Navigating California’s Proposition 65: A Primer for In ... · The perception was that the...
Transcript of Navigating California’s Proposition 65: A Primer for In ... · The perception was that the...
International In-house Counsel Journal
Vol. 5, No. 20, Summer 2012, 1
International In-house Counsel Journal ISSN 1754-0607 print/ISSN 1754-0607 online
Navigating California’s Proposition 65:
A Primer for In-house Counsel1
CAROL J. MONAHAN-CUMMINGS, J.D.
Chief Counsel, California Office of Environmental Health Hazard Assessment
(OEHHA), USA
&
COLLEEN FLANNERY
Student, University of the Pacific School of Law, USA
INTRODUCTION:
In 1986, California voters passed a ballot initiative2 known as "Proposition 65."
3 The Act
was the result of voter distrust of state agencies responsible for regulating the use and
discharge of toxic chemicals.4 The law requires that businesses provide warnings prior to
exposing individuals to chemicals identified by California as known to cause cancer or
reproductive toxicity.5 It also prohibits discharging these same chemicals into sources of
drinking water.6 There are exemptions to the warning and discharge requirements, such
as when exposures are sufficiently low.
Proposition 65 has had a national and even international impact on businesses that
manufacture or sell products that reach consumers in California, or otherwise cause
exposures in California to listed chemicals.7 It can also have impacts on businesses that
may only have an internet "presence" in California, if products are purchased on-line and
delivered in California without the required health warning.8 In-house counsel for any
1 The matters discussed in this paper are the opinion of the authors and not necessarily the opinion of the California Office of
Environmental Health Hazard Assessment, the California Environmental Protection Agency or the Governor of the State of
California or the California Department of Justice
2 California Constitution, Article 2, section 8(a) 3 The Safe Drinking Water and Toxic Enforcement Act on 1986, codified at California Health and Safety Code section 25249.5
et seq., commonly known and referred to herein by its ballot number “Proposition 65” or as “The Act” 4 California Attorney General's Office "Official Title and Summary: proposed Law" at *3
http://www.oehha.ca.gov/prop65/law/pdf_zip/Prop65Ballot1986.pdf (1986). (“The people of California find that hazardous
chemicals pose a serious potential threat to their health and well-being, that state government agencies have failed to provide
them with adequate protection, and that these failures have been serious enough to lead to investigations by federal agencies
of the administration of California's toxic protection programs). See also, Morris, Gabrielle, "Oral History Interview with
Clement Sherman Whitaker, Jr., Political Campaign and Public Relations Specialist," California State Archives State
Government Oral History Program, http://www.sos.ca.gov/archives/oral-history/pdf/whitaker.pdf (1988) * 141 (“You have
the same thing with this Prop. 65 …. The perception was that the legislature was not dealing with the matter adequately”). 5 California Health and Safety Code section 25249.6; See e.g., Environmental Law Foundation v. Wykle Research, Inc., (2005)
134 Cal. App. 4th 60, 66 (Manufacturer must post “reasonable” warning); Ingredient Communication Council, Inc. v.
Lungren, (1992) 2 Cal. App. 4th 1480, 1494 (Warning consists of more than mere “invitation to inquire” about possible
exposures). 6 California Health and Safety Code section 25249.5 7 California Code of Civil Procedure, section 410.10 (Also known as “California’s long-arm statute”). See As You Sow v.
Crawford Labs., (1996) 50 Cal. App. 4th 1859, 1863-1864 (State has limited jurisdiction over Proposition 65 claim even
where non-resident company’s business represented “small fraction” of total revenue) 8 Most of these impacts on large multi-national corporations are seen via consent judgments. See, e.g., As You Sow v.
Amazon.com, Inc., No. CGC-09-488391 at *3. http://oag.ca.gov/system/files/prop65/judgments/2009-00119J1075.pdf (San
Francisco Superior Court, June 2, 2010) (Consent judgment requiring Internet company Amazon.com to halt California sales
of specific supplement product); CEH v. Lulu NYC LLC, et al., No. RG-09-459448 at *7.
http://oag.ca.gov/system/files/prop65/judgments/2010-00072J1144.pdf (Alameda Co. Superior Ct., November 3, 2010)
(Supplemental judgment requiring direct sellers and wholesalers to provide warnings to online or catalogue customers before
their purchase,)
2 Carol J. Monahan-Cummings, J.D. & Colleen Flannery
manufacturer, distributor, retailer or other person doing business in California should
have a basic working knowledge of this law in order to adequately counsel their clients
on its potential impact on their businesses.
Proposition 65’s reach is limited to those chemicals known to cause cancer or
reproductive toxicity.9 It does not apply to chemicals that cause other kinds of health
effects. Chemicals often become subject to Proposition 65 requirements based solely on
scientific information showing that they cause cancer or reproductive toxicity in
laboratory animals .10
The four methods for listing chemicals are discussed later in this
paper. Considerations of actual or potential human exposures and extrapolation of animal
doses to human doses is left to later processes such as the establishment of safe harbour
levels.11
Proposition 65 is a unique law that reduces exposures to toxic chemicals in an unusual
way. It does not ban the use of a chemical.12
Instead, it is considered a right-to-know
law.13
It is designed to provide information to consumers and other individuals in
California about their exposures to toxic chemicals. This can result in a reduction of
exposure to those chemicals in a number of ways. Consumers who see a warning may
decide not to purchase a product. People may avoid a business that posts a warning about
potential exposures at its facilities. Workers who are provided a warning are able to take
advantage of protective equipment or practices to avoid or reduce exposures.
