California Finalizes New "Lead Agency Website" Rulemaking under Proposition 65
California’s Office of Environmental Health Hazard Assessment (OEHHA), which administers Proposition 65, has finalized a rule that will establish a “Lead Agency Website” to provide additional information to consumers on exposure to listed chemicals. See Final Text at http://oehha.ca.gov/proposition-65/crnr/notice-adoption-new-section-25205-proposition-65-lead-agency-website. The new requirements impose reporting requirements on industry in the event that OEHHA requests information. Specifically, within 90 days of a request from OEHHA, the manufacturer, producer, distributor, or importer of a product bearing a Proposition 65 warning must provide, for publication on the Lead Agency Website, information such as: the location of the chemical in the product, the concentration (including mean, minimum, and mode) of the listed chemical in the final product, anticipated routes of exposure, estimated levels of exposure, and “any other related information concerning exposures to listed chemicals." Requests may be answered through a trade association if OEHHA seeks information from two or more businesses regarding the same product or exposure.
However, the new regulations also state that, if the information OEHHA is requesting is not in the possession or control of a business, the business is not required to procure it.
In terms of background, the Safe Drinking Water and Toxic Enforcement Act of 1986 (commonly known as Proposition 65 or Prop 65) requires the governor of California to publish a list of chemicals "known to the State to cause cancer or reproductive toxicity." The law mandates, in part, that no person may knowingly expose any individual to a significant amount of a listed chemical without first providing a "clear and reasonable warning" to such individual.
As highlighted in 2013 comments by Governor Jerry Brown, the current “clear and reasonable warning” contains a limited amount of information (i.e., “WARNING: This product contains chemicals known to the State of California to cause cancer and birth defects or other reproductive harm.”). The Lead Agency Website is one of two rulemaking initiatives undertaken by OEHHA to increase the level of detail provided to Californians under Proposition 65. Specifically, the Lead Agency Website will identify the listed chemicals present in a product, publish concentrations in products, and provide exposure estimates. A second rulemaking initiative that is currently in process would revise the warning language to define “clear and reasonable” to obligate identification of the Proposition 65 listed chemicals present in the given product and refer consumers to the Lead Agency Website for additional information. See http://www.oehha.ca.gov/prop65/CRNR_notices/WarningWeb/2NPRArticle112715.html for additional information on the pending warning requirement rulemaking.
Various industry groups submitted comments highlighting concerns regarding disclosure of information considered to be trade secret or privileged, as well as disputing the accuracy of information posted on the Lead Agency Website by third parties. The final regulation includes text proposed in September 2015 in response to these comments, concerning (1) the method by which OEHHA will evaluate trade secret information, (2) the inability of OEHHA to obtain privileged information from companies, and (3) the ability of companies to request the correction of inaccurate information that may appear on the website.
Manufacturers should monitor the chemicals being considered for listing by OEHHA and be prepared to respond to a request from OEHHA for information on any listed chemicals. Whereas manufacturers may have previously chosen to include a warning on products based on conservative worst-case exposure estimates, the Lead Agency Website requirements may cause manufacturers to conduct more realistic exposure estimates to avoid warnings on products for which they would not be required (i.e., exposure would be less than the safe harbor level). Lastly, companies should become familiar with the trade secret exemption to ensure that trade secret information is appropriately identified in any submissions to OEHHA.
The new regulations go into effect April 1, 2016. For more information, contact us a Prop65@khlaw.com or call Leslie Krasny at (415) 948-2810, David Sarvadi at (202) 434-4249, or Natalie Rainer at (415) 948-2821.