Overview
I am pleased to report we recently secured a win for our client in a Prop 65 food case and this decision is a big deal for defendant food manufacturers. The case is Consumer Advocacy Group, Inc. v. Gulf Pacific Rice Co. (Cal. Super. Ct. 2024 No. BC553427). It involved the chemical lead in rice. On January 19, 2024, Los Angeles Superior Court Judge Elihu Berle entered his decision for the defendant confirming how exposure assessments in food Prop 65 cases are to be conducted, finding: a) exposure is to be calculated based on the average consumption and frequency of consumption by the average consumer using a specific database; b) relying on testing of multiple lots of the product, and not just a single test result, is scientifically more reliable and appropriate; c) calculating the average based on the geometric, and not arithmetic, mean is appropriate for foods containing lead such as rice; and d) a valid food exposure assessment relies on consumption data from all ethnicities who consume the food and not just a specific subpopulation. This decision rejected all of plaintiff's novel and alternative exposure theories. In short, this is a big fat win for the defense.
The Question
The question was, how does one calculate exposure to lead from the rice in question and prove that the exposure is below the state’s established safe harbor level for lead - the level above which warnings are required? In finding that exposure to lead from consuming defendant’s rice fell below this level, Judge Berle interpreted and applied the Prop 65 regulation governing exposure assessments for food. He also followed the exposure assessment methodology endorsed in the key appellate case on food and Prop 65, Beech-Nut Nutrition Corp. (2015) 235 Cal.App.4th 307, as modified on denial of reh’g (Apr. 16, 2015) (lead in baby food and juice). In Beech-Nut, the court addressed many exposure assessment points, but key was its endorsing averaging data across product lots and using the geometric mean for averaging.
The Regulation
Judge Berle analyzed the applicable regulation. 27 California Code of Regulations § 25821(b) provides that, “the level of exposure to a chemical listed as causing reproductive toxicity shall be determined by multiplying the level in question (stated in terms of a concentration of a chemical in a given medium) times the reasonably anticipated rate of exposure for an individual to a given medium. The reasonably anticipated rate of exposure shall be based on the pattern and duration of exposure that is relevant to the reproductive effect which provided the basis for the determination that a chemical is known to the state to cause reproductive toxicity.” [1] The regulation further provides that for food, the rate of intake or exposure shall be based on data for use of a general category or categories of consumer products, such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount Per Day and Per Eating Occasion, where such data are available.” 27 CCR § 25821(c)(2). (Emphasis added.) The database is now called “NHANES.” [2]
Court Applies Regulation and Follows Beech-Nut to Find for Defendant
Defense expert Dr. Barbara J. Petersen conducted a detailed exposure assessment applying the regulation’s requirements and the Beech-Nut methodology. Judge Berle's decision agreed with and adopted Dr. Petersen’s assessment and conclusions, finding that exposure was below the safe harbor warning for lead, ruling:
- To determine the “reasonably anticipated rate of exposure” required in the regulations requires calculating the average consumer’s daily exposure, or average consumption, and the frequency of consumption;
- The NHANES database is the appropriate source for rice consumption data;
- Consistent with the holding in Beech-Nut, averaging across lots and using the geometric mean to derive the value is appropriate;
- Prop 65 assessment requires using more than a single data point and assessments must be based on averages; and
- Exposure assessment based on just one ethnicity is not valid or representative and NHANES already accounts for all subpopulations, ethnicities, gender and sex.
Applying the above, Judge Berle agreed with Dr. Petersen and found that the average consumer’s exposure to lead from the rice product was .01 micrograms a day, well below the safe harbor level of 0.5 micrograms, and that Gulf Pacific’s product was therefore in compliance with Prop 65.
Plaintiff Rejects the Regulation and Beech-Nut
The trial was instructive in that the judge stuck to the Prop 65 regulations and his decision followed the methodology endorsed in the key appellate decision applying them. He rejected plaintiff’s novel theories that relied on sources other than NHANES, and rejected plaintiff’s claim that exposure can be calculated using ethnic subpopulation data. At trial, the plaintiff claimed instead of NHANES, it could rely on small studies related to how much rice Asians ate. Plaintiff claimed that this data, because it focused on Californians, was more appropriate than the 60-year old government NHANES database that relies on data from thousands of participants from all states and not just California. Plaintiff’s argument was that because there are more Asians in California on average than in the U.S. as a whole, the small studies on Asians’ rice consumption (containing numerous flaws) was a better data source than NHANES. Judge Berle rejected this argument and Gulf’s expert testified that California data is already included within the NHANES database and that the data is weighted to ensure the population is adequately represented. It accounts for all ethnicities and consumption and both frequent and infrequent eaters. The regulation does not provide for calculating food exposure based on ethnic, or any, subpopulations. Judge Berle granted motions to strike after trial this novel subpopulation theory and the plaintiff expert who supported it.
Plaintiff Claims One Test Result is Enough
Plaintiff argued that its one test result of one bag of rice was superior to the hundreds of test results Gulf Rice produced because Gulf’s tests could have presumably been of “cleaner” product sent for testing after it received the violation notice, meaning Gulf could have purposely tested product with lower levels of lead after the violation and then relied on these later tests to claim compliance. In addition to this being preposterous, it ignores the fact that companies often cannot test the same lot as from where the noticed product came because an enforcer can wait a year from purchase and then serve the notice of violation. In such a case, by the time a defendant receives a violation notice the product in question has often been sold through. In addition, not all companies keep retain samples for a year, nor is it practicable in many cases to keep a retain from each lot when thousands are made weekly. Hence, as Judge Berle noted, averaging is required in Prop 65 assessments, and averaging results of other lots of the same product as was done in this case is appropriate. Undaunted, plaintiff argued that averaging across lots as endorsed in Beech-Nut was improper as it “dilutes” the lead concentration value of its one test from one bag of rice. Based on the testimony of a chemistry professor who has never worked outside academia, plaintiff asserted that the only way to ensure Prop 65 compliance is testing product purchased from stores in California, i.e., after manufacture and shipping, something that is not necessary and simply not workable in today’s world. Judge Berle granted a motion after trial to strike this expert.
TAKE AWAYS
This decision, by a seasoned judge in the court’s complex litigation department, strengthens the defense of Prop 65 food cases and reinforces the applicability of the Beech-Nut methodology, using NHANES consumption data, and the appropriateness of averaging multiple samples using the geometric mean. These things are critical to companies being able to prove compliance and prevent an enforcer from gaming the system relying on one package from a year before the violation notice. It is also a clear rejection of novel plaintiff theories such as subpopulations that try and calculate exposure ignoring the applicable regulations and case law requiring averaging consumption by the average user. Plaintiffs considering Prop 65 claims against food products need to be aware of this decision and need to compare their exposure analysis to the approved methodology.
This also calls into question the theory of some enforcers who have entered many settlements claiming consumption is not based on average intake, but instead the serving size on a product label, and that the frequency of consumption is every day. This case underscores that this theory is simply not appropriate under the regulations or Beech-Nut.
[1] While the plaintiff alleged that a warning was required for both Prop 65 endpoints – reproductive harm and cancer – the safe harbor level for reproductive harm from lead is lower than that for cancer so this lower number is the basis of the analysis.
[2] “NHANES” is short for the National Health and Nutrition Examination Survey administered by the CDC. NHANES is the successor government database to the one identified in the regulation.
