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.
Fuel Cells and Hydrogen in Transportation - An Introduction
BlueScape & Dentons New Prop 65 Warning Requirements Webinar 011717
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. 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
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. 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. • 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
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. 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. Poll Question #2
Has your company completed a comprehensive
Prop 65 exposure and compliance evaluation?
¢ Yes
¢ No
¢ Prop 65 does not apply
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. 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. 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
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. 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. 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. 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. 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
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. 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. 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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Dentons US LLP
We’ve Got You Covered
October 7, 2015
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