October 14, 2019

October 14, 2019

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October 11, 2019

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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. 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 here 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. 

© 2019 Keller and Heckman LLP

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 Leslie T. Krasny, Keller Heckman, Administrative Law Matters lawyer, Food Supplement Regulation Attorney
Senior Counsel

Leslie Krasny joined Keller and Heckman in June 2001 and was instrumental in opening Keller and Heckman's San Francisco office. Ms. Krasny practices in the areas of regulatory and administrative law, primarily focusing on food/dietary supplement and consumer product industry matters, including safety and labeling, recalls, ingredient evaluations/GRAS opinions, health-related claim substantiation, organic requirements, green/sustainability claims, advertising, California's Proposition 65, recall insurance policies, continuing product guarantees, international trade and...

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David G. Sarvadi, Keller Heckman, Occupational Health and Safety lawyer, Labor Litigation attorney
Partner

David Sarvadi joined Keller and Heckman in 1990. Mr. Sarvadi practices in the areas of occupational health and safety, toxic substance management, pesticide regulation, employment law, and product safety.

Mr. Sarvadi represents clients before a variety of federal and state enforcement agencies in legal proceedings involving OSHA citations, EPA Notice of Violations, TSCA consent orders, CPSC Notices, FIFRA Stop Sale Use and Removal Orders, and EEOC Charges of Discrimination. He works with clients in developing, reviewing, and auditing compliance programs in all of these areas, and in obtaining agency rulings on proposed or novel activities and questions, seeking interpretations of regulations as they apply to specific sets of facts.  He has a background in occupational safety and health, having worked as an industrial hygienist for more than 15 years and became a Certified Industrial Hygienist in 1978, a designation he held until he voluntarily relinquished it in 2010. Prior to becoming an attorney, he was a principal in a small consulting firm, and managed a corporate industrial hygiene and product safety program for a Fortune 500 company. Mr. Sarvadi was selected by the National Academy of Sciences to participate in a panel of the Institute of Medicine that was asked to review a study by the National Institute for Occupational Safety and Health on the use of respirators in the U.S. He was asked to participate because of his expertise in law and industrial hygiene.

202-434-4249
Natalie E. Rainer, Keller Heckman, US Regulatory Compliance Attorney, Environmental Torts Lawyer,
Associate

Natalie Rainer joined Keller and Heckman in 2007. She practices in the area of food and drug law.

Ms. Rainer advises corporate clients regarding regulatory compliance in North America, Latin America, Europe, and Asia. During graduate school, Ms. Rainer worked at the U.S. Department of Justice, Civil Division as an intern in the Environmental Torts Section. In this position she participated in the defense of the federal government in multi-million dollar environmental lawsuits and wrote a successful U.S. Court of Appeals brief defending the...

415-948-2821