In addition, businesses may choose to reformulate a product or change a manufacturing
process to avoid providing a warning. They may do so for various reasons, including the
company’s reputation and avoiding potential loss of market share.
This is particularly true where toxic chemicals are found in foods or personal care
products. For example, two large multi-national companies recently announced the
reformulation of certain caramel colouring that contains a contaminant, 4-
methylimidazole,14
even though the companies dispute the scientific basis for listing the
chemical.15
The reformulation reduced the presence of the chemical used in their
beverages to inconsequential levels. 4-methylimidazole was listed as a known carcinogen
under Proposition 65 in 2010 based on a finding by the U.S. National Toxicology
Program that the chemical causes cancer in laboratory animals.16
Proposition 65 has
resulted in reformulation of such everyday products as potato crisps, 17
toothpaste,18
9 The current list of chemicals is available at: http://www.oehha.ca.gov/prop65/prop65_list/Newlist.html, As of May 2012, the
list contained over 800 chemicals, though some are counted twice because they cause both cancer and reproductive toxicity. 10 AFL-CIO v Deukmejian (1989) 212 Cal. App, 3rd 425 11 Title 27, California Code of Regulations, section 25701 et seq. (no significant risk levels for carcinogens), Title 27, California
Code of Regulations section 25801 et seq. (no observable effect levels for reproductive toxicants), Exxon Mobil Corporation
v. Office of Environmental Health Hazard Assessment (2009) 169 Cal. App.4th,1264 12 Graf, Michael W. Regulating Pesticide Pollution In California Under The 1986 Safe Drinking Water And Toxic Exposure Act
(Proposition 65), 28 Ecology L.Q. 663 (2001). 13 Rechtschaffen, Clifford, The Warning Game: Evaluating Warnings Under California's Proposition 65. 23 Ecology L.Q. 303
(1996) ("This Article analyzes ... how effectively these warnings communicate to the public the information necessary to
promote informed decision-making and satisfy the public's 'right to know' in light of general principles of cognitive
psychology and risk communication."); Katrichis, Harry J. and Keller Jr., Roger A., "Prop. 65: Putting California's Labeling
Horse Back Into the Federal Labeling Barn" 7 Hastings W.-N.W. J. Env. L. & Pol'y 19 (2000) (... “’right-to-know’ statutes
such as Prop. 65”...) 14 Associated Press, Coke and Pepsi change recipe to avoid cancer warning, The Guardian, March 9, 2012;
http://www.guardian.co.uk/business/2012/mar/09/coke-pepsi-recipe-change-avoid-cancer-warning 15 Various trade organizations representing the food and beverage industry sued the California Office of Environmental Health
Hazard Assessment for listing the chemical. The Office prevailed in the trial court and the case is now on appeal to the
California Court of Appeal, California League of Food Processors et al. v Office of Environmental Health Hazard
Assessment, 3rd District, Case No. C070406 16 http://oehha.ca.gov/public_info/facts/4MEIfacts_021012.html 17 See, e.g., People of the State of California v. Frito-Lay Inc. et al, No. BC 338956 at *4.
http://ag.ca.gov/cms_attachments/press/pdfs/n1595_frito-lay_cj_as_entered.pdf ;( reformulation to reduce acrylamide levels
in snack foods)
California’s Proposition 65 3
antacids19
and hair dye,20
as well as various paints, solvents, resins, paint strippers, and
varnish removers.21
1. Basic provisions of Proposition 65
With relatively minor exceptions discussed below, Proposition 65 is a self-executing law
that prohibits discharges of known carcinogens and reproductive toxicants to sources of
drinking water, including releases into or onto land where the chemical may reach a
source of drinking water.22
The law also requires that businesses causing knowing and
intentional exposures to these same chemicals provide a “clear and reasonable” warning
prior to the exposure.23
a. Discharges of toxic chemicals to sources of drinking water
Interestingly, very little litigation has resulted from the discharge prohibition, with a few
notable exceptions. For example, a private enforcement group sued the Exxon Mobil
Corporation for contamination of groundwater with benzene, toluene and lead from
leaking underground fuel-storage tanks. 24
The California Court of Appeal found that the
Proposition 65 prohibition against “discharges” of listed chemicals to sources of drinking
water did not include “passive migration” of chemicals that had already been released
from the tanks. On the other hand, in a case brought by the California Attorney General
against the American Standard Company, among others, for plumbing fixtures that
released lead into tap water, the California Supreme Court ultimately decided that a water
faucet was a “source of drinking water” for purposes of Proposition 65.25
b. Warnings for chemical exposures
Violations of Proposition 65’s warning requirements have been the focus of enforcement
since the law became effective in 1987.26
The vast majority of enforcement cases are
settled without trial.27
This may be because Proposition 65 shifts the burden of proof to
the defendant to show that a warning is not required, once the plaintiff has made a
minimal showing that a listed chemical is present.28
In 2011 alone, defendants paid more
than $16 million U.S. dollars in settlements, including attorney’s fees and costs.29
These
settlements frequently include agreements to reduce or eliminate the exposures caused by
18 See Am. Envtl. Safety Inst. v. Procter & Gamble Distrib. Co., B198821, 2007 WL 4395440 (Cal. Ct. App. Dec. 18, 2007) (not
published) (Reformulation of lead from toothpaste sold nationwide). 19 Press Release, California Attorney General, Attorney General Lockyer Reaches Agreement Requiring Novartis to Lower
Lead Levels in Antacids (June 10, 1999) at http://oag.ca.gov/news/press_release?id=501&y=1999&m=. 20 Am. Int'l Indus. v. Superior Court, 70 Cal. App. 4th 406, 82 Cal. Rptr. 2d 836, 841 vacated, 72 Cal. App. 4th 1376, 85 Cal.
