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 carol.monahan-cummings@oehha.ca.gov.

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