American Chemistry Council v. Office of Environmental Health etc.

Filed 11/10/20 (unmodified opinion attached)

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

THIRD APPELLATE DISTRICT

(Sacramento)

----

AMERICAN CHEMISTRY COUNCIL, C079078

Plaintiff and Appellant, (Super. Ct. No.

34201300140720CUWMGDS )

v.

MODIFICATION OF

OFFICE OF ENVIRONMENTAL HEALTH OPINION

HAZARD ASSESSMENT et al.,

Defendants and Respondents; [NO CHANGE IN

JUDGMENT]

NATURAL RESOURCES DEFENSE COUNCIL,

Real Party in Interest and Respondent.

THE COURT:

It is ordered that the opinion filed herein on October 19, 2020, be modified as

follows:

1. On page 1, in the editorial information of the opinion replace “National” with

“Natural” in the name of the Real Party in Interest and Respondent to read “Joshua R.

1

Purtle, Jennifer A. Sorenson, Michael E. Wall, Avinash Kar for Real Party in Interest

Natural Resources Defense Council.”

2. On page 3, in the second paragraph, first line, replace the word “National” with

“Natural” so the sentence reads in part: “On the same day as the DART-IC

determination, real-party-in-interest Natural Resources Defense Council (NRDC)

petitioned OEHHA.”

3. On page 6, footnote 5, within the last sentence that reads, “BPA had been

identified by NTP as a reproductive intoxicant,” replace “intoxicant” with “toxicant” so

the sentence now reads in part: “BPA had been identified by NTP as a reproductive

toxicant.”

4. On page 20, in the third full paragraph that reads, “OEHHA emphasized the

deferential standard of review to be accorded to it in a case such as this, involving highly

technical record,” insert the word “a” between the word “involving” and “highly” so the

sentence now reads: “OEHHA emphasized the deferential standard of review to be

accorded to it in a case such as this, involving a highly technical record addressing

scientific material.”

5. On page 23, in the second sentence of the first full paragraph that reads, “In

response to the question ‘ “Can [BPA] affect human development or reproduction?” ’

The report answered, ‘possibly,’ ” replace the capital “T” in the word “The” before the

word “report” with a lower case “t” so that it now reads: “In response to the question

‘ “Can [BPA] affect human development or reproduction?” ’ the report answered,

‘possibly.’ ”

On page 52, in the last sentence in the first paragraph that reads, “Therefore, we

turn to the record to consider whether OEHHA’s determination that NTP considered

criteria in subdivision (g) and whether biological plausibility can be determined from the

2

monograph and the studies upon which it relied,” delete the word “whether” between

consider and OEHHA’s determination.

This modification does not change the judgment.

BY THE COURT

………/s/

BLEASE, Acting P. J.

………./s/

MURRAY, J.

………./s/

DUARTE, J.

3

Filed 10/19/20 (unmodified opinion)

CERTIFIED FOR PUBLICATION

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

THIRD APPELLATE DISTRICT

(Sacramento)

----

AMERICAN CHEMISTRY COUNCIL, C079078

Plaintiff and Appellant, (Super. Ct. No.

34201300140720CUWMGDS )

v.

OFFICE OF ENVIRONMENTAL HEALTH

HAZARD ASSESSMENT et al.,

Defendants and Respondents;

NATURAL RESOURCES DEFENSE COUNCIL,

Real Party in Interest and Respondent.

APPEAL from a judgment of the Superior Court of Sacramento County, Timothy

M. Frawley, Judge. Affirmed.

Gibson, Dunn & Crutcher, Daniel M. Kolkey, Theodore J. Boutrous, Patrick W.

Dennis, Kahn A. Scolnick, Daniel S. Nowicki, Vanessa C. Adriance for Plaintiff and

Appellant American Chemistry Council.

Joshua R. Purtle, Jennifer A. Sorenson, Michael E. Wall, Avinash Kar for Real

Party in Interest National Resources Defense Council.

1

Arnold & Porter and Trenton H. Norris as Amicus Curiae Grocery Manufacturers

Association for Plaintiff and Appellant American Chemistry Council.

Kamala D. Harris and Xavier Becerra, Attorneys General, Susan S. Fiering,

Supervising Deputy Attorney General, Harrison M. Pollak, Deputy Attorney General for

Defendants and Respondents Office of Environmental Health Hazard Assessment, et al.

At issue in this case is whether the decision by the Office of Environmental Health

Hazard Assessment (OEHHA) to list Bisphenol A (BPA) as a chemical known to cause

reproductive toxicity under Proposition 65, the Safe Drinking Water and Toxic

Enforcement Act of 1986 (Proposition 65), was an abuse of discretion. OEHHA is our

state’s lead agency for Proposition 65. BPA is used primarily to coat food and beverage

packaging and containers.

Proposition 65 was enacted by the voters to protect the people of California and its

water supply from harmful chemicals. Proposition 65 requires the Governor to publish,

at least annually, a list of chemicals known to the state to cause cancer or reproductive

toxicity. Health and Safety Code section 25249.8,1 added by Proposition 65, provides the

listing obligations and sets forth four independent “listing mechanisms” by which a

chemical can be listed under Proposition 65, including the “state’s qualified expert”

listing mechanism and the “authoritative body” listing mechanism. (§ 25249.8, subds. (a)

& (b).)2

1 Further undesignated statutory references are to the Health and Safety Code in effect at

the time of the proceedings.

2 In pertinent part, section 25249.8 provides: “(a) On or before March 1, 1987, the

Governor shall cause to be published a list of those chemicals known to the state to cause

cancer or reproductive toxicity within the meaning of this chapter, and he shall cause

such list to be revised and republished in light of additional knowledge at least once per

year thereafter. Such list shall include at a minimum those substances identified by

reference in Labor Code Section 6382(b)(1) and those substances identified additionally

by reference in Labor Code Section 6382(d). [¶] (b) A chemical is known to the state to

cause cancer or reproductive toxicity within the meaning of this chapter if in the opinion

2

The National Toxicology Program - Center for the Evaluation of Risks to Human

Reproduction (NTP-CERHR), established by the National Toxicology Program (NTP),

published a “Monograph on the Potential Human Reproductive and Developmental

Effects of [BPA]” (the monograph) in 2008.3 Thereafter, the Developmental and

Reproductive Toxicant Identification Committee (DART-IC), considered whether to list

BPA as a reproductive toxicant under the “state’s qualified experts” listing mechanism of

section 25249.8, subdivision (b). DART-IC is a committee of OEHHA and is our state’s

panel of qualified scientific experts appointed by the Governor. After considering the

monograph, DART-IC voted not to list BPA as a reproductive toxicant.

On the same day as the DART-IC determination, real-party-in-interest National

Resources Defense Council (NRDC) petitioned OEHHA, requesting that OEHHA list

BPA under Proposition 65 on the theory that it had been identified as a reproductive

toxicant by an authoritative body, specifically NTP-CERHR, and therefore it was subject

to listing under the separate authoritative body listing mechanism of section 25249.8,

subdivision (b). OEHHA is authorized by statute and regulation to determine whether an

authoritative body has identified a chemical as a reproductive toxicant. After reviewing

the monograph, OEHHA issued a notice of intent to list BPA as a chemical known to the

state to cause reproductive toxicity and ultimately determined that it should be listed

pursuant to the authoritative body listing mechanism, despite the state’s qualified experts,

DART-IC, having decided against listing BPA.

of the state’s qualified experts it has been clearly shown through scientifically valid

testing according to generally accepted principles to cause cancer or reproductive

toxicity, or if a body considered to be authoritative by such experts has formally

identified it as causing cancer or reproductive toxicity, or if an agency of the state or

federal government has formally required it to be labeled or identified as causing cancer

or reproductive toxicity.” (Italics added.)

3 “NTP” and “NTP-CERHR” are occasionally used interchangeably, both by the parties

and herein.

3

The American Chemistry Council (ACC) commenced this action seeking to enjoin

OEHHA from listing BPA. In an amended complaint, ACC sought a peremptory writ of

mandate directing OEHHA not to list BPA. The trial court denied the requested relief.

ACC appeals, asserting that OEHHA abused its discretion in: (1) refusing to

consider the DART-IC determination against listing BPA; (2) concluding that NTP

formally identified BPA as a reproductive toxicant in the monograph;4 and (3)

4 As ACC points out, OEHHA’s website states that, for purposes of Proposition 65,

“reproductive toxicity” includes three endpoints: male reproductive toxicity, female

reproductive toxicity, and developmental toxicity. (OEHHA (Nov. 1, 1993, Criteria for

Recommending Chemicals for Listing as “Known to the State to Cause Reproductive

Toxicity,” at <https://oehha.ca.gov/media/downloads/proposition-65/proposition-

65/dartcriterianov1993.pdf> [as of October 2, 2020], archived at:

<https://perma.cc/9KSK-2TMJ> (Criteria for Recommending Listing), italics added.)

Through proceedings unrelated to these, as of May 11, 2015, BPA has been listed by the

DART-IC under the state’s qualified expert listing mechanism of Proposition 65 as a

chemical known to the state to cause female reproductive toxicity. (Regs. § 27001, subd.

(c).) ACC points out that the DART-IC panel that made this listing determination

consisted of people who had been substituted for those who appeared on the panel that

made the determination at issue in this case, and the later determination was not made

based on the monograph at issue here. OEHHA responds that all DART-IC appointments

are made by the Governor (Cal. Code Regs., tit. 27, § 25302, subd. (b)(3)), who made the

appointments in 2012, several years after the first DART-IC meeting on BPA in 2009. In

any event, at issue in these proceedings is whether OEHHA’s decision to list BPA as a

chemical known to the state to cause developmental toxicity was an abuse of discretion.

Developmental toxicity is defined as “adverse effects on the products of conception,”

including “[e]mbryo/fetal mortality . . . malformations, structural abnormalities and

variations, altered fetal growth, and change in gestational age at delivery,” postnatal

parameters “including growth and development, physiological deficits and delay,

neurological, neurobehavioral and psychological deficits, altered sex ratio, abnormal

sexual development or function, and morbidity or mortality,” “[t]ransplacental

carcinogenesis,” and “[s]omatic or genetic. . . mutations in the conceptus.” (Criteria for

Recommending Chemicals for Listing, at

<https://oehha.ca.gov/media/downloads/proposition-65/proposition-

65/dartcriterianov1993.pdf> [as of October 2, 2020], archived at:

<https://perma.cc/9KSK-2TMJ>.) Here, the terms reproductive toxicity and

developmental toxicity are used interchangeably throughout the record and briefing and

as a necessary consequence, so do we. (See Exxon Mobil Corp. v. Office of

Environmental Health Hazard Assessment (2009) 169 Cal.App.4th 1264, 1271, fn. 7

4

determining that NTP concluded that studies in experimental animals indicated that there

was sufficient data to establish that an association between adverse reproductive effects

in humans and BPA is “biologically plausible” within the meaning of that term as it is

used in OEHHA’s own regulation. As we shall discuss, OEHHA’s position as to

biological plausibility is based on, among other things, the following presumption:

chemicals that cause harm in experimental animals will also cause similar harm in

humans in the absence of evidence to the contrary.

We affirm.

FACTUAL AND PROCEDURAL BACKGROUND

BPA

BPA is a chemical used primarily in the production of polycarbonate plastics and

epoxy resins. Polycarbonate plastics are used in food and drink packaging and

containers. Epoxy resins are used as lacquers to coat metal products including food cans,

bottle tops, and water pipes. BPA has other, less common, uses as well. Human

exposure to BPA occurs primarily through diet. BPA “can migrate into food from food

and beverage containers with internal epoxy resin coatings and from consumer products

made of polycarbonate plastic such as baby bottles, tableware, food containers, and water

bottles.”

The Monograph

The NTP established the NTP-CERHR in June 1998 “to provide timely, unbiased,

scientifically sound evaluations of the potential for adverse effects on reproduction or

development resulting from human exposures to substances in the environment.” The

NTP-CERHR expert panel on BPA completed an evaluation of BPA in August 2007.

NTP-CERHR published its monograph in September 2008.

(Exxon Mobil) [Proposition 65 use of the term “reproductive toxicity” includes

“developmental toxicity”].)