Rptr. 2d 815 (1999) (not published) (Reformulation of hair colorant products to remove lead). 21 Marina Gatti, Esq., Proposition 65: "Shoot First, Ask Questions Later"-Do the Bullets Really Work? Have We Shot the
Wrong Party? Will They Call Out the Bazookas?, 47 Food & Drug L.J. 739, 741 (1992) 22 California Health and Safety Code section 25249.5 23 California Health and Safety Code section 25249.6 24 Exxon Mobile Corporation v. Consumer Advocacy Group Inc. (2002) 104 Cal. App. 4th 438 25 The People ex rel. Daniel E. Lungren, as Attorney General v. The Superior Court of the City and County of San Francisco,
American Standard, Inc. et al., Real Party in Interest, (1996) 14 Cal. 4th 294 26 See, e.g., As You Sow v. Ascendia Brands, Inc., et al, No. CGC-09-488616 at *3-5.
http://oag.ca.gov/system/files/prop65/settlements/2009-00147S1647.pdf (San Francisco Superior Court, May 21, 2009)
(reformulation of personal care products); Brimer v. The Gillette Company, et al., No. CGC-09-488616 at *2.
http://oag.ca.gov/system/files/prop65/settlements/2009-00418S1295.pdf (Out of court, June 7, 2010) (reformulation of
flashlight straps); CSPA v. Anderson Landfill, No. 2:10-CV-00831-WBS-DAD at *4-5.
http://oag.ca.gov/system/files/prop65/settlements/2010-00454S1654.pdf? (U.S. District Court, Eastern District of California,
May 17, 2011) (change to water runoff management practices to avoid discharge of listed substances). 27 Settlements must be “in the public interest,” and meet established standards of “(1) justiciability ... (2) notice ...and (3) the
statutory requirements of adequate warnings, reasonable fees, and reasonable penalties.” Consumer Advocacy Group, Inc. v.
Kintetsu Enterprises of America, 141 Cal. App. 4th 46, 65 (Cal. App. 2d Dist. 2006). 28 California Health and Safety Code section 25249.10(c) 29 California Office of the Attorney General, Annual Summaries of Private Settlements – Report 2011
(http://oag.ca.gov/sites/all/files/pdfs/prop65/Alpert_Report2011.pdf?). The site reports $16,286,728.32 in settlements
including $11,941,918.8 (or 73.2 per cent) paid toward attorney’s fees in 2011.
4 Carol J. Monahan-Cummings, J.D. & Colleen Flannery
the products or activities. Reduction or elimination of exposures can be achieved through
reformulation, substitution or changes in process
The California Governor designated the California Office of Environmental Health
Hazard Assessment (hereafter referred to as the Office) as the lead agency for
implementing, but not enforcing, Proposition 65.30
The Office has adopted regulations
and issues guidance concerning the Act. It has adopted general “safe harbour” warning
language and methods for providing warnings for consumer product, environmental and
occupational exposures to listed chemicals.31
A business is not required to use these
suggested warnings or methods, but many do so because they are deemed “clear and
reasonable” by the Office and are therefore more easily defended in an enforcement
action.32
These safe harbour provisions do not prohibit different or additional language
being included in the warning. While often referred to as “warning labels,” the warnings
may be given via any method that provides a clear and reasonable warning. These can
include warning messages off-product (shelf sign, point-of-sale, menu), on-product,
posting in affected areas, newspaper ads, or direct mail. Some companies that sell
products delivered to Californians provide electronic warnings at the “point of sale” of
the product when the customer indicates the shipping address.33
Others provide the
warning with the invoice or other documents accompanying the product. When
challenged, the business must prove that such methods are in fact “clear and reasonable”
for both method and content.
In recent years, a number of Proposition 65 settlements have included expanded warning
messages for certain exposures to chemicals in foods. For example, most California
grocery stores post warning signs for mercury contamination in fresh fish that are
modelled after the U.S. Food and Drug Administration advisories for such exposures.34
c. Enforcement
Another unusual aspect of Proposition 65 is that it splits the scientific and regulatory
authority to implement the law from the legal authority to enforce it. As noted above, the
California Office of Environmental Health Hazard Assessment is the lead implementing
agency responsible for the scientific and regulatory work associated with identifying and
listing chemicals that cause cancer and reproductive toxicity and adopting and
maintaining the implementing regulations. However, enforcement has been delegated to
the California Attorney General, local prosecutors and private persons acting in the
public interest.35
Businesses that violate either the discharge or warning requirements of
the Act can be fined up to $2,500 U.S. dollars per day, per violation, though most penalty
amounts are much lower. The person bringing the enforcement action receives 25 per
cent of the penalties, while the remaining 75 per cent portion is provided to the Office to
help support its work.36
Settlements may also include payments for attorney’s fees, costs
and may sometimes include payments for other purposes related to the basis for the
action.37
30 California Health and Safety Code section 25249.12(a); Title 27; California Code of Regulations, section 25102(o) 31 Title 27, California Code of Regulations, section 256016 et seq. 32 See, e.g. Environmental Law Foundation v. Wykle Research, Inc., (2005) 134 Cal. App. 4th 60, 66 33 http://www.amazon.com/gp/help/customer/display.html?ie=UTF8&nodeId=3234041 provides a variety of warnings
applicable to products sold on Amazon.com. 34 For examples of warning signs used by U.S. grocers, see: Grocery Store Mercury Warning Signs, available at
http://oceana.org/en/our-work/stop-ocean-pollution/mercury/learn-act/learn-more/grocery-store-mercury-warning-signs 35 California Health and Safety Code section 25249.7 36 California Health and Safety Code section 25249.12(b) 37 See regulations adopted by the California Attorney General in Title 11, California Code of Regulations,
section 3000 et seq. which provide guidance concerning private enforcement settlements.
