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BlueScape & Dentons New Prop 65 Warning Requirements Webinar 011717

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This webinar by James Westbrook and Robert Kuykendall of BlueScape, and Chuck Pomeroy of Dentons Law Firm, provides an overview of California Proposition 65 (Prop 65) regulation requirements, how to conduct a Prop 65 exposure evaluation to determine whether to provide safe harbor warnings, and discusses the challenges to meeting the new warning requirements provided in Article 6.

James Westbrook and Bob Kuykendall at BlueScape can be reached at training@bluescapeinc.com or 877-486-9257. Chuck Pomeroy at Dentons can be reached at charles.pomeroy@dentons.com or 213-243-6256. Please contact us for questions and support for conducting Prop 65 exposure evaluations, and for the procedures to develop or change Prop 65 warning labels.

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BlueScape & Dentons New Prop 65 Warning Requirements Webinar 011717

  1. 1. New Proposition 65 Warning Requirements To Warn or Not to Warn? January 17, 2017 Dentons & BlueScape training@bluescapeinc.com 877-486-9257 charles.pomeroy@dentons.com 213-243-6256
  2. 2. Prop 65 Webinar Topics Overview of Proposition 65 Requirements Evaluating Prop 65 Exposures New Prop 65 Warnings, Risk and Challenges Summary / Recommendations for your Prop 65 Compliance Program
  3. 3. Proposition 65 Regulation Overview
  4. 4. •  Safe Drinking Water and Toxics Enforcement Act of 1986 •  Statute: H&S Code 25249.5 – 25249.13 •  Regulations: CCR Title 27, Division 4, Sec 25102 - 27001 •  List of Chemicals known to the State of CA to cause: –  Cancer –  Reproductive toxicity •  Prohibition on Contaminating Drinking Water (25249.5) •  Required Warning before Exposure (25249.6) –  No person in course of doing business (10 or more employees) –  Shall knowingly and intentionally expose any individual –  First giving clear and reasonable warning to such individual –  Except, exposure poses no significant risk (25249.10) •  The “Safe Harbor” concept •  Civil penalty: $2,500/day per violation; >$1MM per year Prop 65 Regulation Summary
  5. 5. Poll Question #1 Who can bring Prop 65 enforcement action? ¢ OEHHA ¢ Person in the public interest ¢ CA Dept of Toxic Substances Control ¢ CA Attorney General, city attorney or prosecutor ¢ All of the above  
  6. 6. •  Article 6, Clear & Reasonable Warnings – adopted August 30, 2016 (Title 27 CCR &S 25600-25607.31) •  Changes made to: –  Definitions •  Added terms for "authorized agent", "consumer information" and "retail seller" •  Other terms modified ("environmental exposure", "sign") –  Responsibility for warnings •  Added new mechanism to make retailers more responsible –  "Safe Harbor" methods of transmission and content •  Greater detail on the warning's form •  Chemical and process specificity –  "Safe Harbor" for specific products, chemicals and areas •  Expanded specifics from 1 to 16! •  Operative on August 30, 2018 –  Can opt to follow the “current” regulation (as of Aug. 30, 2016) until then. Summary of Prop 65 Warning Requirement Changes
  7. 7. Evaluating Proposition 65 Exposures  
  8. 8. Prop 65 Exposures •  Consumer Products –  Manufactured Intermediates –  Retail –  Specific Products, Chemical and Area •  Environmental –  Air –  Spill to surface waters •  Occupational –  On-site employees –  Visitors and contractors •  Food, Alcoholic Beverages, Non-Alcoholic Beverage, Prescription Drugs, Diesel Engine Exhaust, etc. •  How do you evaluate Prop 65 exposures and compliance?
  9. 9. Prop 65 Exposure Evaluation Steps •  Step 1: Identify Prop-65 listed chemicals –  Carcinogens –  Reproductive toxicants •  Step 2: Determine exposure type – product, occupational, environmental, etc. •  Step 3: Evaluate individual exposures –  Review OEHHA list of numerical “Safe Harbor Levels” for exposures that provide risk-based guidance –  300 numerical levels established – inhalation, ingestion and dermal •  No Significant Risk Levels (NSRLs) for carcinogens, and Maximum Allowable Dose Levels (MADLs) for reproductive toxicants •  A MADL is 1/1000 NOEL (No Observable Effect Level) –  Product testing, workplace ambient monitoring, off-site dispersion modeling –  Use monitoring results to perform specific risk assessments –  If no Safe Harbor Levels for a chemical, a significant amount of chemical exposure is interpreted broadly as any detectable amount –  Consult with qualified toxicologists •  Step 4: Warn or Not Warn –  Above NSRL or MADLs, should warn –  Workplace warnings typically conducted by HAZCOM training and clear signage