5

The monograph stated that it is possible that BPA can affect human development

or reproduction. The monograph, which primarily addressed studies in laboratory

animals, stated: “Although there is no direct evidence that exposure of people to [BPA]

adversely affects reproduction or development, studies with laboratory rodents show that

exposure to high dose levels of [BPA] during pregnancy and/or lactation can reduce

survival, birth weight, and growth of offspring early in life, and delay the onset of

puberty in males and females.” (Italics added.) The monograph characterized these

“ ‘high’ dose effects” in the animal studies as “not scientifically controversial,” and stated

that they provided “clear evidence of adverse effects on development in laboratory

animals.”5 (Italics added.) The monograph further stated that the “NTP finds that there

is clear evidence of adverse developmental effects at ‘high’ doses of [BPA] in the form

of fetal death, decreased litter size, or decreased number of live pups per litter in rats . . .

and mice . . . , reduced growth in rats . . . and mice . . . , and delayed puberty in male

mice . . . male rats . . . and female rats . . . .” (Italics added.)

5 The monograph explains that “[s]cientific decisions concerning health risks are

generally based on what is known as the ‘weight of the evidence.’ ” Figure 2b of the

monograph sets forth the “weight of evidence that [BPA] causes adverse developmental

or reproductive effects in laboratory animals,” rated along the following continuum:

“Clear evidence of adverse effects”; “Some evidence of adverse effects”; “Limited

evidence of adverse effects”; “Insufficient evidence for a conclusion”; “Limited evidence

of no adverse effects”; “Some evidence of no adverse effects”; “Clear evidence of no

adverse effects.” In tests involving “ ‘High’ dose developmental toxicity,” the

monograph indicated that there was “[c]lear evidence of adverse effects.” In tests

involving reproductive toxicity, the monograph indicated that there was “[s]ome evidence

of adverse effects.” In tests involving “ ‘Low’ dose developmental toxicity,” the

monograph indicated that there was “[l]imited evidence of adverse effects.” As we

discuss post, OEHHA relied on the “high” dose findings in determining BPA had been

identified by NTP as a reproductive intoxicant [notice of intent to list based on “clear

evidence of adverse developmental effects in laboratory animals at ‘high’ levels of

exposure”].)

6

The monograph further stated that there was scientific controversy over

interpretation of “ ‘low’ dose findings” in animals. It stated that, in “addition to the[]

‘high’ dose effects on survival and growth, the NTP recognizes that there are studies that

provide evidence for a variety of effects at much lower dose levels of [BPA] related to

neural and behavioral alterations in rats and mice . . . , preneoplastic lesions in the

prostate and mammary gland in rats . . . , altered prostate and urinary tract development

in mice . . . , and early onset of puberty in female mice . . . .” The monograph stated that

“[t]hese ‘low’ dose findings in laboratory animals have proven to be controversial for a

variety of reasons including concern for insufficient replication by independent

investigators, questions on the suitability of various experimental approaches, relevance

of the specific animal model used for evaluating potential human risks, and incomplete

understanding or agreement on the potential adverse nature of reported effects.”

The monograph stated that there was “[i]nsufficient evidence for a conclusion” as

to whether BPA had adverse developmental or reproductive effects in humans. The

monograph further explained, “evidence from the limited number of studies in humans

exposed to [BPA] is not sufficient to reach conclusions regarding possible developmental

or reproductive hazard.” However, it also said: “Recognizing the lack of data on the

effects of [BPA] in humans and despite the limitations in the evidence for ‘low’ dose

effects in laboratory animals . . . , the possibility that [BPA] may alter human

development cannot be dismissed.” (Italics added.)

Addressing the “very small number of studies [that] have looked at associations

between [BPA] exposure and disorders of reproduction or developmental effects in

humans,” the monograph stated that “there is currently insufficient evidence to determine

if [BPA] causes or does not cause reproductive toxicity in exposed adults,” and that there

“is also insufficient evidence from studies in humans to determine if [BPA] does or does

not cause developmental toxicity when exposure occurs prenatally or during infancy and

7

childhood.” However, the monograph stated that the scientific literature on the toxic

effects of BPA in laboratory animals was “extensive and expanding.”

Turning to the question whether current exposures to BPA are high enough to be

cause for concern, the monograph concluded: “[p]ossibly.” The monograph stated that

the “ ‘high’ dose effects of [BPA] in laboratory animals that provide clear evidence for

adverse effects on development, i.e., reduced survival, birth weight, and growth of

offspring early in life, and delayed puberty in female rats and male rats and mice, are

observed at levels of exposure that far exceed those encountered by humans.” The

monograph continued: “[E]stimated exposures in pregnant women and fetuses, infants,

and children are similar to levels of [BPA] associated with several ‘low’ dose laboratory

animal findings of effects on the brain and behavior, prostate and mammary gland

development, and early onset of puberty in females. When considered together, these

laboratory animal findings provide limited evidence that [BPA] has adverse effects on

development.” The monograph then stated: “The conclusion of similarities between

exposures of certain human populations and laboratory animals treated with ‘low’ doses

of [BPA] is supported by multiple approaches. For this reason, the possibility that human

development may be altered by [BPA] at current exposure levels cannot be dismissed.”

(Italics added.)

In a section entitled “NTP CONCLUSIONS,” the monograph stated that the NTP

“reached the following conclusions on the possible effects of exposure to [BPA] on

human development and reproduction. Note that the possible levels of concern, from

lowest to highest, are negligible concern, minimal concern, some concern, concern, and

serious concern. [¶] The NTP has some concern for effects on the brain, behavior, and

prostate gland in fetuses, infants, and children at current human exposures to [BPA]. [¶]

. . . [¶] The NTP has minimal concern for effects on the mammary gland and an earlier

age for puberty for females in fetuses, infants, and children at current human exposures to

[BPA]. [¶] . . . [¶] The NTP has negligible concern that exposure of pregnant women to

8

[BPA] will result in fetal or neonatal mortality, birth defects, or reduced birth weight and

growth in their offspring. [¶] . . . [¶] The NTP has negligible concern that exposure to

[BPA] will cause reproductive effects in non-occupationally exposed adults and minimal

concern for workers exposed to higher levels in occupational settings.” (Boldface

omitted.)

DART-IC Meeting and Determination

DART-IC held a meeting on July 15, 2009, to consider action on BPA. The

DART-IC considered the monograph, among other things. Following the staff

presentations and public comment, the DART-IC held its discussion.

One of the committee members specifically charged with reviewing the issue of

developmental toxicity stated that “[t]he high dose studies have clear evidence of

developmental toxicity,” in animals, although she continued: “They do occur in the

presence of maternal toxicity. It’s whether or not there is sufficient maternal toxicity to

potentially be causing the other.” As for the low-dose animal studies, she stated that

“there are not clear effects on the low-dose levels, because we have seen situations where

some studies are positive and some studies are negative. And when you do have very

small numbers of animals in groups, that does increase the variability within a group.”

Another committee member stated, “I’m not so sure that . . . the animal model can

extrapolate into the human model, because the doses were so incredibly high. There were

very high doses that we would not expect humans to be exposed to.”

At the conclusion of the discussion, the DART-IC voted on the following

questions: “has [BPA] been clearly shown, through scientifically valid testing, according

to generally accepted principles, to cause” (1) developmental toxicity, (2) female

reproductive toxicity, and (3) male reproductive toxicity. As to each question, the

DART-IC members voted no and accordingly voted against listing BPA. Following the

vote, the DART-IC did not articulate any specific bases for its determinations against

9

listing BPA, although the simple “no” answers to questions asking whether “[BPA] been

clearly shown . . . .” indicated a finding that a clear showing had not been made.

NRDC Petitions

The NRDC sent to OEHHA petitions dated July 15 and 21, 2009, requesting that

OEHHA list BPA under Proposition 65 as a chemical known to cause reproductive

toxicity because it had been identified as a reproductive toxicant by an authoritative body,

specifically NTP-CERHR.

OEHHA Request for Information and Public Forum

OEHHA issued a statement indicating that it had received the NRDC’s petition

and noting that DART-IC had declined to list BPA as a reproductive toxicant under the

state’s qualified experts listing mechanism of section 25249.8. The OEHHA statement

observed that each of the four listing mechanisms established in section 25249.8 (see fn.

2, ante) was separate and distinct, none of which takes precedence over the others.

Consequently, according to OEHHA, it was required to consider listing BPA under the

authoritative body listing mechanism regardless of the DART-IC determination.

OEHHA stated that the monograph “concludes that [BPA] causes developmental toxicity

at high levels of exposure, and appears to satisfy the formal identification and sufficiency

of evidence criteria in the Proposition 65 regulations. [¶] OEHHA is relying on the

NTP-CERHR’s conclusions in the report that BPA causes reproductive toxicity. The

NTP-CERHR report concludes that there is clear evidence of adverse developmental

effects in laboratory animals at ‘high’ levels of exposure.” The OEHHA statement

concluded: “Based on the NTP-CERHR report and the references cited in the report, the

evidence appears sufficient for listing by the authoritative bodies’ mechanism.”

OEHHA announced a public forum scheduled for April 20, 2010, at which anyone

could present scientific data and other information relevant to whether BPA met the

criteria for listing under California Code of Regulations, title 27, section 25306, which

10

describes the authoritative body mechanism.6 A number of participants offered their

opinions at the forum, both in opposition to and in favor of listing BPA.

Included among those who did not favor listing BPA was Dr. Rochelle Tyl, the

author of four of the eight high dose studies discussed in the monograph. Dr. Tyl stated:

“Based on my intimate knowledge of these [high dose] studies and my review of other

relevant studies, I conclude that BPA is not a selective reproductive or developmental

toxicant. [R]eproductive or developmental effects occur only at very high BPA doses in

the presence of profound maternal toxicity. At lower doses with less, but still significant,

maternal toxicity, there are no reproductive or developmental effects. Based on other

relevant studies, it is apparent that maternal toxicity is most likely the critical determinant

of embryo-fetal/offspring toxicity observed at high doses of BPA. Consequently, BPA

does not satisfy the criteria for listing under Proposition 65.”

DART-IC Consideration of NTP’s Designation as an Authoritative Body

ACC filed a petition seeking rescission of NTP-CERHR’s designation as an

authoritative body “for purposes of developmental reproductive identifications.” On July

12, 2011, DART-IC considered the designation of the NTP as an authoritative body.

During the meeting, an attorney for ACC clarified during public remarks that the petition

was “retrospective with respect to monographs that were published by the previously

existing NTP CERHR,” which had purportedly undergone changes in the interim. A

representative of the NRDC asserted that BPA “has really driven much of this

discussion.” The attorney for ACC stated that the petition was filed “because of the

anomaly that came to our attention after the BPA decision two years ago. [Y]our

Committee voted 7 to nothing, unanimously on all three toxicity endpoints to determine

that BPA should not be listed as a reproductive toxicant. [¶] That very day a petition

6Further undesignated references to regulations are to title 27 of the California Code of

Regulations.

11

was submitted asking the chemical to be listed versus [sic] the authoritative bodies

mechanism. . . . [T]he agency is actively considering listing the same chemical under the

authoritative bodies mechanism on the basis of the same document that you reviewed so

carefully and so thoroughly, with days of testimony talking in person to the people who

conducted those studies, to determine whether or not the document, on its face, either

concludes that BPA is a developmental toxicant or that it otherwise identifies the

chemical as a reproductive toxicant. [¶] We think . . . that means if those two things can

happen on the same day and on the basis of the same document, something is seriously

wrong. . . . [I]t’s a question of how this document can be used productively and whether

it can be used productively, consistently, and authoritatively to be served as the

authoritative bodies listing, or conversely, maybe whether it’s not, and instead it should

be considered by you in a forum where you have the freedom to delve down into the data

and make a decision based on the data.”

Ultimately, none of the DART-IC members voted in favor of rescinding NTP-

CERHR’s designation as an authoritative body and five members voted against doing so.

