California Proposition 65
Can you afford not to label your products?
Scott Steady
UL Environment
[email protected]
770-933-0638
UL and the UL logo are trademarks of UL LLC © 2012
What is Proposition 65?
Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of
1986, was enacted as a ballot initiative in November 1986.
Proposition 65 required the Governor of California to publish a list of
chemicals that are “known to the State of California” to cause cancer,
birth defects or other reproductive harm.
The list is updated quarterly by the California’s Office of Environmental
Health Hazard Assessment (OEHHA)
- (http://www.oehha.ca.gov/prop65.html)
- there are ~900 chemicals on the list
Before knowing and intentional exposure of a person in CA to listed
chemicals, a business must provide “clear and reasonable warning”.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Enforcement by Litigation
Enforcement is carried out through civil lawsuits brought
by the California Attorney General, or by a district attorney
or city attorney
Primary enforcement is by private plaintiff’s attorneys
(~95% of cases)*
- Send written notice to public prosecutors and violator
- Wait 60 days to make sure no public prosecutor sues
Nearly 20,000 notices have been served since 1986*
In the past 5 years, settlements have totaled about
$75,000,000*
- Almost 90% of the settlement money goes to plaintiffs attorney
- Settlements typically require product reformulation and/or labeling
* Statistics compiled from http://oag.ca.gov/prop65
THIS PRESENTATION IS FOR
GENERAL INFORMATION
PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL
OR OTHER PROFESSIONAL
ADVICE.
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The Burden of Proof
The plaintiff only has to show “detectable exposure” to a listed chemical
and then the burden of proof is on the defendant.
Defendant must demonstrate that the level of
exposure is not significant.
Businesses that cause exposures greater
than the safe harbor level must provide Proposition 65 warnings.
OEHHA provides safe harbor levels for some listed chemicals.
It is the manufacturers responsibility to develop a safe harbor level if
none exists.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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How do you know if your products need a
warning label?
Proposition 65 applies only to exposures to listed chemicals. It does not
ban or restrict the use of any given chemical.
Use your knowledge of the materials and chemicals used in your
products.
Review the Proposition 65 list to determine if there are any listed
chemicals for which your products may be a source of exposure.
(http://oehha.ca.gov/prop65/getNSRLs.html)
Depending on the level of exposure, you may be required to provide a
warning.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Contact your Attorney!
If a notice is received, the client should contact their legal team. It is
recommended to seek advice from lawyers who specialize in CA Prop
65.
Even if you are proactively investigating risk for your products with
respect to Proposition 65, it may be best to conduct the work under the
direction of an attorney.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Essential Skills for Making a Proposition 65
Determination
Legal
Expertise
Determining anticipated levels of exposure
to listed chemicals can be very
complex. Because a business has the
burden of proving a warning is not
required, you should consider consulting a
qualified professional.
(from OEHHA website FAQs)
Toxicology
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
Chemical
Analysis
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Elements of a Proposition 65 Evaluation
1. Determine the potential listed chemicals that may be
associated with your product.
2. Conduct testing to measure the level of listed chemical in
your product or emitted from your product (leaching or offgassing).
3. Use the data to perform an exposure assessment using
conservative assumptions.
4. Develop a safe harbor level if one doesn’t exist, and compare
the exposure level to the safe harbor level.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Determining Chemicals of Concern
Review MSDS Sheets from all suppliers (and their suppliers when
possible)
Require supplier disclosure of Prop 65 chemicals
Identify settlement restrictions from past litigation
• Halloween costumes (Lead, Cadmium, Formaldehyde, Phthalates)
• Fashion Accessories (Lead)
• Electrical Cords (Lead)
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Identify Potential Exposure Routes
There are 3 primary routes of chemical
exposure:
• Ingestion (oral) – food, water, accidental
• Skin absorption (dermal) – clothing or
routinely handled objects
• Inhalation – gases (VOCs) or particles
All exposure routes may need to be considered
depending on how your product is used.
Different types of testing are recommended
depending on the routes of exposure for your
product.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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What tests need to be conducted?
The regulations provide no guidance on what test methods should be
used.
“Determinations must be based on evidence and standards of
comparable scientific validity to those that form the scientific basis for
the listing of the chemical.”
The test methods will depend on the chemicals suspected to be
present and the anticipated exposure route.
Chemical Content
Testing
Wipe Testing
Environmental Chamber
Testing
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Environmental Chamber Testing
Air Purification
and
Conditioning
Predicting Indoor
Exposure Levels
Environmental
Chamber Testing
Sample
Preparation
Analysis and
Reporting
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Environmental Chamber Guides

