Recent attempts to modify California’s Safe Drinking Water and Toxic Enforcement Act of 1986, Proposition 65, have been the work of the California Legislature.  (See A Sane Tweak To Proposition 65 and California Reenters the GMO Food Labeling Arena – This Time Through The Legislature).  This past week, however, the California Appellate Court for the First District in Environmental Law Foundation (ELF) v. Beech-Nut Nutrition Corp., 2015 B.L. 72035, (Cal. Ct. Ap., No. A139821, 3/17/15) upheld a trial judge who determined, after entertaining extensive expert testimony, that low levels of lead in products including baby food, fruit juice and packaged food do not produce exposures that trigger a requirement for warnings under Proposition 65.

The Beech-Nut case is one of the few situations where a Proposition 65 plaintiffs’ group has had to litigate what triggers a requirement for warnings under the law.  In this case, the court held that the manufacturers met their burden of proof.

Underlying Action:

On September 28, 2011, ELF filed a Proposition 65 action alleging that the manufacturers of foods intended predominantly for babies and toddlers contain lead such that clear and reasonable warnings were required.

Prior to trial, the parties did not dispute that the defendants’ products contained small amounts of lead, an element identified by the State of California to cause cancer and reproductive harm.  The parties also agreed to exchange test data concerning the concentration of lead measured in each of the products.

The trial commenced in March, 2013 based primarily on legal arguments and expert witness testimony.  The manufacturers raised three arguments as to why no warnings were required for their products:

  1. Any such warnings are preempted by federal law;
  2. The lead in their products is “naturally occurring” and therefore does not constitute an “exposure” under Proposition 65; and
  3. The exposures at issue fall below the regulatory “Safe Harbor” level for lead of 0.5µg/day.

The trial court rejected arguments (1) and (2) but focused on the “Safe Harbor” exemption.  That exemption applies when exposure to a chemical is 1,000 times lower than the highest level at which there is no observable reproductive effect.  The trial court found that the expert testimony and analysis presented by the manufacturers to be “far more persuasive” than ELF’s analysis and entered judgment in favor of the manufacturers.

Appeal:

The First District Court of Appeal in California held that it was the defendant’s burden to show, by a preponderance of the evidence,  that the levels of lead in their products fall within the regulatory safe harbor.  ELF claimed that the trial court erred in interpreting the relevant regulations so as to allow defendants to average test results over multiple lots, instead of evaluating each lot individually.  The Appellate Court rejected ELF’s interpretation and accepted the opinion of the manufacturers’ toxicology expert that the levels of lead in their products were insufficient to cause reproductive harm based on a single day of exposure.  ELF also argued that the trial court should not have allowed manufacturers’ expert to average test results from multiple lots of a product.  The Appellate Court rejected this argument as well.

The Appellate Court acknowledged that lead is a toxic metal that, even at low levels, may cause a range of health effects, including behavioral problems and learning disabilities.  Lead has been identified as a known carcinogen and reproductive toxin under Proposition 65.  Notwithstanding that, the court accepted the manufacturers’ expert testimony that the regulatory safe harbor level for carcinogenicity as well as reproductive toxicity for lead was met by the products at issue.

Significance of Ruling:

This case attracted a lot of attention from both the State of California and industry.  The Attorney General’s office submitted an amicus brief supporting ELF’s position suit.  The case attracted Friend of the Court briefs from various environmental groups and associations representing food producers and processors and grocers.

It appears from the listing of defendants as well as companies that filed Friend of the Court briefs on behalf of the defendants, that the companies had the financial wherewithal and the will to “fight the fight.”

The importance of this ruling is that it places science and scientific evidence as the first line of defense in Proposition 65 cases.

It must be cautioned, however, that litigation over lead in food is not over in California whether or not this opinion is appealed to the California Supreme Court.  An action filed in California on January 13, 2015 seeks to force the State of California to rescind its safe harbor of 0.5µg/day for lead, which was set in 1992.  The Proposition 65 plaintiff group (Mateel Environmental Justice Foundation) asserts that there is no safe harbor for lead and that a court should direct the California Office of Environmental Health Hazard Assessment to eliminate the safe harbor for lead.