OEHHA Notice of Intent to List BPA

On January 24, 2013, OEHHA issued a notice of intent to list BPA on the

Proposition 65 list of chemicals known to cause reproductive toxicity. In an attachment,

OEHHA explained that “[u]nder the Proposition 65 regulations, a chemical must be listed

via the authoritative bodies mechanism when two conditions are met: 1) An

authoritative body formally identifies the chemical as causing reproductive toxicity

([Regulation] 25306(d)) [and] 2) The evidence considered by the authoritative body

meets the sufficiency criteria contained in the regulations ([Regulation] 25306(g)).”

OEHHA specified that its decision to list BPA was based on the finding of NTP-CERHR

that BPA caused developmental toxicity in laboratory animals at high levels of exposure.

According to OEHHA, the NTP-CERHR monograph “satisfie[d] the formal identification

and sufficiency of evidence criteria in the Proposition 65 regulations.”

12

ACC’s Complaint and Writ Petition

As a result of the OEHHA’s notice of intent, ACC commenced this action by

filing a verified complaint in the trial court on March 1, 2013, seeking to enjoin OEHHA

from adding BPA to the Proposition 65 list as a reproductive toxicant on the basis of the

monograph. ACC asserted that the monograph did not “formally identify” BPA as

causing reproductive toxicity, but instead only concluded that the “ ‘possibility that

[BPA] may alter human development cannot be dismissed,’ and that ‘studies in

laboratory animals provide only limited evidence for adverse effects on development and

more research is needed to better understand their implications for human health.’ ”

ACC also asserted that OEHHA’s determination to list BPA was contrary to the

determination of DART-IC, which unanimously concluded that BPA should not be listed

based on its review of the same monograph as well as the underlying studies. ACC

emphasized that the monograph specifically stated that the “ ‘weight of evidence that

[BPA] causes adverse developmental or reproductive effects in humans’ is ‘insufficient

evidence for a conclusion.’ ”

ACC went on to contend that OEHHA’s determination to list BPA was an abuse

of discretion, exceeded OEHHA’s authority, and was contrary to law. Specifically, ACC

asserted: (1) OEHHA’s notice of intent to list did not satisfy its own regulations because

it did not allege that the monograph concluded that an association between adverse

reproductive effects in humans and BPA is biologically plausible as required by

Regulation 25306, subdivision (g)(2); (2) the monograph did not formally identify BPA

as causing reproductive toxicity, as required under section 25249.8, subdivision (b), but

instead merely contained intermediate references to studies of mice and rats which

OEHHA treated as formal identification; (3) OEHHA’s conclusion that the monograph

constituted formal identification of BPA as a reproductive toxicant based solely on

studies showing adverse effects in laboratory animals at high doses was contrary to, and

in fact precluded by, the conclusion of DART-IC, the state’s qualified experts who

13

reviewed the same monograph and its underlying studies and voted that BPA should not

be listed; and (4) subsequent studies had superseded any conclusion that BPA caused

reproductive toxicity, and therefore OEHHA’s regulations required a finding that BPA

did not satisfy the definition of “as causing reproductive toxicity” (Regs. § 25306, subd.

(h)), and OEHHA abused its discretion in failing to consider the subsequent studies

and/or by not finding that they precluded the listing of BPA.

ACC complained that, if not enjoined, the listing of BPA pursuant to Proposition

65 would cause immediate and irreparable harm and, conversely, OEHHA would suffer

no harm if the listing of BPA was delayed. ACC also asserted that it had either exhausted

all available administrative remedies or was excused from doing so based on futility,

irreparable harm, or the administrative agency’s lack of jurisdiction to proceed.

In the first cause of action, ACC sought declaratory relief, declaring its rights and

OEHHA’s duties under Government Code section 11350, subdivision (a), and Code of

Civil Procedure section 1060. In the second cause of action, ACC sought preliminary

and permanent injunctive relief, enjoining OEHHA from adding BPA to the Proposition

65 list of chemicals known to the State of California to cause reproductive toxicity. ACC

asserted that it had no adequate remedy at law.

On March 27, 2013, ACC filed a motion for a preliminary injunction, seeking to

enjoin OEHHA from listing or taking any further action in listing BPA as a reproductive

toxicant under Proposition 65 pursuant to the authoritative body listing mechanism.

(Regs. § 25306.)

In an amended complaint, ACC added a cause of action seeking a peremptory writ

of mandate pursuant to Code of Civil Procedure section 1085, directing OEHHA to take

all necessary steps to halt the listing of BPA and directing OEHHA not to list BPA

pursuant to Proposition 65.

14

OEHHA Lists BPA and the Trial Court Grants ACC a Preliminary Injunction

After ACC commenced this action, and after it filed its motion for a preliminary

injunction, OEHHA published notice, effective April 11, 2013, stating that it was adding

BPA to the list of chemicals known to the State of California to cause reproductive

toxicity. OEHHA then filed a notice in the trial court stating that ACC’s case had been

rendered moot as a result of its listing of BPA pursuant to Proposition 65.

In oral argument on ACC’s motion for a preliminary injunction, OEHHA

explained that there are two steps in the process under Proposition 65. In the first step,

the agency determines the type of hazard posed by the subject chemical, such as whether

it is a carcinogen or a reproductive toxin. In the second step, the agency determines what

the concern is for humans being affected by that hazard. OEHHA argued that chemicals

are listed on the Proposition 65 list based on the first step only. In other words, if the

chemical poses a particular hazard, such as being a carcinogen or causing developmental

toxicity, the chemical is added to the list even if the evidence of the hazard posed relates

to animal studies, so long as the “evidence is sufficient and meets the criteria.”

OEHHA asserted that chemicals that are found to be animal toxins are listed

because scientists presume that chemicals which cause harm in animals will also cause

harm in humans. OEHHA stated that hazard identification is “almost always based on

animal studies, because you can’t feed the chemical to humans -- and it identifies the

hazard.”

OEHHA characterized the monograph as stating, in substance: “we don’t have

enough evidence to know what the effect is in humans; we can’t tell you what the

problems are in humans, but we do know that this chemical is a developmental toxin in

animals and we have some concern in humans, some concern for infants exposed to the

chemical at the current levels of exposure . . . .” OEHHA emphasized that the

monograph stated repeatedly that there was clear evidence of developmental toxicity in

animals. OEHHA argued: “they said it in five or six different places in different

15

phrasing, but they kept saying, clear evidence of developmental toxicity in animals. [¶]

That’s the identification of the hazard, developmental toxicity. That’s what OEHHA

looks to, it doesn’t look at the risk to humans at that point.” However, OEHHA does not

merely accept the NTP’s position that the subject chemical poses a particular hazard; “it

has to dig deeper.” The OEHHA scientists review the studies and NTP’s analysis, and

OEHHA independently reaches its conclusion as to whether NTP was correct that the

subject hazard is indeed present. OEHHA further reviews whether it is biologically

plausible that the chemical presents the same hazard, and will cause the same effects, in

humans.

The trial court interposed that, given the DART-IC determination that BPA need

not be listed, there appeared to be a significant scientific dispute as to whether BPA

should indeed be published on the Proposition 65 list. The trial court repeatedly

expressed concern about the time lapse of several years since the publication of the

monograph, and yet OEHHA was suddenly “rushing to list it when you get a lawsuit

filed.”

OEHHA responded that it and the DART-IC, which operate under different listing

mechanisms, approach their review of the NTP findings differently. DART-IC

essentially reviews all of the evidence and considers the matter de novo. Conversely,

OEHHA reviews the NTP findings and considers whether those findings meet the criteria

for listing. According to OEHHA, it “must still list it if it meets the criteria based on

their review of the NTP and [OEHHA’s] inability to substitute their own decision; they

have to accept what the NTP did as long as it meets the criteria in the statute, in the

regulations. So it’s a very different proceeding.”

ACC emphasized that the DART-IC had considered the same monograph and

unanimously voted against listing BPA. On the same day, NRDC petitioned OEHHA for

the listing of BPA under the authoritative body listing mechanism. OEHHA chose to act

on the NRDC petition, but three years passed before it issued the notice of intent to list.

16

Thus, for purposes of the trial court’s consideration of ACC’s motion for a preliminary

injunction, ACC asserted that this timeline demonstrated that there was “no rush

whatsoever here.”

ACC emphasized that, for listing under the authoritative body listing mechanism,

there had to be a finding by OEHHA that the authoritative body had made its formal

identification of the chemical “in conformity with the criteria that require[] that there be

sufficient data to show a biologically plausible association between the chemical and the

-- an adverse effect in humans.” ACC maintained that there was no formal identification

in the monograph that BPA was a reproductive toxicant. It emphasized the language in

the monograph which stated: “despite the limitations in the evidence for low dose effects

in laboratory animals . . . the possibility that [BPA] may alter human development cannot

be dismissed.” ACC also emphasized the monograph language stating: “ ‘Overall, the

current literature cannot yet be fully interpreted for biological or experimental

consistency or for relevance to human health,’ ” and “ ‘[a]dditional research is needed to

understand the metabolism of [BPA] in both laboratory animals and humans.’ ” ACC

suggested that this language did not amount to the formal identification of a chemical that

would warrant listing.

ACC further noted that OEHHA’s intent to list was solely based on high dose

studies, and “the NTP, with respect to the high dose studies, had only minimal or

negligible concern with respect to any risk for humans.” ACC further asserted that,

inasmuch as OEHHA was “acting contrary to the state’s gubernatorially appointed

scientific experts, that is also an abuse of discretion.”

In reply, OEHHA asserted that the ACC was “mixing apples and oranges.

[D]iscussions about the risks to humans are not the identification, it’s the clear evidence

of developmental effect that’s at issue here.” OEHHA further asserted that, as stated in

case law, the NTP need not make a particular statement, or, in other words, use particular

17

terminology; OEHHA must look at the monograph and determine whether the “correct

identification in the findings were made.”

The trial court granted ACC’s motion for a preliminary injunction, directing

OEHHA to immediately remove BPA from the Proposition 65 list. Thereafter, OEHHA

issued a notice announcing that BPA was delisted.

NRDC Intervenes

On June 18, 2013, the trial court granted NRDC’s motion to intervene as a party

defendant.

Hearing in the Trial Court

At the beginning of the hearing, ACC asserted that “the State of California of

Scientists [sic], the DART-IC, and every governmental organization worldwide that’s

evaluated BPA has considered it safe for humans.” ACC then asserted that the

“erroneous” listing of BPA would cause significant harm, both to ACC and to the public.

ACC argued that there was no formal identification and emphasized that the

monograph only concluded that “the possibility that BPA may alter human development

cannot be dismissed.” According to ACC, that statement amounted to a conclusion that

NTP could not say that BPA is a reproductive toxicant. ACC asserted that this

conclusion—that the NTP could not dismiss the possibility that BPA may alter human

development—is irreconcilable with the conclusion that the NTP had formally identified

BPA as a reproductive toxicant. ACC asserted that the contrast in the language between

what the NTP used in other briefs when it has formally identified a chemical as a

reproductive toxicant and the monograph on BPA here was “quite dramatic” and

“striking.” For example, for a different chemical, the monograph stated: “[T]he NTP

judges the scientific evidence of the effect on laboratory animals sufficient to conclude

that [the chemical] may adversely affect human development and reproduction if

exposures are sufficiently high.” Based on this, ACC contended that the NTP knew how

18

to state that a chemical is or may be a developmental toxicant, and it had not done so

here.

ACC also emphasized the low levels of concern expressed in the monograph.

Given that the monograph for the most part stated that the NTP had negligible or minimal

concern in most areas, ACC asserted that it could not reasonably be concluded that the

monograph constituted a formal identification of BPA as a reproductive toxicant.

ACC further asserted that, under the regulations, to warrant listing BPA, the data

had to show that it was biologically plausible that the adverse reproductive effects will

occur in humans. Thus, according to ACC, animal data alone is insufficient to establish

reproductive toxicity. Instead, there had to be a conclusion that it was biologically

plausible that those effects seen in experimental animals will occur in humans.

ACC characterized the monograph as “replete with concerns about the ability to

translate the animal data to human effects.” Therefore, according to ACC, there was no

leeway for OEHHA to maintain it was biologically plausible that the effects found in

animals would occur in humans. ACC maintained a statement that NTP could not

dismiss the possibility that BPA may alter human development does not constitute a

finding that those effects are biologically plausible in humans.

