Proposition 65 Update: Proposed Warnings, Website and other Woes ACC Environmental & Sustainability Legal Quick Hit Laura Duncan, Principal September 10, 2015 This presentation is not intended as, nor is it a substitute for, legal advice. You should consult with legal counsel for advice specific to your circumstances. This presentation may be considered lawyer advertising under applicable laws regarding electronic communications.
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Overview Proposed Amendments to Prop. 65 Warning Regulations OEHHA Proposition 65 Website Proposal Labor Code Listing Mechanism (final) Prospective Rulemaking on MADLs and Lead Newly Listed Chemicals & Prospective Listings 5
Proposed Amendments to Article 6 - Clear and Reasonable Warnings Revised Warning Content Revised Warning Methods Other Specific Warnings Assigned Responsibility Timing of revised proposal; adoption; effective date 6
Proposed: Product Exposure Warning Content WARNING: This product can expose you to a chemical [or chemicals] known to the State of California to cause [cancer] [birth defects or other reproductive harm]. For more information go to www.p65warnings.ca.gov/product. WARNING This product can expose you to chemicals such as [names of chemicals required to be listed] that are known to the State of California to cause cancer and birth or other reproductive harm. For more information, go to www.p65warnings.ca.gov/product. WARNING Cancer and Reproductive Harm -www.p65warnings.ca.gov/product. 7
Proposed: Identification of Certain Chemicals in Product Warnings Acrylamide Arsenic Benzene Cadmium Carbon monoxide Chlorinated Tris Formaldehyde Hexavalent Chromium Lead Mercury Methylene Chloride Phthalate[s] 8
Proposed: Product Warning Methods Label on the product. Product-specific shelf tag or sign at each display. Product-specific warning via an electronic device or automatic process that provides warning prior to or during purchase of the product, without requiring purchaser to seek out the warning. Internet purchases: clearly marked hyperlink on product display page or otherwise prominently displayed to purchaser before purchase. Catalog purchases: warning clearly associated with item. 9
Proposed: Assigned Responsibility for Product Warnings Primary responsibility for warnings is on product manufacturer, producer, packager, importer, or distributor. May convey warning by: affixing label; or, Providing written notice to retailer and receiving written acknowledgement from retailer (repeat each 180 days). Retailer responsible for initiating warning when: product sold under retailer brand or retailer caused/ specified chemical addition; retailer is also the importer, distributor, or packager; retailer received notice or obscured/altered warning; or, retailer has actual knowledge re exposure and parties primarily responsible are not subject to Proposition 65. Responsibility for warnings allocated by contract. 10
Proposed: Other Warning Specifications - Content & Method Food Alcoholic Beverages Restaurants Dental Care Prescription Drugs Raw Wood Products Furniture Products Diesel Engines (except passenger vehicles) Passenger Vehicles Enclosed Parking Facilities Amusement Parks Environmental Exposures (general + petroleum products, vehicle service stations, designated smoking areas) 11
Proposed: Lead Agency Website OEHHA website proposed by regulation Purpose: To provide more detailed information on chemicals and ways to reduce exposure Industry Implications: Provide information upon request when reasonably available 12
For proposed website: product manufacturer, producer, distributor or importer must provide the following information upon request when reasonably available Name and contact info reporting company and manufacturer Name of chemicals for which warning provided Location of chemicals in product or source and area for environmental warnings Concentration in final product or component part(s) Component or substrate containing the chemical Anticipated pathways / routes of exposure Estimated level of exposure 13
Lead Agency Website New draft proposal released 9/4/2015 Businesses must respond to OEHHA requests w/ in 90 days No information development Procedure for claiming trade secrets; not req d to submit privileged info Trade Assns may respond to requests directed to member companies 14
Regulations Clarifying the Labor Code Listing Mechanism (Background) 2014 Proposed regulations and three rounds of public comment January 2015 The Office of Administrative Law ( OAL ) disapproved the proposed regulation February 2015 OEHHA issued revised proposed regulations March 2015 Regulation modified for increased clarity and consistency with: Styrene Information and Research Center v. OEHHA Sierra Club v. Schwarzenegger 15
Labor Code Listing Mechanism: Adopted Regulation July 6, 2015, OAL approved Labor Code Listing Mechanism Regulation New Section: 27 CCR 25904 A chemical shall be listed under Proposition 65 if it is classified by the International Agency for Research on Cancer ( IARC ) in its Monographs or in its list of Agents Classified by the IARC Monographs as Group 1 or 2A, or 2B if there is sufficient evidence of carcinogenicity in experimental animals. Comments on proposed chemical listings limited to whether or not substance meets the requirements of Labor Code 6382(b)(1); no comments related to the underlying scientific basis for IARC s classification will be considered. The regulation goes into effect on October 1, 2015 A person may petition OEHHA to consider adding or removing a chemical from the list. 16
Lead MADL and Calculating Exposures to Reproductive Toxicants Mateel v. OEHHA no safe level of lead (Jan) ELF v. Beech-Nut appellate decision affirming successful defense (March) Averaging of exposures over time Geometric mean consumption/exposure Average levels calculated across lots CEH petition (July) Repeal or amend MADL for lead Issue regulation clarifying that MADL for lead is for single day exposure 17
OEHHA Response OEHHA released pre-regulatory discussion drafts to signal intent to Set different MADLs for lead depending on the frequency of exposure. Clarify OEHAA s intent that MADLs are set as the highest exposure that can occur in a single day. Clarify OEHHA s intent that the concentration of a listed chemical in food be determined based on single lot. Clarify OEHHA s intent that rate of intake or exposure be calculated as the arithmetic (not geometric) mean of rate of exposure. 18
Pre-Regulatory Workshops & Drafts Pre-regulatory draft amendment to 27 CCR 25821(a) to clarify that for reproductive toxicants, the concentration of a listed chemical in food must be determined based on single lot. Workshop on 10/19. Pre-regulatory draft amendment to 27 CCR 25821(c) to clarify that the reasonably anticipated rate of exposure to a reproductive toxicant must be calculated as arithmetic mean of daily intake or exposure for product users. Workshop on 10/19. Pre-regulatory draft amendment to 27 CCR 25805 to: (1) clarify that all existing MADLs are set for single day exposure; and (2) set new MADLs for lead, expressed in maximum exposures for different exposure frequencies. Public hearing on CEH petition on 10/14. Pre-regulatory draft 27 CCR 25501.1 to provide specific levels of lead and inorganic arsenic considered to be naturally occurring in certain foods 19
Several Recently Listed Chemicals DINP BPA Ethylene Glycol Warning requirements went into effect on December 20, 2014 NSRL of 146 micrograms per day proposed but not yet been formally adopted Safe Use Determinations requested for: Vinyl flooring Vinyl carpet tile Fabric in outdoor furniture PVC roofing products On May 11, 2015, OEHHA added Bisphenol A ( BPA ) to the list of chemicals known to the State of California to cause reproductive toxicity Warning requirements for BPA will take effect May 11, 2016 On June 19, 2015, OEHHA added Ethylene Glycol to the list of chemicals known to the State of California to cause reproductive toxicity Warning requirements for ethylene glycol (ingested) will take effect on June 19, 2016 Several others: Beta-Myrcene, CMNP, Teriparatide 20
Chemicals on the Horizon for Listing Styrene 1 Bromopropane Aloe Vera Whole Leaf Extract Goldenseal Sedaxane Furfuryl Alcohol Nickel Pentachlorophenol PFOA PFOS Tetrachloroethylene
Questions? Thank You! Laura Duncan Principal San Francisco Products Regulation and Litigation Lduncan@bdlaw.com 415-262-4003 22