Health Care Market Solutions: California Proposition 65
[Proposition 65 Warnings: Questions and Answers]
3M Commercial Care Division is committed to keeping our customers informed and educated on regulatory issues which may impact them. In order for you to make your own informed decision based on facts, we have outlined some key points from recent industry studies. Below is an excerpt from communications that we have prepared for our 3M representatives and distribution.
Most or all phenolic disinfectant cleaners contain either o-phenylphenol or sodium o-phenylphenate, both of which are active ingredients listed as carcinogens by California Proposition 65.
California Proposition 65 requires the Governor to publish a list of chemicals that are known to the State of California to cause cancer, birth defects or other reproductive harm. Agents that can cause cancer are called carcinogens; those that can cause birth defects or other reproductive harm are called reproductive toxicants. Under Proposition 65, businesses are required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical.
California Proposition 65 listed o-phenylphenol, an ingredient in our 3M Phenolic Disinfectant Cleaner, as a carcinogen on August 4, 2000. Companies using this material in their product(s) must either provide carcinogen warnings for all products sold in California by August 4, 2001 or be able to show that their product is below the "no significant risk level".
The o-phenylphenol was listed on Prop 65 based on a 1994 study by the environmental Protection Agency (EPA), and 1983 and 1999 studies by International Agency for Research on Cancer (IARC). IARC rated their studies as inconclusive. However, the EPA identified o-phenylphenol as a possible human carcinogen because there was an increase in cancer in laboratory studies.
As a result of the human health risk assessment performed by 3M Corporate Toxicology, Commercial Care Division, beginning August 1, 2001 has included a cancer warning on both our concentrate and ready-to-use 3M Phenolic Disinfectant Cleaner Material Safety Data Sheets (MSDSs). You may decide to continue using your current phenolic and take necessary precautions or switch to a quat with a HB claim to meet the OSHA Bloodborne Standard. This warning is only required for products sold in California; however, it is 3M policy to provide consistent warnings to all of our customers.
If you should have any questions that you would like clarification on, please feel free to contact our Regulatory Specialist at 651-733-5590.
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Proposition 65 Warnings: Questions and Answers
What is California Proposition 65 and how does it relate to 3M Phenolic Disinfectant Cleaner?
Proposition 65 requires the Governor to publish a list of chemicals that are known to the State of California to cause cancer, birth defects or other reproductive harm. Agents that can cause cancer are called carcinogens; those that can cause birth defects or other reproductive harm are called reproductive toxicants. Under Proposition 65, businesses are required to provide a "clear and reasonable" warning before knowingly and intentionally exposing anyone to a listed chemical.
California Proposition 65 listed o-phenylphenol as a carcinogen on August 4, 2000. For all products sold in California, companies using this material in their products must either provide a carcinogen warning by August 4, 2001 or be able to show that their product is below the "no significant risk level".
The o-phenylphenol was listed on Proposition 65 based on a 1994 study by the Environmental Protection Agency (EPA) and 1983 and 1999 studies by International Agency for Research on Cancer (IARC). IARC rated their studies as inconclusive. However, the EPA identified o-phenylphenol as a possible human carcinogen because there was an increase in cancer in laboratory studies.
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Based on a human health risk assessment of our Phenolic Disinfectant by 3M Corporate Toxicology, we have determined that a carcinogen warning is appropriate for both our concentrate and ready-to-use products. This warning would be required for products being sold in California only; however, 3M is providing this warning to all of our customers regardless of where they are located. The 3M risk assessment was based on several known typical practices used in the healthcare industry (leading users of disinfectants).
How Does a Chemical Get Listed on Prop 65?
The State of California, when listing a chemical relies upon information that already exists in the scientific literature when determining the threat of a chemical. A chemical is listed if the "state's qualified experts" -- two independent committees of scientists and health professionals appointed by the Governor -- find that the chemical has been clearly shown to cause cancer or birth defects or other reproductive harm.