ACC further argued that there was no other evidence in the administrative record

of biological plausibility. Addressing what OEHHA referred to as a presumption of

biological plausibility, ACC asserted that OEHHA had “not submit[ed] anything that

suggest[s] why there is biological plausibility in this case other than saying, ‘We assume

that the results of animal data apply to humans.’ ” However, according to ACC,

OEHHA’s own regulations require that there be a determination based on various factors

indicating biological plausibility in humans.

ACC also contended that the statement in the monograph that “high dose studies

are not controversial and provide clear evidence of adverse effects on development in

laboratory animals,” was not offered as a conclusion in that section. According to ACC,

19

the question posed in that section of the monograph was: “Can [BPA] affect human

development reproduction?” ACC asserted that the statement concerning the high dose

studies was not intended to answer that question, but instead “indicat[ed] that this is some

data that it’s considering,” and was noting that this information was derived using

“hugely excessive” dosage levels.

ACC also emphasized that the monograph stated that there was scientific

controversy as to the lower dose findings. According to ACC, when considered together,

the high dose and low dose studies “provide[] limited evidence of adverse effects.”

ACC then asserted that it was an abuse of discretion for OEHHA to disregard the

2009 DART-IC declination. ACC emphasized that the attorney for the NRDC advanced

the same arguments before OEHHA that it had earlier made before the DART-IC, and the

DART-IC rejected those arguments. According to ACC, the DART-IC “made express[]

statements that they didn’t think that the effects in the high dose studies could be

extrapolated to humans.” ACC asserted that OEHHA should not be permitted to list

BPA given what the DART-IC stated about the inability to use the high dose studies as a

basis for listing BPA.

OEHHA emphasized the deferential standard of review to be accorded to it in a

case such as this, involving highly technical record addressing scientific material. It then

asserted that “[a] lot of ACC’s argument hinges on its confusion between hazard

identification and risk.” Hazard identification refers to the inquiry into what harm a

chemical causes, such as reproductive toxicity or developmental toxicity. Risk, on the

other hand, is related to how much people are exposed to the chemical and how real the

threat to people is. OEHHA asserted that ACC “keeps . . . muddling the concepts here

and trying to confuse the hazard identification with the level of concern or the risk.”

OEHHA asserted that, while the monograph stated that there was insufficient

evidence from humans to draw a conclusion, this circumstance was actually common.

OEHHA argued there are very few chemicals for which there is “sufficient human

20

evidence” because “we don’t do experiments on humans.” Therefore, scientists generally

have to consider animal evidence.

In the hazard identification stage, according to OEHHA, NTP concluded that there

was limited evidence of developmental toxicity in low dosages, and evidence of adverse

effects of reproductive toxicity. OEHHA acknowledged, however, that neither of these

findings would be sufficient to support listing BPA because limited evidence and some

evidence is not enough. However, the monograph also stated that there was clear

evidence of adverse effects of developmental toxicity in high dosages. OEHHA stated

that this was what it considered in the monograph, which was identical to what it

considered in all other NTP monographs it had reviewed. OEHHA also emphasized the

language in the monograph stating that the high dose effects were not considered

scientifically controversial and provided clear evidence of adverse effects on

development in laboratory animals. The monograph further stated that the NTP found

“clear evidence of adverse developmental hazards at high doses of” BPA. OEHHA

stated that the foregoing statements constituted the hazard identification, and this is what

OEHHA considers in determining whether or not to list a chemical.

OEHHA again argued that ACC’s focus on the level of concern portions of the

monograph was not “relevant to the listing here, because that is the risk assessment

portion. That is what’s telling us whether people are exposed to the chemical and if so,

should we be worried about it. [I]t’s a clear hazard, a clear developmental hazard, but we

are going to have negligible concern because people don’t get exposed to the chemical.”

OEHHA acknowledged that the analysis for listing does not end with the

identification. After identifying the hazard, OEHHA must determine whether the studies

relied upon were sufficient to indicate that it is biologically plausible that the chemical

will cause harm in humans. According to OEHHA, biological plausibility is a technical

term that does not refer to exposure or level of concern. Rather, it refers to the

determination of “whether it’s appropriate to extrapolate from animals to humans,” a

21

question that arises with virtually all animal studies. OEHHA stated that, as a general

principle, in the absence of evidence to the contrary, it is proper to assume that a

chemical that causes harm in animals will cause harm in humans. According to OEHHA,

the general presumption, which is supported by Exxon Mobil, supra, 169 Cal.App.4th

1264, is that, absent evidence to the contrary, “you always make this extrapolation and

that is what constitutes the biological plausibility.” As an example of a circumstance

indicating biological plausibility is not present, OEHHA referenced a situation when the

animal has a particular physical structure that is harmed but that physical structure is not

present in humans. Another example would be when there is evidence the animal

metabolizes the chemical differently than humans. OEHHA argued, “absent that

evidence, the normal assumption is that you always make this extrapolation and that is

what constitutes the biological plausibility.”7

OEHHA argued that Exxon Mobil made clear that the monograph does not have to

explicitly say anything about biological plausibility and there is “no magic language . . .

that a report would have to use. The real responsibility is on OEHHA to look at the

underlying studies, to make sure that they are adequate, to make sure that there is no

evidence to the contrary that would indicate it’s not appropriate to extrapolate from

animals to humans and to determine biological plausibility.” OEHHA asserted that

biological plausibility is a scientific term that calls not for determining plausibility in a

7 OEHHA’s argument was consistent with the response it offered to comments in the

administrative process. There, OEHHA wrote: “There is no requirement that

developmental or reproductive effects have actually been demonstrated in humans.

Although the biological plausibility that effects could occur in humans is considered

under the criteria in [Regulation] 26306(g), it is a fundamental assumption of toxicology

that the results of toxicity testing of chemicals in animal models are indicative of

potential effects in humans. [¶]…[¶] [I]n the absence of convincing data that effects are

not plausible in humans because of metabolic, physiologic or other biological

considerations, it is assumed that a chemical that causes developmental toxicity in an

animal model may do so in humans.”

22

“lay sense,” but rather in a “technical sense.” It is “appropriate to extrapolate, and the

rule is that you do so unless there is evidence to the contrary. So by stating ‘possibly,’

NTP was in effect indicating we have not seen any evidence to the contrary that would

lead us to refute the normal toxicological principle that permits you to extrapolate . . .

from animals to humans.”

Here, however, OEHHA stated that the monograph did contain a statement about

biological plausibility. In response to the question, “ ‘Can [BPA] affect human

development or reproduction?’ ” The report answered, “possibly.” According to

OEHHA, this, in itself, is a statement of biological plausibility. OEHHA argued, “it’s . . .

easy to confuse lay terms and lay meanings and to say ‘. . . possible doesn’t mean

plausible.’ But we are dealing with a technical scientific term. We’re not dealing with a

lay term as to what is plausible.” The scientific term biological plausibility is an

extrapolation. “Clearly the NTP believed that it was appropriate to extrapolate from

animals to humans and that there was not counter evidence.” According to OEHHA, the

NTP’s statement that the possibility that BPA may alter human development cannot be

dismissed is essentially the same as saying biological plausibility cannot be rejected.

Regarding the different language used in other NTP reports, OEHHA noted that

instead of saying the NTP “judges the evidence sufficient” to conclude [BPA] can cause

reproductive toxicity in humans, the report said that the NTP “can’t omit the possibility

that this could cause harm in humans.” According to OEHHA, this “formulation actually

means the same thing. In both cases the NTP is saying, ‘we can’t reject biological

plausibility. We have to go with the normal toxicological assumption.’ ”

OEHHA asserted that, in any event, NTP did not have to say anything about

biological plausibility because it was OEHHA’s responsibility to determine whether there

was biological plausibility and whether it would be appropriate to extrapolate. OEHHA

reviewed the studies and determined they “ ‘don’t demonstrate a lack of biological

23

plausibility.’ ” There was no evidence to “ ‘refute biological plausibility and that would

lead [OEHHA] not to extrapolate from animals to humans.’ ”

The Trial Court’s Ruling

The trial court denied the relief requested in the amended complaint. The court

rejected the premise that, to support listing under Proposition 65, there must be clear

evidence that a chemical is known, not merely suspected, to cause cancer or reproductive

toxicity in humans, noting that this court had rejected that argument in AFL-CIO v.

Deukmejian (1989) 212 Cal.App.3d 425 (Deukmejian). The trial court reasoned that

Proposition 65 is not limited to chemicals known to cause cancer or reproductive toxicity

in humans, and the omission of any such limitation implies that chemicals are to be listed

even if they are known to cause cancer or reproductive toxicity only in animals. The

court recognized that because of the difficulties in making determinations through studies

involving humans, extrapolation from animal testing is widely accepted as both

justifiable and necessary. Thus, Proposition 65 applies to chemicals determined to cause

cancer or reproductive toxicity in humans or animals. The trial court stated that the

operative question for listing a chemical under Proposition 65 is not whether it is

probably carcinogenic or toxic to humans, but rather whether it is a known carcinogen or

reproductive toxin.

The trial court stated that “the [m]onograph involves a two-phase process. In

[p]hase 1, the hazard identification phase, the [m]onograph assesses the scientific

evidence to determine whether a substance causes adverse effects on reproduction and

development. In [p]hase 2, the [m]onograph reviews the data and expresses a ‘level of

concern’ for humans based on current levels of exposure to the chemical.”8 The trial

court reasoned that ACC’s contention that NTP found insufficient evidence to conclude

8 We note that it is not the monograph that involves a two-step process. Rather, as we

discuss post, it is Proposition 65 that sets out a two-step process.

24

that BPA is a reproductive toxicant was based on statements addressed to the phase 2

analysis. However, the monograph, in its phase 1 analysis, found there to be “clear

evidence” of adverse developmental effects in laboratory animals administered high

doses of BPA. The trial court concluded that this was “sufficient to satisfy the hazard

identification phase of the regulatory listing requirements.”

The trial court also rejected ACC’s contention that OEHHA abused its discretion

in finding that there was sufficient evidence to conclude that an association between

adverse reproductive effects in humans and BPA was “biological[ly] plausible.” (Regs.

§ 25306, subd. (g).) Concluding that ACC misconstrued the meaning of “biological

plausibility,” the trial court stated that “[b]iological plausibility is not concerned with the

level of exposure to a chemical or the level of concern to humans from such exposure; it

is concerned with whether adverse effects reported in animal studies reasonably can be

extrapolated to humans.” Therefore, according to the trial court, the NTP’s conclusion

that there was “negligible” or “minimal” concern to humans for certain adverse effects at

current levels of exposure did not necessarily preclude a finding of biological plausibility.

The trial court found that OEHHA interpreted its regulation’s biological

plausibility requirement based on the holding in Exxon Mobil, supra 169 Cal.App.4th

1264. Consistent with Exxon Mobil, OEHHA interprets biological plausibility to mean

that, absent evidence to the contrary, effects observed in laboratory animals are assumed

to be subject to extrapolation in humans. The trial court emphasized that the Exxon

Mobil court upheld this assumption notwithstanding the fact that the authoritative body in

that case did not explicitly discuss whether the findings as to animals were relevant to

humans. (Id. at pp. 1287-1288.) The trial court read Exxon Mobil to suggest that

extrapolation from animals to humans is inappropriate only where evidence shows that

experimental animals differ in physiologically significant ways from humans. Thus,

according to the trial court, the Exxon Mobil court approved of a “ ‘generally accepted

toxicological assumption’ that, absent evidence to the contrary, a chemical that causes

25

developmental harm in experimental animals, will cause similar harm in humans.” (Id. at

p. 1289.) The trial court concluded that OEHHA did not abuse its discretion by

following that principle in this case. Nor did it abuse its discretion by finding that NTP

formally identified BPA as causing reproductive toxicity within the meaning of

Proposition 65.

The trial court further ruled that OEHHA did not abuse its discretion by

disregarding the state’s qualified experts, DART-IC. The court agreed with OEHHA that

the DART-IC’s determination against listing BPA under the state’s qualified experts

listing mechanism did not preclude OEHHA from listing it under the separate

authoritative body listing mechanism. These listing mechanisms are separate and

independent, and DART-IC’s determination under one is not controlling of the other.

