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Proposition 65 Regulatory Changes Being Contemplated

Products (e.g., food, dietary supplements, cosmetics) distributed in California are subject to Proposition 65, a voter initiative that became the Safe Drinking Water and Toxic Enforcement Act of 1986.   Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm.  This list, which must be updated at least annually, has grown to include approximately 800 chemicals (e.g., lead, arsenic) since it was first published in 1987.  Proposition 65 also requires that businesses provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone in California to a listed chemical, unless the exposure is low enough to pose no significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm.  This warning may be given by a variety of means, such as labeling a consumer product.

The Office of Environmental Health Hazard Assessment (OEHHA), a part of the California Environmental Protection Agency, administers the Proposition 65 program.  As part of its duties, OEHHA has authority to adopt, amend, and repeal regulations related to the Proposition 65, including safe harbor levels for listed chemicals.

OEHHA presently is considering a number of significant changes to implementation of Proposition 65, including:

  1. Repeal or Amendment of the Safe Harbor Level for Lead

On July 3, 2015, OEHHA received an electronic copy of the “Petition by Center for Environmental Health for Administrative Rulemaking to repeal or amend Proposition 65 regulations pertaining to the Maximum Allowable Dose Level (MADL) for lead.”   Following review of the petition and related materials, OEHHA determined that it will initiate a rulemaking to update the existing MADL for lead set out in Title 27, Cal. Code of Regs., section 25805(b).  As a starting point for discussion, OEHHA has provided draft regulatory language and explanatory information for a possible new set of MADLs for lead.  [Note: These are pre-regulatory documents that could change substantially prior to the commencement of a formal rulemaking.  Additional opportunities for public comment will be provided during the formal rulemaking process.]  OEHHA has provided a Notice of Hearing on the petition.  The hearing will be held on October 14, 2015 from 10:00 a.m. to 12:00 noon in the Coastal Hearing Room at the CalEPA Headquarters building at 1001 I Street in Sacramento.

  1. Naturally-Occurring Background Levels for Certain Chemicals Found in Un-Processed Foods

OEHHA is considering adopting a regulation that would establish background levels for certain ubiquitous chemicals, such as lead, which are naturally present in unprocessed foods.  As a starting point for discussion, OEHHA has provided draft regulatory language and explanatory information for a possible new regulation.  [Note: These are pre-regulatory documents that could change substantially prior to the commencement of a formal rulemaking.  Additional opportunities for public comment will be provided during the formal rulemaking process.]  A workshop has been scheduled to be held on October 14, 2015 from 1:00 p.m. to 4:00 p.m. (i.e., the afternoon of the hearing on the preceding matter) in the Coastal Hearing Room at the CalEPA Headquarters building at 1001 I Street in Sacramento.

  1. Level of Exposure to Chemicals Causing Reproductive Toxicity

OEHHA is considering amending an existing regulation (i.e., Title 27, Cal. Code of Regs., section 25821(c)) to clarify that the reasonably anticipated rate of intake or exposure to a listed chemical must be calculated as the arithmetic mean of daily intake or exposure for product users.  As a starting point for discussion, OEHHA has provided draft regulatory language and explanatory information for the possible amendment.  [Note: These are pre-regulatory documents that could change substantially prior to the commencement of a formal rulemaking.  Additional opportunities for public comment will be provided during the formal rulemaking process.]  A workshop has been scheduled to be held on October 19, 2015, at 10:00 a.m. in the Auditorium in the Elihu Harris State Building at 1515 Clay Street in Oakland, California.

  1. Level of Exposure to Chemicals Causing Reproductive Toxicity (Measuring Concentrations of Chemicals in Products)

OEHHA is considering adopting amendments to an existing regulation (i.e., Title 27, Cal. Code of Regs., section 25821) concerning the calculation of the concentration of listed chemicals in foods.  Certain provisions of the existing regulations lack clarity.  In particular, subsection (a) of the regulation has been interpreted to allow for averaging of samples from various lots of products that were gathered over extended time periods and geographic areas.  This is contrary to the intent of the regulations and OEHHA has determined that clarification is necessary in order to ensure that the regulation furthers the purposes of Proposition 65.  As a starting point for discussion, OEHHA has provided draft regulatory language and explanatory information for a possible new regulation.  [Note: These are pre-regulatory documents that could change substantially prior to the commencement of a formal rulemaking.  Additional opportunities for public comment will be provided during the formal rulemaking process.]  A workshop has been scheduled to be held on October 19, 2015 from 1 p.m. to 4 p.m. (i.e., the afternoon of the workshop on the preceding matter) in the Auditorium at the Elihu Harris State Building at 1515 Clay Street in Oakland, California.

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The hearing and workshops are open to the public for those interested in these Proposition 65 matters.

 

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