There’s been a lot of talk about California’s Proposition 65 and what it means to anyone shipping products directly or indirectly into California, including the caps, grips, and plugs made at Harman. Here we’ll try to break down Proposition 65 in an understandable format and provide suggestions on how you can comply and respond as you ship your products into California.
Proposition 65 is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986. The Act requires businesses to provide a warning label for products that contain certain naturally occurring or man-made chemicals that the State of California says are, “known to cause cancer or birth defects or other reproductive harm.'' The State publishes a list of chemicals which is updated annually and requires that the packaging for products containing any of these chemicals carry a warning label if shipped into California.
For example, Harman manufactures products that may contain phthalates to help keep the vinyl flexible and pliant. Phthalates are on the California list of chemicals so Harman includes a “Prop 65” warning on our boxes and our website to let California buyers (and others) know when our products may contain a chemical that is found on the Proposition 65 chemical list.
Do you need a Proposition 65 Warning?
If you’re shipping products into California, or have distributors that are shipping your products into the state, and any of the components on your product may include a chemical found on the California Proposition 65 list, you should include a warning label with your packaging. And that means ANY component in your product.
If you don’t you run the risk of a lawsuit.
A Proposition 65 warning by no means indicates that your product causes cancer. The warning simply means that your business has either evaluated the exposure to the chemical and concluded that it exceeds the "no significant risk” level when it comes to causing cancer or birth defects or, (as is the case with most of us), your company has not attempted to evaluate the exposure level of the chemical and has chosen instead to include the warning based on their knowledge about the presence of a listed chemical.
The law states that a warning is required even if just one of the listed chemicals is present in a product. Though a company can get around this by demonstrating that the exposure to the chemicals poses “no significant risk” for cancer or birth defects; proving “no significant risk” is difficult and costly.
According to Sharp USA: “With respect to carcinogens, the "no significant risk" level is defined as the level which is calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime. In other words, if you are exposed to the chemical in question at this level every day for 70 years, theoretically, it will increase your chances of getting cancer by no more than 1 case in 100,000 individuals so exposed.
Sharp USA adds “With respect to reproductive toxicants, the "no significant risk" level is defined as the level of exposure which, even if multiplied by 1,000, will not produce birth defects or other reproductive harm. In other words, the level of exposure is below the "no observable effect level," divided by 1,000. (The "no observable effect level" is the highest dose level which has not been associated with observable reproductive harm in humans or test animals.)”
Are you really going to try and prove all that?
For small businesses like Harman that don’t have the resources to test and certify that there is “no significant risk” when it comes to cancer or birth defects, the choice to include a warning label becomes obvious.
So let me repeat the paragraph above: If you’re shipping products into California, or have distributors that are shipping your products into the state, and any of the components on your product may include a chemical found on the California Proposition 65 list, you should include a warning label with your packaging. That means ANY component in your product. If you don’t you run the risk of a lawsuit.
Proposition 65 and Lawsuits
Mike Gatto, a former Legislator in the California State Assembly wrote in an opinion posted on the Orange County Register website entitled, “Intended to protect consumers, Prop. 65 has become a threat to small businesses”. He wrote in part:
“Proposition 65 works by requiring businesses to give proper warning to consumers when products contain dangerous chemicals that have been linked to cancer or birth defects. A problem arises when the overzealous take this mandate too far.
“Many lawyers genuinely care about the environment and health. But when predatory lawyers come after small businesses for technical Prop. 65 violations, the businesses are often left with two bad choices: try to fight the claim in court or reach a settlement agreement, no matter how ridiculous the alleged violation may be. Since many small-business owners know that even if they win in court, it will cost them a lot of money and time, they often settle just to be done with it. Many of the bad actors also target business owners who speak poor English, thinking that immigrant business owners will be even more likely to settle. This is morally wrong.”
One story told to me personally was of a Fortune 500 company that shipped a multi-million dollar piece of manufacturing equipment with built in computing power and software to a plant in California. One of the computer chips buried inside this giant machine contained a chemical listed on the California Proposition 65 chemical list but, because it was simply a computer chip, the company didn’t label this giant machine with a Proposition 65 warning prior to shipping the product to be installed in a manufacturing facility in California. After the equipment was installed in CA, a lawsuit was filed against the manufacturer and a claim was made that the company was out of compliance with Proposition 65 because of the microchip installed in this equipment. Though there may not have been malice or deceit intended, the chip did include chemicals found on the Proposition 65 list of chemicals and the manufacturer was out of compliance.