Rather, if the listing requirements are met for the authoritative body mechanism, OEHHA

is mandated under the law to list a chemical even where the state’s qualified experts have

declined to do so. And because the authoritative body listing mechanism is separate and

independent from the qualified experts mechanism, the court reasoned that OEHHA was

not required to consider DART-IC’s opinion. However, the court went on to note that the

record showed OEHHA did, in fact, consider that opinion.

Finally, the trial court determined that OEHHA did not abuse its discretion by

disregarding the opinion of Dr. Tyl, who opined that BPA does not satisfy the criteria for

listing under Proposition 65. The trial court stated that Dr. Tyl’s opinion was not binding

on OEHHA, and OEHHA’s determination that her opinion was not persuasive was within

its discretion.

The trial court denied all relief requested by ACC in the amended complaint. It

also denied ACC’s request for a stay pending appeal, although it left in place the

preliminary injunction until the expiration of ACC’s time to file a notice of appeal, thus

affording ACC the opportunity to file a petition for a writ of supersedeas.

26

Motion for New Trial and Judgment

Later, the trial court denied ACC’s motion for a new trial. Thereafter, the court

entered judgment, denying ACC all relief requested in the amended complaint in

accordance with its prior ruling. The court again indicated that it would stay the

judgment and keep the previously entered preliminary injunction in place until the

expiration of the time for filing a notice of appeal to allow ACC the opportunity to file a

petition for a writ of supersedeas.

Stay Pending Appeal

Another panel of this court construed ACC’s “Petition for Writ of Supersedeas or

Other Extraordinary Relief” to be a request for a stay pending appeal, granted that

request, and directed that the stay shall remain in effect pending further order of this

court.

DISCUSSION

I. Standards of Review

A. Writ of Mandate

“In determining whether to grant a petition for traditional mandamus, we review

for an abuse of discretion. ‘ “ ‘Abuse of discretion is established if the respondent

[agency] has not proceeded in the manner required by law, the order or decision is not

supported by the findings, or the findings are not supported by the evidence.’

[Citations.]” [Citation.]’ [Citation.] ‘In determining whether the agency complied with

the required procedures and whether the agency’s findings are supported by substantial

evidence, the trial court and the appellate courts essentially perform identical roles. We

review the record de novo and are not bound by the trial court’s conclusions.’ ” (Exxon

Mobil, supra, 169 Cal.App.4th at p. 1276.)

We further note that “[i]n a mandate proceeding, the party seeking the writ must

show a clear and present duty of the respondent to act in conformity with the proposed

writ.” (Western Crop Protection Association v. Davis (2000) 80 Cal.App.4th 741, 757

27

(Western Crop).) Thus, as the party seeking a judicial remedy, ACC bears the burden of

showing OEHHA’s listing under Proposition 65 is inconsistent with law. (Ibid.)

B. Declaratory and Injunctive Relief

A complaint seeking declaratory and injunctive relief may also be an appropriate

means by which to challenge OEHHA’s listing of a chemical on the Proposition 65 list.

(See Styrene Information and Research Center v. Office of Environmental Health Hazard

Assessment (2012) 210 Cal.App.4th 1082 (Styrene).) The decision to grant or deny

injunctive relief is generally reviewed by the appellate court under the abuse of discretion

standard (Salazar v. Eastin (1995) 9 Cal.4th 836, 849-850), as is the decision to deny a

request for declaratory relief (County of Los Angeles v. California State Water Resources

Control Bd. (2006) 143 Cal.App.4th 985, 997-998). “However, to the extent our review

involves basic questions of statutory and regulatory interpretation, we review those

questions of law de novo.” (Californians for Pesticide Reform v. California Dept. of

Pesticide Regulation (2010) 184 Cal.App.4th 887, 899.) Additionally, “to the extent the

trial court had to review the evidence to resolve disputed factual issues, and draw

inferences from the presented facts, an appellate court will review such factual findings

under a substantial evidence standard.” (Shapiro v. San Diego City Council (2002) 96

Cal.App.4th 904, 912.)

C. Review of Government Agency Interpretations of Regulations

“As a general matter, courts ‘will be deferential to government agency

interpretations of their own regulations, particularly when the interpretation involves

matters within the agency’s expertise and does not plainly conflict with a statutory

mandate. [Citation.] . . . [W]e will not disturb the agency’s determination without a

demonstration that it is clearly unreasonable.’ [Citation.] While final responsibility for

interpreting a statute or regulation rests with the courts and a court will not accept an

agency interpretation that is clearly erroneous or unreasonable, ‘ “[a]s a general rule, the

courts defer to the agency charged with enforcing a regulation when interpreting a

28

regulation because the agency possesses expertise in the subject area.” ’ ” (Exxon Mobil,

supra, 169 Cal.App.4th at pp. 1276-1277.)

At issue in this case is whether OEHHA’s listing of a chemical comports with

section 25249.8 and the regulations promulgated thereunder. “In considering this issue,

the scope of our review ‘ “is limited, out of deference to the agency’s authority and

presumed expertise: ‘The court may not reweigh the evidence or substitute its judgment

for that of the agency. [Citation.]’ ” [Citation.] “In general . . . the inquiry is limited to

whether the decision was arbitrary, capricious, or entirely lacking in evidentiary

support . . . .” [Citation.] When making that inquiry, the “ ‘ “court must ensure that an

agency has adequately considered all relevant factors, and has demonstrated a rational

connection between those factors, the choice made, and the purposes of the enabling

statute.” [Citation.]’ ” [Citation.]’ [Citation.] This limited judicial review is further

constrained by the recognition that ‘ “[i]n technical matters requiring the assistance of

experts and the study of marshaled scientific data as reflected herein, courts will permit

administrative agencies to work out their problems with as little judicial interference as

possible.” ’ ” (Exxon Mobil, supra, 169 Cal.App.4th at p. 1277.) We discuss in more

detail post rules applicable to the regulation at issue here.

II. Proposition 65 - Statutory and Regulatory Scheme

A. Proposition 65

Proposition 65, adopted in 1986, was intended to protect people and the water

supply from harmful chemicals. (Deukmejian, supra, 212 Cal.App.3d at p. 429.) “The

initiative . . . imposes severe penalties upon those who contaminate drinking water with

carcinogenic and toxic chemicals and who expose individuals to such chemicals without

warning.” (Id. at p. 430.)

Proposition 65 added sections 25249.5 through 25249.13 to the Health and Safety

Code. (Exxon Mobil, supra, 169 Cal.App.4th at p. 1268; Deukmejian, supra, 212

Cal.App.3d at p. 429.) It applies only to those chemicals “that have been identified and

29

listed as chemicals ‘known to the state to cause cancer or reproductive toxicity.’ ”

(Deukmejian, at p. 431, quoting § 25249.5.) Therefore, the identification and listing of

those chemicals as such “are pivotal to the entire statutory scheme.” (Deukmejian, at

p. 431.)

Section 25249.8, subdivision (a), requires the Governor to publish “a list of those

chemicals known to the state to cause cancer or reproductive toxicity within the meaning

of this chapter,” and to have the list revised and republished at least annually. A review

of the chemicals listed pursuant to Proposition 65 reveals that, when a chemical is listed

as known to cause reproductive toxicity, the listing specifies which endpoint was

implicated: male reproductive toxicity, female reproductive toxicity, and/or

developmental toxicity. (Regs. § 27001, subd. (c); see fn. 4, ante.)

B. OEHHA, DART-IC, and Implementing Regulations

Proposition 65 required the Governor to designate a lead agency and other

agencies that may be required to implement Proposition 65. (§ 25249.12, subd. (a).) In

1991, the Governor designated OEHHA as the lead agency. (§ 25102, subd. (o).) As the

lead agency, OEHHA was authorized to promulgate regulations to implement Proposition

65. (§ 25249.12, subd. (a); Exxon Mobil, supra, 169 Cal.App.3d at p. 1279.) The

OEHHA regulations identify the DART-IC as the qualified experts on developmental and

reproductive toxicants. DART-IC is a committee of OEHHA. (Regs. § 25102, subds.

(c), (t); California Chamber of Commerce v. Brown (2011) 196 Cal.App.4th 233 (Cal.

Chamber).)

C. The Statutory Listing Mechanisms

Section 25249.8 provides four separate listing mechanisms: (1) the Labor Code

reference mechanism – “substances identified by reference in Labor Code Section

6382(b)(1) and those substances identified additionally by reference in Labor Code

30

Section 6382(d)” (§ 25249.8, subd. (a));9 (2) the qualified experts mechanism –

chemicals for which “in the opinion of the state’s qualified experts it has been clearly

shown through scientifically valid testing according to generally accepted principles to

cause cancer or reproductive toxicity”; (3) the authoritative body mechanism – “a body

considered to be authoritative by such experts has formally identified it as causing cancer

or reproductive toxicity”; and (4) the formally required mechanism – “an agency of the

state or federal government has formally required it to be labeled or identified as causing

cancer or reproductive toxicity.”10 (§ 25249.8, subd. (b); see fn. 2, ante.)

Regarding the authoritative body mechanism, “[t]he regulations provide that the

‘lead agency’ (OEHHA) ‘shall determine which chemicals have been formally identified

by an authoritative body as causing cancer or reproductive toxicity.’ ” (Exxon Mobil,

supra, 169 Cal.App.4th at p. 1270, citing Regs. § 25306, subd. (c).) “OEHHA must

further determine whether the authoritative body relied upon ‘sufficient evidence’ of . . .

reproductive toxicity as defined in the regulations or did not consider ‘scientifically valid’

data, but it does not ‘substitute its scientific judgment for that of the authoritative body.’ ”

(Cal. Chamber, supra, 196 Cal.App.4th at pp. 245, 259, citing Exxon Mobil, at p. 1283.)

The NTP is identified in Regulation 25306 as an authoritative body for the

identification of chemicals as causing reproductive toxicity, but solely as to final reports

9 See Cal. Chamber, supra, 196 Cal.App.4th 233.

10 The formally required mechanism “involves no independent evaluation by OEHHA or

the expert committees. Rather, OEHHA ‘shall’ list chemicals ‘if . . . [it] . . . determines

that an agency of the state or federal government has formally required the chemical to be

labeled or identified as causing cancer or reproductive toxicity.’ ” (Cal. Chamber, supra,

196 Cal.App.4th at p. 245, quoting Regs. § 25902, subd. (a).)

31

of the NTP-CERHR. (Regs. § 25306, subd. (l)(3); see Exxon Mobil, supra, 169

Cal.App.4th at p. 1270 & fn. 6.)11

D. The Two-step Process of Proposition 65

As OEHHA and NRDC point out, Proposition 65 prescribes a two-step process.

In the first step, the “hazard-identification” stage, the state creates a list of chemicals

known to the state to cause cancer or reproductive toxicity. (§ 25249.8, subd. (a); Exxon

Mobil, supra, 169 Cal.App.4th at pp. 1291-1292.) In the second step, which occurs after

the chemical is listed, businesses are required to give a “ ‘clear and reasonable warning’

before exposing individuals to the chemical” and are prohibited from knowingly

discharging listed chemicals into water or onto land where the chemical will or probably

will pass into any source of drinking water. (§§ 25249.5, 25249.6; Exxon Mobil, at

pp. 1268, 1291-1292.) However, as part of this second step, a business can obtain an

exemption from these requirements if it can demonstrate the discharge or release “will

not cause any significant amount of the discharged or released chemical to enter any

source of drinking water” (§ 25249.9, subd. (b)(1)), or that the exposure to the chemical

poses no significant risk at specified exposure levels. (§ 25249.10, subd. (c).)12 (Exxon

Mobil, at p. 1268.)

11 The other listed authoritative bodies are the United States Environmental Protection

Agency, the United States Food and Drug Administration, the International Agency for

Research on Cancer (solely as to transplacental carcinogenicity), and the National

Institute for Occupational Safety and Health. (Regs. § 25306, subd. (l).)