Clean air generation systems

Monitoring and control systems

Chamber performance

Sample collection and analysis equipment
•
ISO 16000-9 - Determination of the emission of volatile organic compounds from building products
•
ASTM D 5116-06 – Standard Guide for Small-Scale Environmental Chamber Determinations of
and furnishing — Emission test chamber method
Organic Emissions from Indoor Materials/Products
•
ASTM D 6670-01 – Standard Practice for Full-Scale Chamber Determination of Volatile Organic
Emissions from Indoor Materials/Products
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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VOC Measurement
 ASTM D 6196 / ISO 16000 Part 6
 Collect chamber air on Tenax Sorbent Media, thermally
desorb chemicals and analyze by GC/MS
 Applicable to the following listed compounds
100-41-4
106-46-7
108-88-3
110-80-5
Benzene, ethyl
Benzene, 1,4-dichloro
Toluene (Methylbenzene)
Ethanol, 2-ethoxy
111-15-9
Ethanol, 2-ethoxy-, acetate (Ethylene glycol monoethyl ether acetate)
123-91-1
127-18-4
149-57-5
71-43-2
79-01-6
872-50-4
91-20-3
96-18-4
100-40-3
1,4-Dioxane
Ethene, 1,1,2,2-tetrachloro (Tetrachloroethylene)
Hexanoic acid, 2-ethyl
Benzene
Ethene, 1,1,2-trichloro (Trichloroethylene)
2-Pyrrolidinone, 1-methyl
Naphthalene
Propane, 1,2,3-trichloro
Cyclohexene, 4-vinyl (4-Ethenylcyclohexene)
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Aldehyde Measurement
ASTM D 5197 / ISO 16000 Part 3
Collect chamber air on DNPH Cartridge, elute with
acetonitrile and analyze by HPLC
Applicable to formaldehyde and acetaldehyde
Particle Measurement
Applicable to titanium dioxide and other airborne particulate
that may contain listed chemicals
Captured on filters for further analysis
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Building Product and Furniture Test Methods
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Personal Exposure Studies
Perform activity in large chamber
Recreate “true consumer experience”
Measure concentrations in the breathing zone and/or in the rest of the room
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Predicting Exposure Concentrations
• Define the product use environment
- Room Volume
- Product loading (surface area, units)
- Ventilation (air changes per hour)
• Determine duration and
frequency of exposure
- Hours/day
- Days/year
- Product life (years)
• Compare the total exposure to the Safe Harbor Level
- Average daily lifetime exposure (over 70 years) for Carcinogens
- Maximum daily exposure for Reproductive Toxins
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Safe Harbor Levels
NSRL
• Carcinogen Safe Harbor Levels are termed No Significant Risk
Levels (NSRL).
• They are based on the most sensitive study meeting certain
requirements and calculations described in regulations for an
exposure level that results in 1 excess cancer in an exposed
human population of 100,000 over a 70-yr lifetime.
MADL
• Reproductive Toxin Safe Harbor Levels are termed Maximum
Allowable Dose Level (MADL).
• They are based on the most sensitive study meeting certain
requirements at a level that is 1,000 fold below the no observable
effect level (NOEL) of the study.
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Legal Review
Even if your product is shown to be under the safe harbor levels for any
chemicals of concern, manufacturers should consult their attorney
regarding the decision to label or not label their products!
THIS PRESENTATION IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT
INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.
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Questions?
For more information on UL Environment services related to
Proposition 65, please contact us at
ul.com/environment
888.485.4733
[email protected]
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Scott Steady Presentation - Chemical Fabrics and Film Association