Environmental Law Foundation v. Beech-Nut Nutrition Corp.

Filed 3/17/15

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT

DIVISION ONE

ENVIRONMENTAL LAW

FOUNDATION,

Plaintiff and Appellant, A139821

v. (Alameda County

BEECH-NUT NUTRITION CORP. et al., Super. Ct. No. RG11597384)

Defendants and Appellants.

INTRODUCTION

Plaintiff, the Environmental Law Foundation (ELF), filed a complaint against

Beech-Nut Nutrition Corporation and various other food manufacturers, distributors, and

retailers, seeking enforcement of the provisions of the Safe Drinking Water and Toxic

Enforcement Act of 1986, commonly referred to as Proposition 65 (Health & Saf. Code,

§ 25249.5 et seq.).1 ELF alleged certain of defendants’ products contain toxic amounts of

lead sufficient to trigger the duty to provide warnings to consumers. After a bench trial,

the trial court entered judgment in favor of defendants, concluding they had no duty to

warn because they satisfactorily demonstrated that the average consumer’s reasonably

anticipated rate of exposure to lead from their products falls below relevant regulatory

thresholds. ELF has appealed from the judgment. We affirm.

1

Unless otherwise noted, all statutory references are to the Health and Safety Code.

FACTUAL AND PROCEDURAL BACKGROUND

I. Proposition 65 Warning Requirements and Lead

“Proposition 65, added by voter initiative in 1986, is a ‘right to know’ statute

requiring companies that expose consumers to carcinogens or reproductive toxins to

provide a warning, subject to specified defenses. Section 25249.6 states that ‘[n]o person

in the course of doing business shall knowingly and intentionally expose 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, except as provided in Section

25249.10.’ ” (People ex rel. Brown v. Tri-Union Seafoods, LLC (2009) 171 Cal.App.4th

1549, 1555 (Tri-Union).)

Lead is a toxic metal that, even at low levels, may cause a range of health effects,

including behavioral problems and learning disabilities. Young children are most at risk

because their brains are developing. According to the United States Food and Drug

Administration (FDA), lead is present in small amounts throughout the environment due

to its natural occurrence and its release into the environment by human activities. Lead in

soil can be deposited on or absorbed by plants, including plants grown for food. Lead

that gets in or on the plant cannot always be completely removed by washing or other

steps in the processing of the food.

Lead has been identified as a known carcinogen and reproductive toxin under

Proposition 65. “The Act is enforced in accordance with regulations promulgated by the

Office of Environmental Health Hazard Assessment [OEHHA], the primary agency that

implements the Act. [Citations.]” (Consumer Cause, Inc. v. Smilecare (2001)

91 Cal.App.4th 454, 463-464.) Under California Code of Regulations, title 27

(Regulations), section 25821, subdivision (a),2 “[t]he procedures for calculating the

2

Subsequent references to Regulations are to the Proposition 65 regulations of title 27 of

the California Code of Regulations.

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exposure to a chemical in food start with the quantification of the ‘chemical

concentration of a listed chemical for the exposure in question.’ [Citation.] This

concentration is called the ‘ “level in question.” ’ [Citation.] The level in question is

then multiplied by ‘the reasonably anticipated rate of exposure for an individual’ to the

food. [Citation.] This rate of exposure must be ‘based on the pattern and duration of

exposure that is relevant to the reproductive effect’ which formed the basis for listing the

chemical as causing reproductive toxicity. [Citation.] Thus, an ‘exposure of short

duration’ is the appropriate frame of reference for a teratogenic chemical. [Citation.] A

teratogen is a chemical that can cause birth defects.” (Tri-Union, supra, 171 Cal.App.4th

at p. 1556.)

Section 25249.10, subdivision (c), provides that the warning requirements of

section 25249.6 do not apply to an exposure to a listed chemical if “the person

responsible can show . . . that 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 added.) This exemption is sometimes referred to

as the “safe harbor” defense. (DiPirro v. Bondo Corp. (2007) 153 Cal.App.4th 150, 191

(DiPirro).)

“The ‘no observable effect level,’ or NOEL, is a scientific term denoting the

maximum dose level at which a chemical is found to have no observable reproductive

effect. [Citation.] The NOEL is determined through scientific inquiry and assessment as

detailed in the framework set forth in the regulations. [Citations.] In turn, the NOEL is

divided by 1,000 to arrive at the maximum allowable dose level (MADL), which is the

threshold warning level for a listed chemical. [Citations.]” (Tri-Union, supra,

171 Cal.App.4th at p. 1555.) Thus, the MADL is set as one one-thousandth of the

NOEL. “At trial, a defendant can secure the protection of the exposure exemption by

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establishing (1) the NOEL; (2) the level of exposure in question, and ultimately that the

level of exposure was 1,000 times below the NOEL. [Citations.]” (Id. at p. 1556.)

The OEHHA has already determined the MADL for lead. The regulations set the

“safe harbor” warning threshold for carcinogenicity as to lead at 15 micrograms per day.

(Regulations, § 25705.) The regulatory safe harbor level for reproductive toxicity for

lead is 0.5 micrograms per day. (Id., § 25805, subd. (b).) The OEHHA relied on the

United States Occupational Safety and Health Administration’s (OSHA) Permissible

Exposure Limit (PEL) to establish the reproductive safe harbor level. OEHHA

multiplied the OSHA PEL of 50 micrograms per cubic meter by 10 cubic meters (the

amount OEHHA determined workers breathed over an eight-hour period) to yield a value

of 500 micrograms, which it then divided by 1,000 to arrive at the 0.5 microgram-per-day

standard.