12 Under section 25249.10, subdivision (c), the business must demonstrate that the

chemical “poses no significant risk assuming lifetime exposure at the level in question for

substances known to the state to cause cancer, and that the exposure will have no

observable effect assuming exposure at one thousand (1000) 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 . . . .’ ” (§ 25249.10, subd. (c); Exxon

Mobil, supra, 169 Cal.App.4th at p. 1268; see Regulations §§ 25801, 25803, 25821.) A

businesses may also “ ‘request that the agency set . . . a “safe harbor” level for a specific

32

Only the first step — hazard identification — is at issue here. As we shall discuss,

ACC’s arguments pertaining to exposure levels are appropriate for the second step which

is not at issue here.

E. Chemicals Known to Cause Cancer or Reproductive Toxicity

“ ‘[O]nly those chemicals that are known, and not merely suspected, of causing

cancer or reproductive toxicity must be [placed] on the [Proposition 65] list.’ ” (Western

Crop, supra, 80 Cal.App.4th at p. 749, quoting Deukmejian, supra, 212 Cal.App.3d at

pp. 436-437; see Styrene, supra, 210 Cal.App.4th at p. 1101.) However, section 25249.5

does not expressly limit a chemical subject to listing to those known to cause cancer or

reproductive toxicity in humans. (Deukmejian, at p 435.) The chemical agent must be

listed even if it is known to be carcinogenic or a reproductive toxin only in animals.

(American Chemistry Council v. Office of Environmental Health Hazard Assessment

(2020) 51 Cal.App.5th 918, 921 (American Chemistry Council); Western Crop, at p. 749;

Deukmejian, at p. 438, fn. 7.)

Regulation 25306 addresses chemicals formally identified by authoritative bodies.

Subdivision (d)(1) of Regulation 25306 provides in pertinent part: “a chemical is

‘formally identified’ . . . when the lead agency determines that: [¶] the chemical . . . is

the subject of a report which is published by the authoritative body and which concludes

that the chemical causes cancer or reproductive toxicity.”13 Subdivision (g) provides that

chemical, if none exists.’ ” (Exxon Mobil, at p. 1291.)

13 In full, Regulation 25306, subdivision (d), provides: “For purposes of this section a

chemical is ‘formally identified’ by an authoritative body when the lead agency

determines that: [¶] (1) the chemical has been included on a list of chemicals causing

cancer or reproductive toxicity issued by the authoritative body; or is the subject of a

report which is published by the authoritative body and which concludes that the

chemical causes cancer or reproductive toxicity; or has otherwise been identified as

causing cancer or reproductive toxicity by the authoritative body in a document that

indicates that such identification is a final action; and [¶] (2) the list, report, or document

specifically and accurately identifies the chemical, and has been: [¶] (A) Reviewed by

33

“as causing reproductive toxicity” means that either “[s]tudies in humans indicate that

there is a causal relationship between the chemical and reproductive toxicity,” or

“[s]tudies in experimental animals indicate that there are sufficient data, taking into

account the adequacy of the experimental design and other parameters such as, but not

limited to, route of administration, frequency and duration of exposure, numbers of test

animals, choice of species, choice of dosage levels, and consideration of maternal

toxicity, indicating that an association between adverse reproductive effects in humans

and the toxic agent in question is biologically plausible.” 14 (Italics added.) Thus, as we

read Regulation 25306, addressing chemicals that cause reproductive toxicity in animals,

it has two components: (1) formal identification of the chemical, within the meaning of

subdivision (d)(1), as causing reproductive toxicity in animals, and (2) biological

plausibility of adverse reproductive effects in humans pursuant to subdivision (g). As we

shall discuss post, ACC’s contentions implicate the interpretation that OEHHA gives to

these component parts of Regulation 25306.

an advisory committee in a public meeting, if a public meeting is required, or [¶] (B)

Made subject to public review and comment prior to its issuance, or [¶] (C) Published

by the authoritative body in a publication, such as, but not limited to, the federal register

for an authoritative body which is a federal agency, or [¶] (D) Signed, where required,

by the chief administrative officer of the authoritative body or a designee, or [¶] (E)

Adopted as a final rule by the authoritative body, or [¶] (F) Otherwise set forth in an

official document utilized by the authoritative body for regulatory purposes.” (Italics

added.)

14 In full, Regulation 25306, subdivision (g), provides: “For purposes of this section, ‘as

causing reproductive toxicity’ means that either of the following criteria have been

satisfied: [¶] (1) Studies in humans indicate that there is a causal relationship between

the chemical and reproductive toxicity, or [¶] (2) Studies in experimental animals

indicate that there are sufficient data, taking into account the adequacy of the

experimental design and other parameters such as, but not limited to, route of

administration, frequency and duration of exposure, numbers of test animals, choice of

species, choice of dosage levels, and consideration of maternal toxicity, indicating that

an association between adverse reproductive effects in humans and the toxic agent in

question is biologically plausible.” (Italics added.)

34

III. Consideration of the DART-IC Determination and Dr. Tyl’s Opinion

We first address ACC’s contention that OEHHA abused its discretion by refusing

to consider the DART-IC’s determination, in which it voted unanimously against listing

BPA.15 This appears to be an issue of first impression as we have found no published

cases on point or any that involve a situation where OEHHA and DART-IC disagree on

whether a particular chemical should be listed.16

ACC points out that DART-IC made its determination based on the same

monograph reviewed by OEHHA and notes that DART-IC members expressed

skepticism as to whether the conclusions from the animal studies could be extrapolated to

humans. ACC emphasizes that all of the OEHHA staff who ultimately would participate

in the decision to list BPA attended the DART-IC hearing and further maintains that,

15 OEHHA asserts that it did consider the opinions of members of the DART-IC, as well

as the opinion of Dr. Tyl, ACC’s expert. However, OEHHA argues that it was not

required to defer or afford great weight to these opinions which, it asserts, differed from

the conclusions of the NTP. For its part, ACC asserts that a declaration submitted by

OEHHA’s general counsel in response to a request to augment the administrative record

proves OEHHA did not consider the DART-IC declination. In the declaration, the

general counsel stated under oath that “ ‘[t]he DART-IC documents ACC seeks to add to

the Administrative Record were not submitted to OEHHA during the listing process for

BPA; they were therefore not considered by OEHHA as part of its determination’ ” Read

in the context of ACC’s request to augment the record, the general counsel’s statement

pertains to documents that were not part of the OEHHA determination. The general

counsel did not say OEHHA never considered the determination of the DART-IC or the

opinions of its members or of Dr. Tyl, all of which OEHHA was aware without reference

to the documents.

16 In Western Crop, supra, 80 Cal.App.4th 741, the plaintiffs asserted that OEHHA

usurped DART-IC in deciding to list certain chemicals under the authoritative body

listing recommendation based on the formal identification of the United States

Environmental Protection Agency. (Id. at p. 747.) However, in that case, DART-IC had

not made any prior determination regarding the chemicals at issue. This court held that,

based on the record before it, there had been no usurpation and the plaintiffs failed to

establish that OEHHA abused its discretion in listing the chemical at issue under the

authoritative body mechanism. (Id. at pp. 749, 757-758.)

35

despite the fact that OEHHA members were present at the DART-IC meeting, they

nonetheless refused to consider the views of the DART-IC panel. If, under an applicable

statute or regulation OEHHA were required to consider DART-IC’s determination, and if

we concluded that OEHHA failed to do so, it is possible those circumstances would

establish an abuse of discretion by OEHHA. However, as we shall discuss, we find no

such statutory or regulatory requirement, and, accordingly, no such abuse of discretion.

There is no statutory or regulatory provision that requires OEHHA to consider

DART-IC’s listing declination when determining whether to list a chemical under the

authoritative body listing mechanism. On the other hand, Regulation 25306 does set

forth mandatory interaction between OEHHA and its committee, DART-IC. Subdivision

(i) provides that OEHHA must notice DART-IC with its intention to list a chemical

pursuant to the authoritative body mechanism. Thereafter, DART-IC members have 30

days to review and comment on the proposed action. In the matter before us, neither

DART-IC nor its members offered any comments pursuant to OEHHA’s notice.

Subdivision (i) also provides that if OEHHA finds there is no substantial evidence that

the criteria in subdivision (g) have been satisfied, OEHHA shall refer the chemical to

DART-IC to determine whether, in the opinion of the committee, “the chemical has been

clearly shown through scientifically valid testing according to generally accepted

principles to cause cancer or reproductive toxicity.” (Regs. § 25306, subd. (i); Cal.

Chamber, supra, 196 Cal.App.4th at p. 245.)17

17 Regulation 25306, subdivision (i), provides in relevant part: “At least 60 days prior to

adding a chemical determined to have been formally identified by an authoritative body

as causing cancer or reproductive toxicity to the list of chemicals known to the state to

cause cancer or reproductive toxicity, the lead agency shall cause to be published in the

California Regulatory Notice Register a notice identifying the authoritative body and the

chemical, and stating the lead agency’s intention to cause the chemical to be added to the

list. Copies of the notice shall be provided to the Carcinogen Identification Committee or

the DART Identification Committee, as appropriate, to permit the appropriate Committee

36

Subdivision (j) of Regulation 25306, also touches on the relationship between

OEHHA and DART-IC in the listing process. It sets forth a provision for reconsideration

of OEHHA’s listing pursuant to the authoritative body mechanism. OEHHA “shall”

reconsider its determination that a chemical has been formally identified as causing

reproductive toxicity if it subsequently finds: “(1) there is no substantial evidence that

the criteria identified in subsection (e) or subsection (g) have been satisfied, or (2) the

chemical is no longer identified as causing cancer or reproductive toxicity by the

authoritative body.” (Regs. § 25306, subd. (j).) This reconsideration may be initiated by

OEHHA or on the request of an interested party, including any member of DART-IC.

(Regs. § 25306, subd. (j).) OEHHA “shall refer chemicals under reconsideration . . . to

[DART-IC] for a recommendation concerning whether the chemical should continue to

be included on the list of chemicals known to the state to cause cancer or reproductive

toxicity. Pending such reconsideration, the chemical shall remain on the list.” (Ibid.)18

No request for reconsideration has been made here.

at least 30 days to review and comment on the proposed action. Within 30 days

following the publication of the notice, interested parties, including any member of the

appropriate Committee, shall submit to the lead agency their written objections to the

addition of the chemical to the list of chemicals known to the state to cause cancer or

reproductive toxicity, along with any supporting documentation. Objections shall be

made on the basis that there is no substantial evidence that the criteria identified in

subsection (e) or in subsection (g) have been satisfied. The lead agency shall review such

objections. If the lead agency finds that there is no substantial evidence that the criteria

identified in subsection (e) or in subsection (g) have been satisfied, the lead agency shall

refer the chemical to the appropriate Committee to determine whether, in the Committee’s

opinion, the chemical has been clearly shown through scientifically valid testing

according to generally accepted principles to cause cancer or reproductive toxicity.”

(Italics added.)

18 Regulation 25306, subdivision (j), provides, in full: “Subsequent to the addition of a

chemical determined to have been formally identified by an authoritative body as causing

cancer or reproductive toxicity to the list of chemicals known to the state to cause cancer

or reproductive toxicity, the lead agency shall reconsider its determination that the

chemical has been formally identified as causing cancer or reproductive toxicity if the

37

Subdivisions (i) and (j) of Regulation 25306, appear to encompass the extent of

the interactions mandated by the regulations between OEHHA and DART-IC relative to

listing pursuant to the authoritative body mechanism. Thus, these provisions would

appear to represent the only obligations OEHHA has relative to DART-IC in the context

of the authoritative body listing mechanism. ACC fails to identify any authority for its

premise that OEHHA was required to take into account the earlier DART-IC

determination. Consequently, ACC has failed to establish that OEHHA did not comply

with a statutory or regulatory obligation, and, in the absence of evidence to the contrary,

we presume regular performance of an official duty. (Cf. City of Sacramento v. State

Water Resources Control Bd. (1992) 2 Cal.App.4th 960, 976 [the relevant inquiry here is

whether the record contains evidence the agency failed to comply with the requirements

of its regulatory program; in the absence of contrary evidence, we presume regular

performance of official duty]; Evid. Code, § 664 [“It is presumed that official duty has

been regularly performed”].)

