California Proposition 65:
An Introduction to Requirements
& Compliance Strategies
A White Paper from Bureau Veritas Consumer Products Services
Prepared by Matthew Nudell, Global Consulting Specialist – October 2011
© 2011 Bureau Veritas Consumer Products Services, Inc.
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Contents
Introduction .............................................................................................................. 4
Overview ................................................................................................................... 5
Enforcement ............................................................................................................. 6
Compliance Strategies ............................................................................................. 8
Summary ................................................................................................................. 11
Additional Resources.............................................................................................. 11
About this White Paper ......................................................................................... 12
About the Author.................................................................................................... 13
A White Paper from Bureau Veritas Consumer Products Services
3
Introduction
Proposition 65 is a California law passed by direct voter initiative in 1986. Known as The
Safe Drinking Water and Toxic Enforcement Act of 1986, it prohibits the contamination
of drinking water with chemicals known to the State of California to cause cancer or
reproductive toxicity and it requires companies to provide a warning prior to knowingly
exposing a person to such chemicals.
The warning requirement of the law applies to companies that have ten or more
employees and that operate in California, including those that manufacture, distribute,
or sell consumer products in the state. It requires these companies to warn individuals
prior to exposure to chemicals known to the State of California to cause cancer or
reproductive toxicity. Companies must warn workers or the community when they
expose them to these chemicals, or when a product would expose consumers.
Landlords must also warn tenants when renovations and other construction results in
chemical exposure.
The law has had a large impact on companies that make, distribute or sell consumer
products in California. This white paper provides an overview of the law, trends in
enforcement, and potential strategies companies in the consumer products industry
can use to address the law.
4
California Proposition 65
Overview of Proposition 65
Proposition 65 is essentially a right-to-know law. It gives Californians the opportunity to
make informed decisions about exposure to chemicals that the state has identified as
cancer-causing or reproductive toxicants. By requiring companies to warn Californians prior
to exposure, consumers can take appropriate action, such as not purchasing a product.
Under the law, the governor of California is required to publish a list of chemicals
that are known to the state to cause cancer or reproductive toxicity. This list, which
is available on the website of the California Office of Environmental Health Hazard
Assessment, must be updated every year, and currently contains over 800 chemicals.
Proposition 65 does not ban listed chemicals or even limit their use, although they may
be banned by other laws or regulations. Proposition 65 only requires that companies
provide warnings to consumers when a product exposes them to a Proposition 65
chemical in excess of limits determined by California’s Office of Environmental Health
Hazard Assessment, or federal agencies such as the Food and Drug Administration or
the Environmental Protection Agency.
Limits established under Proposition 65, commonly referred to as “safe harbor levels,” are
expressed in terms of micrograms of exposure per day. For carcinogens, the safe harbor
level is equal to the “no significant risk level” (NSRL), which is defined as the level that
does not result in more than one excess case of cancer in 100,000 individuals exposed
over 70 years. For reproductive toxicants, the safe harbor level is equal to 1000 times
less than the “no observable effect level” (NOEL), which is defined as the level that will
not produce birth defects or other reproductive harm. NOEL and NSRL levels have been
defined for many of the chemicals on the Proposition 65 list, but a significant number of
them do not have an established NOEL or NSRL. Without an established NOEL and NSRL
for a chemical, it is not possible to calculate its safe harbor level. Since companies must
ensure that exposure to a chemical is below safe harbor levels they are responsible for
determining the NOEL and NSRL levels when they have not been established.
Proposition 65 requires companies to provide clear and reasonable warnings if in the
course of doing business they knowingly and intentionally expose individuals to chemicals
identified by the State of California as causing cancer or reproductive toxicity. In other
words, if a product exposes a consumer to amounts of a Proposition 65 chemical greater
than its safe harbor level, then a Proposition 65 warning must be provided.
Violators of Proposition 65 can face fines of up to $2,500 per violation, per day, for each
product sold in California.
A White Paper from Bureau Veritas Consumer Products Services
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Enforcement
Companies in violation of Proposition 65 may be subject to immediate legal action. This
can be initiated by the attorney general of the State of California, any district attorney in
California, and city attorneys of a Californian city having a population in excess of 750,000.
