California Proposition 65:
Top 10 Questions & Answers
Unfortunately, there is no official list that divides CA Prop 65 listed substances according to industry. Some of the listed substances overlap across multiple industries, so it is incumbent upon each company to determine which substances have relevance for their products. Listed substances include food ingredients, heavy metals, pesticides, etc. It is important to also consider packaging materials as well as any products themselves.
It is critical for a company to understand its supply chain and ingredients, sometimes down to the component and sub-component level in the case of complex materials. Most suppliers understand the need for this transparency in terms of CA Prop 65 and can either provide a statement about the status of the ingredients they supply or complete a vendor questionnaire provided by the user. For example, for a purchased flavor, a customer might ask if the flavor contains any ingredients that are currently listed on CA Prop 65. The flavor supplier would then provide a simple statement of CA Prop 65 compliance and identify any listed substance such as acetaldehyde.
Yes, there are several exemptions as noted below.
Governmental agencies and public water utilities: All federal, state, and local government agencies, as well as entities operating public municipal water systems, are exempt.
Businesses with nine or fewer employees
Exposures that pose no significant risk of cancer. A warning about listed chemicals known to cause cancer (carcinogens) is not required if the business can demonstrate that the exposure occurs at a level that poses "no significant risk." This means the exposure is calculated to result in not more than one excess case of cancer in 100,000 individuals exposed over a 70-year lifetime. The Proposition 65 regulations identify "no significant risk" levels for certain carcinogens.
Exposures that will produce no observable reproductive effect at 1,000 times the level in question. A warning is not required for chemicals known to the State to cause birth defects or other reproductive harm (reproductive toxicants) if the business can demonstrate that the exposure will produce no observable effect, even at exposures 1,000 times the level in question. This is known as the "maximum allowable dose level." Basically, the level of exposure must be below the "no observable effect level (NOEL)," divided by 1,000, as required by the statute. The NOEL is the highest dose level that has not been associated with observable adverse reproductive or developmental effects.
Exposures to listed chemicals that occur naturally in foods. Listed chemicals can occur naturally in certain foods, as an inherent part of the food's composition. An example of this might be acrylamide which is produced when some plants are baked, fried, roasted, etc. Acrylamide is a natural part of making French fries or roasting a chicken. Chemicals that occur naturally in the soil are often absorbed by agricultural crops, and an example is heavy metals or pesticides. To avoid excessive warnings on common food items, OEHHA regulations allow an exemption for listed chemicals in food that a business proves to be "naturally occurring" and reduced to the "lowest level currently feasible." The term "naturally occurring" is defined in specific and narrow terms in the regulations. (CA Code of Regulations, Title 27, Section 25501) These "naturally occurring" chemicals in food do not count toward the exposure under Proposition 65.
Discharges that do not result in a "significant amount" of the listed chemical entering a source of drinking water: There is an exemption for businesses that can demonstrate that the discharge will not cause a "significant amount" of the listed chemical to enter any drinking water source so long as the chemical complies with all other applicable laws, regulations, permits, requirements, and/or orders. A "significant amount" is defined as any detectable amount with a burden on the business to prove that the discharge does not exceed the "no significant risk" or "maximum allowable dose" levels.
Product manufacturers have primary responsibility in terms of providing Prop 65 warnings. Manufacturers can choose whether to put warning labels on their products or provide notices to their distributors, importers, and retail sellers. Manufacturers may also enter into written agreements with retailers to modify this allocation of responsibility as long as the end consumer receives a clear and reasonable warning before being exposed to a Proposition 65 listed chemical.
California Proposition 65 requirements override FDA in terms food and packaging regulatory requirements. There has long been tension between the federal government and the state of California regarding the application of Prop 65 requirements.
Enforcement is carried out through lawsuits brought by the California Attorney General, by a district attorney or a city attorney of a city with a population exceeding 750,000. Private parties acting “in the public interest” can also bring Proposition 65 lawsuits so long as the party has provided at least a 60-day notice of the alleged violation to the business in question as well as to the Attorney General and the appropriate district attorney or city attorney and those attorneys have not yet taken action. The initial notice must provide adequate information about the alleged violation and comply with the requirements specified in the regulations per the CA Code of Regulations, Title 27, Section 25903, and Title 11, Sections 3100-3102.
If a business is found to be in violation of CA Proposition 65, a court may order the business to stop committing the violation and issue penalties. The business is also subject to civil penalties of up to $2,500 per day for each violation. Most CA Prop 65 litigation settled out of court, and the details are not considered in future litigation.
For catalog or internet purchases of a consumer product, warnings can be provided on the product display page. However, this has been challenged in court so that many internet businesses also provide a warning either on or along with the product.
A business or facility that provides signage in a language other than English must also provide Prop 65 warnings in the non-English language as well. This includes signage, shelf tags, etc. If a business provides signage only in English, there is no requirement to provide Prop 65 information in an alternate language.
In addition to general warnings, there are provisions for specific warnings. Examples include alcoholic beverages, diesel engines, designated smoking areas in hotels, restaurants, etc. Enclosed parking facilities and amusement parks are additional examples – even the Happiest Place on Earth has Prop 65 warnings and signage.
Yes, the regulations allow for this pursuant to government code sections 11340.6 and 11340.7 (petition for rulemaking).