CBI’s Risk Mitigation and
Compliance for Consumer Healthcare
Products Conference
October 14, 2015
Toledo Don LLP © 2015
Peg Carew Toledo
TOLEDO DON LLP
[email protected]
www.toledodon.com
Today’s Agenda
A.
Prop 65 Compliance Basics
B.
Hot Topics
Lead
2. The Proposed New Warning Regulations
1.
2
Proposition 65
“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 to such individual, except as
provided in Section 25249.10.”
Cal. Health & Safety Code § 25249.6.
3
To Whom Does Prop 65 Apply?
 Companies doing business in California
 If a product is sold to a California consumer, then it
must comply with Prop 65
 The only exceptions are:
 Companies with fewer than 10 employees
 Governmental units
 Anyone operating a public water system
4
What actions can you take
to help reduce the likelihood of
receiving a
notice of violation?
Elements of a
Prop 65 Compliance Program
1.
2.
3.
4.
5.
6.
7.
8.
Know Your Products
Know Maximum Theoretical Concentrations and
Typical Concentrations
Know Your Suppliers
Know How Your Products are Used
Conduct Formal Prop 65 Assessments
Track and Adapt to Enforcement Activity
Proactively Defend your Products
Defend Ingredient Listings
1. Know Your Products






Formula Ingredients
Ingredient Sources
Contaminants
Reaction By-Products
Suppliers
Product Packaging
IGNORANCE is not Bliss
2. Know Chemical Concentrations
 Intentionally Added Ingredients
 Formula Cards
 Raw Material Mixtures (Flavors, Perfumes, etc.)
 Contaminants
 Raw Material Specification Limits (Theoretical Max)
 Raw Material Analyses (Typical Levels)
 Product Analyses (confirmation or baseline)
3. Know Your Suppliers
 Ingredient Suppliers
 Where are they based and where does their supply stream
originate?
 What data are they willing to provide you?
 Have they ever heard of Prop 65?
 Finished Product Manufacturers
 Do they have a Prop 65 Compliance Program
 Will they certify their products as being Prop 65 Compliant?
 Will they indemnify you if their products are challenged?
4. Know How Your Products are
Used
Determine Consumer Usage
 Consumer Habits and Usage
 Published Studies and Models
 Primary Intended Exposure(s)
 Secondary Routes/Mechanisms for Exposure
 “Foreseeable” Misuse
Determine “Prop 65” Exposure
 Consider Consumer Use
 Consider Chemical Level in Product
5. Conduct Formal Prop 65 Product
Assessments
Assessment Principles
 Ensure that the person conducting the analysis knows
Prop 65 requirements and has the proper skills.
 Include a Prop 65 compliance assessment as part of the
regular process for approving each product for marketing
in the US.
 Maintain Prop 65 compliance assessments in documents
separate from other product compliance assessments.
5. Conduct Formal Prop 65 Product
Assessment (cont.)
Outline of Product Launch Assessment Process
 Determine NSRL and/or MADL.
 OEHHA has published some NSRLs and MADLs.
 Where not published, calculate using OEHHA Methods
 Request a Safe Use Determination?
 Compare Product Exposure to MADL/NSRL
 ABOVE: Provide Prop 65 Warning
 BELOW: No Prop 65 Warning Is Required
 Define the Margin of Compliance
 Determine how closely key raw materials and or
finished product requires monitoring.
6. Track and Adapt to
Enforcement Trends
TRACK
 Chemicals involved with enforcement activity
 Product categories with enforcement activity
 Settlements and Court Decisions
ADAPT
 Collect more Product Data?
 Reduce Contaminant Levels?
 Reformulate Product to Remove an Emerging
“Problem” ingredient?
7. Proactively Defend Your
Products
Use compliance assessment as basis for developing initial
response to a notice of violation.
 Evaluate the theoretical highest level case scenario –
If even this is below the NSRL or MADL, most plaintiffs will
lose interest fairly quickly.
 Be prepared to assess plaintiff methodology and references
Are analytical methods valid and accurately done?
Are exposure models relevant for this type of product and
this type of exposure?
8. Defend Ingredient Listings
 Monitor OEHHA for listing-related notices and
announcements
 Track activities of “authoritative bodies” which allow
for streamlined chemical listings
 Challenge proposed listings of chemicals important to
your business (directly and strategically)
Prop 65 Compliance Challenges
New Chemical Listings
Newly Published NSRLs and MADLs
Calculating MADLs and NSRLs for chemicals without
published values
Uncertainty and Variability of Enforcement Actions -When, What and from Whom?
Lead
 Trial Court Ruling (July 2013)
 Defense Victory



Federal Preemption – No
Naturally-Occurring – No
Exposure Below Maximum Allowable Dose Level (“MADL”) of
0.5 µg/day – Yes
 ELF v. Beech-Nut, 235 Cal. App. 4th 307 (2015)
 Defense Victory


Averaging across lots
Averaging lead exposure over time
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Lead
 Court Challenge to Lead MADL
 In January 2015, plaintiff Mateel Environmental
Justice Foundation sued OEHHA
 Challenging scientific and legal basis for 0.5
µg/day MADL for lead
 The action seeks to require Prop 65 warnings on
any consumer product with any detectible lead
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Lead
 Administrative Challenge to Lead MADL
 In July 2015, plaintiff Center for Environmental Health
filed a petition with OEHHA seeking the repeal or
amendment of the MADL for lead
 OEHHA has released its proposal to repeal the current
0.5 µg/day
 A hearing will be held today - October 14, 2015
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Proposed Changes To The
Warning Regulations
 Clear and Reasonable
Warnings
 New Website
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Proposed Changes to Product Warnings
Proposed Cancer Warning
WARNING This product
can expose you to a
chemical [or chemicals]
such as [name or names of
chemicals] that is [are]
known to the State of
California to cause cancer.
For more information go to
www.P65Warnings.ca.gov/
product.
Current Cancer Warning
WARNING: This product contains
a chemical known to the State of
California to cause cancer.
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1. Acrylamide
2. Arsenic
3. Benzene
4. Cadmium
5. Carbon Monoxide
6. Chlorinated Tris
7. Formaldehyde
8. Hexavalent Chromium
9. Lead
10. Mercury
11. Methylene Chloride
12. Phthalate[s]
Proposed 27 CCR § 25602
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Proposed Product Warnings
Alternative: On-Product Warning Label
WARNING
Cancer - www.P65Warnings.ca.gov/product
WARNING
Reproductive Harm - www.P65Warnings.ca.gov/product
WARNING
Cancer and Reproductive Harm www.P65Warnings.ca.gov/product
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Proposed Product Warnings
Alternative - On-Product Warning Label
 Must contain the symbol
 WARNING must be in all capital letters, in bold, no
smaller than 10-point type.
 “Cancer - www.P65Warnings.ca.gov/product” must be no
smaller than 8-point type
 The Dirty Dozen need not be mentioned!
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2 Years
If adopted, the new warning regulations will become
effective 2 years after the date of adoption.
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Peg Carew Toledo
Toledo Don LLP
[email protected]
www.toledodon.com
(916) 462-8951