3B Medical, Inc. is dedicated to the safety of workers and patients and the protection of the environment, and is fully compliant with all relevant laws and regulations. 3B Medical, Inc. sells sleep devices which should be used under the direction and care of appropriately credentialed medical personnel.
Proposition 65, also known as The Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted by California voters in 1986 and updated in 2017. Proposition 65 requires businesses to provide warnings on their products relating to potential exposure to chemicals that are known to the state of California to cause cancer, birth defects or other reproductive harm. The full list of chemicals identified by the State of California pursuant to Proposition 65 may be found online at the following website: https://oehha.ca.gov/proposition-65/proposition-65-list. Approximately 900 chemicals are listed on the November 23, 2018 Proposition 65 List. Some of these chemicals can be found in everyday items, including drugs and food additives. California does not ban the listed chemicals. It does require a warning where the exposure to one of the chemicals exceeds the “no significant risk level.”
For chemicals that are listed as causing cancer, the “no significant risk level” is defined 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 “no observable effect level” is determined 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. See https://www.p65warnings.ca.gov/.
Many businesses place Proposition 65 warnings on their products. This generally means that either the business has evaluated the exposure and has concluded that it exceeds the “no significant risk level,” or the business has concluded that it is not scientifically possible or not economical to test each product for each of the approximately 900 chemicals to 100% certainty relating to potential exposure within the “no significant risk level.” 3B Medical, Inc. has chosen to provide the “safe harbor” warning suggested by the State of California on all products without evaluating the level of exposure, even though the actual exposure may be well below the “no significant risk level,” out of an abundance of caution. 3B Medical, Inc. products therefore display the following warning label on the product or product packaging:
Some people may find the Proposition 65 safe harbor warning concerning. If you visit the state of California, you will find this warning on many everyday items and locations, including restaurants, grocery stores, and amusement parks. Even products purchased outside of California may include the warning, as it would not be feasible to separate or know in advance which 3B Medical, Inc. products might be purchased within California. In order to ensure compliance with the law, 3B Medical, Inc. places the warning on all products. Some other, similar products containing the same chemicals may not have the Proposition 65 warning if the manufacturer of that product does not sell it into California, because that is the only state which requires the warning label. The presence of a Proposition 65 warning does not necessarily mean that the product violates any law or safety standard.
3B Medical, Inc. continues to strive for excellence in every facet of business and to comply with all applicable rules and regulations.