California’s Proposition 65 5
d. Exceptions
Proposition 65 and its implementing regulations provide certain exceptions to the
warning requirements and discharge prohibitions discussed above.
The government of the United States, state and local governments and public
water suppliers are not covered by the law.38
Very small businesses with ten or fewer employees are also exempt. This
includes full-or part-time employees located in or outside the state.39
Discharges of a listed chemical that occur within 20 months of the chemical’s
listing are not prohibited.40
Warnings for exposures to listed chemicals are not required until 12 months
after the chemical is listed.41
Warnings are not required where the person causing the exposure can show
that the exposure is below a certain level.42
Regulations describing how these
levels are derived and providing levels for certain chemicals are discussed later
in this paper.
Warnings are not required for certain exposures to chemicals that occur
naturally in foods.43
Determining the real-world application of this exception
to a particular food-related exposure can be difficult; however the Office and
courts have provided some guidance in this area.44
Certain discharges of listed chemicals are also covered by limited regulatory
exceptions.45
2. How can a California public health/environmental law have a global impact?
a. Long-arm jurisdiction
While state laws generally only apply within the state that enacted them, some activities
outside a state can result in sufficient contacts to allow a state to exercise jurisdiction
over the business engaged in those activities. Therefore, California may claim jurisdiction
over any individual or business that has sufficient contacts within the state.46
In the
context of Proposition 65, California law can apply to virtually any business-related
activity that causes an exposure to a listed chemical in California. This includes consumer
product, environmental and occupational exposures to listed chemicals.47
38 California Health and Safety Code section 25249.11(b) 39 Title 27, California Code of Regulations, section 25102, An employee is a person who performs services for remuneration 40 California Health and Safety Code section 25249. 41 California Health and Safety Code section 25249.10(b) 42 California Health and Safety Code section 25249.9(b)(1) and Section 25249.11(c),for discharges; Section 25249.10(c) for
warnings. See: http://www.oehha.ca.gov/prop65/getNSRLs.html. Businesses also may adopt their own exposure levels. See,
e.g., DiPirro v. Bondo Corp., 153 Cal. App. 4th 150, 193-194 (Cal. App. 1st Dist. 2007) 43 Title 27, California Code of Regulations, section 25501 [Upheld in Nicolle-Wagner v. Deukmejian, 230 Cal. App. 3d 652,
661, 281 Cal. Rptr. 494, 499 (Ct. App. 1991)] 44 See, e.g.. OEHHA, Interpretive Guideline No. 2012-01: Consumption of Methanol Resulting from Pectin that Occurs
Naturally in Fruits and Vegetables (http://www.oehha.ca.gov/prop65/ig/pdf/IG_12001Methanol.pdf) ; Total Fumonisins In
Corn Snack Food Products (July 16, 2010) (http://www.oehha.ca.gov/prop65/crnr_notices/safe_use/sud071610.html);
Nicole-Wagner v Deukmejian (1991) 230 Cal. App. 3rd 652 45 Title 27, California Code of Regulations, section 25401 (discharges of water containing listed chemical at time of receipt),
25402 (discharges from hazardous waste facilities), 25405,(discharges of pesticides), 25504 (exposure to air). 46 California Code of Civil Procedure, section 410.10 47 Title 27, Cal. Code of Regulations, sections 25603(consumer products); 25604(occupational exposure);
25605(environmental)
6 Carol J. Monahan-Cummings, J.D. & Colleen Flannery
b. Other states and cities in the United States use the
Proposition 65 chemical list
Further, other states and cities in the United States rely on the Proposition 65 list of
chemicals for various local programs. The table below summarizes programs identified
by the Office in 2012.
U.S. state and city governments that rely on the Proposition 65 list of chemicals
State Application of Proposition 65
New Jersey
Uses the Proposition 65 list in part to spot potential air toxics.
http://www.nj.gov/dep/airtoxics/diesemis.htm
Relied on Proposition 65 list to identify perchloethylene as a
carcinogen in its own rulemaking.
http://www.nj.gov/dep/rules/proposals/121707b.pdf
Maine
The state’s Department of Environmental Protection utilized
the Proposition 65 list in creating their own "Maine List of
Chemicals of High Concern."
http://www.maine.gov/dep/oc/safechem/highconcern/DEP.CH
C.%20Web.Background%20Document%206.26.09.doc
New York
Used Proposition 65 exposure levels and reference doses as a
source in drafting brownfield cleanup standards.
http://www.dec.ny.gov/docs/remediation_hudson_pdf/techsup
pdoc.pdf (p. 43 “Bibliography”).
