Regulation – Understanding Proposition 65

We’ve looked at the federal regulations governing our food, cosmetics, and other ingredients in the USA. This post looks at state legislation that’s frequently the center of attention, Proposition 65.

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).

How does Prop 65 impact people outside of California? 

California’s economy is the 5th biggest globally and would be ranked between Germany and the United Kingdom if it were a country. It has the largest economy and the largest population in the US. Due to its size, businesses and manufacturers may reformulate a product or add a warning label to all products to ensure they can sell it in California. 
Inevitably this impacts the entire country because a manufacturer will apply the changes to all products, not just ones sold in California.

How is Prop 65 different than the federal regulations? 

Prop 65 requires businesses and manufacturers to inform customers through labeling that an ingredient could potentially cause harm. It doesn’t determine the overall safety of a product (1).  
Federal regulations generally work to ensure the overall safety of a product when used as intended. 

If a product has Prop 65 warning label, does that mean the product will cause harm?

As we’ve discussed, the dose makes the poison. Just because we’re exposed to an ingredient that could cause harm doesn’t mean it will cause harm. Additionally, the product could contain an ingredient known to cause harm at specific levels, but it’s located in a way (say, on the inside of an electronic product) that we would not be exposed to it for any duration. 
This is where our understanding of risk becomes important (1,2).

Let’s break it down. 

A warning label may contain an ingredient that could cause harm. This ingredient is the hazard.
How frequently and how much we’re exposed to the ingredient is the exposure
Hazard X exposure = risk
If we’re exposed to the hazard at a low level infrequently, there’s not much of a risk, so we know it’s unlikely to cause us harm. 
If we’re exposed to the hazard at high levels, frequently, there’s more risk, so we know that it could cause us harm if we don’t take proper precautions.

The good news.  

Understanding the goal of hazard, exposure, and risk can help us make better decisions. Now when we see a Prop 65 warning label that identifies a hazard, we can put that hazard into context to understand if it’s an actual risk to our personal health and wellbeing


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