II. Procedural History

On September 28, 2011, ELF filed suit against defendants seeking injunctive relief

and civil penalties arising from defendants’ alleged knowing and intentional exposure of

consumers to lead-containing products without providing clear and reasonable warnings,

in violation of Proposition 65. The products in question include foods intended

predominantly or exclusively for babies and toddlers, such as baby foods, fruit juice, and

packaged peaches, pears, and fruit cups.

Prior to trial, the parties stipulated that ELF would be deemed to have met its

burden of proof with respect to its affirmative case. The parties did not dispute that

defendants’ products contain small amounts of lead, an element known to the State of

California to cause cancer and reproductive harm. They also agreed to exchange test data

concerning the concentration of lead measured in each of the products.

In March 2013, the parties submitted trial briefs and their expert witnesses’ direct

testimony. This testimony was presented in the form of sworn declarations accompanied

by the evidence and literature on which the experts relied. In their brief, defendants

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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 in question fall below the regulatory “safe harbor” level for lead of 0.5

micrograms per day. Live testimony consisting of cross- and redirect examination of the

parties’ expert witnesses (and testimony from one percipient witness) began on April 8,

2013, and concluded after 11 trial days.

III. Testimony And Evidence

A. Defendants’ Case

1. Dr. Barbara Petersen

Dr. Barbara Petersen is a nutritional biochemist. She has conducted food-related

exposure analyses for more than 30 years and has done over 1,000 such studies, including

work for the United Nations’ Food and Agriculture Organization and the World Health

Organization. For this case, she prepared an analysis to determine the average

consumer’s exposure to lead from each of the products at issue. She was provided with

data from over 2,000 individual lead samples. She also obtained data concerning the

amounts of the products eaten by average consumers, and the associated frequency with

which the products are typically consumed over a two-week period.

Petersen used three types, or “buckets,” of data to arrive at the average consumer’s

lead intake per day for each of the food products at issue: (1) the average lead levels in

the food products, (2) the average amounts of the food products consumed per eating

occasion, and (3) the average number of eating occasions on which the products are

consumed. She then multiplied the three figures together to determine the average

consumer’s level of exposure to lead. Her results showed the exposure levels

consistently fell below the safe harbor level of 0.5 micrograms per day. The average

user’s daily intake of lead from the consumption of each of the products was shown to

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range from 0.001 micrograms to 0.42 micrograms, depending on the company and

product type in question.

The underlying data used to calculate the average lead levels was derived from the

data exchanged between the parties, including data from ELF. Petersen stated that she

averaged the data samples taken from each product to provide a reliable estimate of that

product’s lead content. Single samples are less accurate because lead adheres differently

to the different nutritional components of food. Additionally, lead is not homogenous

within a product because it is held in suspension, not in solution. Because of these

variables it is necessary to average data points in order to obtain a reasonable and reliable

estimate of the actual lead levels in each product.

Petersen also relied on the U.S. Centers for Disease Control and Prevention

National Center for Health Statistics’ National Health and Nutrition Examination Survey

(NHANES) database. The common name for this survey is “What We Eat in America.”

What We Eat in America is prepared by workers who interview household members and

collect their food consumption data over a two-day period. ELF’s expert Dr. Britt

Burton-Freeman used this same data in preparing her analysis. Petersen testified that

food consumption data is not plotted in a bell-shaped curve. Instead, it has peaks due to

the presence of some high consumers. These peaks will distort the overall estimate if

they are not properly accounted for. She elected to average the food consumption data

because she was trying to estimate the lead exposure for the typical consumer. She stated

the serving sizes found on product labels are not a reliable source of information for this

purpose.

Petersen used the National Eating Trends (NET) survey to determine the

frequency of consumption of the products. The survey method for the NET asks

respondents to keep a food diary that covers a 14-day period. Petersen combined the

NET and What We Eat In America because they both are conducted nationwide and

collect information for thousands of foods. They also both contain estimates for children

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under two years of age. The FDA has contracted with Petersen’s firm to prepare software

so that it can use the NET in tandem with What We Eat In America. The tools her firm

has designed to capture information from both surveys have been tested and validated.

In her analysis for this case, Petersen computed averages using the geometric

mean, not the arithmetic mean.3 When she first analyzed the data, she observed there

were some high numbers that skewed the data such that they were “log normally

distributed.” Her decision to use the geometric mean was based on her conclusion that

the data were not “normally distributed,” that is, they did not follow the standard bell-

shaped curve but were instead “log normally distributed.” It is possible to verify this type

of distribution by comparing the geometric and arithmetic means. If the geometric mean

is lower than the arithmetic mean, this indicates that the data were logged normal. If the

two measurements are the same, then the data were normally distributed. She explained

that the geometric mean is widely used in scientific analyses of log normal distributions,

including studies relating to Proposition 65, to ensure that exposure estimates reliably

reflect an accurate average.

2. Dr. F. Jay Murray

Dr. F. Jay Murray is a consulting toxicologist for business and government

agencies. He served for three years on the Proposition 65 Scientific Advisory Panel.

Murray testified that blood lead levels are the primary biomarker for lead

exposure. Because of the long half-life of lead and the stability of blood lead levels, low-

level exposures to lead must be analyzed over an extended period of time. Measurement

of the pattern and duration of exposure to lead should be analyzed over at least a 30-day

period. Petersen’s exposure analysis was limited to a two-week period, which is even

3

The parties agreed that: “A geometric mean is a type of mean or average of a set of

numbers which is derived by taking the nth root the product being the result of

multiplying together all numbers in a dataset.” An “arithmetic mean” is “the sum of

values of a set of data points divided by the number of data points in the set.”