S. 7070 (pending in the NY General Assembly) would set up
a system for regulating chemicals potentially present in
children's products. Proposition 65 would be one tool used to
evaluate what chemicals may harm kids.
http://open.nysenate.gov/legislation/bill/S7070
Washington Weighs Proposition 65-Program created “safe harbor” values
when conducting a review required under the Washington’s
Children’s Safe Products Act (CSPA).
http://www.ecy.wa.gov/programs/swfa/rules/pdf/p3text.pdf
Relies on Proposition 65 as one of set of criteria for
identifying "high priority chemicals."
http://www.ecy.wa.gov/programs/swfa/pdf/ChildrensRuleSept
ListHandout.pdf
Rhode Island Uses chemicals identified by California as “known to cause
cancer” to identify potential air toxics.
http://www.dem.ri.gov/programs/benviron/air/pdf/airtoxgl.pdf
(page 8).
Arizona State Attorney General relied on Proposition 65 warnings to
advise Arizonans in avoiding lead in toys.
http://www.azag.gov/press_releases/nov/2009/Lead%20in%20
Toys%20advisory%202010.html
Oregon Proposition 65 list of developmental toxins used in creating
Oregon’s Priority Persistent Pollutant List.
http://www.deq.state.or.us/wq/sb737/docs/P3LReportFinal.pdf
(See pg. 19)
California’s Proposition 65 7
U.S. City Application of Prop. 65
City of Bloomington, Ind. Uses Proposition 65 list to identify potentially health-
harmful chemicals that are found within the city
limits.
http://bloomington.in.gov/documents/viewDocument.
php?document_id=3000#10
City of New York References the Proposition 65 list of chemicals
known to the state to cause developmental harm (in a
local law forbidding application of any pesticide that
appears on that list).
http://www.nyc.gov/html/nycwasteless/downloads/pd
f/laws/law05037.pdf
City of Seattle Relies on Proposition 65 as one of multiple criteria
for identifying environmentally preferable chemicals
for purchase.
http://www.seattle.gov/environment/documents/janit
orialspecs.pdf
c. Proposition 65’s effects outside California
California boasts the 8th largest economy in the world with a gross domestic product of
$1.9 trillion U.S. dollars in 2009.48
Because of the size of the California market,
companies may find it more cost-effective to provide Proposition 65 warnings for all
their products rather than limiting warnings to products only intended for sale in the state.
Further, it is virtually impossible for businesses to ensure that products without required
warnings that are sold outside the state without the required warnings may not make their
way into the California market.49
Therefore, Proposition 65 warnings may appear on
products sold outside California.50
These warnings can result in customer enquiries from
non-California residents who may be more sensitive to the warnings than their California
countertypes because Californians have seen such warnings for more than 25 years.
Managing customer relations in these situations can provide further incentive to
reformulate a product to avoid the need to provide a warning at all. Some businesses have
argued that the simple act of listing a chemical can have significant impact on a business
that sells the chemical in or outside California.51
48 Legislative Analyst's Office. CalFacts: 2011. Available from Legislative Analyst's Office website,
http://www.lao.ca.gov/reports/2011/calfacts/calfacts_010511.pdf; Accessed 5/22/2012 (Ranking California behind only the
United States - excluding California, Japan, China, Germany, France, United Kingdom and Italy). 49 See, e.g., State of California v Effem Mexico y Compania SNC de C.D. et al., No. 07-09-2004 at *2.
http://ag.ca.gov/newsalerts/cms06/06-062_0a.pdf (Los Angeles County Superior Court, June 29, 2006) (State action against
lead in candy imported from Mexico); In re Vinegar Litigation. No. CGC-03-421108 .at * 5-6.
http://oag.ca.gov/system/files/prop65/settlements/2003-00569S406.pdf. (Applying Proposition 65 requirements to Italian
wine vinegar suppliers who “may reasonably be expected” to offer products for sale in California). 50 See, e.g., Hydro Designs, Inc., California Proposition 65 Warning, available at
http://www.hydrodesignsinc.com/images/WI_HBVB_PROP65_Draft4.pdf (Plumbing bibs); Frequently Asked Questions:
Prop 65, available at https://www.volatileusa.com/faqs.php?cid=3 (Footwear); Laerdal Medical, California Proposition 65
Q & A, available at http://www.laerdal.com/us/doc/873/California-Proposition-65-Q-A (Health care products); Travel
Goods Association, available at: http://www.travel-goods.org/stories/prop65-update-090805.asp (Travel goods, even those
not "ultimately sold" in California). 51 See, e.g. Defendant’s Complaint, Styrene Information and Research Center v. Office of Environmental Health Hazard
Assessment, No. 34-2009-00053089 www.saccourt.ca.gov. (Sacramento County Superior Court, July 14, 2009) at *2.
