Glossary
This glossary defines terms commonly used in Proposition 65 fact sheets.
To learn more about legal or regulatory terms related to Proposition 65 implementation, please refer to California Health and Safety Code Chapter 6.6 and Title 27, Division 4, Chapter 1 of the California Code of Regulations.
A
- Aerosol
An aerosol is a suspension of liquid or solid particles in the air. Examples include diesel engine exhaust, cannabis smoke, tobacco smoke, spray paint, hair spray, and spray-on sunscreen.
- Authoritative Body (AB) Listing Mechanism
An AB is an external organization that has been designated by the Carcinogen Identification Committee (CIC) to determine which chemicals cause cancer; or an external organization designated by the Developmental and Reproductive Toxicant Identification Committee (DARTIC) to determine which chemicals cause reproductive harm.
An AB’s publications, reports, and actions are used to consider which chemicals may be added to the Proposition 65 list.
A chemical is added to the Proposition 65 list if one of the ABs formally identifies it as causing cancer or birth defects or other reproductive harm, and if the chemical meets the regulatory criteria in Title 27, Cal. Code of Regulations, section 25306.
The following organizations have been designated by the CIC (27 CCR § 25306(m)) as ABs for determining the carcinogenicity of chemicals:
- US Environmental Protection Agency (US EPA)
- US Food and Drug Administration (US FDA)
- National Institute for Occupational Safety and Health (NIOSH)
- National Toxicology Program (NTP) of the US Department of Health and Human Services (HHS)
- International Agency for Research on Cancer (IARC) of the World Health Organization (WHO)
The following organizations have been designated by the DARTIC (27 CCR § 25306(l)) as ABs for determining the reproductive toxicity of chemicals:
- US Environmental Protection Agency (US EPA)
- US Food and Drug Administration (US FDA)
- National Institute for Occupational Safety and Health (NIOSH)
- Center for the Evaluation of Risks to Human Reproduction (CERHR) of the National Toxicology Program (NTP) of the US Department of Health and Human Services (HHS)
- International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) (for transplacental carcinogenicity).
B
- Birth Defect
A birth defect is a physical abnormality that a baby develops while it is in the mother’s uterus. Most birth defects happen during the first three months of pregnancy.
C
- Cancer
Cancer is a collection of related diseases in which some cells in the body begin to divide abnormally and uncontrollably. These cells often spread into surrounding tissues or organs.
- Carcinogen
A carcinogen is a chemical, physical, or biological entity or agent, or an exposure circumstance that can cause cancer.
The Proposition 65 List includes chemical carcinogens but excludes physical and biological carcinogens.
- Carcinogen Identification Committee (CIC)
The Carcinogen Identification Committee (CIC) is a group of expert scientists appointed by the Governor of California to identify chemicals that have been shown to cause cancer.
Under Proposition 65, the CIC is one of two independent committees of scientific experts designated as the “State's Qualified Experts” tasked with evaluating which chemicals should be added to the Proposition 65 list.
D
- Developmental and Reproductive Toxicant (DART)
[Refer to “Developmental Toxicity” and “Reproductive Toxicity” in this glossary.]
- Developmental and Reproductive Toxicant Identification Committee (DARTIC)
The Developmental and Reproductive Toxicant Identification Committee (DARTIC) is a group of expert scientists appointed by the Governor of California to identify chemicals that have been shown to cause reproductive harm (including developmental harm, female reproductive harm, and/or male reproductive harm).
Under Proposition 65, the DARTIC is one of two independent committees of scientific experts designated as the “State's Qualified Experts” tasked with evaluating which chemicals should be added to the Proposition 65 list.
- Developmental Toxicity
Developmental toxicity can cause adverse effects on a developing embryo or fetus. These effects can occur when a mother is exposed to a chemical before or during pregnancy, or when a father is exposed to the chemical before conception. They do not always appear immediately, but can occur later at any stage of life, or even in future generations.
- Dose
A dose is the amount of a substance taken into the body over a given period of time.
E
- Endpoint
Under Proposition 65, chemicals are listed for cancer and/or reproductive harm, which are referred to as endpoints. Under Proposition 65, reproductive toxicity comprises the three endpoints of "developmental toxicity," "female reproductive toxicity," and "male reproductive toxicity." Cancer is defined as a separate endpoint.
F
- Female Reproductive Toxicity
Female reproductive toxicity occurs when something damages any aspect of a female's ability to reproduce, eventually resulting in interference with the ability to conceive, lactate, or sustain a successful pregnancy. Damage may be to any organ or part of the body involved in reproduction, including the gonads and parts of the nervous and endocrine systems that influence reproduction.
- Formally Required to be Labeled or Identified (FR) Listing Mechanism
A chemical is added to the Proposition 65 list if an agency of the State of California or the federal government requires that it be labeled or identified as causing cancer or reproductive harm according to the regulatory criteria in Title 27, Cal. Code of Regulations, section 25902.
Most chemicals listed this way are prescription drugs that are required by the US Food and Drug Administration (FDA) to carry warnings relating to cancer or birth defects or other reproductive harm.
I
- International Agency for Research on Cancer (IARC)
The International Agency for Research on Cancer (IARC) is the specialized cancer agency within the World Health Organization (WHO). Under Proposition 65, IARC is designated as an authoritative body (AB). IARC identifies chemicals that cause cancer and one specific form of reproductive harm (transplacental carcinogenicity).
