News from CRIS: Regulation - Understanding Proposition 65

September 28, 2021

What are the differences between federal and state regulations?

Generally speaking (there are some exceptions), federal regulations regarding foods, cosmetics, and ingredients must be followed by all states in the United States of America (US). States can enact rules and laws that are in addition to the federal standards.
Federal regulatory agencies that help protect our food, cosmetics, drug, and other personal and household products include the Food and Drug Administration (FDA), the Center for Disease Control and Prevention (CDC), US Department of Agriculture (USDA), the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), and the Consumer Product Safety Commission (CPSC).   
States also have agricultural, environmental, and health departments, each structured differently to suit the state’s needs. These agencies frequently work with federal agencies to help ensure regulations are met (1).
States may also enact legislation and standards above those required by federal regulations, which is the case of Proposition 65 in California. 

What is Proposition 65?

In California, Proposition 65 (Prop 65) is formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986. It’s legislation that requires businesses and manufacturers to provide Californians warning labels on products that contain chemicals that are known to cause cancer, birth defects, or other reproductive harm at levels above California’s “safe harbor” guidelines (1,2,3).
Within the legislation, California’s government must keep a list of chemical ingredients known to cause harm and update it yearly. There are currently 900+ chemicals on that list.
While there are 900+ chemicals listed in the database, only approximately 300 have a safe harbor level established. The safe harbor levels can be set well below the known safe level threshold established by the FDA and other federal regulatory agencies. 
The warning labels must be clearly visible, and they must list the chemical ingredient that’s known to cause harm.

Suppose a product doesn’t contain the warning label and the product’s found to have a listed ingredient above safe harbor guidelines, the business or manufacturer can face a fine of up to $2,500 per day they are in violation (1,2,3,4).


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