You may have seen the following warning, which is required by California State law, included with certain of our products.
WARNING: This product contains chemicals known to the State of California to cause cancer, birth defects or other reproductive harm.
Similar warnings appear on products sold by others, and you will likely see this warning on an increasing number of products in the future.
Does this warning mean that our products are unsafe?
The warning is necessary due to a California law known as the "California Safe Drinking Water and Toxic Enforcement Act of 1986," or "Proposition 65." See this link for a summary. This law requires that the warning be given when a product contains certain chemicals designated by the State, even if only in extremely low, trace amounts, and even if they do not make the product unsafe. The California government has stated: "The fact that a product bears a Proposition 65 warning does not mean by itself that the product is unsafe. You could think of Proposition 65 more as a 'right to know' law than a pure product safety law." April 2012, CA Office of Environmental Health Hazard Assessment.
A Proposition 65 warning does not necessarily mean a product is in violation of any product- safety standards or requirements. Our products comply with Federal Food and Drug Administration regulations.
What chemicals are covered by Proposition 65?
Proposition 65 requires that the Governor of California maintain and publish a list of chemicals that are known to cause cancer, birth defects and/or other reproductive harm. The list, which must be updated annually, includes a wide variety of chemicals that can be found in many everyday items. There are currently more than 900 chemicals that are listed for purposes of Proposition 65.
Why is the company providing the warning?
Proposition 65 imposes large penalties, enforceable through civil litigation, for failing to provide a warning unless the company can prove that the presence of the listed chemical presents "no significant risk," which is defined in a way that renders definitive proof difficult, costly, and uncertain. Companies are often faced with the expense of having to defend civil litigation merely due to the presence of a listed chemical in a product without a warning, regardless of whether it presents any actual risk to humans or results in exposure levels sufficient to trigger a warning requirement. Providing a warning, in an abundance of caution, is a practical way to avoid the uncertainty and financial risk of Proposition 65 litigation.
What triggers the warning requirement?
A warning must be given if the listed chemical is merely present in a product unless a business can demonstrate that the exposure it causes poses "no significant risk," as that term is defined for purposes of Proposition 65.
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 who are exposed over a 70-year lifetime. This means that if an individual is exposed to the chemical in question at this level every day for 70 years, theoretically, it will increase that person's chance of getting cancer by no more than 1 case in 100,000 individuals who are exposed at that level.
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" (the highest dose level not associated with observable reproductive harm in humans or animals) divided by 1,000.
To demonstrate that a particular product presents "no significant risk," it is not enough to know how much of the listed chemical is present. Rather, one must demonstrate the anticipated exposure to the listed chemical that will be caused by the product. Determining anticipated levels of exposure can be very complex. It requires consideration of how the product is normally used, who uses it, the length of exposure, and the method of exposure (e.g., oral, inhalation, or skin contact), among other things. Because this analysis involves the exercise of judgment, it is difficult to develop definitive proof that would eliminate the risk of a litigation challenge.
Why is the warning included on products that are sold outside of California?
We source and sell our products on an international basis. We cannot determine with any certainty whether a particular product will ultimately be sold or used in California. The company has therefore elected to place the warning on all of its products.
Teleflex is a trademark or registered trademark of Teleflex Incorporated or its affiliates. 2013-2611