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this "no observable effect level" to be divided by 1,000 in order to provide an ample margin of safety. Thus, businesses subject to Proposition 65 must provide a warning if they cause exposures to developmental or reproductive toxicant chemicals at a level over 1/1000th of the "no observable effect level."
How do I know if the chemical is present at those levels?
OEHHA has developed "safe harbor numbers" for certain listed chemicals. A business has "safe harbor" from Proposition 65 warning requirements or discharge prohibitions if exposure to a chemical occurs at or below these levels. These safe harbor numbers consist of no significant risk levels for chemicals listed as causing cancer and maximum allowable dose levels for chemicals listed as causing birth defects or other reproductive harm.
OEHHA has established safe harbor numbers for nearly 250 chemicals to date. If there is no safe harbor number established then it is the burden of the business to prove there is no risk.
How are warnings given?
Warnings can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper.
Companies with fewer than 10 employees and government agencies are exempt from the warning provision.
What must the warning say?
The statute governing Proposition 65 provides some "safe harbor" warning language for consumer products:
For carcinogens: "WARNING: This product contains a chemical known to the State of California to cause cancer."
For reproductive toxins: "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm."
Other safe harbor warning language has been established for occupational and environmental exposures, for alcoholic beverages, and for restaurants.
Without safe harbor warning, specific warning language must be negotiated to prevent potential liability.
What happens when a listed chemical is discharged into a source of drinking water?
Proposition 65 Prohibits California businesses from knowingly discharging a "significant" amount of a listed chemical into a "source of drinking water."
"Source of drinking water" is very broadly defined as "either a present source of drinking water or water which is identified or designated in a water quality control plan adopted by a regional board as being suitable for domestic or municipal uses."
A "significant" amount is any detectable amount, unless the discharger can show that the amount would meet the "no significant risk" or "no observable effect" test for carcinogens and developmental toxins, respectively.
How is Proposition 65 enforced?
Proposition 65 is not enforced by OEHHA. Instead it is enforced when legal action is brought against a business that allegedly has failed to warn or has discharged a listed chemical into a source of drinking water. There are three ways that Proposition 65 can be enforced:
Lawsuits have been filed by the Attorney General's Office, district attorneys, consumer advocacy groups, and private citizens and law firms. Penalties for violating Proposition 65 by failing to provide notices can be as high as $2,500 per day for each violation.
How is a business notified that it may be in violation of Proposition 65?
A party, acting in the public interest and alleging that a business is in violation, must first send the business a notice of the alleged violation 60 days before filing a suit. This is known as a 60-day notice letter. In the interim, the Attorney General may take over the case. Public prosecutors do not need to send 60-day notices.
Because Proposition 65 is not enforced by a government agency such as OSHA, a business should seek legal advice upon receiving a 60-day notice letter.
What is the outcome of these lawsuits?
Because the penalties for violating Proposition 65 can be very costly, most business settle before the case goes to trial. Businesses usually pay the plaintiff's attorney fees and cost. Plaintiffs might also ask for restitutionmoney that goes to a public interest group, usually in lieu of penalties.
The settlement usually will also include some provision for the company to reformulate the product, give some type of warning or remove the product from the market.
Proposition 65 is the "Safe Drinking Water and Toxic Enforcement Act of 1986," a ballot initiative passed by the voters in November 1986. It is administered by the Office of Environmental Health Hazard Assessment (OEHHA), which is part of the California Environmental Protection Agency (Cal/EPA).
What does Proposition 65 do?
Proposition 65 provides that persons doing business in California may not expose individuals to chemicals known to cause cancer or reproductive toxicity without first giving clear and reasonable warning, nor discharge such chemicals into drinking water.
How do I know which chemicals cause cancer or reproductive toxicity?
The state publishes a list of "chemicals" known to cause cancer or birth defects or other reproductive harm, which is updated at least once a year. This is known as the "Proposition 65 list" of chemicals.
The list now contains about 750 substances. The chemicals include both individual chemicals and categories of chemicals. The chemical may be present, for example, in common household products such as food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust.
How do chemicals get on the list?
A chemical can be placed on the list in any of the following three ways:
- An organization designated as an "authoritative body" by the state's Science Advisory Board has identified the chemical as causing cancer or birth defects or other reproductive harm. This is the most common way chemicals are placed on the list. The designated authoritative bodies are:
- U.S. Environmental Protection Agency
- U.S. Food and Drug Administration (U.S. FDA)
- National Institute for Occupational Safety and Health
- National Toxicology Program
- International Agency for Research on Cancer
- The state's Science Advisory Board finds that the chemical has been clearly shown to cause cancer or birth defects or other reproductive harm. The Board consists of two independent committees of scientists and health professionals-- the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant (DART) Identification Committee. OEHHA staff scientists compile relevant scientific evidence on various chemicals for the committees to review before making their decisions whether to list a chemical.
