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

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

Proposition 65

Regulation Overview

•  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

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

 

•  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

Evaluating Proposition 65 Exposures  

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?

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

Poll Question #2

Has your company completed a comprehensive Prop 65 exposure and compliance evaluation?

¢ Yes ¢ No ¢ Prop 65 does not apply

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

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

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

Proposition 65 New Warnings, Risk and

Challenges  

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.  

 

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.  

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?

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.

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

Proposition 65 Summary & Recommendations  

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

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

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

 

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