L
- Labor Code (LC) Listing Mechanism
Chemicals that are identified in California Labor Code (LC) sections 6382(b)(1) and 6382(d) must be added to the Proposition 65 list. These include:
- Chemicals identified by the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO) as causing cancer in humans or laboratory animals.
- Any substance covered by the federal Hazard Communication Standard, established by the federal Occupational Safety and Health Administration (OSHA).
M
- Male Reproductive Toxicity
Male reproductive toxicity occurs when something damages any aspect of a male's ability to reproduce, eventually resulting in interference with the ability to father offspring. Damage may be to any organ or part of the body involved in reproduction, including the gonads and parts of the nervous and endocrine systems that influence reproduction.
- Maximum Allowable Dose Level (MADL)
A Maximum Allowable Dose Level (MADL) is a “safe harbor level” for a chemical that causes reproductive harm. If a business exposes you to a Proposition 65-listed chemical that is a reproductive toxicant, but the exposure is at or below the MADL, the business does not have to provide a Proposition 65 warning.
For information on how a MADL is calculated, see H&S C 25249.10(c) and 27 CCR 25801-25821. To see the MADLs OEHHA has adopted for specific chemicals, refer to 27 CCR 25705.
N
- National Institute for Occupational Safety and Health (NIOSH)
The National Institute for Occupational Safety and Health (NIOSH) is an organization within the federal Centers for Disease Control and Prevention (CDC). Under Proposition 65, NIOSH is designated as an authoritative body (AB) to identify chemicals that cause cancer or reproductive harm.
- National Toxicology Program (NTP)
The National Toxicology Program (NTP) is an organization within the federal Department of Health and Human Services (HHS) that coordinates toxicology research and testing. Under Proposition 65, it is designated as an authoritative body (AB) for identifying chemicals that cause cancer.
Within the NTP, the Center for the Evaluation of Risks to Human Reproduction (CERHR) is designated as an AB for identifying chemicals that cause reproductive harm.
- No Significant Risk Level (NSRL)
A No Significant Risk Level (NSRL) is a “safe harbor level” for a chemical that causes cancer. If a business exposes you to a Proposition 65-listed carcinogen, but the exposure is below the NSRL, the business does not have to provide a Proposition 65 warning.
For information on how a NSRL is calculated, refer to H&S C 25249.10(c) and 27 CCR 25701 –25721. To see the NSRLs OEHHA has adopted for specific chemicals, refer to 27 CCR 25705.
O
- Office of Administrative Law (OAL)
The Office of Administrative Lawis a California state agency responsible for reviewing administrative regulations proposed by other California state agencies, and overseeing the publication and distribution of the California Code of Regulations and California Regulatory Notice Register.
R
- Reproductive Toxicant
A reproductive toxicant is an agent that can cause reproductive harm.
- Reproductive Toxicity
Reproductive toxicity occurs when a chemical interferes with the ability to produce normal, healthy offspring. This includes effects on the female and male reproductive systems. It also includes adverse effects on the developing embryo or fetus resulting from the mother’s exposure to the chemical before or during pregnancy, or from the father’s exposure to the chemical before conception. These adverse effects to the embryo or fetus do not always appear immediately; they can occur at any stage of life or in future generations.
Under Proposition 65, "reproductive toxicity" includes "developmental toxicity," "female reproductive toxicity," and "male reproductive toxicity."
S
- Safe Harbor Levels
Safe harbor levels are chemical exposure levels that are low enough to be exempt from the warning requirements of Proposition 65. If a product or place exposes you to a chemical, and the exposure is at or below the safe harbor level, then a business does not have to provide a Proposition 65 warning.
Safe harbor levels include no significant risk levels (NSRLs) for chemicals that cause cancer, and maximum allowable dose levels (MADLs) for chemicals that cause reproductive harm.
- State's Qualified Experts (SQE) Listing Mechanism
The state’s qualified experts (SQE) are scientific experts appointed by the Governor of California to serve on two independent committees that determine whether a chemical has been clearly shown to cause cancer and/or reproductive harm. These experts may also provide advice on other aspects of Proposition 65 implementation.
These two committees are the Carcinogen Identification Committee (CIC) and the Developmental and Reproductive Toxicant Identification Committee (DARTIC).
- Susceptibility
Susceptibility refers to the varying responses of individuals to toxic substances due to a combination of genetic, environmental, socioeconomic, lifestyle and other factors. Some factors that can affect susceptibility include genes, gender, age, stage of development, and the state of a person’s health.
T
- Toxicity
Toxicity is the extent to which a substance or a mixture of substances can cause damage to a biological system, such as a cell, an organ, or a person. This damage can range from affecting cell or organ function, to producing cancer or death.
U
- United States Environmental Protection Agency (US EPA)
The US Environmental Protection Agency (US EPA) is a federal government agency tasked with protecting human health and the environment. Under Proposition 65, it is designated as an authoritative body (AB) to identify chemicals that cause cancer or reproductive harm.
- United States Food and Drug Administration (US FDA)
The US Food and Drug Administration is an agency of the federal government that protects public health by regulating drugs, vaccines, and other biological products and medical devices, as well as foods, tobacco products, and products that give off radiation. Under Proposition 65, the US Food and Drug Administration (US FDA) is designated as an authoritative body (AB) to identify chemicals that cause cancer or reproductive harm.
W
- Warning
Proposition 65 requires businesses to give a clear and reasonable warning prior to exposing any individual to a chemical on the Proposition 65 list. A business is responsible for determining whether its product or place of business causes an exposure at a level that requires a warning. The business itself is required to provide the warning.