Many consumers nationwide can recite from memory the common warning phrase, “This product contains chemicals known to the state of California to cause cancer and birth defects or other reproductive harm.” Although familiar with the phrase, many are not sure of the meaning or direct implications of the warning. Whether you are a contractor working professionally or a homeowner performing repairs, it is important to have at least a basic understanding of Proposition 65, its regulatory effects and how it serves to protect consumers.
While popularly known as Proposition 65, the law’s official title is the “Safe Drinking Water and Toxic Enforcement Act of 1986.” It took effect in November of 1986 after approval from 63 percent of California voters1. Proposition 65 requires manufacturers and distributors to provide clear and reasonable warnings whenever a product may expose users to chemicals known to the state of California cause cancer, birth defects, or other reproductive harm. It is important to note that Proposition 65 does not ban any chemical, but rather is a tool to generate awareness. The purpose of the law is to allow consumers to make informed decisions about chemical exposure based on an understanding of any harmful chemicals in the products they use.
An integral component of Proposition 65 is the requirement for the Governor of California to maintain and publish a list of chemicals that are known to the state of California to cause cancer, birth defects, or other reproductive harm. This list now contains more than 900 chemicals and must be updated at least once a year by law. Chemicals on the list vary from those used in industrial processes to chemicals found in the food and beverages we consume each day2. Listed chemicals include both synthetic and naturally occurring chemicals and are added to the list one of four ways3:
- All chemicals identified in the California Labor Code as carcinogens are required to be listed.
- Chemicals determined by the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant identification Committee (DARTIC) to cause cancer or birth defects or other reproductive harm are listed.
- Chemicals may be identified by “authoritative bodies.” These bodies include the US Environmental Protection Agency, US Food and Drug Administration, and the National Institute for Occupational Safety and Health.
- Any chemical that an agency of the state or federal government requires to be labeled as causing cancer, birth defects, or other reproductive harm will be listed.
Proposition 65 requires a warning to be listed for any product containing an identified chemical unless it has been proven that the user’s exposure will not pose a significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. When determining acceptable exposure levels, the law distinguishes between chemicals listed as causing cancer and chemicals listed as causing birth defects or other reproductive harm. For chemicals listed as causing cancer, Proposition 65 defines a “no significant risk” level for each individual chemical. This “no significant risk” level is defined as the level of chemical exposure that would result in not more than one excess case of cancer in 100,000 individuals exposed to the chemical over a 70 year lifetime. For chemicals listed as causing birth defects or other reproductive harm, Proposition 65 defines a “maximum allowable dose level.” This level is determined through testing. Each chemical must be tested to determine the level of exposure which poses no harm to humans or laboratory animals. Once this safe exposure level is determined, that level is divided by 1,000 to define the “no observable effect level”3.
Proposition 65 places the burden of proof on manufacturers and distributors to comply with applicable regulations. In order for a manufacturer to prove that the chemical exposure from their product is below the threshold levels, the product must undergo extensive testing and evaluation. Testing these exposure requirements is often prohibitively expensive and results in many manufacturers, especially those with large product portfolios, to label all their products in accordance with Proposition 65 requirements, even when those products may pose no health risk to users. Also, the presence of a Proposition 65 warning does not indicate that a product is in violation of any state or federal safety requirement. In fact, the California government has provided a clarification that “the fact that a product bears a Proposition 65 warning does not mean by itself that the product is unsafe”3. The Proposition 65 warning informs the consumer of exposure or the possibility of exposure that exceeds the established threshold levels, which is not the same as the regulatory of decision whether a product is deemed safe or unsafe. Users can seek additional information on the level of exposure from the manufacturer or distributor from which they purchased the product4.
While Proposition 65 is a California state law, the resulting warning labels are often encountered outside of the state of California. The law requires that products manufactured or sold in California be appropriately labeled. It is common for manufacturers and distributors who do business in multiple states or countries to label all products in accordance with Proposition 65 requirements. This is because it may be impossible to determine in advance where any individual product will be sold or used at a later date. As a result, many products encountered across the country and around the globe carry the Proposition 65 warning even when not required by federal, state, or provincial regulations. Consumers should also be aware that under Proposition 65, manufacturers and distributors may convey warnings in ways other than labeling the physical product. Businesses may also provide notifications via signs or newspapers.
The requirements of Proposition 65 may be enforced by any individual acting in the public interest. This includes the Attorney General, law firms, and even private citizens. Penalties for businesses found to be in violation of Proposition 65 can reach $2,500 per day5. Because of these strict penalties and the ability of anyone to bring a lawsuit, many companies choose to act in an abundance of caution when labeling their products.
Proposition 65 has recently been revised with changes effective in August of 2018. One of these changes is updated safe harbor warnings which now say the product “can expose you to” a Proposition 65 listed chemical rather than saying the product “contains” the chemical. The revisions also provide new warning labels that include a triangular yellow warning symbol and list the internet address for OEHHA’s new Proposition 65 warning website. This website provides additional information on the health effects of Proposition 65 chemicals and ways to reduce or eliminate exposure to chemicals. Examples of acceptable warning labels under the new regulations are shown above. The new changes also require e-commerce retailers to provide warnings for each product before a purchase is finalized.
Acting as an informed consumer is important and Proposition 65 facilitates increased awareness of the chemicals we are exposed to on a daily basis. For further information and to view the list of chemicals included in Proposition 65, visit www.p65warnings.ca.gov.
REFERENCES
- OEHHA. (August, 2018). What is Proposition 65. https://www.p65warnings.ca.gov.
- OEHHA. (September, 2016). Acrylamide. https://www.p65warnings.ca.gov/fact-sheets/acrylamide.
- OEHHA. (February, 2013). Proposition 65 in Plain Language. https://oehha.ca.gov/proposition-65/general-info/proposition-65-plain-language.
- Office of the Attorney General. (August, 2018). Proposition 65 Frequently Asked Questions. https://oag.ca.gov/prop65/faqs-view-all.
- OEHHA. (August, 2018). About Proposition 65. https://oehha.ca.gov/proposition-65/about-proposition-65.