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more conservative. Murray opined that lead does have a clearly identified safe threshold

level; however, the thresholds for some health effects of lead have not been reliably

established to date. He admitted there is some evidence that prenatal exposure to lead

causes measurable neurologic effects in children, and that a single exposure to lead can

impact blood lead levels if there is a high enough dose. He also acknowledged that lead

stored in our bones can be released into the blood and impact blood lead levels. About 73

percent of the lead in children’s bodies is stored in their bones.

In conducting his own risk assessments, Murray relies on the safe harbor level

established by the state and the NOEL that is used to establish the MADL. The

reproductive safe harbor level presumes that one can be exposed to a thousand times the

safe harbor level without suffering any adverse reproductive effects. The OEHHA has

not taken a position as to whether averaging exposures to lead is appropriate when

performing evaluations under Proposition 65. Murray opined that there is no reasonable

scientific theory to support a claim that the exposure to lead from the consumption of

defendants’ products on a single day could cause adverse reproductive or developmental

impacts.

3. Barbara D. Beck

Barbara D. Beck is a board-certified toxicologist. In her work, she has analyzed

scientific literature to calculate the dose of chemicals the body receives under different

exposure scenarios, and to predict likelihood of health effects attributable to such

exposures. In the present case, she was asked to assess the quantitative impacts on blood

lead and bone lead of consumption of defendants’ products as compared to the safe

harbor level of lead, using modeling to quantify the impacts and conduct this comparison.

Specifically, she was asked to test ELF’s expert’s assertion that exposure to a single dose

of lead from defendants’ products will result in a higher blood lead level than if that same

dose is spread over time.

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The models Beck used in her analysis are known as the O’Flaherty model and the

Leggett model, which also known as the ICRP model. Both models can analyze the

impact of intermittent exposures on blood lead or bone lead. She had to use both models

because the O’Flaherty model cannot be used for intermittent exposures over the period

of gestation.

Modeling was performed for products containing the highest average value of lead

in each of three food categories (packaged fruit, juice, and baby food). The models were

based on Petersen’s food intake data for the average consumer over a 14-day period. In

each case, the impact on blood lead and bone lead from actual consumption for the

products produced results that were the same, or slightly lower than, the impact from

daily consumption of a food containing lead at the MADL level. Modeling was

performed on two female age groups (average 21-year-olds and average 28-year-olds)

and four-month-old children under several exposure scenarios.

Blood lead modeling is used because lead exposure is best understood based on

how much a particular dose affects blood lead level. The dose in food is not a direct

indication of blood lead level. A model is needed to predict that level. Health effects of

lead are also evaluated based on blood lead levels. The Proposition 65 MADL value is

based on the OSHA permissible exposure level, which is ultimately based on blood lead

levels. Here, the models showed the exposures, even the peaks arising from a single

exposure, do not exceed the blood level amounts associated with the safe harbor. Even

when Beck modeled using Burton-Freeman’s analysis, the levels did not exceed the safe

harbor blood lead levels.

4. Dr. Carl Keen

Dr. Carl Keen is developmental nutritionist and professor of nutrition and internal

medicine in the Department of Nutrition at University of California at Davis. He has

done significant research on the impact that maternal nutrition has on embryonic and fetal

development. He also served for 19 years as a member of the Developmental and

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Reproductive Toxin Committee for the OEHHA. The committee provides OEHHA with

scientific expertise on issues related to the putative reproductive toxicities of select

metals and compounds that have been identified by the state as being of potential concern

with respect to reproductive risk.

Keen testified that the developmental harm caused by lead has never been isolated

to a specific day or period during pregnancy. Scientific literature does not suggest that

short, one-day exposures at levels such as those at issue here cause an increase in

maternal blood lead levels. It is a scientifically sound and well-accepted practice to

evaluate the effects of exposure to lead at the levels seen in food products based on the

frequency with which they are consumed over an extended period of time.

B. ELF’s Case

1. Dr. Howard Hu

Dr. Howard Hu holds an M.D. from the Albert Einstein College of Medicine and a

Sc.D. in Epidemiology from the Harvard School of Public Health. He has devoted much

of his professional career to studying the adverse health effects that can result from

exposure to lead. Hu opined that when performing an exposure assessment under

Proposition 65, one should not average a consumer’s lead exposure across several days or

weeks. He also opined that the level of lead in defendants’ products is not safe for

consumers and should be reduced. This case is the first in which he was asked to provide

testimony as an expert relating to Proposition 65. On cross-examination, he stated that

low-level lead exposure associated with blood levels less than 10 micrograms per

deciliter is not a “frank teratogen”—that is, it does not cause birth defects. He admitted

Regulations, section 25821 does not state that exposure must be assessed based on a

single day.4

4

Murray disagreed with Hu’s assertion that the OEHHA had “formally adopted the

position” that only one-day exposures should be considered for purposes of compliance

with Proposition 65. Hu’s statement concerned leaded crystal decanters, a product that is

10

For purposes of this litigation, the parties have agreed that the “window of

susceptibility for exposure to lead” shall mean the period of time during which exposure

may cause a reproductive, including developmental, effect. Hu admitted he had not seen

epidemiological literature that identified a window of susceptibility as an interval shorter

than either eight weeks or a single trimester. He also admitted that in animal studies that

administered lead during pregnancy, only one of the studies demonstrated the

reproductive toxicity of a single exposure to lead.

Keen had criticized Hu’s opinion that even a single exposure to lead can cause

reproductive toxicity because the studies Hu relied on involve animals who were given

lead by intravenous injection. When asked about his opinion that “there is now a

consensus among the scientific community that lead does not have a safe threshold,” Hu

admitted that in several cases the authorities that he relied on actually stated that no

clearly established threshold level for lead-induced toxicity had been established. As to

his opinion that the level of lead in defendants’ products is unsafe, he disagreed with the

FDA’s previous conclusion that the level of lead found in defendants’ products does not

pose an unacceptable risk to health. Although Hu has published an article relating to the

OSHA PEL in which he urged OSHA to lower that level, the agency has not acted to do

so. He also disagrees with the OEHHA standard for the NOEL that governs lead

exposure in California.

