Filed 4/16/15 Unmodified version attached

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT

DIVISION ONE

ENVIRONMENTAL LAW 

FOUNDATION,

Plaintiff and Appellant, 

v.

BEECH-NUT NUTRITION CORP. et al.,

Defendants and Appellants.

A139821

(Alameda County

Super. Ct. No. RG11597384)

ORDER MODIFYING OPINION 

AND DENYING REHEARING

[NO CHANGE IN JUDGEMENT]

THE COURT:

It is ordered that the opinion filed herein on March 17, 2015, be modified as 

follows:

1. On page 4, in the last sentence of the first full paragraph, the reference to 

OEHHA should be to OSHA, so the sentence reads, “OSHA multiplied the OSHA PEL 

of 50 micrograms per cubic meter by 10 cubic meters (the amount OSHA determined 

workers breathed . . . .”

2. On page 7, in the next to the last sentence in the first full paragraph, the last 

two words in the sentence should be changed from “logged normal” to “log-normal,” so 

the sentence now reads: “If the geometric mean is lower than the arithmetic mean, this 

indicates that the data were log-normal.”

3. On page 13, in the first three words on the page should be “were log-normal.”
2

4. On page 15, on the sixth line of the first paragraph, “far more persuasive 

that . . .” should be changed to “far more persuasive than . . . .”

5. The text of footnote 8 on page 20 is deleted in its entirety and replaced by 

the following two paragraphs, so that footnote 8 now reads:

At oral argument ELF spent much of its time criticizing Petersen’s “methodology” 

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

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

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

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). 

In a petition for rehearing, ELF faults our failure to discuss the recent Supreme 

Court opinion in Duran v. U.S. Bank National Assn. (2014) 59 Cal.4th 1. Duran is 

distinguishable because, in that case, the trial court was found to have erroneously 

extrapolated liability findings based on a skewed sample group, the composition of which 

neither party had endorsed. (Id. at p. 15.) In the present case, both sides stipulated to the 

admission of the underlying sampling data that was used by their expert witnesses. 

6. On page 23, in the last paragraph, in the second and third lines from the 

bottom of the page, the phrase “consumption before comparing the exposure to the 0.5 

microgram per day regulatory MADL” should be changed to include the words “safe 

harbor,” so the phrase now reads, “consumption before comparing the exposure to the 

0.5 microgram per day regulatory safe harbor MADL.” 

7. On page 23, in the last line of the page, the phrase, “She urges that a defendant 

that relies on a regulatory MADL must accept . . .” should be changed to include the 

words “safe harbor,” so that the phrase now reads, “She urges that a defendant that relies 

on a regulatory safe harbor MADL must accept . . . .”
3

8. On page 24, in the first line of footnote 10, the term “MADL” should be be 

replaced with the term “regulatory safe harbor,” so that the first line of footnote 10 

now reads, “We note the regulatory safe harbor level for carcinogenic exposures is 

also set at a per-day level.”

There is no change in the judgment. The petition for rehearing is denied.

_____________________________

HUMES, P.J.
4

Trial Court Alameda County Superior Court

Trial Judge Hon. Steven A. Brick

Counsel for Plaintiff and Appellant 

Environmental Law Foundation

Laura J. Baughman

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 

Plaintiff and Appellant 

California Grocers Association and 

California Retailers Association

Jeffrey B. Margulies

Fulbright & Jaworski

Counsel for Amicus Curiae on behalf of 

Plaintiffs and Appellants 

Mateel Environmental Justice Foundation

David H. Williams

William Verick

Klamath Environmental Law Center

Counsel for Amicus Curiae on behalf of 

Plaintiffs and Appellants 

Attorney General Kamala D. Harris

Sally Magnani

 Assistant Attorney General

Susan S. Fiering

Harrison Pollak

Elizabeth Rumsey

 Deputy Attorneys General
5

Counsel for Defendants and Appellants 

Beech-Nut Nutrition Corporation; Golden Star 

Trading; Topco Associates LLC; Clement 

Pappas & Co., Inc.; Cliffstar LLC; Del Monte 

Foods; Dole Packaged Foods; Gerber Products 

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

Michele B. Corash

Linda E. Shostak

Robert L. Falk

Miriam A. Vogel

Morrison & Foerster LLP

Counsel for Defendants and Appellants 

CVS Pharmacy, Inc.; Walgreen Co.; and Save 

Mart Supermarkets

Renee D. Wasserman

Rogers Joseph O’Donnell

Counsel for Defendant and Appellant 

Raley’s

Thomas A. Evans

Reed Smith

Counsel for Defendant and Appellant 

Smart & Final, Inc.

Richard W. Lasater II

Foley & Lardner

Counsel for Defendant and Appellant 

Stater Bros. Markets

Brenden W. Brandt

Varner & Brandt

Counsel for Defendant and Appellant 

The Kroger Co.

Lisa A. Cole

Nixon Peabody

Counsel for Defendant and Appellant 

Trader Joe’s Company

Margaret A. Moeser

O’Melveny & Meyers

Counsel for Defendant and Appellant 

Wal-Mart Stores, Inc.

Michael D. Abraham

Bartko, Zankel, Bunzel & Miller

Robert H. Bunzel

Bartko, Zankel, Tarrant & Miller
6

Counsel for Defendant and Appellant

Whole Foods Market California, Inc.