8 Carol J. Monahan-Cummings, J.D. & Colleen Flannery
3. How are chemicals listed under Proposition 65?
Proposition 65 identifies four ways a chemical can be listed as known to cause cancer or
reproductive toxicity.52
The four listing mechanisms can overlap, but the criteria for each
mechanism are different. A chemical is listed if it meets the criteria for at least one of the
listing mechanisms, even if it might not meet the criteria for any of the others. The Office
has adopted regulations describing the listing and de-listing processes for three of the
four mechanisms and publishes flow charts describing each listing mechanism.53
54
Draft
regulations for the fourth mechanism were published informally but have not yet been
adopted.55
Each of the four mechanisms is discussed briefly below.
a. Labour Code listings
Proposition 65 identifies the minimum base list of chemicals and substances that must be
included on the Proposition 65 list of known carcinogens and reproductive toxins:
“… [The] list shall include at a minimum those substances identified by reference
in [California] Labour Code Section 6382(b)(1) and those substances identified
additionally by reference in Labour Code Section 6382(d).”56
While this provision may appear to be a straightforward incorporation by reference to
another list of chemicals, it actually requires some “drilling down” into the Code of
Federal Regulations referred to in the Labour Code sub-sections. To summarize,
California is required to include all carcinogens and reproductive toxins identified by the
U.S. National Toxicology Program, the World Health Organization’s International
Agency for Research on Cancer, the U.S. Occupational Safety and Health Administration
and the American Conference of Governmental Industrial Hygienists (reproductive toxins
only).
The Office updates the Proposition 65 list periodically with chemicals identified via this
listing mechanism. Because it is considered a ministerial task, the Office provides a 30-
day public comment period that is limited to comments concerning whether the chemical
or substance has been identified by one of the entities listed above as a human or animal
carcinogen or reproductive toxin.
Various court challenges to the listings have been pending for several years.57
A recent
decision in one of the cases provides a good description of the process and affirms that
the statute requires the on-going ministerial listing and delisting of chemicals identified
via this mechanism.58
Two other challenges to minor listing issues under this mechanism
are still pending.59
The outcome of this litigation may provide guidance for the Office’s
efforts to develop regulations to clarify the process for this listing mechanism.60
(“Listing styrene would stigmatize [manufacturers] and their products by creating a false public perception that styrene and
styrene products are dangerous to human health.”). (This case is awaiting oral argument in Cal. Court of Appeals, Third
District, No. C064301). 52 Health and Safety Code section 25249.8 53 OEHHA, Mechanisms for Listing and Delisting Chemicals Under Proposition 65" (May 2007)
(http://www.oehha.ca.gov/prop65/policy_procedure/listde051007.html) 54 See Title 27, California Code of Regulations section 25306 (authoritative bodies), section 25902 (formally required), section
25305(a)(1), (state’s qualified experts) 55 OEHHA, Possible Regulatory Language (May 2008) http://www.oehha.ca.gov/prop65/law/workshop051608.html) 56 California Health and Safety Code section 25249.8(a) 57 See: OEHHA, Possible Regulatory Language (May 2008), id. 58 California Chamber of Commerce v Edmund G. Brown (2011) 196 Cal. App. 4th, 233 59 Styrene Information and Research Council v Office of Environmental Health Hazard Assessment, California 3rd District
Court of Appeal, No. C064301 (pending since February 2010); Sierra Club et al. v Brown, Alameda County Superior Court
No. RG07356881 (Judgment on the pleadings entered in June 2009, but decision may be appealed.) 60 California Chamber of Commerce v Edmund G. Brown (2011) 196 Cal. App. 4th, 233
California’s Proposition 65 9
b. Authoritative bodies listings
Regulations setting out the process for listing chemicals via this mechanism can be found
in Title 27 of the California Code of Regulations, section 25301et seq. These regulations
contain the most specific listing criteria and process of the four listing mechanisms. They
include a list of “authoritative bodies” which include some of those discussed above in
regard to Labour Code listings; the U.S. National Toxicology Program and the
International Agency for Research on Cancer. In addition, the U.S. Environmental
Protection Agency, the U.S. Food and Drug Administration and the U.S. National
Institute for Occupational Safety and Health are included as authoritative bodies for
purposes of identifying carcinogens and reproductive toxins.
The regulations specify certain criteria that must be met in order to list a chemical via this
mechanism including procedural as well as scientific standards. This listing mechanism
provides an opportunity for discussion concerning the quality and sufficiency of the
scientific evidence the authoritative body relied on in making its identification. Common
arguments against listing include challenges to the types and quality of the laboratory
animal studies relied on and the relevance of the animal evidence to humans.61
Arguments concerning the relevance of current or anticipated human exposures to the
chemical and calculation of dose-response are not appropriate at the listing stage of the
Proposition 65 process. These issues can be addressed later in the process when a “safe
harbour” level is calculated for the chemical. Safe harbours are discussed below under
“defences.”