2. Dr. Britt Burton-Freeman

Dr. Britt Burton-Freeman is the Director of the Center for Nutrition Research for

the Institute for Food Safety and Health. The present case is the first time she has been

designated as an expert witness. She testified on cross-examination that this was the first

exposure analysis she had done for lead. She has never personally assessed the level of

lead in a food product.

inapposite to the products at issue here. His position has never been adopted by OEHHA

in any formal or informal agency communication.

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Burton-Freeman testified that in contrast to Petersen, she would analyze individual

lead dose levels because averaging obscures the presence of higher levels of lead in some

products. In her view, it is important to show the high levels so that one can decide

whether these levels indicate a possible unintended introduction of lead through

manufacturing or other processes. In opining that lead levels should not be averaged, she

did not rely on any scientific observation about how fruit and lead interact with each

other. She did not deny that it is very common for researchers to average the lead

concentrations in food products.

Burton-Freeman used two different kinds of methodologies to assess the level of

exposure of lead in defendants’ products. One method was to define average consumers

as those who consume foods at the 85th percentile. The other method calculated an

eating occasion number and then calculated a frequency number. As to the 85th

percentile, she stated her belief that this method is an appropriate way to measure the

intake of the average consumer because the 85th percentile approximates the serving size

of the products as shown on the FDA’s serving size labels. Although she started from the

same stipulated test data as Petersen, she calculated exposures in a range as high as 0.05

to 29.38 micrograms per day.

Unlike Petersen, Burton-Freeman used the NHANES What We Eat In America

survey only. She did not use the NET. She had never worked with the NET database and

believed that it does not reflect the United States’ population and therefore does not

reflect the average consumer. Even assuming the FDA has determined it is appropriate to

use consumption data from the NHANES and frequency data from the NET in preparing

an exposure analysis, she would still disagree with Petersen’s approach.

Also in contrast to Petersen, Burton-Freeman used the arithmetic mean and not the

geometric mean. In her opinion, the geometric mean is not necessary or appropriate

because it artificially lowers the results. Because she wanted to demonstrate all the

underlying data, she believed no form of normalization should be used, even if the data

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were logged normal. She also used descriptive statistics and not comparative statistics

because she wanted to describe the sets of data, not compare the sets of data to any other

sets of data.

Burton-Freeman agreed the NHANES study is a two-day tool. On the first day, it

identifies a population of everyone who has consumed the product on a particular day.

Nonconsumers are removed from the survey. The second day looks at the number of

people who are repeat consumers of the product. With respect to the food products at

issue in this case, the actual rate of second-day intake is between 10 and 30 percent,

depending on the product. She did not agree that her analysis overestimates consumption

even though the first day in the NHANES study has a total population of 100 percent.

She acknowledged that short-term food studies like the NHANES have been criticized

because they overestimate consumption. She also admitted that her method, which

involved extrapolating principles from the National Cancer Institute’s model and

applying those principles to the NHANES data, has not been validated in any reported

study.

In her testimony, Petersen criticized Burton-Freeman’s use of the 85th percentile.

In her view, it is error to use the 85th percentile analysis because it does not reflect an

average. Petersen had never seen anyone use that measurement as an indication of

average exposures. The 85th percentile is the high end of the distribution.5 Petersen also

5

In its brief on appeal, ELF indicates that the use of the 85th percentile was based on our

approval in DiPirro, supra, 153 Cal.App.4th 150, of a consumption pattern based on

using the 85th percentile to reflect the “average consumer,” rendering Burton-Freeman’s

approach “entirely reasonable and ‘properly protective’ of the consumer under

Proposition 65.” In DiPirro, the trial court accepted a model that included 75 to 85

percent of the users of automobile touch-up paint in determining the exposure of an

average consumer. (Id. at p. 175.) We affirmed the lower court’s finding but did not

suggest that this percentage was relevant in all cases. In fact, we specifically observed

that other standards, including a 95 percent standard, could be appropriate in some cases.

(Id. at p. 194, fn. 30.)

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criticized Burton-Freeman’s work because she relied on the NHANES survey for both

eating occasion and frequency. That survey only covers a two-day period, resulting in

Burton-Freeman assuming that every product was consumed at least once over that time

span. This methodology is flawed because the NET data shows these foods are not eaten

that often. The methodology used by Burton-Freeman would work better for things that

tend to be consumed every day, like coffee or bread.

3. James Donald

James Donald was called by plaintiffs as a percipient witness. He is a senior

toxicologist with the OEHHA and chief of the reproductive toxicology and epidemiology

section.

Donald testified that the safe harbor number is the number OEHHA believes meets

the statutory requirements for exposures that are exempt from the warning requirement.

The OEHHA does not have a policy that differs from the information that is contained in

its publicly available documentation regarding the MADL. The appropriate time frame

of exposure is calculated on a microgram-per-day basis. In Donald’s view, the OEHHA

believes its regulations permit combining days of exposure with days of nonexposure in

determining whether the MADL has been exceeded. However, this approach is not

permitted for purposes analyzing the regulatory safe harbor defense.

On cross-examination, Donald admitted he had not discussed his view on this

point with everyone in the relevant group in OEHHA. In order to find this interpretation

of the regulations, a member of the public would have to call his office and pose the

question to someone there. This policy is not available on the policy page of the

agency’s website. Donald admitted there is no written guideline expressing the policy he

articulated.

IV. Ruling And Statement Of Decision

After closing briefs were filed, the trial court heard closing arguments on May 16,

2013.