- An agency of the state or federal government requires that the chemical be labeled or identified as causing cancer or birth defects or other reproductive harm. Most chemicals listed in this manner are prescription drugs that are required by the U.S. FDA to contain warnings relating to cancer or birth defects or other reproductive harm.
In addition to these three listing methods, chemicals meeting certain scientific criteria and identified by the state's Labor Code as causing cancer or birth defects or other reproductive harm are placed on the list. This method was used to establish the initial list of chemicals.
How does a business know when to give a warning?
The warning requirement states that "No person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual."
"Knowingly" means aware that the chemical was present. The courts have interpreted this very phrase very broadly.
"Intentionally" means intending to sell a product or perform some other act, with the requisite knowledge.
How much of the chemical needs to be present before a company must provide a warning?
For carcinogens, the "no significant risk level (NSRL)" is the level of exposure that would result in no more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70-year lifetime.
For developmental toxins, the "no observable effect level (NOEL)" is determined by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this "no observable effect level" to be divided by 1,000 in order to provide an ample margin of safety. Thus, businesses subject to Proposition 65 must provide a warning if they cause exposures to developmental or reproductive toxicant chemicals at a level over 1/1000th of the "no observable effect level."
How do I know if the chemical is present at those levels?
OEHHA has developed "safe harbor numbers" for certain listed chemicals. A business has "safe harbor" from Proposition 65 warning requirements or discharge prohibitions if exposure to a chemical occurs at or below these levels. These safe harbor numbers consist of no significant risk levels for chemicals listed as causing cancer and maximum allowable dose levels for chemicals listed as causing birth defects or other reproductive harm.
OEHHA has established safe harbor numbers for nearly 250 chemicals to date. If there is no safe harbor number established then it is the burden of the business to prove there is no risk.
How are warnings given?
Warnings can be given by a variety of means, such as by labeling a consumer product, posting signs at the workplace, distributing notices at a rental housing complex, or publishing notices in a newspaper.
Companies with fewer than 10 employees and government agencies are exempt from the warning provision.
What must the warning say?
The statute governing Proposition 65 provides some "safe harbor" warning language for consumer products:
For carcinogens: "WARNING: This product contains a chemical known to the State of California to cause cancer."
For reproductive toxins: "WARNING: This product contains a chemical known to the State of California to cause birth defects or other reproductive harm."
Other safe harbor warning language has been established for occupational and environmental exposures, for alcoholic beverages, and for restaurants.
Without safe harbor warning, specific warning language must be negotiated to prevent potential liability.
What happens when a listed chemical is discharged into a source of drinking water?
Proposition 65 Prohibits California businesses from knowingly discharging a "significant" amount of a listed chemical into a "source of drinking water."
"Source of drinking water" is very broadly defined as "either a present source of drinking water or water which is identified or designated in a water quality control plan adopted by a regional board as being suitable for domestic or municipal uses."
A "significant" amount is any detectable amount, unless the discharger can show that the amount would meet the "no significant risk" or "no observable effect" test for carcinogens and developmental toxins, respectively.
How is Proposition 65 enforced?
Proposition 65 is not enforced by OEHHA. Instead it is enforced when legal action is brought against a business that allegedly has failed to warn or has discharged a listed chemical into a source of drinking water. There are three ways that Proposition 65 can be enforced:
- The California Attorney General can bring an enforcement action.
- Any district attorney or city attorney (for cities whose population exceeds 750,000) may also enforce Proposition 65.
- Any party (individual or group) acting in the public interest may enforce Proposition 65 by filing a lawsuit against a business alleged to be in violation of this law.
Lawsuits have been filed by the Attorney General's Office, district attorneys, consumer advocacy groups, and private citizens and law firms. Penalties for violating Proposition 65 by failing to provide notices can be as high as $2,500 per day for each violation.
How is a business notified that it may be in violation of Proposition 65?
A party, acting in the public interest and alleging that a business is in violation, must first send the business a notice of the alleged violation 60 days before filing a suit. This is known as a 60-day notice letter. In the interim, the Attorney General may take over the case. Public prosecutors do not need to send 60-day notices.
Because Proposition 65 is not enforced by a government agency such as OSHA, a business should seek legal advice upon receiving a 60-day notice letter.
What is the outcome of these lawsuits?
Because the penalties for violating Proposition 65 can be very costly, most business settle before the case goes to trial. Businesses usually pay the plaintiff's attorney fees and cost. Plaintiffs might also ask for restitutionmoney that goes to a public interest group, usually in lieu of penalties.
The settlement usually will also include some provision for the company to reformulate the product, give some type of warning or remove the product from the market.