c. State’s qualified experts listings
This listing mechanism is the only one of the four that does not rely on the scientific
work of other organizations to identify carcinogens or reproductive toxins. Under this
listing mechanism, scientific experts appointed by the Governor of California conduct a
de novo review of the scientific evidence for and against such a finding. The public has
multiple opportunities for comment and may present evidence for and against the
potential listing. Two expert committees, the Carcinogen Identification Committee and
the Developmental and Reproductive Toxicant Identification Committee meet once each
year in a public forum to review and discuss the scientific evidence and hear from
members of the public. The committees decide whether the chemical has been “clearly
shown through scientifically valid testing according to generally accepted principles to
cause cancer or reproductive toxicity”.62
If the answer is yes, the chemical is listed. The
regulations governing this listing mechanism do not explain the procedures by which a
chemical is listed. However the committees have adopted scientific guidance for their
decisions63
and the Office has adopted a detailed prioritization procedure and summarizes
the scientific evidence for review by the committees. 64
d. Formally-required listings
The least-used listing process is called the “formally required” mechanism. This is
because this mechanism relies on a formal labelling requirement for products that cause
61Courts have upheld extrapolation of animal-testing data to humans for Proposition65 purposes. AFL-CIO v. Deukmejian,
(1989) 212 Cal. App. 3d 425, (1989); Exxon Mobil Corp. v. Office of Environmental. Health Hazard Assessment,(2009);169
Cal. App. 4th 1264, 1288-89, 87 62 California Health and Safety Code section 25249.8(b) and Title 27, California Code of Regulations, section 25305(a)(1) 63 OEHHA, Guidance Criteria for Identifying Chemicals for Listing as “Known to the State to Cause Cancer”
(http://www.oehha.ca.gov/prop65/policy_procedure/pdf_zip/revcriteria.pdf) (Carcinogens).; OEHHA, Criteria For
Recommending Chemicals For Listing As "Known To The State To Cause Reproductive Toxicity" (Nov. 1993)
(http://www.oehha.ca.gov/prop65/policy_procedure/pdf_zip/revcriteria.pdf) (Reproductive toxicity); 64 OEHHA, Process For Prioritizing Chemicals For Consideration Under Proposition 65 By The "State’s Qualified Experts"
(Dec. 1994) (http://www.oehha.ca.gov/prop65/CRNR_notices/state_listing/pdf/finalPriordoc.pdf)
10 Carol J. Monahan-Cummings, J.D. & Colleen Flannery
cancer or reproductive toxicity. Most often, these listings are based on U.S. Food and
Drug Administration required statements regarding carcinogenicity or reproductive
toxicity in package inserts for prescription drugs. However, the regulations exempt
prescription drugs from the law’s warning requirements if the cancer or reproductive
toxicity of the chemical is described in the patient information.65
This exception does
not extend to over-the-counter drugs.
4. Defences to enforcement actions
Proposition 65 places the primary responsibility on the business causing the exposure or
discharge to prove that a warning is not required or a discharge is not prohibited.66
Due to the heavy burden of proving an exception, businesses may settle even though they
believe they have a meritorious defence. To reduce such actions; the statute was modified
to require that plaintiff’s file a certificate of merit with the California Attorney General’s
Office prior to taking an enforcement action.67
Where applicable, defences challenging
the format and manner of notice given by plaintiffs also have prevailed,68
as have certain
pre-emption arguments.69
From time to time, a group of businesses decide to take on a scientifically and legally
complex defence strategy that is ultimately successful. A recent example is a case
brought by the California Attorney General’s Office against businesses that produce
canned tuna. The Attorney General’s Office alleged that a warning for mercury exposures
was required on these products. After a long and expensive trial and appeal process, the
appellate court found that the trial court’s conclusion that the mercury was “naturally
occurring” in the fish was sufficiently supported by the evidence and found in favour of
the tuna companies on that narrow issue.70
In a related action against grocery sellers for
exposures to mercury in fresh fish, the supermarkets settled and posted warnings.71
Given the difficulty of defending an enforcement action, some businesses choose to
provide a warning to avoid litigation without verifying that one is required.72
However,
for those businesses that believe a warning is not required, the Office provides a method
for obtaining an opinion concerning the applicability of the laws and regulations to
particular exposures.73
The Office also issues guidelines that interpret the law and
65 Title 27, California Code of Regulations, sections 25902(listings) and section 25603.3(c) (prescription drug exemption) 66 California Health and Safety Code section 25249.9 (discharge) and 25249.10 (warning). 67 California Health and Safety Code section 25249.7(d)(1) 68 See, e.g., Consumer Def. Group v. Rental Hous. Indus. Members, 137 Cal. App. 4th 1185, 1203 (2006) (rejecting proposed
settlement because notice to Attorney General was “vague, inadequate and overbroad”); Consumer Advocacy Group, Inc. v.
Kintetsu Enterprises of Am., 150 Cal. App. 4th 953, 977 (2007) (notices inadequate where they failed to ‘identify the
location of the source of the exposure.’). 69 See, e.g. Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal. 4th 910, 917-18, 88 P.3d 1, 3 (2004) (Proposition 65
pre-empted by Food and Drug Act only where the warning would “directly contradict” that act); Am. Meat Inst. v. Leeman,
(2009) 180 Cal. App. 4th 728, 761 (Warning on meat or meat products triggers Federal Meat Inspection Act's pre-emption
clause); In re Vaccine Cases, (2005) 134 Cal. App. 4th 438, 449, and Cal. Code Regs., tit. 22, § 12601, subds. (b), (c) & (d).)
