Proposition 65 Regulatory Update
February 1, 2016 •
Lead Agency Website Final Regulation Released
On Jan. 25, 2016, California’s Office of Environmental Health Hazard Assessment (OEHHA) released a final regulation introducing a New Section 2 into the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop 65) regulations. The new section 2 gives OEHHA the authority to develop a website to provide information regarding chemical exposure from Prop 65 listed chemicals to the public. The regulations require OEHHA to populate the website with information on how consumers can be exposed to chemicals, information on how to reduce exposures to chemicals, links to other regulatory bodies, and any other public information OEHHA determines is relevant.
The regulations also give OEHHA the authority to mandate that chemical manufacturers, selling products containing Prop 65 chemicals, provide information to be posted on the website. OEHHA can request a variety of exposure related information, including: location of the chemical, the chemical concentration, and an estimated level of exposure. The regulations do not require manufacturers to conduct testing and manufacturers are only required to provide information that is reasonably available. Importantly, the website regulations are not required under Section 6 – Clear and Reasonable Warnings and therefore are cannot be enforced under the civil penalty provisions of Prop 65.
Prop 65 prohibits a person in the course of doing business from knowingly or intentionally exposing any individual to a chemical known to the state of California to cause cancer or reproductive toxicity without first giving “clear and reasonable” warning to the individual.
ACA commented on the regulation throughout the rulemaking process (three times), and OEHHA made revisions and four changes in direct response to those critiques, including the following:
- OEHHA now provides a pathway for manufactures to correct information on OEHHA’s website;
- OEHHA will put a disclaimer on all information, not just information from industry, stating that it cannot assure the accuracy of information received;
- There is now a 90-day deadline for industry to respond to a request; and
- OEHHA will allow for trade groups to respond on behalf of industry, if OEHHA requests information from multiple manufacturers in the same trade group.
The Lead Agency Website regulation takes effect on April 1, 2016, and the website will likely launch later in the year.
ACA Submits Comments in Response to Proposed Clear and Reasonable Warnings Regulations
Also on Jan. 25, 2016, ACA submitted comments to OEHHA on the new proposed amendments to Section 6 of Prop 65 – Clear and Reasonable Warnings. ACA has been involved in the regulatory process since July of 2013 and submitted comments and attended stakeholder workshops on a number of iterations of the proposed amendments.
In response to ACA’s previous comments submitted last year, and comments from other industry stakeholders, OEHHA made numerous changes in the new proposal. Notably, OEHHA altered the chemical specific warning requirements from 12 pre-selected chemicals to requiring the chemical manufacturers to select one or more chemicals to cite in the warning. It is worth noting that under the current proposal, if manufacturers provide an “on-product” warning – or warn on the product label – they are not mandated to use the chemical specific warnings. Additional changes included options for a black and white pictogram, as opposed to yellow and black and type size requirements.
In this round of comments, ACA continued to argue that chemicals specific warnings would not support the goals of amending Prop 65 – to reduce frivolous litigation and to make warnings more meaningful. ACA stated that chemical specific warnings do not provide any context or additional safety information to inform the consumer and therefore the requirement should be abandoned. ACA also commented on the requirement for internet and catalog purchases as well as the proposed type size requirements. Significantly, ACA urged OEHHA to adopt the interpretation that if a manufacturer provides an on-product Prop 65 warning label, then they do not have to provide another Prop 65 warning for the purpose of internet sales and catalog sales if that product is sold by downstream retailers.
ACA expects OEHHA to release one more draft prior to finalizing the regulations.