Proposition 65 is unique in that it also allows private parties acting in the public
interest to bring legal action against violators. As a result, private individuals, lawyers,
environmental organizations, and other non-governmental organizations (NGOs) can
also enforce Proposition 65. Prior to bringing an enforcement action, the private party
must provide notice of the alleged violation to the attorney general, the appropriate
district attorney and city attorney, and the business accused of the violation. These
notices are known as 60-day notices because state and city attorneys have 60 days to
decide if they will initiate their own lawsuit. If no action is taken by public attorneys,
then a private enforcer may take legal action. While a 60-day notice must be issued
prior to legal action by private enforcers, a notice does not guarantee that a settlement
will be reached.
Once legal action is taken, companies must either prove that they did not provide
exposure in excess of safe harbor levels or negotiate a settlement agreement with the
enforcer. Settlements often require a company to pay fines, which the enforcer may
receive a portion of, as well as the enforcer’s legal fees. The fact that an enforcer can
collect fines and legal fees can provide a financial incentive to private Proposition 65
enforcers.
Enforcement of Proposition 65 has been extremely active and more than 100 separate
settlements have been reached every year except for one year over the past decade.
Monetary awards can range from a few thousand dollars to over $100,000 with the
average being between $50,000 and $100,000. On the following page is a summary
of the number and total amount of settlement payments made every year for the past
10 years.
6
California Proposition 65
Yearly Summary of Private Settlements
Year
Number of
Settlements
Total Settlement
2010
187
$13,620,981
2009
321
$14,608,178
2008
199
$24,537,330
2007
156
$11,846,737
2006
98
$13,613,065
2005
148
$10,252,438
2004
101
$15,367,638
2003
137
$8,482,194
2002
166
$8,067,345
2001
223
$10,962,134
(Source: Information compiled from annual Proposition 65 Settlement Executive
Summaries, Attorney General of California, http://ag.ca.gov/prop65/index.php )
A White Paper from Bureau Veritas Consumer Products Services
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Compliance Strategies
Consumer product companies can take several different approaches to address the
requirements of Proposition 65. The following section outlines some of the strategies
that companies can attempt to implement in an effort to reduce the risk of noncompliance.
Full Testing
The most straightforward strategy is to test every component of a product for all
chemicals on the Proposition 65 list. This approach presents some challenges.
One issue with full testing is that safe harbor levels have not been established for all
chemicals listed under Proposition 65. When they are established, they are expressed
in terms of micrograms per day of exposure. Analytical testing alone can only determine
the amount of the chemical in a component, not the amount of the chemical that
someone will be exposed to on a daily basis. It is possible, through toxicological risk
assessment, to determine the daily exposure, given the amount of a chemical present.
A toxicological risk assessment (TRA) is conducted by certified toxicologists who
analyze a number of factors such as how the product will be used, potential routes of
exposure, expected lifetime of a product, and the amount of the chemical in a product.
Toxicological risk assessment is highly dependent on the formulation of a product;
therefore, it only applies to the particular product formulation under review. As a result,
if the formulation of the product is altered, such as a change in material of a product, or
a design change causes an inaccessible component to become accessible, then a new
toxicological risk assessment may need to be conducted.
Other challenges with full testing include testing costs and the availability of appropriate
standard analytical test methods. Testing for all listed chemicals in every component
and conducting a TRA on every formulation of every product is expensive. Considering
that some companies have hundreds or thousands of products, the expense of this
strategy can quickly become cost prohibitive. Even if cost was not an issue, an analytical
test method that can determine the amount of a chemical in a material may not be
available. While a wide range of analytical testing methods that can determine the
amount of a particular chemical in a particular material exist, one does not exist for every
chemical in every material.
8
California Proposition 65
Targeted Testing
A second, related approach to full testing would be for a company to target their
testing to particular Proposition 65 chemicals in components. Rather than testing every
component of a product for all Proposition 65 chemicals, targeted testing focuses on
certain substances likely to be found in high-risk components of a product. Testing
components for only a handful of Proposition 65 chemicals is less costly than testing
for over 800 chemicals. Nevertheless, this approach still requires a toxicological risk
assessment for every formulation of every product. It also relies on the ability of the
company to accurately assess the substances likely to be found in high-risk components.
Vendor Agreements
An alternate approach to product testing is to place responsibility for Proposition 65
compliance on vendors through the use of vendor agreements. Such agreements
obligate a vendor to supply products that would not trigger the warning label
requirement of Proposition 65. However, in many cases vendors may not be aware of
Proposition 65 limits for chemicals, or whether their products contain listed chemicals.
