What is Proposition 65?
In November 1986, a ballot initiative, commonly referred to as Proposition 65 (aka. Prop 65) and formally titled The Safe Drinking Water and Toxic Enforcement Act, was passed in the state of California. The goal of Prop 65 is to protect the drinking water from toxic substances as well as to address public concern regarding consumer exposure to both naturally-occurring and synthetic chemicals.
Who regulates Prop 65?
Proposition 65 is implemented by the California Office of Environmental Health Hazard Assessment (OEHHA), a department within the California Environmental Protection Agency (CalEPA). The OEHHA utilizes scientific data regarding the health risks posed by environmental contaminants to compile and maintain the list of substances subject enforcement under Prop 65.
Businesses are required to provide a “clear and reasonable” warning to Californian consumers if their product could cause exposure to any of the over 900 listed chemicals, thus enabling Californians to make informed decisions regarding their health. Any business selling a consumer good to California, whether directly or indirectly, is subject to Proposition 65 law and the warning requirement.
What products need a Prop 65 warning?
Proposition 65 warnings can be found on a variety of consumer products such as insecticides, building materials, household cleaning supplies, food, elevators and cars and in a variety of settings like hospitals, grocery stores and restaurants.
Which chemicals are included under Prop 65?
Known carcinogens such as asbestos and nicotine are included on the list, but naturally-occurring environmental substances like heavy metals, such as lead and cadmium are also found. The published list even contains substances such as aloe vera extract and gentian violet, plants commonly used as an alternative to traditional therapies as well as commonly prescribed medicines, such as doxycycline, an antibiotic and lovastatin, a cholesterol-lowering drug.
The chemicals on the Prop 65 list have been evaluated by the OEHHA and have been determined that exposure through breathing, swallowing or touching may cause cancer, reproductive toxicity and birth defects.
What types of warnings are required under Prop 65?
Proposition 65 differentiates between two different types of toxicities: cancer and reproductive. If the product can potentially pose consumer exposure to a published chemical, the chemical and associated toxicity type should be identified in a warning following the format below:
WARNING: Consuming this product can expose you to chemicals including [name of one or more chemicals], thich is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.cs.gov/food.
Many Proposition chemicals have a safe harbor level, developed by the OEHHA. Safe harbor levels can vary depending on the type of toxicity; No Significant Risk Levels (NSRLs) are for those chemicals with a cancer risk and Maximum Allowable Dose Levels (MADLs) are for those chemicals with a reproductive harm or birth defect risk. The Safe Harbor Level identifies the highest daily level of exposure to a listed chemical where businesses do not need to provide a Prop 65 warning.
NSRLs are defined by the OEHHA as “the level of 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.” Take lead for example, a naturally-occurring heavy metal that OEHHA lists as both a cancer and reproductive toxicity Prop 65 chemical. Lead has an NSRL of 15 micrograms (mcg) / day, meaning that if a person was exposed to 15 mcg of lead per day for 70 years, they would have a 1/100,000 chance of developing cancer as a result of that level of daily lead exposure. To put this into perspective, according to information released in 2018 by the American Cancer Society, both women and men have a 1/3 risk of developing cancer in her or his lifetime.
MADLs are calculated in a highly conservative method by the OEHHA, based on identifying the level of exposure shown to cause reproductive harm and dividing the number by 1,000. Any product with 1/1000th of the amount shown to cause harm would be subject to Prop 65 requirements. Lead has an MADL which is listed at 0.5 mcg / day. Therefore, any product exposing the consumer to 0.5 mcg or more of lead daily must provide a reproductive toxicity warning to the consumer, even though this level is 1/1000th of the amount shown to cause harm.
What chemicals could be in dietary supplements?
Chemical elements such as lead, arsenic and mercury are abundant throughout the world. These heavy metals occur naturally in the air, water and soil and levels can vary depending on region and season. Ingredients such as botanicals and minerals, since they originate from the earth, naturally contain trace amounts of these and other elemental metals.
At FoodScience Corporation, we source many botanical and mineral ingredients for use in our high-quality formulas. We strive to keep our customers informed and our truth in labeling pledge means that our family of products contain only the purest and most potent ingredients. Our goal is to use the most natural ingredients possible, which means there are naturally occurring miniscule traces of common environmental heavy metals in our products.
How do Proposition 65 Limits compare to federal chemical limits?
Proposition 65 limits are based on the evaluations performed by the OEHHA. Other federal regulating bodies such as the Food and Drug Administration, Occupational Safety and Health Administration and Environmental Protection Agency all have a different set of limits for certain contaminants.
Lead is a chemical listed on the Proposition 65 list and any product that exceeds a daily exposure of 0.5 mcg requires notice to the consumer for a reproductive toxicity warning. To put this level into perspective, 0.5 mcg is the amount of lead that can be found in about ½ cup of fresh spinach. The World Health Organization established a limit for lead consumption of 250 mcg per day for the average adult. This variation in levels shows the different perspectives that agencies have.
How is Proposition 65 enforced and are there penalties for non-compliance?
Proposition 65 is enforced by the California Attorney General’s office as well as by any individual acting in the public interest. Civil lawsuits are common in Prop 65 enforcement and have been filed not only by the Attorney General and district attorneys, but also by individuals, consumer advocacy groups and law firms.
Monetary penalties can be as high as $2500 / day. Many business have been sued for failing to comply with Proposition 65. The burden of proof can be costly to prove in the court of law, causing many companies to settle these litigations outside of court.
Where can I learn more?
For more information about Prop 65 law or to see the complete chemical list visit the OEHHA Prop 65 website.