In addition, a chemical can be listed if it has been classified as a carcinogen or as a reproductive toxicant by an organization that has been designated as "authoritative" for purposes of Proposition 65. For carcinogens, the organizations that have been designated as authoritative are the U.S. Environmental Protection Agency, U.S. Food and Drug Administration, National Institute for Occupational Safety and Health (NIOSH), the National Toxicology Program (NTP) and the International Agency for Research on Cancer (IARC).
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What are the Responsibilities of Companies Doing Business in California?
Any company with ten or more employees that sells products in California must comply with the requirements of Proposition 65, which include warning for carcinogens, unless a business demonstrates that exposure to their product poses no significant risk.
For a chemical that is listed as a carcinogen, 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.
What are the penalties for violation of the warning requirement?
Penalties for violating the warning requirement may be assessed in the amount of $2,500 per day per violation (per container in commerce). In addition, product recalls may be required.
How long after a chemical is listed must a warning be given?
The warning must be provided for all products in commerce twelve months after a chemical has been added to the list of chemicals known to California to cause cancer or reproductive harm for exposures above the "no significant risk" level.
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How does Prop 65 warnings differ from warnings for carcinogens listed by OSHA, IARC or NTP?
Chemicals listed by OSHA, IARC or NTP must include a carcinogen warning when they are in a mixture at 0.1% or above, unless there has been a carcinogen study of the product which shows that the product does not cause an increase in cancer in laboratory studies. If there is no risk assessment allowed, the warning is required strictly by percentage in the mixture. Prop 65 allows a risk assessment, but there is no cut-off percentage below which a warning is not required.
How does the difference in Prop 65 and other agencies affect the warning on the Phenolic Disinfectant?
The ready-to-use 3M Phenolic Disinfectant Cleaner contains o-phenylphenol at 0.04%. Under the other agencies, a carcinogen warning would not be required. Under Prop 65, 3M has determined that a carcinogen warning is necessary based on the risk assessment performed by 3M Corporate Toxicology, which was based on several known typical practices used in the healthcare industry (leading users of disinfectants).
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Why does California override the EPA registered products warning requirements for disinfectants/sanitizers?
The California Department of Pesticide website states that "twelve months after a chemical, such as a pesticide, is added to the Proposition 65 chemical list, businesses with ten or more employees must provide a warning…. The warning must be clear and reasonable."
Although, the federal EPA will not allow companies to add a warning to the label text that they have approved, the California's Office of Environmental Health Hazard Assessment (California Proposition 65) recommends companies to provide a clear and reasonable warning through their MSDSs.
Why do some of our competitor's phenolic products not have a similar cancer warning?
Most or all of the phenolic disinfectants contain either o-phenylphenol or sodium o-phenylphenate. Proposition 65 recently listed the o-phenylphenol as a carcinogen. The sodium o-phenylphenate has been listed as a carcinogen under Proposition 65 since 1990 and additionally is listed as a carcinogen under IARC.
3M has determined that products containing these components should have a cancer warning.
If the competitor's product does not have a similar cancer warning, one of the following conditions may exist:
- The competitor may have performed laboratory carcinogen studies on their products with negative results or their risk assessments may have been performed differently than 3M's.
- The competitor may have decided to provide the carcinogen warning on only those products sold in California, while 3M policy is to provide consistent warning statements on MSDSs regardless of the state in which the products are being sold.
- The competitor may have erroneously concluded that since disinfectants are regulated by the EPA, a warning under Proposition 65 was not necessary.
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Additional information on the carcinogen studies and listings by the various agencies:
California Proposition 65 - Listing of carcinogens/reproductive toxins (PDF, 52Kb)
California Proposition 65 -Reasons for listing the o-phenylphenol as a carcinogen and data on the EPA and IARC studies (PDF, 11Kb)
IARC - Information on the IARC study on both phenyls.
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