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On July 31, 2013, the trial court filed its 45-page statement of decision. The court

determined defendants had not established federal preemption or that the regulatory

“naturally occurring” defense was applicable to their products. The court concluded,

however, that warnings were not required as each of their products was at or below the

regulatory safe harbor exposure level. The court found the expert testimony and analysis

presented by defendants to be “far more persuasive” that ELF’s analysis. For example,

the court rejected Burton-Freeman’s use of the 85th percentile of the NHANES database

“as a proxy for amounts consumed by average users,” instead accepting Petersen’s

average consumption per day calculations based on the geometric mean.

On August 7, 2013, the trial court filed its judgment in favor of defendants. This

appeal followed.6

DISCUSSION

I. Standard of Review

It was defendants’ burden to show, by a preponderance of the evidence, that the

levels of lead in their products fall within the regulatory safe harbor. (Regulations,

§ 25805, subd. (b); Evid. Code, § 115.) “A party required to prove something by a

preponderance of the evidence ‘need prove only that it is more likely to be true than not

true.’ [Citation.] Preponderance of the evidence means ‘ “that the evidence on one side

outweighs, preponderates over, is more than, the evidence on the other side, not

necessarily in number of witnesses or quantity, but in its effect on those to whom it is

addressed.” (Italics added.)’ [Citation.] In other words, the term refers to ‘evidence that

has more convincing force than that opposed to it.’ [Citation.]” (Tri-Union, supra,

171 Cal.App.4th 1549 at p. 1567.)

6

Defendants have filed a protective cross-appeal, contesting the trial court’s rulings in

favor of ELF on the “naturally occurring” and preemption defenses. In light of our

conclusion that the judgment based on the regulatory safe harbor defense should be

affirmed, we need not address the issues raised in the cross-appeal.

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“When findings of fact are challenged on appeal, we are bound by the familiar and

highly deferential substantial evidence standard of review. This standard calls for review

of the entire record to determine whether there is any substantial evidence, contradicted

or not contradicted, to support the findings below. We view the evidence in the light

most favorable to the prevailing party, drawing all reasonable inferences and resolving all

conflicts in its favor. [Citations.]” (Tri-Union, supra, 171 Cal.App.4th 1549 at p. 1567.)

“The substantial evidence rule applies equally to expert and lay testimony. Thus,

expert testimony does not constitute substantial evidence when based on conclusions or

assumptions not supported by evidence in the record [citation], or upon matters not

reasonably relied upon by other experts [citation]. Further, an expert’s opinion testimony

does not achieve the dignity of substantial evidence where the expert bases his or her

conclusion on speculative, remote or conjectural factors. [Citation.] When the trial court

accepts an expert’s ultimate conclusion without critically considering his or her

reasoning, and it appears the conclusion was based on improper or unwarranted matters,

we must reverse the judgment for lack of substantial evidence. [Citation.] On the other

hand, the trial court is free to reject testimony of a party’s expert, so long as the trier does

not do so arbitrarily. [Citation.]” (Tri-Union, supra, 171 Cal.App.4th 1549 at pp. 1567-

1568.)

II. Use Of Averaging Test Results Over Multiple Lots

ELF claims the trial court erred in interpreting the relevant regulations so as to

allow defendants to average lead test results over multiple lots, instead of evaluating each

lot individually. ELF claims the need for a warning should be evaluated independently

for each individual test result on a product including the single highest one, without

regard to the other data in the record on the same product. In support of its contention

ELF asserts that the OEHHA “has explicitly rejected Dr. Petersen’s methodology of

reducing multiple lots into a single average lead concentration instead of considering the

lead concentration of individual lots.”

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As evidence of this rejection, ELF relies on a passage within the OEHHA’s final

statement of reasons (FSOR) for Article 8 of the Proposition 65 regulations: “One

commentator recommended that the regulation provide guidance for determining the

chemical concentration of a listed chemical, since the level of a listed chemical in a

product may fluctuate from unit to unit of production, and specifically recommended that

it refer to ‘level in question’ as the mean or average level of a listed chemical unless

exposure to the listed chemical produced acute adverse reproductive effects as the result

of a brief period of exposure. . . . The Act does not appear to provide a basis for such a

distinction. . . . A consistent interpretation of the words ‘level in question’ appears to be

much less confusing and more consistent with the Act. Accordingly, this

recommendation was not adopted.”

Contrary to ELF’s interpretation, the gist of this passage is not that averaging

contaminants over units of production is impermissible. Rather, the passage reflects the

agency’s view that lending different meanings to the term “level in question” with respect

to chemicals that produce acute adverse reproductive effects, as contrasted with those that

produce chronic effects, would be confusing and inconsistent with the Act. Thus, we do

not read the passage as stating an agency policy that “oppose[s] the use of averages when

determining compliance with food standards.”

Additionally, we do not perceive the method of averaging across lots for a single

product to be the same as “ ‘the deliberate mixing of adulterated food with good food,’ ”

a strategy that ELF correctly notes has been rejected by the FDA. In the first place, the

present case does not concern adulterated food. As Petersen indicated, and ELF fails to

refute, samples from defendants’ products show various levels of lead not just across

units but within each individual unit depending on how the lead has bonded with the

sample’s constituents. Accordingly, we cannot concur with ELF’s position that

Petersen’s methodology “would allow products with levels above the MADL to be sold

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without a warning based on the fact that other samples of the same product bought by

different consumers were below the MADL.”

ELF next asserts that Regulations, section 25801, subdivision (a), cited by the trial

court in its statement of decision, does not undermine the “prohibition against averaging

across lots.” The cited regulation, on its face, applies to establishing “that a level of

exposure has no observable effect,” not the MADL. The regulation includes the

statement that “[n]othing in this article shall preclude a person from using evidence,

standards, assessment methodologies, principles, assumptions or levels not described in

this article to establish that a level of exposure has no observable effect at one thousand

(1,000) times the level in question.” (Ibid.) As we have indicated, we do not believe

there is a prohibition against averaging across lots. Hence, even if the trial court’s

reliance on Regulations, section 25801, subdivision (a) was erroneous, the error is

harmless.