ACC argues that, because the findings required by Regulation 25306, subdivision

(g) relative to the authoritative body mechanism in large measure parallel those made by

DART-IC relative to the qualified experts listing mechanism, OEHHA cannot refuse to

consider DART-IC’s views as to biological plausibility. However, the statutory and

regulatory scheme makes clear, and the parties agree, that there are different listing

lead agency finds: [¶] (1) there is no substantial evidence that the criteria identified in

subsection (e) or subsection (g) have been satisfied, or [¶] (2) the chemical is no longer

identified as causing cancer or reproductive toxicity by the authoritative body. [¶]

Reconsideration may be initiated by the lead agency on its own motion, or on a request

from an interested party, including any member of the appropriate Committee. The lead

agency shall refer chemicals under reconsideration pursuant to this subsection to the

appropriate Committee for a recommendation concerning whether the chemical should

continue to be included on the list of chemicals known to the state to cause cancer or

reproductive toxicity. Pending such reconsideration, the chemical shall remain on the

list.” (Italics added.)

38

mechanisms pursuant to Proposition 65. The state’s qualified experts listing mechanism

and the authoritative body listing mechanism, both found in section 25249.8, subdivision

(b), are separate and distinct means by which a chemical may be listed under Proposition

65.

Moreover, contrary to ACC’s contention, the findings required for each listing

mechanism are not parallel. The requirement in subdivision (b) of section 25249.8

relative to the qualified expert’s mechanism expressly states a standard of proof and

specific information the expert panel must consider; the DART-IC may list when “it has

been clearly shown through scientifically valid testing according to generally accepted

principles to cause cancer or reproductive toxicity.” (Italics added.) That same standard

is not expressly tied to the authoritative body mechanism, which requires OEHHA to list

the chemical “if a body considered to be authoritative by such experts has formally

identified it as causing cancer or reproductive toxicity.” (§ 25249.8, subdivision (b); see

fn. 2, ante.) Thus, as OEHHA points out, DART-IC and OEHHA answer different

questions under the two separate listing mechanisms. DART-IC acts as an independent

finder-of-fact under the qualified experts listing mechanism. OEHHA, on the other hand,

determines whether there was sufficient evidence in the record to support the

authoritative body’s formal identification of the chemical as a reproductive toxicant. In

listing pursuant to the authoritative body mechanism, OEHHA cannot substitute its

judgment, or that of DART-IC, for that of the authoritative body. And OEHHA’s

determination under section 25249.8, subdivision (b), and Regulation 25306 are to be

based on its own interpretation as to the authoritative body’s conclusions, not DART-

IC’s. Nothing in section 25249.8, subdivision (b) or the regulations, suggests OEHHA

must consult with or consider DART-IC’s previously announced opinion except when

made in a formal comment after OEHHA’s notice of intent to list. Where DART-IC

makes formal comment in response to OEHHA’s notice of intent, Regulation 25306,

subdivision (i) requires OEHHA to consider such comment, but as noted, no post-notice-

39

of-intent comment was made by DART-IC here. Nor did any DART-IC member make a

request for reconsideration under Regulation 25306, subdivision (j). While it may be

reasonable and logical for OEHHA to take into account DART-IC’s previous conclusions

on the matter, there is no statutory or regulatory requirement that it do so.

We cannot conclude that OEHHA abused its discretion in purportedly declining to

do something it had no obligation or direction to do. Therefore, even if OEHHA did not

consider the DART-IC determination, it cannot be said to have abused its discretion in

failing to do so or even in failing to consider the reasons for the DART-IC listing

declination.

Nor are we persuaded that OEHHA abused its discretion in not adopting Dr. Tyl’s

opinion. OEHHA concluded that NTP in the monograph formally identified BPA as a

reproductive toxicant, and that an association between adverse reproductive effects in

humans and BPA is biologically plausible. As such, it determined it was required to list

BPA under the authoritative body listing mechanism, notwithstanding Dr. Tyl’s

disagreement.

And as we next discuss, OEHHA’s decision was not arbitrary, capricious, or

entirely lacking in evidentiary support.

IV. OEHHA's Authoritative Body Listing Determination

A. ACC’s Contentions

ACC contends that OEHHA abused its discretion in concluding that NTP formally

identified BPA as a reproductive toxicant in the monograph. According to ACC,

OEHHA’s conclusion was not supported by the content of the monograph; was based on

language different than that which NTP employs when it formally identifies a chemical

as a reproductive toxicant; conflicted with OEHHA’s own regulations defining formal

identification of a reproductive toxicant; and resulted from the misapplication of

controlling case law.

40

We disagree. We conclude that OEHHA did not abuse its discretion in

interpreting its own regulations and determining NTP identified BPA as a reproductive

toxicant.

B. Interpretation of Regulation 25306 Subdivisions (d)(1) & (g)

Pursuant to Regulation 25306, subdivisions (d)(1) and (g), OEHHA concluded that

NTP identified BPA as a reproductive toxicant. Thus, how those provisions are to be

interpreted is at issue here.

As the Exxon Mobil court stated, our analysis of the meaning of OEHHA’s

regulations “necessarily is guided by the applicable standard of review. ‘As a starting

point, the interpretation of an administrative regulation is subject to the same principles

as the interpretation of a statute. [Citation.] However, there is an important difference

between the interpretation of a statute and the interpretation of a regulation. “ ‘The

Legislature has no authority to interpret a statute.’ ” [Citations.] On the other hand,

where the language of the regulation is ambiguous, it is appropriate to consider the

agency’s interpretation. [Citation.] Indeed, we defer to an agency’s interpretation of a

regulation involving its area of expertise, “ ‘unless the interpretation flies in the face of

the clear language and purpose of the interpretive provision.’ ” ’ ” (Exxon Mobil, supra,

169 Cal.App.4th at p. 1280.) Consequently, “our inquiry is not the ‘correct’

interpretation of [the regulation], but whether the interpretation offered by OEHHA is

reasonable in light of the regulation’s language and purpose.” (Ibid.)

C. Component Elements of Regulation 25306

Relative to Reproductive Toxicity in Animals

As noted, Regulation 25306, addressing chemicals that cause reproductive toxicity

in animals, has two component elements: (1) formal identification of the chemical,

within the meaning of subdivision (d)(1), as a reproductive toxicant in animals, and (2)

biological plausibility of adverse reproductive effects in humans.

41

1. Formal Identification as a Reproductive Toxicant

Regulation 25306, subdivision (d)(1), provides that a chemical is “formally

identified” by an authoritative body when, among other possibilities, OEHHA determines

that the chemical “is the subject of a report which is published by the authoritative body

and which concludes that the chemical causes cancer or reproductive toxicity” and certain

other requirements regarding the report are met. (See fn. 13, ante.) Here, the

monograph stated: “Although there is no direct evidence that exposure of people to

[BPA] adversely affects reproduction or development, studies with laboratory rodents

show that exposure to high dose levels of [BPA] during pregnancy and/or lactation can

reduce survival, birth weight, and growth of offspring early in life, and delay the onset of

puberty in males and females.” (Italics added.) The monograph characterized these “

‘high’ dose effects” as not scientifically controversial, and stated that they “provide clear

evidence of adverse effects on development in laboratory animals.” (Italics added.) The

monograph further stated that the “NTP finds that there is clear evidence of adverse

developmental effects at ‘high’ doses of [BPA] in the form of fetal death, decreased litter

size, or decreased number of live pups per litter in rats . . . and mice . . . , reduced growth

in rats . . . and mice . . . , and delayed puberty in male mice . . . male rats . . . and female

rats . . . .” (Italics added.) And the monograph characterized the weight of the evidence

that BPA causes adverse developmental or reproductive effects in laboratory animals

based on high dose developmental toxicity as indicating “[c]lear evidence of adverse

effects,” the strongest showing along the weight-of-the-evidence continuum it employs.

(See fn. 5, ante.) It was this conclusion in the monograph that OEHHA relied upon in

deciding to list BPA.

OEHHA did not abuse its discretion in concluding that NTP, based on the high-

dose animal testing, formally identified BPA as a chemical that causes reproductive

toxicity. The italicized language in the monograph passages set forth ante establishes as

42

much, and the monograph emphasized that these “ ‘high’ dose effects” were not

scientifically controversial.

And the statutes and the case law are clear that, for a chemical to be formally

identified as causing cancer or reproductive toxicity, it need not be proven that the

chemical causes cancer or reproductive toxicity in humans. Proposition 65 applies to

those chemicals which authoritative bodies have already determined cause cancer or

reproductive toxicity in humans or experimental animals. (American Chemistry Council,

supra, 51 Cal.App.5th at p. 921; Deukmejian, supra, 212 Cal.App.3d at p. 441.) A

finding that a chemical is known to cause reproductive toxicity “can be ‘satisfied’ by

‘[s]tudies in experimental animals [which] indicate . . . an association between adverse

reproductive effects in humans and the toxic agent in question is biologically plausible.’

”19 (Western Crop, supra, 80 Cal.App.4th at p. 749, quoting former Regs., tit. 22,

§ 12306, renumbered as Cal. Code Regs., tit. 27, § 25306.) In the passages of the

monograph set forth ante, NTP formally identified BPA as a chemical known, not merely

suspected, to cause reproductive toxicity, albeit based on high-dose animal studies.

As ACC points out, the monograph acknowledged the existence of a scientific

controversy over interpretation of “ ‘low’ dose findings.” However, it was the high-dose

studies, and the NTP’s conclusion with regard thereto, not the low-dose studies or the

studies of effects in humans, that formed the basis for OEHHA’s conclusion that NTP

had formally identified BPA as a chemical known to the state to cause reproductive

toxicity.

Regarding whether current human exposures to BPA are high enough to be cause

for concern, the monograph concluded: “[p]ossibly.” The monograph observed that the

“ ‘high’ dose effects of [BPA] in laboratory animals that provide clear evidence for

19 We discuss biological plausibility in part IV.C.2 of the Discussion, post.

43

adverse effects on development, i.e., reduced survival, birth weight, and growth of

offspring early in life, and delayed puberty in female rats and male rats and mice, are

observed at levels of exposure that far exceed those encountered by humans.” The

monograph continued: “However, estimated exposures in pregnant women and fetuses,

infants, and children are similar to levels of [BPA] associated with several ‘low’ dose

laboratory animal findings of effects on the brain and behavior, prostate and mammary

gland development, and early onset of puberty in females. When considered together,

these laboratory animal findings provide limited evidence that [BPA] has adverse effects

on development.” The monograph then stated: “The conclusion of similarities between

exposures of certain human populations and laboratory animals treated with ‘low’ doses

of [BPA] is supported by multiple approaches. For this reason, the possibility that human

development may be altered by [BPA] at current exposure levels cannot be dismissed.”

(Italics added.) While this language clearly speaks of BPA as being a reproductive

toxicant, we agree with OEHHA that the discussion of whether current levels of human

exposure are high enough to warrant concern is a question to be addressed to the second

step of Proposition 65’s two-step process involving an exemption related to the level of

exposure, not to the first step concerning hazard identification. (See Exxon Mobil, supra,

169 Cal.App.4th at pp. 1291-1292 [noting that Exxon could present its exposure

argument to OEHHA in the second step of Proposition 65, seeking a Safe Use

Determination, or it could present its argument to the court in the future if it is ever sued

for failing to provide a Proposition 65 warning; but Exxon’s exposure argument is not

relevant to determining whether a chemical should be listed].)

We are not persuaded by ACC’s arguments that the NTP did not formally identify

BPA in the monograph here because it did not employ the same language that it had

previously used in other monographs in which it formally identified other chemicals. For

example the monograph discussed in Exxon Mobil stated: “ ‘In this case, recognizing the

lack of human data and the evidence of effects in laboratory animals, the NTP judges the

44

scientific evidence sufficient to conclude that DIDP is a developmental toxicant and

could adversely affect human development if the levels of exposure were sufficiently

high.’ ” (Exxon Mobil, supra, 169 Cal.App.4th at p. 1285, italics added.) ACC points

out that similar language is used in eight other monographs, arguing that when NTP

identifies a chemical as a developmental or reproductive toxicant, it does so stating,

“what it judges as its conclusion.”