Rather than waging a costly legal battle, the company chose to settle when sued. The person who told me the story, who claimed to have firsthand knowledge of the situation, said the settlement was in the mid six figure range including legal fees.
Proposition 65 and other States
Though Proposition 65 is a California law, as stated above it applies to any company that is shipping products into the state of California either directly or indirectly. For example, Harman is based in Michigan, but because we may ship into California, and those using our products may ship into California, we’ve made the decision to label all of our boxes with the Prop 65 warning.
This is a state law that has far reaching effects to manufacturers and distributors across the United States and around the world.
California is often the leader when it comes to this type of legislation and certainly has led the way with law being enacted in 1986. Other states, including Massachusetts, are considering this type of legislation for the future.
Products requiring Proposition 65 Warnings
You might be surprised by the wide breadth of products that require warnings for Proposition 65. As stated above, Harman is based in Michigan where the evenings can be cool, so it’s common to have a “fire pit” in the backyard of many Michigan homes. I recently picked up some fire starting sticks at the local grocery store, essentially sawdust and wax that help the fire get started quickly, and prominently displayed on the packaging was the Prop 65 warning because the product creates smoke, and smoke could cause cancer.
With about 900 chemicals found on the Proposition 65 chemical list, the number and breadth of products containing those chemicals is extensive. Amazon.com has an extensive list of product categories that they say may carry the Proposition 65 label. Those include:
- Tools - because the dust created by sanding, sawing, drilling or doing general construction activities may contain lead, silica or another chemical found on the Proposition 65 list of chemicals
- Ceramics - because some ceramic tableware may have minute amounts of lead. Even though they may be in compliance with FDA standards, California requires separate labeling.
- Tiffany style lamps and some jewelry - again, lead is the culprit here.
- Cars - because fuel, oil, batteries etc have chemicals on the list (lead)
- Fresh fruits, nuts, and vegetables
- Alcoholic beverages including wine, beer and distilled beverages
- Beauty products
- Canned and bottled food and beverages
- Coffee (yes, coffee), some roasted nuts, baked goods and snack foods
Proposition 65 and Harman
Our personal experience was that we were trepidatious to put the Prop 65 warning label on our boxes years ago. Harman was concerned when we first began to label our products that customers and prospects would react poorly to a warning label on our boxes that indicates our products may contain chemicals that the State of California found to potentially cause cancer.
When we first began using the Proposition 65 labels we did get a few phone calls from concerned clients, many of whom are long time clients who noticed the label, and we were able to discuss with them why we were labeling our boxes as we do while providing options for products that do not contain chemicals found on the Proposition 65 list.
We have also had very positive feedback from many of our customers that have indicated they appreciate the Proposition 65 warning found on our boxes. Many of our customers are very aware of Proposition 65 and if they are shipping directly or indirectly into California, need to be aware of products that they use that may then require them to provide a warning label on their packaging. One customer indicated that our warning label prompted them to have deeper discussions about Proposition 65 and ultimately make the decision to include a warning label on their products as a precaution.
Harman solutions without Phthalates (no warning required)
If you’re in a position where you’re buying caps, grips, or plugs and don’t want to label your products, a great solution when buying from Harman is to have your products made with non-phthalate material. It is the phthalates that keep vinyl products flexible, particularly DINP, that shows up on the California Proposition 65 list of chemicals, and Harman can make any of your caps, grips, and plugs in any shape, any size, and any color with non-phthalate material, typically with a very marginal cost difference.
Harman has been making non-phthalate products for over a decade because we work with many companies in the toy industry who were early adopters of non-phthalate materials.
Harman has dedicated non-phthalate production lines so there is no cross-contamination of product. We can make virtually any color, shape or size product to meet your needs.
Clients that have chosen non-phthalate material for years include makers and distributors of children’s toys, tools, sporting goods, and medical devices.Over the past two years however, we’ve seen an increase in requests for non-phthalate products, primarily because of Prop 65.
Harman is here to help you succeed and can make your products with non-phthalate material so no warning label is required for the products we manufacture for you. Give us a call today to find out more.