Court Of Appeal Upholds “Safe Harbor” Exemption From Prop 65 Warnings For Lead In Fruit Products

In a much anticipated decision, a California Court of Appeal has upheld a trial court ruling for the defense, finding that trace levels of lead in packaged fruits, vegetables and fruit juice products require no Proposition 65 warning to consumers.  Environmental Law Foundation v. Beech-Nut, et al.[1]  In so doing, the Court of Appeal affirmed that the averaging of data to determine whether potential exposure is below the “safe harbor” is scientifically appropriate and consistent with applicable Proposition 65 regulations.

Background on Proposition 65

Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act,[2] was enacted by voter initiative in 1986.  The statute prohibits companies that have 10 or more employees and do business in California from “knowingly and intentionally expos[ing] any individual to a chemical known to the state to cause cancer or reproductive toxicity without first giving clear and reasonable warning to such individual.”[3]  The California Office of Environmental Health Hazard Assessment (OEHHA) has published and periodically updates a list of chemicals that are “known to the state to cause cancer and reproductive toxicity,” which are commonly referred to as “listed chemicals.”  Enforcement is allowed by private individuals and groups, in addition to government entities, and a prevailing plaintiff may recover a percentage of penalties as well attorneys’ fees and costs.

Companies with products that are sold in California and contain a listed chemical must provide consumers with a Proposition 65 warning regarding potential exposure unless there is an applicable exemption:  (1) federal warning requirements that preempt state law; (2) in the case of food products, the chemical is “naturally occurring;” (3) the exposure poses no significant risk of cancer, assuming lifetime exposure at the level in question; or (4) the exposure will have no observable effect for reproductive toxicity, assuming exposure at 1,000 times the level in question.[4]

For certain listed chemicals, OEHHA has established No Significant Risk Levels (NSRLs) and Maximum Allowable Dose Levels (MADLs) that provide a “safe harbor” from Proposition 65 warning requirements if risk analysis shows potential exposures are below the applicable level.[5]  That is, no Proposition 65 warning is required if the company meets its burden of establishing that potential exposures are below the “safe harbor” level, below the NSRL or MADL if there is no safe harbor, or are otherwise exempt from warning requirements.[6]  For lead, OEHHA established an MADL “safe harbor” of 0.5 micrograms per day. 

Court of Appeal Upholds “Safe Harbor” Exemption

The Proposition 65 claims in Beech-Nut involved alleged failure to warn of exposure to lead in packaged fruits, vegetables and fruit juice products.  The defense contended that no warnings were required because (1) federal law preempts Proposition 65 warning requirements for these products; (2) lead in the products was naturally occurring and therefore exempt from warning requirements under Proposition 65; and (3) potential exposures were below the Proposition 65 “safe harbor” of 0.5 micrograms per day. 

The trial court found that federal preemption did not apply and that the defendants had not established that lead in the products was solely or predominantly from natural sources.  However, the court ruled in favor of the defense, finding that “it is scientifically appropriate .  .  .  to determine the average user’s frequency of exposure,” and that when average consumption rates were applied, potential exposure was below the “safe harbor” and therefore exempt from Proposition 65 warning requirements.[7]  Both sides appealed, and the California Attorney General filed a brief as amicus curiae in support of plaintiff’s position.

The Court of Appeal affirmed the trial court’s judgment for the defense, finding that the trial court did not err in accepting defendants’ experts opinions that the products qualify for exemption from Proposition 65 warnings under the safe harbor for lead.  In reaching this result, the Court accepted the defense expert’s use of government survey data for determining consumption rates of average consumers under Proposition 65, and accepted averaging the data over time using a geometric mean. 

The Court also noted the defense expert’s opinion that there is no scientific theory to support a claim that exposure to lead on a single day could cause reproductive or developmental harm, that plaintiff’s expert had conceded that low level lead exposure does not cause birth defects, and that Proposition 65 regulations do not require exposures to be assessed based on a single day.  The Court observed that the Proposition 65 statute and regulations support averaging for MADL determinations, and that the California Attorney General’s expert’s opinion to the contrary was not supported by any authorized OEHHA policy. 

Although it was not an issue on appeal, the Court also noted a defense expert’s testimony that “serving sizes found on product labels are not a reliable source of information” for estimating lead exposure consumption rates, and that “it is undisputed that the challenged products are not typically eaten on a daily basis.”  Given the affirmance based on the safe harbor exemption, the Court did not reach the question presented by defendants’ cross appeal – whether the trial court erred in finding that the defense had not established the “naturally occurring” exemption.

Additional Appellate Guidance for Proposition 65 Compliance

The Beech-Nut ruling provides businesses with additional clarity concerning applicable standards for determining whether potential exposures are below the “safe harbor,” or below the NSRL or MADL for chemicals where OEHHA has not determined a safe harbor, and therefore exempt from Proposition 65 warning requirements.  The ruling should also place limits on the ability of plaintiffs to seek to impose Proposition 65 warning requirements for trace levels of chemicals that pose no significant risk from exposure.  

Companies distributing products in California that contain listed chemicals still have the burden for conducting the analysis to make this determination if they seek to rely on this exemption.  Alternatively, businesses can continue to provide warnings for products that pose the potential for exposure to a listed chemical, or can consider reformulating the product to reduce or eliminate the chemical.

The plaintiff in Beech-Nut could seek review of this decision by the California Supreme Court.  However, the Court of Appeal opinion is well-reasoned and based directly on the language of the Proposition 65 regulations and generally accepted scientific principles.  Moreover, the California Supreme Court has previously acknowledged that Proposition 65 can result in “over-warning” of consumers.[8]


[1] __Cal.App.4th__, Docket No. A139821 (First Appellate District, March 17, 2015).

[2] Cal. Health & Safety Code §§ 25249.5-25249.13

[3] Cal. Health & Safety Code §§ 25249.6, 25249.11(b).

[4] Cal. Health & Safety Code § 25249.10; 27 Cal. Code of Regs § 25501.

[5] 27 Cal. Code of Regs §§ 25701-721, 25801-821.

[6] Cal. Health & Safety Code § 25249.10(c).

[7] Environmental Law Foundation v. Beech-Nut, et al., No. RG11597384 (Ca. Sup. Ct., Alameda County).

[8]  See Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal.4th 910, 932-35 (2004), observing that “the problems of overwarning are exacerbated if warnings must be given even as to very remote risks.”