Two recent cases represent a significant win for the food industry. These holdings reaffirm the correct way to ensure compliance and calculate exposure to chemicals listed under California’s Proposition 65 right-to-know warning law. If these decisions had adopted the plaintiff’s inflexible and extreme method of exposure assessment, it would have resulted in an explosion of the already too many unnecessary prophylactic warnings on many foods sold in the state and, given California’s size, the country and beyond.

Proposition 65

Proposition 65 was a ballot initiative enacted by the voters in 1986. The law, known as the “Safe Drinking Water and Toxic Enforcement Act of 1986 (CA Health & Safety Code § 25249.6), requires companies doing business in California that expose consumers to two endpoints—carcinogens or reproductive toxins—in products or food to provide a warning unless the defendant can prove no warning is required for the chemical in question. A defendant can win if it can prove the consumer’s exposure to the specific Prop 65-listed chemical does not exceed a level requiring a warning. There are almost 1,000 chemicals listed currently.

For chemicals causing reproductive harm, the law provides that a defense exists if the company can show “the exposure will have no observable effect assuming exposure at one thousand (1,000) times the level in question for substances known to the state to cause reproductive toxicity, based on evidence and standards of comparable scientific validity to the evidence and standards which form the scientific basis for the listing of such chemical. . ..” (Italics in original.) 

Few Prop 65 Cases go to Trial Because of the Expense and Risk

Less than 5% of Proposition 65 cases have made it to trial throughout the law’s 38 years. Defending and trying these cases is both expensive and risky. This has resulted in many foods sold in California carrying warnings as a prophylactic measure even though they are completely safe to eat. Going to trial means a defendant must retain experts such as toxicologists and food scientists who then conduct “exposure assessments” to determine whether exposure to the chemical in the food or product exceeds the “safe harbor” level established by the state (or proven by defense experts) for that chemical. In addition to that expense, the risk in litigating these cases is penalties and attorneys’ fees. Prop 65 imposes penalties of up to $2,500 per violation and requires the party who loses at trial, or who settles, pay the plaintiff’s attorney’s fees and costs in addition to penalties.  

The Defense Wins Two Prop 65 Food Cases

Two defendants refused to settle and took their cases to trial—and won. Both judges rejected plaintiff private enforcer’s (“bounty hunter”) theories across the board. (Proposition 65 cases are decided by judges and not juries.)

In March, 2024, Los Angeles Superior Court Judge Elihu Berle entered judgment for a large rice manufacturer following a three-week bench trial in the case Consumer Advocacy Group, Inc. v. Gulf Pacific Rice Co. Case No. BC556594. The court ruled defendant proved its defense and that the exposure to the average consumer of the chemical lead found naturally in rice did not rise to the level requiring a warning. Plaintiff may appeal, though it would all but certainly be denied. 

The second case was brought by the same plaintiff and was tried in November 2023, and involved lead in the spice turmeric. Plaintiff made the same arguments and was met with a decision in favor of the defendant spice company. Consumer Advocacy Group, Inc. v. Ross Dress for Less, Inc., Los Angeles Superior Court Case No. 19STCV38610. Judgment was entered on May 6, 2024. It is unlikely to be appealed.

How to Calculate Consumption by the Average Consumer

The rulings in both cases made clear how food exposure assessments in food Prop 65 cases are to be conducted and firmly rejected alternative methods proposed by the plaintiff. Those methods would have dealt a huge blow to food manufacturers, distributors and retailers who sell products in California. The question presented in both cases was how does one calculate the average consumer’s exposure to lead from consuming the rice or spice in question and prove that the exposure is below the state’s established safe harbor level? In finding that exposure to lead from consuming these defendants’ foods fell below this level that would have required a warning, the judges agreed with the calculations and interpretation of the regulations offered by the defense experts.

Both judges ruled in favor of the defense regarding the correct method for measuring consumption. The Prop 65 regulations identify a specific government food survey database to be used absent better data—the U.S. Center for Disease Control and Prevention's National Center for Health Statistics' National Health and & Nutrition Examination Survey (NHANES). Because it would be fatal to its case if it had to use the database, the plaintiff argued that it had better methods to calculate consumption which it claimed would show people ate a lot more. The judges, however, disagreed and affirmed the correct method was the NHANES database, the one defense experts used. And it is also the same one the FDA and the California agency that writes the Proposition 65 regulations use. Both judges found that the plaintiff’s alternative data was not scientifically valid nor workable for food assessment, much less superior to the data the defense used from NHANES.