(Prescription drugs exempted). But see People ex rel. Lungren v. Cotter & Co., (1997) 53 Cal. App. 4th 1373, 1388 (Federal
Hazardous Substances Labeling Act does not pre-empt Proposition 65); Chem. Specialties Mfrs. Ass'n, Inc. v. Allenby, 958
F.2d 941, 947 (9th Cir. 1992) Federal Insecticide, Fungicide, and Rodenticide Act does not pre-empt Proposition 65). 70 People ex rel Edmund G. Brown Jr. etc., et al. v Tri-Union Seafood et al. (2009) 171 Cal.App.4th 1549 (Companies prevailed
on narrow sufficiency-of-the-evidence grounds surrounding source of methyl mercury in
tuna);http://oag.ca.gov/news/press_release?id=690&y=2004&m=. 71 Press Release, California Attorney General, Attorney General Lockyer Pushes Grocers to Warn Consumers about Mercury in
Fish (Jan. 17, 2003) at http://oag.ca.gov/news/press_release?id=764&y=2003&m. 72 Rechtschaffen, Clifford, The Warning Game: Evaluating Warnings Under California's Proposition 65. 23 Ecology L.Q. 303,
356 (1996) ("There is no question, however, that many businesses have chosen to warn "protectively" by providing warnings
when not required to do so.") Providing a warning when there is no factual basis for doing so can expose a business to a
claim of false or misleading advertising under California Business and Professions Code, sections 17500 or 17508. 73 Title 27, California Code of Regulations, section 25204;
http://www.oehha.ca.gov/prop65/CRNR_notices/safe_use/pdf_zip/SUDfacts081809.pdf;
California’s Proposition 65 11
regulations as they apply to certain exposure scenarios.74
While this guidance is not
binding on courts, the Office’s scientific opinions are entitled to deference.75
Further, the
Office adopts safe-harbour levels for certain listed chemicals to assist businesses in
determining if a warning is required or a discharge is prohibited.76
More than 250 safe
harbour values have been established in regulation. Where a safe harbour has not been
adopted, the regulations provide guidance on how a business may calculate the level.77
The Office has worked with business associations and others to develop warning
messages and programs to help them comply with the law. It also gives practical
guidance to consumers. For example, the Office worked jointly with a wood products
trade association and the California Attorney General’s Office to develop a warning
program for exposures to wood dust, a known human carcinogen.78
SUMMARY
Proposition 65 is a right-to-know law that functions as a deterrent to chemical discharges
and a vehicle for informed choices. It takes a unique approach to reducing exposures to
toxic chemicals by providing information to consumers rather than banning the chemicals
or products that contain them. It also splits the scientific and regulatory authority to
implement the law from the legal authority to enforce it. While the California Office of
Environmental Health Hazard Assessment is responsible for the scientific and regulatory
work of identifying and listing chemicals that cause cancer and reproductive toxicity,
enforcement is delegated to the California Attorney General, local prosecutors and
private persons acting in the public interest.
More than 25 years after it was approved by California voters, Proposition 65 is more
important than ever. Virtually all companies doing business in California, shipping
products into the state, or otherwise producing or selling products that cause exposures
within the state could be affected by this law. Because of its national and international
implications, a working knowledge of Proposition 65 is essential to enable counsel to
anticipate issues and resolve them before enforcement actions are filed.
***
Carol Monahan-Cummings was appointed Chief Counsel at the California Office of
Environmental Health Hazard Assessment in October 2003. In this capacity, Ms.
Monahan-Cummings advises the Director, other Executive Office members, as well as
staff on all legal matters affecting the Office. Principal areas of responsibility include:
Proposition 65, developing and amending regulations, and serving as liaison to the
Attorney General's Office for all lawsuits in which the Office is a party. She can be
reached at [email protected].
74 OEHHA, Proposition 65 Interpretive Guidelines (http://www.oehha.ca.gov/prop65/ig/index.html) (Provides links to various
interpretive guidelines) 75Exxon Mobil Corp. v. Office of Envtl. Health Hazard Assessment, 169 Cal. App. 4th 1264, 1290-91, 87 Cal. Rptr. 3d 580,
600-01 (2009) (Deferring to scientific findings made by OEHHA in listing determination); Yamaha Corporation of America
v State Board of Equalization (1998) 19 Cal. 4th 1 (Deference to state agency’s expertise and technical knowledge).
Californians for Pesticide Reform v. Department of Pesticide Regulation, (2010) 184 Cal. App. 4th 887, 903 (Supporting
deference to state agency's scientific findings where they exhibit "the expertise and technical knowledge the court lacks”);
California Forestry Assn. v. California Fish & Game Commission, (2007) 156 Cal. App. 4th 1535, 1546 (Deference to
"scientific expertise" of state department). \ 76 Title 27, California Code of Regulations, sections 25705 (carcinogens) and 25805 (reproductive toxins). Businesses also may
ask OEHHA to set a safe-harbour level, where none exists. Exxon Mobil Corp. v. Office of Envtl. Health Hazard Assessment,
169 Cal. App. 4th 1264, 1291 (2009). 77 Title 27, California Code of Regulations, sections 25703 (carcinogens) and 25803 (reproductive toxins). 78 Hardwood Plywood & Veneer Association "Wood Dust.” Available at http://www.hpva.org/node/941. (Provides the
following warning text: WARNING: Drilling, sawing, sanding or machining wood products generates wood dust, a
substance known to the State of California to cause cancer. Avoid inhaling wood dust or use a respirator or other
safeguards for personal protection).
12 Carol J. Monahan-Cummings, J.D. & Colleen Flannery
Colleen Flannery is a student at the University of the Pacific School of Law and works
in the Office’s Legislative Unit. She provided invaluable assistance in research for this
paper.
The Office of Environmental Health Hazard Assessment is the scientific arm of the
California Environmental Protection Agency. Our mission is to protect public health and
the environment by scientific evaluation of the risks posed by hazardous substances.
Specific descriptions of each of the Office's program areas can be found at
http://www.oehha.ca.gov/about/program.html