By Ann Grimaldi, Principal and Founder of Grimaldi Law Offices in San Francisco, California. Grimaldi Law Offices counsels clients on chemical and product regulatory compliance and defends them in enforcement actions.

For nearly thirty years, two questions have dogged companies undertaking Proposition 65 exposure analyses:  (1) may a company average the results of product testing to determine the amount of a listed chemical in a product; and (2) may a company average the exposure to a listed reproductive toxicant?  The answers to these questions are critical for both pre-enforcement exposure analyses and for establishing a key statutory defense to a Proposition 65 enforcement action.

In a much anticipated decision and a vindication for Proposition 65 defendants, the California Court of Appeal in Environmental Law Foundation v. Beech-Nut Nutrition Corporation, et al.1 has answered “yes” to both questions.  However, lest members of the regulated community celebrate too soon, they should take note:  a separate lawsuit against the Office of Environmental Health Hazard Assessment (“OEHHA”) threatens to undo the Court of Appeal’s good work.

In 2011, plaintiff Environmental Law Foundation (“ELF”) filed a lawsuit against numerous manufacturers, distributors, and retailers of certain baby foods and juices.2  ELF alleged that defendants knowingly and intentionally exposed consumers to lead in these products without a warning, thereby violating Proposition 65.  ELF sought injunctive relief and civil penalties.

Passed in 1986 as a California voter initiative, Proposition 65 (formally known as the “Safe Drinking Water and Toxic Enforcement Act of 1986”) requires the California Governor, through OEHHA, to list chemicals known to the State of California to cause cancer or reproductive harm.3  Although the law also prohibits the discharge of such chemicals into sources of drinking water, Proposition 65 is best known for its warning requirement.4  Under that provision, businesses are prohibited from knowingly and intentionally exposing individuals to a listed chemical without first providing “clear and reasonable” warnings.  Violators are subject to civil penalties of up to $2500 per day of violation as well as injunctive relief.5

The law is enforceable through civil lawsuits filed by specified public authorities like the California Attorney General.6  However, the vast majority of enforcement actions are filed directly by plaintiffs’ attorneys or private actors, like ELF, “in the public interest” pursuant to the law’s citizen-suit provision.7

Proposition 65 provides numerous incentives for citizen suits.  Private litigants are entitled to 25% of civil penalties imposed8and, under a separate California law, may be reimbursed for their reasonable attorneys’ fees if certain requirements are met.9    These monetary incentives have sustained a robust litigation cottage industry targeting thousands of companies throughout the United States and internationally, in broadly diverse industries ranging from dietary supplements to hand tools, from fashion accessories to cosmetics.  With almost 900 chemicals on the Proposition 65 list including common chemicals like heavy metals, there is almost no limit to what industry or entity may be targeted by a Proposition 65 citizen suit.

In ELF v. Beech-Nut, the parties stipulated that ELF would be deemed to have met its burden of proof with respect to its affirmative case.10    Thus, the burden was immediately shifted to the defendants to prove their statutory affirmative defenses, including the statutory defense that no warnings were required for the products.11 Section 25249.10(c) of Proposition 65 exempts from the warning requirement exposures below the “no significant risk level” or NSRL (for listed carcinogens) or below the “maximum acceptable dosage level” or MADL (for listed reproductive toxicants).  Although lead is listed as both a carcinogen and a reproductive toxicant, the lead MADL drives Proposition 65 litigation, because at 0.5 micrograms per day, it is much lower than the lead NSRL of 15 micrograms per day.

Calculating exposure levels under Proposition 65 is deceptively difficult, with each step of the calculation subject to challenge by a plaintiff.  The calculation requires as its starting point the level of the listed chemical in the product.  In ELF v. Beech-Nut, the parties disputed issues as fundamental as whether it is appropriate to average the lead content testing results within a lot and over multiple lots.  ELF, raising the argument that virtually all public and private enforcers have asserted over the last 30 years, argued instead that the highest lead test result should be used.12

The Beech-Nut trial court disagreed and the appellate court affirmed.  First, the appellate court rejected ELF’s argument that OEHHA prohibited such averaging.13  Second, the court identified extensive evidence in the record supporting the trial court’s findings.14

With that issue determined, the court next considered whether exposures to lead may be averaged over time. For nearly three decades, both public and private enforcers have taken the position that a single day of exposure to any Proposition 65 reproductive toxicant above its MADL triggers the warning requirement.  Again, the Court of Appeal upheld the trial court’s rejection of this position based on the extensive factual record.

