Proposition 65 Summary

Background

California's Proposition 65, The Safe Drinking Water &;Toxic Enforcement Act of 1986, was a voter initiative passed to address citizen concerns about exposure to substances which cause cancer or reproductive toxicity. The law prohibits businesses from discharging such chemicals into sources of drinking water, and requires that warnings be given to individuals exposed to them.

Text of the Act is available on line. 

Prop 65's List of Chemicals Known to the State to Cause Cancer and Reproductive Toxicity

The state's scientific advisory board determines which chemicals are "known to the state" to cause cancer or reproductive toxicity, and periodically publishes updated lists in the California Regulatory Notice Register.

Who Is Subject to the Act?

Companies with 10 or more employees that discharge listed chemicals into sources of drinking water, or expose individuals to such chemicals. Exposures can occur in the following situations:

• The manufacture, distribution, or sale of consumer or commercial products
• Industrial or commercial operations that discharge chemicals into the environment
  
• Occupational exposures to listed chemicals

Who Is Exempt From the Act?

• Businesses with fewer than 10 employees
• Businesses that can prove that the exposure falls below the level for which a warning is required
  • for carcinogens, exposures which will not cause more than 1 excess lifetime case of cancer per 100,000 individuals exposed (NSREL).
  • for reproductive toxins, exposures which are less than 1/1000 of the level at which there is no observable effect (NOEL).
• Businesses that cause exposures where federal law preempts state warning requirements
• State and local governmental entities

How Does A Company Comply With the Act?

Determine if individuals will be exposed to chemicals in an amount that exceeds the NSREL or 1/1000 of the NOEL.

Chemicals on the state's list of carcinogens and reproductive toxins are updated frequently. The current Prop 65 list can be found on the web or in the California Code of Regulations, Title 22, section 12000.

Methods for performing risk assessments are also discussed in the regulations, and can be found in section 12703 for carcinogens and 12803 for reproductive toxins. Cal/EPA has set exposure levels for a number of chemicals which can be utilized by companies performing risk assessments. These can be found in the regulations at sections 12705, 12709, 12711 (carcinogens) and 12805 (reproductive toxins). Companies are permitted to use other exposure levels, if scientifically valid, but they bear the burden of proof on the use of other levels in an enforcement action.

Eliminate discharges into sources of drinking water.

The definition of a "source of drinking water" was recently defined by the California Supreme Court to include tap water faucets.

Obtain a "Safe Use Determination"

The regulations provide for a limited "safe use determination" where the lead agency "will consider the applicability of the Act or the exemptions specified in the Act to business activities or prospective business activities." 22 Cal. Code Regs. section 12104(a). Several important exceptions apply, including the fact that these determinations are not binding on public or private prosecutors, or the courts. Additionally, the agency will not provide a safe use determination in several circumstances, including where the subject matter of the request is at issue in a pending civil or criminal case, or where the request does not involve a current or planned activity of the requester. For a complete listing of exceptions, see section 12014(b).

Provide Appropriate Warnings

Regulations passed to implement Prop 65 provide limited guidance on appropriate warning methods and messages. These vary depending upon the types of exposures (e.g., consumer products, environmental, occupational). The rules can be found in the California Code of Regulations, Title 22, section 12601.

The regulations provide "safe harbors," which, if followed, are "deemed" to be in compliance with the statute. Actual experience in enforcement actions has revealed, however, that may be difficult for companies to rely upon many of the safe harbor provisions to avoid expensive litigation.

The Act may be enforced by the California Attorney General, county district attorneys, and other law enforcement officials. If, after 60 days notice of a claimed violation, no public prosecutor has commenced and is diligently prosecuting an action against the alleged violator, any person may bring an enforcement action in the public interest.

Past violations of the warning requirements may be penalized by assessment of civil penalties of up to $2500 per exposure. Injunctions may be obtained to prevent threatened or occurring violations of the Act.

Public and private prosecutors often seek to simultaneously enforce the Act under the state's Unfair Competition Statute. That law allows public prosecutors to obtain an additional penalty of $2500 per violation, and allows any enforcer to obtain restitution against the alleged violator.

This page last updated 7/8/02