James T. W. Blaxter

Blaxter Law

Counsel for Defendants and Appellants

Lucerne Foods, Inc.; Safeway, Inc.; and Target 

Corporation

Jeffrey B. Margulies

Fulbright & Jaworski

Counsel for Amicus Curiae on behalf of 

Defendants and Appellants 

Teamsters California State Council of Cannery 

& Food Processing Unions; International 

Brotherhood of Teamsters; Change to Win 

Teague P. Paterson

Beeson Tayer & Bodine APC

Counsel for Amicus Curiae on behalf of 

Defendants and Appellants 

California League of Food Processors, 

California Farm Bureau Federation; Western 

Growers Association; Northwest Horticultural 

Council; Agricultural Council of California; 

California Canning Peach Association; and 

Grower Shipper Association of Central 

California

Dale A. Stern

Steven H. Goldberg

Leila C. Bruderer

Downey Brand LLP

Counsel for Amicus Curiae on behalf of 

Defendants and Appellants 

Grocery Manufacturers Association and 

American Beverage Association

Mark C. Goodman

Hogan Lovells US LLP

Counsel for Real Party in Interest

State of California

Office of the Attorney General

Proposition 65 Enforcement Office
Filed 3/17/15 Unmodified version

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

FIRST APPELLATE DISTRICT

DIVISION ONE

ENVIRONMENTAL LAW 

FOUNDATION,

Plaintiff and Appellant, 

v.

BEECH-NUT NUTRITION CORP. et al.,

Defendants and Appellants.

 A139821

 (Alameda County

 Super. Ct. No. RG11597384)

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.
2

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.
3

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 
4

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 
5

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 
6

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 
7

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 bellshaped 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, lowlevel 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.” 
8

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. 
9

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 
10

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 
11

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. 
12

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 
13

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.) 
14

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. 
15

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.
16

“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.” 
17

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 
18

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.)
19

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.” 7It 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.)
20

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). 
21

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 
22

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 
23

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 shortterm 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 caseby-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 crossexamination 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 
24

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.
25

According to Beck’s model, the effect on the blood lead levels of women of childbearing 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. 
26

_________________________

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.
27
Trial Court Alameda County Superior Court

Trial Judge Hon. Steven A. Brick

Counsel for Plaintiff and Appellant 

Environmental Law Foundation

Laura J. Baughman

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 

Plaintiff and Appellant 

California Grocers Association and 

California Retailers Association

Jeffrey B. Margulies

Fulbright & Jaworski

Counsel for Amicus Curiae on behalf of 

Plaintiffs and Appellants 

Mateel Environmental Justice Foundation

David H. Williams

William Verick

Klamath Environmental Law Center

Counsel for Amicus Curiae on behalf of 

Plaintiffs and Appellants 

Attorney General Kamala D. Harris

Sally Magnani

 Assistant Attorney General

Susan S. Fiering

Harrison Pollak

Elizabeth Rumsey

 Deputy Attorneys General
29

Counsel for Defendants and Appellants 

Beech-Nut Nutrition Corporation; Golden Star 

Trading; Topco Associates LLC; Clement 

Pappas & Co., Inc.; Cliffstar LLC; Del Monte 

Foods; Dole Packaged Foods; Gerber Products 

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

Michele B. Corash

Linda E. Shostak

Robert L. Falk

Miriam A. Vogel

Morrison & Foerster LLP

Counsel for Defendants and Appellants 

CVS Pharmacy, Inc.; Walgreen Co.; and Save 

Mart Supermarkets

Renee D. Wasserman

Rogers Joseph O’Donnell

Counsel for Defendant and Appellant 

Raley’s

Thomas A. Evans

Reed Smith

Counsel for Defendant and Appellant 

Smart & Final, Inc.

Richard W. Lasater II

Foley & Lardner

Counsel for Defendant and Appellant 

Stater Bros. Markets

Brenden W. Brandt

Varner & Brandt

Counsel for Defendant and Appellant 

The Kroger Co.

Lisa A. Cole

Nixon Peabody

Counsel for Defendant and Appellant 

Trader Joe’s Company

Margaret A. Moeser

O’Melveny & Meyers

Counsel for Defendant and Appellant 

Wal-Mart Stores, Inc.

Michael D. Abraham

Bartko, Zankel, Bunzel & Miller

Robert H. Bunzel

Bartko, Zankel, Tarrant & Miller
30

Counsel for Defendant and Appellant

Whole Foods Market California, Inc.

James T. W. Blaxter

Blaxter Law

Counsel for Defendants and Appellants

Lucerne Foods, Inc.; Safeway, Inc.; and Target 

Corporation

Jeffrey B. Margulies

Fulbright & Jaworski

Counsel for Amicus Curiae on behalf of 

Defendants and Appellants 

Teamsters California State Council of Cannery 

& Food Processing Unions; International 

Brotherhood of Teamsters; Change to Win 

Teague P. Paterson

Beeson Tayer & Bodine APC

Counsel for Amicus Curiae on behalf of 

Defendants and Appellants 

California League of Food Processors, 

California Farm Bureau Federation; Western 

Growers Association; Northwest Horticultural 

Council; Agricultural Council of California; 

California Canning Peach Association; and 

Grower Shipper Association of Central 

California

Dale A. Stern

Steven H. Goldberg

Leila C. Bruderer

Downey Brand LLP

Counsel for Amicus Curiae on behalf of 

Defendants and Appellants 

Grocery Manufacturers Association and 

American Beverage Association

Mark C. Goodman

Hogan Lovells US LLP

Counsel for Real Party in Interest

State of California

Office of the Attorney General

Proposition 65 Enforcement Office