  10. 10. Poll Question #2 Has your company completed a comprehensive Prop 65 exposure and compliance evaluation? ¢ Yes ¢ No ¢ Prop 65 does not apply
  11. 11. Prop 65 Exposure Evaluation Consumer Products – Manufacturing and Retail •  Gain greater understanding of suppliers, raw materials and intermediate chemicals used •  Review their chemical technical information included Safety Data Sheets for Prop 65-listed chemicals •  Review your manufacturing processes and end products (including packaging) to determine if Prop 65-listed chemicals are present and cause exposure •  Conduct appropriate consumer product testing prior to product release to market •  Evaluate alternative raw materials, chemical intermediates or even use of different suppliers to reduce potential levels of Prop 65-listed chemicals in consumer products •  Ensure Prop 65 consumer product warnings are commensurate with exposure risks •  Update product labeling with new warning format
  12. 12. Prop 65 Exposure Evaluation Occupational Exposure – Prop 65 Compliance Evaluation •  Conduct inventory (types-quantities) of all chemicals used, stored, handled •  Review HAZCOM documents for existing warnings •  Review each chemical’s SDS, manufacturer’s technical bulletins, & other chemical product hazard info sources •  Identify work areas and non-work area (conference rooms) •  Review worker chemical use practices – process equipment, containers, handling methods •  Understand facility HVAC system operations & impacts to non-work areas •  Conduct appropriate ambient and/or work place exposure monitoring – e.g. TO15 VOCs •  Review exposure monitoring results for risk exposure limits - NSRLs, MADLs – safe harbor levels •  If feasible, identify potential methods to reduce occupational exposures •  Update HAZCOM program with updated revised Prop 65 warnings •  Update employee training
  13. 13. Prop 65 Exposure Evaluation Environmental Exposures •  Review current Prop 65 warnings for facility at entrances •  Conduct inventory (types-quantities) of all chemicals used, stored, handled •  Walk around the facility & adjacent properties – notice odors, potential emission points & exterior activities •  Review potential emission sources in facility and emission points from facility •  Develop list of chemicals for emission risk modeling, or •  Conduct ambient exposure monitoring or dispersion modeling – TO15 VOCs •  Review exposure monitoring or modeling results for risk exposure limits - NSRLs, MADLs, safe harbor levels •  Evaluate potential methods to reduce environmental exposures •  Update Prop 65 exposure warnings as needed
  14. 14. Proposition 65 New Warnings, Risk and Challenges  
  15. 15. New Prop 65 Warnings Before: New: Environmental  exposure  example   –  Sec.  25605(a)(1)-­‐(3)                          WARNING:       Entering  this  area  can  expose  you   to  chemicals  known  to  the  State   of  California  to  cause  cancer  and   birth  defects  or  other   reproducBve  harm,  including   hexavalent  chromium  from   grinding  and  coaBng  operaBons.   For  more  informaBon  go  to   www.P65Warnings.ca.gov.    
  16. 16. Prop 65 Changes – Clear & Reasonable Warnings OEHHA has stated that the new warnings:1 •  Are more meaningful to the public •  Reduce over-warning •  Resolve conflict between manufacturer and retailer responsibilities •  Provide more product/place specific warnings •  Update methods to take into account technology advances •  Provide increased clarity regarding compliance – the how and where Actually, they are more complicated! 1From  “Clear  and  Reasonable  Warnings”  presented  at  the  2016  Environmental  Law  Conference  at  Yosemite   by  Carol  Monahan  Cummings,  Chief  Counsel,  OEHHA,  October  6,  2016,  State  Bar  AssociaKon  of  California.  
  17. 17. Ambiguity, Risks and Other Challenges •  Section 25600.2 identifies a new mechanism allowing manufacturers to pass warning responsibility to retailers through a written notice to the authorized agent •  Includes all necessary warning materials, along with specific product identification and confirmed receipt of notice •  Notice (and its confirmation) provided initially, then after six months, then once per year •  New chemicals and end points trigger another notice •  Retailer is also responsible for warning if manufacturer isn't "a person in the course of doing business" AND doesn't have in CA an agent for service of process or a place of business •  What if retailer is exempt too? •  What if manufacturer has no agent for service of process but is otherwise subject to Prop 65? •  How is the authorized agent determined and designated?