III. Sufficiency of the Evidence to Support Averaging Across Lots

“Evidence Code section 801 provides: ‘If a witness is testifying as an expert, his

testimony in the form of an opinion is limited to such an opinion as is: [¶] (a) Related to a

subject that is sufficiently beyond common experience that the opinion of an expert

would assist the trier of fact; and [¶] (b) Based on matter . . . that is of a type that

reasonably may be relied upon by an expert in forming an opinion upon the subject to

which his testimony relates, unless an expert is precluded by law from using such matter

as a basis for his opinion.’ (Italics added.) Subdivision (b) clearly permits a court to

determine whether the matter is of a type on which an expert may reasonably rely.”

(Sargon Enterprises, Inc. v. University of Southern California (2012) 55 Cal.4th 747,

769-770.) This statute has been construed to mean “that the matter relied on must

provide a reasonable basis for the particular opinion offered, and that an expert opinion

based on speculation or conjecture is inadmissible.” (Lockheed Litigation Cases (2004)

115 Cal.App.4th 558, 564.)

18

ELF claims there was insufficient evidence to support the use of the methodology

of averaging across lots. ELF contends defendants were required to demonstrate that the

concentration data used to calculate exposure were “adequate in number or representative

as to the numerous various lead contamination sources.” Specifically, ELF states that a

“fatal omission” in Petersen’s opinion “is a lack of any showing that she calculated the

average lead concentration based on data that are scientifically and statistically sound for

this purpose.” 7 It relies on In re Marriage of Riddle (2005) 125 Cal.App.4th 1075, 1082-

1083 for the rather self-evident principle that “[a] sample must be representative of what

is being sampled.”

We first observe this argument was not timely raised in the trial court and may

therefore be deemed forfeited on appeal. (See Locke v. Warner Bros., Inc. (1997)

57 Cal.App.4th 354, 368; see also Johnson v. Greenelsh (2009) 47 Cal.4th 598, 603

[issues not raised in the trial court cannot be raised for the first time on appeal]; Dietz v.

Meisenheimer & Herron (2009) 177 Cal.App.4th 771, 799-800 [appellant asserting error

must have raised the issue in the trial court and given the trial court an opportunity to

correct the error].) While ELF asserts insufficiency of the evidence objections are not

waived even if raised for the first time on appeal, its objection does not go to the

sufficiency of the evidence but instead argues that Petersen used a statistically flawed

7

Amicus Curiae Mateel Environmental Justice Foundation requests that we take judicial

notice of the following mathematical principles: (1) Under the laws of statistical

inference and probability an estimate of a population parameter from a randomly selected

sample necessarily contains random error which can be estimated and expressed in a

confidence interval; and (2) the geometric mean is always smaller than the arithmetic

mean, except in the special case where all the data are exactly the same. We grant the

request. (Evid. Code, § 452, subd. (h), 459, subd. (a); see People v. Bradley (1982)

132 Cal.App.3d 737, 743, fn. 6.)

19

methodology in conducting her analysis. This objection should have been made prior to

the trial court’s issuance of its proposed statement of decision.8

Even assuming the argument is not forfeited, Petersen testified that the data she

used are not extraordinarily high or low, but are in line with the results from the FDA’s

own multi-decade testing program. She also testified that changing the number of

samples did not affect the result of her calculations. ELF asserts Petersen lacked

sufficient data for many of the products, even when using both ELF’s and defendants’

test results. It notes that of the 106 different products identified in Petersen’s analysis, 57

had less than 10 individual lab test results, 30 had five or less results, and five products

had only a single test result. Yet ELF offers no compelling argument as to why the

number of samples is insufficiently representative of the products tested. Instead it relies

on Petersen’s own conclusion that a result exceeding the MADL was not a reliable

estimate of average lead exposure because it was based on only five data points. We note

the single product in question was a fruit juice blend that included some juices that were

not within the scope of the current case. This anecdotal evidence is insufficient to

demonstrate that Petersen’s analysis was based on statistically unreliable data.

8

At oral argument appellant spent much of its time on the Petersen “methodology” at

trial. As indicated below, we, like the trial court, find her approach legally appropriate.

We note further that after full discovery, appellants submitted but two motions in limine

and “objections to relatively small portions of defendants’ expert declarations.”

Appellants’ objection to the evidentiary basis for Petersen’s expert testimony was

addressed by the trial court’s statement of decision: “[T]he testing data the parties agreed

could be admitted without objection at trial [now] provided an inadequate evidentiary

basis for Dr. Petersen’s expert testimony on the lead concentrations in Defendants’

products. Plaintiff did not make this argument in its opening trial brief, its posttrial brief,

its decision tree identifying issues for the Court to decide[,] or at closing argument.

Indeed, Plaintiff’s expert, Dr. Burton-Freeman[,] used the same testing data to support

her different conclusions . . . . It is far too late in this case for Plaintiff to introduce a new

argument about the claimed inadequacy of the testing data used by both sides during

trial.” (Italics added).

20

Taking another tactic, ELF questions the data used in the Beech-Nut sweet potato

product because the product includes raw sweet potatoes that are processed in different

facilities by various suppliers. ELF points out that there is no analysis as to whether the

six data points used to determine the lead levels in the Beech-Nut product constitute a

sufficient number of individual tests such that a reliable estimate of the lead

concentration in the product can be determined.