Acknowledging that the nature of the chemical and its reproductive effect is relevant, the appellate court first rejected ELF’s argument that the lead levels in the subject products could cause harm based on a single day of exposure.15   The court based its conclusion in part on defendants’ expert testimony regarding the mode of action of lead, i.e., that lead exposures must be high enough to raise the levels of lead in the maternal blood sufficiently so as to affect the developing fetus.16  In this regard, the court observed that eight weeks would be the shortest period during which an exposure to lead at levels detected in the products would be expected to have an adverse reproductive effect.17 Notwithstanding that observation, the court relied on defendants’ evidence that a 14-day averaging period was appropriate based on the frequency of consumption of the subject products.18  That frequency of consumption information, in turn, was based on the well-recognized National Health and Nutrition Examination Survey (“NHANES”) and National Eating Trends (“NET”) survey.19

The appellate court rejected ELF’s arguments that OEHHA policy and regulations prohibited defendants from averaging exposures.  It found that the regulations specifically permitted averaging and that OEHHA did not have a formal policy on the question.20  As to the latter issue, the court rejected testimony from the Senior Toxicologist of OEHHA’s Reproductive and Cancer Hazard Assessment Branch that purportedly established that the agency prohibited the averaging practice.21

Based on the average levels of lead in the subject products, and by averaging the exposures to lead in those products, the defendants’ calculated exposures to lead fell below the lead MADL of 0.5 micrograms per day.22  With no legal or scientific error on which to premise an opposite conclusion, the trial court ruled that Proposition 65 did not mandate warnings and the appellate court upheld that ruling.23

Because ELF challenged the trial court’s findings of fact, the appellate court’s review was “the familiar and highly deferential substantial evidence standard of review,” under which the record is reviewed, in the light most favorable to the prevailing party, to determine whether substantial evidence exists to support the trial court findings even if that evidence is contradicted.24  The defendants’ success in this case thus rested almost entirely on the testimony of their experts and the sufficiency of the evidence they introduced at the 11-day trial.  Proposition 65 defendants should extract a clear lesson from this decision: develop the most robust expert record possible.

Beech-Nut establishes clear guidance on how Proposition 65 exposure analyses may be undertaken.  At a minimum, the opinion establishes that it is appropriate to average chemical test results within product lots and across product lots.  The guidance on this point should also assist in pre-litigation negotiations with Proposition 65 plaintiffs.  And, depending on the specific reproductive toxicant, its mode of action, and the frequency of exposure, it may be appropriate to average exposures over time.  That is what Proposition 65 defendants have always posited, and now in binding precedent an appellate court opinion at last has confirmed it is so.

However, this clear guidance soon may be disrupted by the outcome of a second, unrelated lawsuit—Mateel Environmental Justice Foundation v. OEHHA.25  In that case, the plaintiff—another prolific Proposition 65 bounty hunter—seeks a court order requiring OEHHA to rescind the lead MADL of 0.5 micrograms per day because it allegedly is not based on scientifically valid testing according to generally accepted principles.26  Mateel essentially seeks an even lower MADL for lead.  In addition, Mateel seeks a court order clarifying whether averaging exposures to lead, as per Beech-Nut, is authorized.27  OEHHA has filed a statute of limitations challenge to the action, with a hearing date of June 5, 2015.  Stay tuned.


Ann Grimaldi is Principal and Founder of Grimaldi Law Offices in San Francisco, California.  Grimaldi Law Offices counsels clients on chemical and product regulatory compliance and defends them in enforcement actions.

  1. 235 Cal.App.4th 307 (2015).
  2. Environmental Law Foundation v. Beech-Nut Corp. et al., Alameda County Superior Court Case No. RG 11597384.
  3. Cal. Health & Safety Code § 25249.8.
  4. Cal. Health & Safety Code § 25249.5 (discharge prohibition); Cal. Health & Safety Code §25249.6 (warning requirement).
  5. Cal. Health & Safety Code § 25249.7(b)(1).
  6. Cal. Health & Safety Code § 25249.7(c).
  7. Cal. Health & Safety Code § 25249.7(d).
  8. Cal. Health & Safety Code § 25249.12(c).
  9. Cal. Code of Civil Procedure § 1021.5.  The California Attorney General’s office, in its capacity of supervising private Proposition 65 enforcement, maintains information regarding private Proposition 65 enforcement.  According to the Attorney General’s website, for 2013, a fairly typical year and the last year for which such data is available:

    • 22 plaintiffs represented by 17 law firms obtained 352 settlements;
    • Those settlements resulted in total payments to plaintiffs of approximately $17,400,000; and
    • 73% of those payments were for plaintiff’s attorneys’ fees.

  10. 235 Cal.App.4th at 314.
  11. The other available statutory exemptions are relatively narrow:  warnings are not required where federal law specifically preempts Proposition 65 requirements, and no warnings are required for exposures occurring in the one-year period after a chemical is first listed.  Cal. Health & Safety § 25249.10(a), (b).
  12. 235 Cal.App.4th at 323.
  13. Id. at 324-325.
  14. Id. at 325-326.
  15. Id. at 327.
  16. Id. at 329; see also id. at 316-318.
  17. Id. at 328.
  18. Id.
  19. Id. at 315-316.
  20. Id. at 327-328.
  21. Id. at 321-322, 329.
  22. Id. at 327.
  23. Id. at 329.
  24. Id. at 322-323.
  25. Mateel Environmental Justice Foundation v. California Office of Environmental Health Hazard Assessment, Alameda County Superior Court Case No. RG 15754547.
  26. First Amended Verified Petition for Writ of Mandate and Complaint for Declaratory Relief and Injunction, Prayers for Relief and related allegations.
  27. Id.