California’s Proposition 65

Proposition 65 was enacted almost 30 years ago to address the concerns of California citizens about exposure to toxic chemicals. The purpose of Proposition 65 is to notify consumers that they are being exposed to chemicals known to the state to cause cancer or reproductive toxicity. Proposition 65 requires the State of California to publish a list of such chemicals. This list, which must be updated at least once a year, has grown to include more than 800 chemicals since it was first published. Manufacturers, distributors, and retailers who manufacture, distribute or sell consumer products in California are subject to Proposition 65, whether located in California or not. Proposition 65 applies to a very wide range of consumer products.

Proposition 65 requires that businesses provide a clear and reasonable warning to consumers if a product contains any of the listed chemicals, unless the exposure to the chemical that is likely to result from the use of the product is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. By providing this information, Californians are able to make informed decisions when deciding whether or not to use a product.

For chemicals listed as causing cancer, the State has defined the "no significant risk level” 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. In other words, a person exposed to the chemical at the “no significant risk level” for 70 years would not have more than a “one in 100,000” chance of developing cancer as a result of that exposure.

For chemicals that are listed as causing birth defects or reproductive harm, the State determines the “no observable effect level” by identifying the level of exposure that has been shown to not pose any harm to humans or laboratory animals. Proposition 65 then requires this “no observable effect level” to be divided by 1,000 in order to provide an ample margin of safety. Businesses subject to Proposition 65 are required to provide a warning if they cause exposures to chemicals listed as causing birth defects or reproductive harm that exceed 1/1000th of the “no observable effect level.”

As noted above, it is important to remember that the inclusion of a Proposition 65 warning with the Moda-flx Hemodialysis System does not mean that it is unsafe or in violation of any product safety standards or requirements.

The following factors are relevant to the decision of many businesses to include a Proposition 65 warning with their products:

• The threshold exposure limits for listed chemicals which trigger the need for a warning are very low and, in some cases, well below limits set by other regulatory agencies.
• In order to determine whether a warning is required, it is difficult to determine with any certainty whether the use of a product containing a listed chemical will result in an exposure which exceeds the threshold exposure limits detailed above. It is not enough to know whether a chemical is present in a product in any particular concentration, you also need to determine the level of exposure that will result from a person’s use of the product at that particular concentration. The level of exposure will depend on several assumptions concerning the frequency, duration and intensity of exposure. These assumptions involve the exercise of judgment and will be specific to the circumstances surrounding the composition and use of each product.
• The penalties for not including a warning notice on a product are as high as $2,500 per violation per day. The risk of litigation is also high as Proposition 65 may be enforced not only by the California Attorney General and local district attorneys, but also by any private individual. There is a financial incentive for private individuals to bring lawsuits because the law allows individuals to recover their litigation costs and, more significantly, to retain for their own personal benefit a percentage of the penalty amount obtained in each lawsuit.
• After considering the above factors, Diality has decided that including a Proposition 65 warning notice with the Moda-flx Hemodialysis System is a practical and reasonable way to avoid the uncertainty and financial risk associated with Proposition 65 and its application to Diality products.

As a manufacturer of medical devices, we plan to distribute and sell products across the United States. Although Proposition 65 only applies in California, it is difficult to determine whether any particular product will ultimately be distributed or used in California.

For more information about Proposition 65 please go to:  http://oehha.ca.gov/prop65.html