  18. 18. Ambiguity, Risks and Other Challenges - con'd •  Section 25600.2(i) creates a mechanism allowing the manufacturer, importer, distributor, etc., to enter into an agreement with the retailer to allocate legal responsibility among the parties that supersedes other provisions in 25600.2, but only if the consumer receives a compliant warning before exposure •  What's the value of shifting liability if compliance has to always exist? The regulation should address changed circumstances •  A retailer's "actual knowledge" can include receiving notice under 25249.7(d)(1) (enforcement notice). •  If this is retailer's first actual knowledge, it does not occur until five business days after receipt •  Five day window allows an opportunity to cure without saying it.
  19. 19. Recommendations •  Do a Prop 65 “audit” and know the risks •  Conduct Exposure Evaluation – Warn or not Warn •  Manage and reduce exposures, communication •  Understand new Prop 65 warning complexity –  Especially product manufacturers and retailers –  Manage your Safe Harbor, risk, potential liability •  Review current warnings, plan to change –  Don’t lose your Safe Harbor! –  2017 is the change over period •  Prepare for a “compliance” lawsuit
  20. 20. Proposition 65 Summary & Recommendations  
  21. 21. Summary & Recommendations •  Do a Prop 65 “audit” and know your risks •  Conduct Exposure Evaluation – Warn or not Warn? •  Manage and reduce exposures as needed •  Understand new Prop 65 warning complexity –  Especially product manufacturers and retailers –  Manage your Safe Harbor, risk, potential liability •  Review current warnings, plan to change –  Don’t lose your Safe Harbor! –  1.5 years for the change over period •  Prepare for a “compliance” lawsuit
  22. 22. Questions Contact Information Chuck Pomeroy, Dentons 213-243-6256 charles.pomeroy@dentons.com James Westbrook, Bob Kuykendall, BlueScape 877-486-9257 training@bluescapeinc.com www.bluescapeinc.com Connect with me on Linkedin! The webinar presentation will be posted on Slideshare and YouTube
  23. 23. About Dentons •  Chuck practices environmental regulatory and OSHA compliance, transactional counseling and administrative law, with particular emphasis on California's unique regulatory systems, like Prop 65. •  Chuck’s practice routinely addresses many related areas, including real estate, insurance, OSHA regulations and tax. •  Chuck currently advises and represents manufacturing and service companies, including metal finishers, in all aspects of environmental laws and regulations. •  Chuck has a Masters of Science degree in Environmental and Occupational Health and is a former California Registered Environmental Health Specialist and Registered Environmental Assessor.   Charles H. Pomeroy D +1 213 243 6256 E charles.pomeroy@dentons.com Dentons US LLP     601 South Figueroa Street, 25th Floor Los Angeles, CA 90017-5704 大成 Salans FMC SNR Denton McKenna Long  
  24. 24. Key Offices and associate officesx Associate firms and special alliances* Kansas City Edmonton CalgaryVancouver Phoenix Dallas Atlanta New York Short Hills Washington, DC St. Louis Chicago London Milton Keynes Madrid Barcelona Paris Brussels Berlin St. Petersburg Moscow Kyiv Warsaw Istanbul Prague Bratislava Budapest Frankfurt BucharestZürich Baku Ashgabat Tashkent Almaty Algiers Tripoli Nouakchott Praia Bissau Accra São Tomé Luanda Cape Town Maputo Port Louis Lusaka Nairobi Kampala Kigali Beirut Cairo Muscat Dubai Doha Abu Dhabi Singapore Hong Kong Beijing Shanghai New Orleans Miami Boston Amman Riyadh Lagos Tbilisi Krasnodar Rostov on Don Astana Houston Casablanca Minsk Johannesburg Tysons San Francisco Silicon Valley Los Angeles Toronto Montreal Ottawa Orange County San Diego Albany Denver Seoul 24 Dentons US LLP We’ve Got You Covered October 7, 2015
  25. 25. About BlueScape •  Founded in 1997 •  Extensive experience with Environmental, Health & Safety Regulations –  Air Quality, Prop 65, Spill Prevention, Storm Water, Chemical Risk Management, Hazardous Waste Management, Environmental Management Systems –  See www.bluescapeinc.com •  Wide Range of Industries Served –  Chemical plants, power plants, data centers, building materials, aerospace, refineries, coating manufacturing, industrial gas, and oil & gas processing •  BlueScape Technical Services - Solve tough EHS permit and compliance issues: -  Develop permit and compliance strategies, quickly obtain permits -  Technical analysis tools -  Leverage agency relationships, lead negotiations -  Compliance, enforcement and variance support •  BlueScape EHS – EMS and managed compliance services •  Move business forward, reduce business risk  

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