We note Burton-Freeman also relied on the exact same data as Petersen in

determining that the products contain excessive levels of lead. Thus, the same argument

that ELF seeks to use to invalidate defendants’ expert’s conclusions can be used to

invalidate its own expert’s opinion stating contrary conclusions. Further, in criticizing

Petersen’s methodology, Burton-Freeman faulted defendants for failing to individually

assess each ingredient source and each of the various manufacturing processes and

facilities. Her reason for advocating doing so was that an analysis of individual lead

testing results “would clearly identify problematic samples,” thereby allowing “track[ing]

them to the source of the issue for remediation.” However, this case does not involve

food safety law enforcement or remediation. The purpose of the data used in this case

was not to conduct a product recall, but simply to determine whether Proposition 65

consumer warnings are or are not appropriate, regardless of the source of the ingredients

that are used in the manufacturing process.

We do not disagree with the proposition the reliability of sampling is increased

when more data points are used. However, we are not persuaded that the methodology

employed by Petersen invalidates her opinions. In sum, we are satisfied that the evidence

relied on by both Petersen and Burton-Freeman is the type of evidence that expert

witnesses may reasonably rely on in forming their opinions.

IV. Averaging Exposure Over Time

The trial court concluded there was no scientific support for ELF’s assertion that

“exposures to Defendants’ products on a single day would increase the blood lead level

21

of pregnant women enough to cause a central nervous system deficit in the fetus.” ELF

claims the trial court erred in interpreting the regulations so as to allow defendants to

average the level of exposure over multiple days instead of evaluating the exposure on

the day the food is actually consumed. As they admit, all of defendants’ toxicologist

experts opined that the level of lead in the products at issue was insufficient to cause

reproductive harm based on a single day of exposure. Thus, absent an underlying legal or

scientific error, substantial evidence supports the conclusion that it was appropriate to

evaluate the level of exposure over time.

Under the regulations, the “level of exposure” is determined by “multiplying the

level in question . . . times the reasonably anticipated rate of exposure for an individual to

a given medium.” (Regulations, § 25821, subd. (b).) The level of exposure is based in

part on the “pattern and duration of exposure that is relevant to the reproductive effect

which provided the basis for the determination that [lead] is known to the state to cause

reproductive toxicity.” (Ibid.) The same regulation describes a number of default

assumptions for use in calculating the reasonably anticipated rate of exposure. For

example, “[w]here a maternal exposure to a chemical listed as causing reproductive

toxicity has an effect on the [embryo or fetus], the level of exposure shall be based on the

reasonably anticipated rate of exposure for the mother during the nine-month gestation

period.” (Regulations, § 25821, subd. (c)(3).)

The FSOR states that in evaluating a reproductive toxins, “one needs to view the

exposure as the one that may cause the acute [reproductive] effect. For example, if a

food is eaten once per week, and if that food contains a teratogen, a proper assessment

would require the assumption that ingestion of that food will occur on any day and,

hence, every day[,] of the pregnancy. In other words, averaging to a daily intake would

be inappropriate, since the embryonic response ought to be assumed to occur on the day

of the ingestion of that food.” The statement also provides, however, that “[i]f it is

22

scientifically more appropriate to evaluate a reproductive toxicant for chronic toxicity,

this section does permit it.”

ELF first claims the trial court committed “legal error” because the determination

of whether a reproductive toxin is capable of acute toxicity, as opposed to chronic

toxicity, is not limited to a consideration of “exposures to Defendants’ products.”

Instead, ELF asserts “the relevant ‘pattern and duration of exposure’ should be based on

the effects that can result from levels of lead that are higher than the actual level in

Defendants’ products.” ELF also contends defendants’ failure to evaluate whether short-

term exposure to higher levels of lead is capable of causing harm is fatal to their safe

harbor defense. We disagree. As we stated in DiPirro, Proposition 65 “envisions a case-

by-case approach which takes into account the totality of the quantitative risk assessment

evidence presented.” (DiPirro, supra, 153 Cal.App.4th 150, 193.)

As noted above, Petersen relied on the NET survey for average eating occasions

over a 14-day period. Substantial evidence established that the products here are eaten no

more frequently than four times per month. Experts on both sides agreed that there is at

least an eight-week “window of susceptibility” to lead. In other words, eight weeks is the

shortest period during which an exposure to lead at levels detected in the products would

be expected to have an adverse reproductive effect. Even Hu conceded on cross-

examination that the evidence supported the eight-week time frame. Further, it was

undisputed that the challenged products are not typically eaten on a daily basis.

In an amicus brief, the Attorney General advances ELF’s claim, contending

Proposition 65’s regulations prohibit the trial court from allowing defendants to average

the single-day lead exposure from their products over a number of days between

consumption before comparing the exposure to the 0.5 microgram per day regulatory

MADL. She urges that a defendant that relies on a regulatory MADL must accept a

23

single-day exposure period.9 According to her, defendants are prohibited from

converting the single-day maximum exposure of 0.5 micrograms into an average

exposure over 14 days (7 micrograms per 14 days) because they did not independently

determine a MADL based on an average exposure over an extended and defined period of

time. Thus, they are not allowed to calculate average exposure to a reproductive toxicant

and then compare it to the regulatory MADL, which is set as maximum single-day

exposure.10 In support of this assertion, she relies on Donald’s testimony and claims the

trial court improperly declined to give deference to this testimony.

“[W]hile interpretation of a statute or regulation is ultimately a question of law, we

must also defer to an administrative agency’s interpretation of a statute or regulation

involving its area of expertise, unless the interpretation flies in the face of the clear

language and purpose of the interpreted provision.” (Communities for a Better

Environment v. State Water Resources Control Bd. (2003) 109 Cal.App.4th 1089, 1104.)

