Flame Retardants and California Proposition 65 · The overlying principle in toxicology is that the dose makes the poison. ... enforce the Act ... Slide 1 Author: Candice

© - Copyright Bureau Veritas

Flame Retardants and California Proposition 65:

An Overview and Update on Enforcement Trends and

Settlements

Alison Tuzzolino

Bureau Veritas Consumer Products Services

September 22, 2016

2 Bureau Veritas Presentation: September 2016 © - Copyright Bureau Veritas

► Proposition 65 Overview

► Enforcement trends

► Questions & Answers

Agenda


CA Proposition 65 Overview


► 1986 ballot initiative adopted by California voters

► Requires the Governor to publish a list of chemicals that are known to the State of California to cause cancer, birth defects or other reproductive harm

► These chemicals are categorized by the California Office of Environmental Health Hazard Assessment (OEHHA)

► List must be updated at least once a year

► As of August over 800 chemicals have been listed

Proposition 65 - Origins


Proposition 65 Requirements

► Only requires warnings:

“No person in the course of doing business shall knowingly and intentionally

expose any individual to a chemical known to the state to cause cancer or

reproductive toxicity without first giving clear and reasonable warning . . .”

► Warnings are intended to:

• Protect California's drinking water sources from chemical contamination,

• Allow California consumers to make informed choices about the products they purchase, and

• Enable residents or workers to take whatever action they deem appropriate to protect themselves from exposures to harmful chemicals.

► Warnings are required when:

• Exposure limits, in the form of human daily intake levels that apply to chemicals that appear on this list, are exceeded.


Toxicology

► Toxicology is the study of the effects of chemicals on living organisms. Through the study of chemicals, their properties and effects, they can be classified according to their hazard.

► The overlying principle in toxicology is that the dose makes the poison.

Steps of a toxicological risk assessment:

• Starts with product formulation

• Determine exposure

• Calculate maximum exposure


What are Safe Harbor Levels?

► Acceptable levels of chemical exposure that do not require a Prop 65 warning.

► For carcinogens, the safe harbor levels are called No Significant Risk Levels (NSRL).

► For reproductive toxins, the safe harbor levels are called Maximum Acceptable Dose Levels (MADL).

► Safe harbor levels have not been established for all listed chemicals.

• Carcinogens – ~500 chemicals as of August 2016 • No Significant Risk Levels (NSRL) – ~260 compounds

• Reproductive Toxins – ~300 chemicals as of August 2016 • Maximum Acceptable Dose Levels (MADL) - 45 compounds


Responsibilities

Enforcer Defendant

• Prove “contact” with the

chemical

• Easy to prove

• Prove no significant risk

• Quantify exposure

Difficult to prove

Many chemicals have no exposure levels set by the state

Exposure levels are often extremely low

Exposure level must be translated to chemical content of product


Enforcement

► No regulatory agency oversight

• OEHHA lists chemicals and identifies exposure levels, but does not enforce the Act

► Enforcement is by lawsuit

► Attorney General or DA can file enforcement action without notice

► Any private person may sue if no prosecutor takes the case within 60 days of notice of violation


Potential Costs of Litigation

► In 2015 the Total Settlement Payments were $26,266,261

► Settlements range from $8,750 to over $300,000

► Total number of settlements in 2015 was 583

► Average cost per settlement including attorney fees was $45,000


Settlement Overview

► Settlements – 60 Day Notices

60 Day Notice

• Private enforcers must file

• Issued prior to legal action

• Identifies chemicals

• Identifies products

Settlement Finalized

Settlement Requirements


► Settlements – Finalized Settlements

60 Day Notice Settlement Finalized

• Filed at Court

• Names Defendants

• States Chemical(s) and Product(s) Covered

• List Requirements and Penalties


Settlement Overview


► Settlements – Reformulation Requirements

60 Day Notice

Settlement Finalized


• Warnings

• Visible

• “Warning”

• Known to the state of California

• Chemical

• Cancer / reproductive harm

• Other

• Reformulation

• Typically given as ppm requirement

• Sometimes prohibits labeling

• Can have deadlines

Settlement Overview


• Ceramics

• Brass

• PVC/Vinyl

• Lead

• Phthalates (6)

• Cadmium

• Flame retardants

• Children’s products

• Household Items

• Jewelry

Frequent Enforcement Targets

Chemicals Materials Products


How Can You Comply with Prop 65?

► Test for specific products to prior Prop 65

product litigation; or

► Require a certified toxicologist review the

product to determine if an exposure

exceeding safe harbor limits exists; or

► Label with the appropriate Prop 65 warning

statement

WARNING: This product contains lead, a chemical known to the State of

California to cause birth defects and other reproductive harm.

WARNING: The solder in this product contains a chemical known to the

State of California to cause birth defects or other reproductive harm.

Wash hands after handling.


60 Day Notices Issued for Q2 2016


Chemicals Targeted – Q2 2016


Flame Retardant Settlements


• Tris (1,3-dichloro-2-propyl) phosphate - TDCPP

• Tris (2-chloroethyl) phosphate - TCEP

• Tris (1-chloro-2-propyl) phosphate - TCPP

Proposition 65 - Lawsuits & Settlements

Flame retardants currently targeted

Products targeted

• Polyurethane foam

• Upholstered furniture

• Car seats

• Cushions

• Tent/shelter fabric

• Children’s play tents

• Tents (camping)


Settlement Example

► Injunctive Relief (example)

Detectable – containing more than 25 parts per million (“ppm”) (the equivalent of

0.0025%) of each TDCPP, TCEP, and/or TDBPP in any material, component or

constituent of a subject product when analyzed pursuant to EPA testing

methodologies 3545 and 8270C, or equivalent methodologies utilized by federal or

state agencies to determine the presence and measure the quantity in a solid

substance.

Reformulated Products – any product containing no detectable amount of each

TDCPP, TDBPP, or TCEP.

► Interpretation (example)

Each component of the identified product is tested for the listed flame retardants.

If all of the results are less than 25 ppm than no warning label is required.

If any of the components have a result equal to or greater than 25 ppm then the

product requires a warning label.


Additional Resources

► Office of Environmental Health Hazard Assessment (Prop 65 Summary) – http://www.oehha.ca.gov/prop65/background/p65plain.html

► Office of Environmental Health Hazard Assessment (Background Info) – http://www.oehha.ca.gov/prop65/background/index.html

► Chemical Listings and Legal News on Prop 65 – http://www.prop65clearinghouse.com

► California Attorney General – http://ag.ca.gov/prop65

http://www.oehha.ca.gov/prop65/background/p65plain.html

http://www.oehha.ca.gov/prop65/background/index.html

http://www.prop65clearinghouse.com/



http://ag.ca.gov/prop65


Contact Information

For more information, you can reach me at the following:

Alison Tuzzolino

(716) 505-3434

[email protected]

mailto:[email protected]



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Flame Retardants and California Proposition 65 · The overlying principle in toxicology is that the dose makes the poison. ... enforce the Act ... Slide 1 Author: Candice