Exposure Assessment is Based on Average Population and Not One Group

The judges also rejected plaintiff’s novel theory of “ethnic subpopulations.” Plaintiff claimed that Prop 65 allowed for the option of calculating consumption of a food based only on one ethnicity’s eating habits—in this case Asians. It argued that because Asians allegedly eat more rice than other ethnicities they should be considered the average consumer under the law. If that were the case, the exposure to lead from eating rice would exceed the safe harbor given the consumption data that plaintiff sought to use would supposedly be much higher than that of the rest of the population. Plaintiff offered no scientifically valid basis for its assumptions and conclusions. Regardless, nothing in Proposition 65 allows calculation by just one group or ethnicity and the judge rejected the theory, noting the language of the regulations is clear that average consumer specified in the regulations means average of the entire population that consumes the product. Using true average data, which includes Asians and all ethnicities, as well as frequent and heavy eaters, is the appropriate way to calculate exposure.

In the spice case, the judge held that, even if a food exposure assessment could consider a specific subpopulation based on ethnicity when calculating the amount of the food consumed, the evidence presented at trial to support such a theory was ”wholly deficient and inherently unreliable.” Plaintiff argued another method could be used—extrapolating and making various assumptions about spices from import/export data. The court rejected this novel theory and found it irrelevant and inadmissible.

Averaging Across Multiple Lots is Valid and One Test is Not

How many samples must be tested to have a reliable, scientifically appropriate result? The plaintiff claimed in both cases just one test result of one container or bag was enough to show it met its initial burden so as to require the defendant to prove its defense. Because lead does not distribute evenly in products such as rice or spice, and because one test result cannot be validated as accurate, the judges ruled that one test was not enough to shift the burden to a defendant. Both agreed with the defense experts that multiple test results averaged by geometric mean from multiple lots of product was the scientifically acceptable way to calculate the value of lead in food. The judge in the rice case held that, “use of the geometric mean, rather than arithmetic mean, is more appropriate in calculating average amounts of lead in rice because it reduces the effect of ‘outlier’ test.” The judge in the spice case ruled that relying on one test “was novel and not generally accepted by the scientific community,” and found the testimony based on one test result inadmissible. 

Both judges agreed that the averaging was appropriate under the one appellate case to consider the issue, Environmental Law Foundation v. Beech-Nut Nutrition Corp. (2015) 235 Cal.App.4th 307. (Beech Nut). The courts reinforcing and following the Beech-Nut case is key as it gives predictability to the exposure assessor when determining whether a warning is required. There remains one more case to be decided on this point (see below).

Impact on Food Industry Goes Beyond Rice and Spice

These decisions have an impact beyond rice and spice, and beyond California. If plaintiff’s theories were adopted, it would upend the entire food industry as lead is, of course, naturally occurring in virtually all foods. The extreme way plaintiff sought to measure lead exposure by focusing on just one ethnic group’s eating habits in the rice case, and in both cases basing test data on just one sample rather than averaging results from multiple lots, would have immediately created compliance issues with all manner of food and beverages sold in California. Foods that are in compliance with the law today would be out of compliance under the new extreme calculation. Possibly most foods sold would be affected. The plaintiff’s position rejecting averaging across lots is counter to testing and manufacturing practices worldwide, whether food or otherwise, and certainly not scientifically sound given the known heterogenicity of lead in foods. 

The end result would be companies making the decision to place yet more Proposition 65 warnings on thousands more foods and beverage products sold in California that are perfectly safe to eat in an effort to prevent the explosion of fresh violation notices that would surely come if such an interpretation were allowed. This makes a mockery of Proposition 65 and its professed goals of informing consumers of potentially hazardous chemicals in their foods. And because of the size of the California market and those who supply it, the plaintiff’s method would almost surely impact the international marketplace.

And to what end? What purpose does it serve if a strict and unrealistic method is adopted? What purpose is served putting still more of these warnings on food? What impact on parents’ buying decisions would unnecessary and alarmist warnings have? On the elderly who should be eating certain foods? Do we trade nutrition for an ineffective warning that some perceive as suggesting danger in simply eating a serving or two of an already safe food? Do we increase our risk if we avoid certain foods? 

Additional Case

In addition to these two cases, there is a third that is currently being tried and involves lead in seven spices. Consumer Advocacy Group, Inc. v. Gel Spice, et al., Los Angeles Superior Court Case BC665798. The trial is not expected to conclude until June and final judgment likely will not be entered until the end of the year. This will be the third trial in two years with the same plaintiff and the same arguments. If the third trial is in the defendant’s favor, and if all cases are upheld on any long-shot appeal, a 0-3 record for the plaintiff from three different judges may very well may spell the end of any serious challenges to how exposure is to be calculated in Prop 65 food cases. It would be a welcome development—and long overdue.