What are some of the exemptions under the Proposition 65 regulation? Are drug products exempt from issuing warnings under Proposition 65?
California Proposition 65 does have a few exempted categories, but drug products are not one of them. The following categories are exempt from the warning requirements under California Proposition 65.
- Governmental agencies and public water utilities: All federal, state and local government agencies, as well as entities operating public 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." In other words, 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, because chemicals that occur naturally in the soil are taken up by food crops, or for other reasons. 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 into any 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, and complies with all other applicable laws, regulations, permits, requirements, or orders. A "significant amount" is any detectable amount, unless the business can prove that the discharge does not exceed the "no significant risk" or "maximum allowable dose" levels.
Reference #1 - (Consumer Healthcare Products Association’s review of Prop 65 impacts): https://oag.ca.gov/prop65/faq#
Reference #2 - (The most recent list of no significant risk levels (NSRL’s)): http://www.oehha.ca.gov/prop65/getNSRLs.html.
Reference #3 - (The most recent list of maximum allowable dose levels can be found here): http://www.oehha.ca.gov/prop65/getNSRLs.html.
Reference #4 - (Link to Consumer Healthcare Products Association discussion on Prop 65): https://www.chpa.org/CAProp65.aspx
**Article contents valid as of 2017-06-20