Although administrative agencies’ interpretation of their regulations and language is

entitled to great weight, we will not defer when the construction is unauthorized,

unreasonable, or clearly erroneous. (See North Gualala Water Co. v. State Water

Resources Control Bd. (2006) 139 Cal.App.4th 1577, 1607.) As the trial court noted, the

evidence supplied by Donald was insufficient to demonstrate that his views represent the

authorized, formal policy of the OEHHA. We concur with that assessment.

9

A company can establish its own MADL if it wishes, for which OEHHA has also issued

regulations. (Regulations, § 25803.) In this case, defendants elected to use the regulatory

safe harbor level adopted by OEHHA.

10

We note the MADL for carcinogenic exposure is also set at a per-day level. (See

Regulations, § 25705.) We further note that the regulatory MADL for lead is based on

workplace inhalation exposure, not exposure caused by consumption of food. These

factors suggest there is room for alternative scientifically appropriate methods of

determining levels of exposure from food products containing lead.

24

According to Beck’s model, the effect on the blood lead levels of women of child-

bearing age and four-month old children from exposures at the safe harbor level would be

greater than or equal to the effect from exposures shown by Petersen’s analysis. As the

trial court observed, “[s]ince no warning would be required under the modeled regulatory

NOEL standard it is difficult to see why frequency of use should not be considered in

determining whether that standard has been met in this case.” In sum, on the record here,

we cannot conclude that the trial court erred in accepting defendants’ experts’ opinions

that the products qualify for the exemption under the safe harbor defense of Regulation

25801, subdivision (b)(2).

DISPOSITION

The judgment is affirmed.

25

_________________________

Dondero, J.

We concur:

_________________________

Humes, P.J.

_________________________

Jenkins, J.*

* Associate Justice of the Court of Appeal, First Appellate District, Division Three,

assigned by the Chief Justice pursuant to article VI, section 6 of the California

Constitution.

26

27

Trial Court Alameda County Superior Court

Trial Judge Hon. Steven A. Brick

Counsel for Plaintiff and Appellant Laura J. Baughman

Environmental Law Foundation Thomas M. Sims

Baron & Budd, P.C.

April M.Strauss

Law Office of April Strauss

James R.Wheaton

Lowell Chow

Environmental Law Foundation

Counsel for Amicus Curiae on behalf of Jeffrey B. Margulies

Plaintiff and Appellant Fulbright & Jaworski

California Grocers Association and

California Retailers Association

Counsel for Amicus Curiae on behalf of David H. Williams

Plaintiffs and Appellants William Verick

Mateel Environmental Justice Foundation Klamath Environmental Law Center

Counsel for Amicus Curiae on behalf of Sally Magnani

Plaintiffs and Appellants Assistant Attorney General

Attorney General Kamala D. Harris Susan S. Fiering

Harrison Pollak

Elizabeth Rumsey

Deputy Attorneys General

Counsel for Defendants and Appellants Michele B. Corash

Beech-Nut Nutrition Corporation; Golden Star Linda E. Shostak

Trading; Topco Associates LLC; Clement Robert L. Falk

Pappas & Co., Inc.; Cliffstar LLC; Del Monte Miriam A. Vogel

Foods; Dole Packaged Foods; Gerber Products Morrison & Foerster LLP

Company; The Hain Celestial Group, Inc.;

Independent Foods LLC; Pacific Coast

Producers; Smucker Natural Foods, Inc.;

Kedem Foods Products International; Langer

Juice Company, Inc.; Seneca Foods Corp.;

Tree Top, Inc.; Truitt Bros., Inc.; and Welch’s

Foods, Inc., A Cooperative

Counsel for Defendants and Appellants Renee D. Wasserman

CVS Pharmacy, Inc.; Walgreen Co.; and Save Rogers Joseph O’Donnell

Mart Supermarkets

Counsel for Defendant and Appellant Thomas A. Evans

Raley’s Reed Smith

Counsel for Defendant and Appellant Richard W. Lasater II

Smart & Final, Inc. Foley & Lardner

Counsel for Defendant and Appellant Brenden W. Brandt

Stater Bros. Markets Varner & Brandt

Counsel for Defendant and Appellant Lisa A. Cole

The Kroger Co. Nixon Peabody

Counsel for Defendant and Appellant Margaret A. Moeser

Trader Joe’s Company O’Melveny & Meyers

Counsel for Defendant and Appellant Michael D. Abraham

Wal-Mart Stores, Inc. Bartko, Zankel, Bunzel & Miller

Robert H. Bunzel

Bartko, Zankel, Tarrant & Miller

29

Counsel for Defendant and Appellant James T. W. Blaxter

Whole Foods Market California, Inc. Blaxter Law

Counsel for Defendants and Appellants Jeffrey B. Margulies

Lucerne Foods, Inc.; Safeway, Inc.; and Target Fulbright & Jaworski

Corporation

Counsel for Amicus Curiae on behalf of Teague P. Paterson

Defendants and Appellants Beeson Tayer & Bodine APC

Teamsters California State Council of Cannery

& Food Processing Unions; International

Brotherhood of Teamsters; Change to Win

Counsel for Amicus Curiae on behalf of Dale A. Stern

Defendants and Appellants Steven H. Goldberg

California League of Food Processors, Leila C. Bruderer

California Farm Bureau Federation; Western Downey Brand LLP

Growers Association; Northwest Horticultural

Council; Agricultural Council of California;

California Canning Peach Association; and

Grower Shipper Association of Central

California

Counsel for Amicus Curiae on behalf of Mark C. Goodman

Defendants and Appellants Hogan Lovells US LLP

Grocery Manufacturers Association and

American Beverage Association

Counsel for Real Party in Interest Office of the Attorney General

State of California Proposition 65 Enforcement Office

30