As a result, vendors could sign an agreement without understanding how to meet
its terms. Ultimately this could result in vendors supplying non-compliant products or
vendors attempting full Proposition 65 testing only to find out that it is cost prohibitive
and the standard test methods needed are not available. Vendors that do understand
the implications of such an agreement may refuse to enter in to it.
Labeling
Another approach that does not involve testing is providing Proposition 65 warnings for
every product sold in California either by ensuring that every product has a Proposition
65 warning label that is visible prior to purchasing the item, or by putting up Proposition
65 warning signs throughout a store. Labeling all products can cause issues if products
are also sold in other states. While California consumers are familiar with the Proposition
65 warning labels, people in other states are not, and they may become alarmed when
they see a product with a label that says it contains a chemical that causes cancer
or reproductive harm. Putting signs up in stores requires store employees who may
not be familiar with Proposition 65 warning requirements to make sure that they are
appropriately displayed and maintained.
A White Paper from Bureau Veritas Consumer Products Services
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Settlements
Companies may also elect to follow limits established by existing Proposition 65
settlements. These agreements generally involve specific Proposition 65 chemicals
in particular products and they establish limits that can be measured directly through
analytical chemistry.
Because settlements only exist for certain chemicals in certain products, this strategy
results in focused testing that limits costs in comparison to other testing approaches.
This approach also avoids the need for toxicological risk assessments.
Of course, this strategy only works when a relevant settlement already exists. While
settlements involving specific chemicals in a wide range of products have been
established, many products and chemicals have not been the subject of litigation. It is
important to note, however, that once a settlement is reached, it essentially establishes
a precedent, which increases the likelihood that similar settlements will be pursued
in the future. As a result, following the requirements of existing settlements has the
added benefit of targeting chemicals and products that are more likely to be involved
in future legal action.
It should be stressed that, technically, only those companies named in a particular
Proposition 65 settlement must comply with it, and following the limits of a settlement
does not guarantee that a product is in compliance with Proposition 65 requirements.
Rather, this strategy seeks to reduce the risk of being targeted by Proposition 65
enforcers and of being involved in future similar settlements.
10
California Proposition 65
Summary
This white paper has provided a general overview of Proposition 65 and its requirements.
It has also reviewed several different strategies for reducing the risk of non-compliance
and being targeted by enforcers. Understanding the requirements of Proposition 65
and the possible approaches to dealing with the law are first steps toward managing
compliance risks. Bureau Veritas Consumer Products Services can assist you in
all aspects of establishing a Proposition 65 approach. For more information on
these services or to subscribe for complimentary regulatory updates, please visit us at
www.bureauveritas.com/chemical.
Additional Resources
State of California Department of Justice, Office of the Attorney General
http://ag.ca.gov/prop65/index.php
California Office of Environmental Health Hazard Assessment
http://oehha.ca.gov/prop65.html
Current list of Proposition 65 chemicals
http://oehha.ca.gov/prop65/prop65_list/files/p65single090211.pdf
Safe Drinking Water and Toxic Enforcement Act of 1986
(Chapter 6.6 added by Proposition 65 1986 General Election)
http://oehha.ca.gov/prop65/law/pdf_zip/P65LAW72003.pdf
A White Paper from Bureau Veritas Consumer Products Services
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About this White Paper
This white paper is published by the Information Resources Center of Bureau Veritas
Consumer Products Services. For over 15 years, our Information Resources Center
has worked successfully with top companies around the world to help them better
understand the consumer market and regulatory environment. With access to a print
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To learn more about how our Information Resources Center can help you, please visit
us at: www.bureauveritas.com/knowledge or call us for a complimentary consultation
at 1-716-505-3591.
12
California Proposition 65
About the Author
As a Global Consulting Specialist with the Analytical Technical Services Team, Matthew
Nudell is the lead technical consultant for Bureau Veritas Consumer Products Services
on California Proposition 65 in North America. His primary responsibilities include
providing global support to internal staff and clients on analytical technical issues
related to California Proposition 65 and other US legislation. This includes monitoring
analytical regulatory trends and events in the Americas as well as authoring internal and
external communications related to analytical subject matter. Matthew also consults
with clients and Bureau Veritas personnel to improve their understanding of regulatory
requirements and to assist them by providing technical interpretations and guidance.
Matthew is a featured presenter in Bureau Veritas webinars on analytical issues
including the Quarterly Technical Review series.
A White Paper from Bureau Veritas Consumer Products Services
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About Bureau Veritas and
Bureau Veritas Consumer Products Services
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