This argument must be rejected. No specific language is required. And as we

have concluded ante, the language of the monograph supports OEHHA’s determination

that NTP formally identified BPA as a reproductive toxicant in animals; thus, OEHHA

did not abuse its discretion in determining that NTP formally identified BPA as a

chemical known to cause reproductive toxicity merely because NTP did not use language

it had previously used. We agree with OEHHA that the language employed in other

monographs is not relevant to our determination here. In any event, as OEHHA notes,

the language it identifies as the phase one hazard identification – “ ‘[c]lear evidence of

adverse effects’ ” – used in the monograph at issue here is identical to the same language

used in each of the other monographs ACC offered for comparison.

At oral argument, ACC relied on Styrene, supra, 210 Cal.App.4th 1082, in a way

not advanced in its briefing on appeal. ACC pointed out that the court in Styrene held the

chemical at issue there could not be listed because the authoritative body only found the

chemical was “possibly” carcinogenic. ACC argued the Styrene court emphasized the

Proposition 65 requirement that the chemical be known, and not merely suspected, to

cause cancer or reproductive toxicity in order to list, and argued that Styrene is analogous

because the authoritative body here found there was insufficient evidence to conclude

BPA is a reproductive toxicant in humans, although it could not dismiss the possibility.

ACC argued that Proposition 65 requires known risks to humans, and since the NTP

report did not make that finding, reversal is warranted here. ACC’s newly placed

reliance on Styrene is misplaced for two reasons.

45

First, the chemical at issue in Styrene was found by the authoritative body to

“possibly” be carcinogenic to humans based on “limited evidence of carcinogenicity in

both humans and experimental animals.” (Styrene, supra, 210 Cal.App.4th at p. 1092,

italics added.) From this, the court held that the findings in the authoritative body’s

monograph did not satisfy the standard of section 25249.8 that the chemical agent be

“known to cause cancer.” (Styrene, at p. 1101.) But here, unlike in Styrene, NTP found

at high dose levels “clear evidence of adverse effects on development in laboratory

animals.” In other words, where the evidence as to both humans and experimental

animals was lacking in Styrene, here there was evidence of the adverse effects on

animals. Indeed, the court in Styrene distinguished the chemical at issue there with the

chemical at issue in Deukmejian, supra, 212 Cal.App.3d 425, for a similar reason.

(Styrene, at p. 1095.) As the Styrene court noted, in Deukmejian the authoritative body

found there was sufficient evidence of carcinogenicity in animals, whereas the issue

before the court in Styrene was “whether substances identified by reference in [the

authoritative body’s] monograph for which there is not sufficient evidence of

carcinogenicity in either humans or animals must be included on the list.” (Ibid.)

Styrene does not address the possibility a chemical is a reproductive toxicant in humans

when there is clear evidence it is a reproductive toxicant in experimental animals.

Second, ACC conflates the task of determining whether a chemical causes cancer

with determining whether the chemical causes reproductive toxicity. Styrene involved

carcinogenicity not reproductive toxicity. Although the Styrene court had no occasion to

interpret or otherwise consider the relevant regulations, we note the regulations governing

carcinogens and reproductive toxicants in animals are different. Regulation 25306,

subdivision (e)(2) governs carcinogens and provides: “For purposes of this section, ‘as

causing cancer’ means that . . . the following criteria has been satisfied: [¶] (2)

Sufficient evidence of carcinogenicity exists from studies in experimental animals. For

purposes of this paragraph, “sufficient evidence” means studies in experimental animals

46

indicate that there is an increased incidence of malignant tumors or combined malignant

and benign tumors in multiple species or strains, in multiple experiments (e.g., with

different routes of administration or using different dose levels), or, to an unusual degree,

in a single experiment with regard to high incidence, site or type of tumor, or age at

onset.” (Italics added.) As the italicized text highlights, the provision addressing

carcinogenicity in experimental animals has very different criteria compared to the

provision related to reproductive toxicants in experimental animals, Regulation 25306,

subdivision (g)(2). (See fn. 14, ante.) Indeed, there is no biological plausibility

component to the regulatory provision governing carcinogens. Styrene is of no help to

ACC.

We conclude OEHHA did not abuse its discretion when it concluded NTP has

formally identified BPA as a reproductive toxicant in animals under Regulation 25306,

subdivision (d)(1). We further discuss case law relevant to OEHHA’s determination of

formal identification, and additionally focus on the “biological plausibility” requirement

for listing under subdivision (g) of Regulation 25306.

2. Biological Plausibility

ACC asserts that OEHHA abused its discretion in concluding that the adverse

effects found in high-dose rodent studies were biologically plausible in humans.

According to ACC, the monograph does not support the conclusion that NTP found the

results in rodent studies biologically plausible in humans and OEHHA may not merely

assume such biological plausibility. Additionally, ACC asserts that OEHHA’s review of

the studies themselves is insufficient to establish that NTP found biological plausibility.

These arguments are similar to those made in Exxon Mobil. Exxon asserted that

“[T]he NTP Brief [on the chemical at issue] did not consider the mandatory criteria under

Regulations, section 25306, subdivision (g) . . . , and did not make the required

determination that an association between adverse reproductive effects in humans and

[the chemical] is biologically plausible.” (Exxon Mobil, supra, 169 Cal.App.4th at

47

p. 1275.) Exxon argued that “OEHHA may list a chemical based on the ‘authoritative

body’ provision of section 25249.8 only if an authoritative body’s report includes the

findings prescribed by regulation 25306(g)—i.e., that there are sufficient data from valid

animal studies to demonstrate that adverse effects in humans are biologically plausible.”

(Exxon Mobil, at p. 1277.) Exxon maintained that an authoritative body’s report

considering animal studies that neither takes into account the scientific criteria set forth in

Regulation 25306, subdivision (g)(2), “ ‘nor contains the required finding of “biological

plausibility” in humans does not (and cannot) satisfy the requirements of [regulation

25306(g)(2)].’ ” (Exxon Mobil, at p. 1278.) OEHHA responded that the authoritative

body listing mechanism is triggered if the authoritative body formally identifies a

chemical in a report and satisfies the report formalities set forth in Regulation 25306,

subdivision (d)(2) (see fn. 13, ante), but the authoritative body’s report “need not include

the detailed findings set out in [R]egulation 25306, [subdivision] (g). Instead, once the

chemical is ‘formally identified’ by an authoritative body as a developmental toxicant,

OEHHA reviews the scientific record before the authoritative body to determine whether

there is substantial evidence to support a listing. If it concludes on the basis of its review

that the [R]egulation 25306(g) criteria are satisfied—i.e., that the experimental animal

data considered by the authoritative body are sufficient to support a conclusion that an

association between adverse reproductive effects in humans and the toxic agent is

biologically plausible—then it lists the chemical.” (Exxon Mobil, at pp. 1278-1279.)

OEHHA reprises this argument here.

The Exxon Mobil court held: “To list a chemical pursuant to [R]egulations, 25306

. . . , OEHHA must conclude that an authoritative body has determined that … the

experimental animal data are sufficient to support a conclusion that adverse effects in

humans are biologically plausible. Nothing in [R]egulations, section 25306 suggests,

however, that OEHHA must base this conclusion solely on the authoritative body’s

report. Rather, as OEHHA suggests, the language of Regulations, section 25306 is broad

48

enough to allow OEHHA to premise its conclusion on the authoritative body’s report and

other factors, such as the scientific literature on which the authoritative body relied and

OEHHA’s knowledge of the authoritative body’s methodology. In other words, so long

as OEHHA is able to conclude on the basis of the authoritative body’s report and the

underlying scientific record that an authoritative body has identified a chemical as a

reproductive toxicant and that the identification takes the regulatory criteria into account,

OEHHA may list it pursuant to Regulations, section 25306.” (Exxon Mobil, supra, 169

Cal.App.4th at pp. 1280-1281.) Later in the opinion, the Exxon Mobil court reiterated its

conclusion that “OEHHA properly can conclude that the authoritative body made the

necessary findings based on OEHHA’s review of the scientific literature on which the

authoritative body relied and its knowledge of the authoritative body’s methodology.” In

other words, OEHHA can look to the entire record before it in determining whether the

authoritative body made the [R]egulation 25306(g) findings. (Exxon Mobil, at p. 1282.)

The Exxon Mobil court concluded that its interpretation Regulation 25306,

subdivision (g), was supported by, among other things, the final statement of reasons

(FSOR), which was issued in connection with the adoption of that regulation as required

by Government Code section 11346.9. (Exxon Mobil, supra, 169 Cal.App.4th at

p. 1282.) After discussing statements set forth in the FSOR, the Exxon Mobil court

explained the regulatory provision concerning the designation of authoritative bodies:

“Considered together, we understand these statements to mean that when designating a

body as authoritative within the meaning of the statute, the DART Committee determines

whether the body uses ‘the same or substantially the same criteria’ set out in Regulation

25306(g). Only if it does will it be deemed an ‘authoritative body.’ The authoritative

body designation thus allows OEHHA to presume that the body made the prescribed

findings when it determined a chemical to be a reproductive toxicant: ‘In effect, there is

a presumption that the authoritative body properly applied the criteria.’ ” (Exxon Mobil,

at p. 1283, quoting FSOR, supra, at p. 25.)

49

Like ACC argues here, Exxon argued “that OEHHA abused its discretion by

basing its listing decision solely on data derived from experimental animal studies.”

(Exxon Mobil, supra, 169 Cal.App.4th at p. 1288.) The Exxon Mobil court disagreed.

(Ibid.) The court reiterated that Regulation 25306, subdivision (g)(2), “expressly permits

a finding of reproductive toxicity to be based on experimental animal studies, so long as

the studies indicate that ‘there are sufficient data . . . indicating that an association

between adverse reproductive effects in humans and the toxic agent in question is

biologically plausible.’ [Citation.] Nothing in the regulation thus precludes OEHHA

from concluding that there is substantial evidence of biological plausibility based solely

on animal studies—to the contrary, the regulation appears to contemplate extrapolation

from animal studies to humans. ” (Exxon Mobil, at p. 1288.)

The court in Exxon Mobil then went on to discuss the presumption of biological

plausibility relied on by OEHHA here: “Further, there is support in the record for

OEHHA’s assertion that it is a ‘generally accepted toxicological assumption that, absent

evidence to the contrary, a chemical that causes developmental harm in experimental

animals, will cause similar harm in humans.’ In this regard, the Guidelines for

Developmental Toxicity Risk Assessment promulgated by the federal Environmental

Protection Agency[20] state: ‘[I]t is assumed that an agent that produces an adverse

developmental effect in experimental animal studies will potentially pose a hazard to

humans following sufficient exposure during development. This assumption is based on

the comparisons of data for agents known to cause human developmental toxicity

[citations], which indicate that, in almost all cases, experimental animal data are

20 The Guidelines for Developmental Toxicity Risk Assessment are part of the

administrative record here, and OEHHA cited the Guidelines in discussing the

presumption of biological plausibility in response to a comment during the administrative

process. (See fn.7, ante.)

50

predictive of a developmental effect in humans.’ [Citation.] NTP apparently operates

under a similar assumption: ‘In the absence of human data to the contrary, it is assumed

that the effects observed in laboratory animals are relevant to humans.’ ” (Exxon Mobil,

supra, 169 Cal.App.4th at pp. 1288-1289, fn. omitted, citing Deukmejian, supra, 212

Cal.App.3d at p. 438, fn. 7.) Because OEHHA interprets its own regulation’s

requirement of biological plausibility to incorporate this presumption and because the

court in Exxon Mobil acknowledged as much, we defer to OEHHA’s continuing

interpretation. OEHHA’s interpretation does not “fl[y] in the face of the clear language

and purpose of” section 25249.8 or Regulation 25306, and “[it] is reasonable in light of

the regulation’s language and purpose.” (Exxon Mobil, at p. 1280.)

We further agree with OEHHA that it was not necessary for the monograph to

contain express language specifically stating that “[s]tudies in experimental animals

indicate that there are sufficient data . . . indicating that an association between adverse

reproductive effects in humans and the toxic agent in question is biologically plausible.”

(Regs. § 25306, subd. (g)(2).) As the Exxon Mobil court noted, the language of

Regulation 25306 is broad enough to allow OEHHA to premise its conclusion on the

authoritative body’s report and other factors, such as the scientific literature on which the

authoritative body relied and OEHHA’s knowledge of the authoritative body’s

methodology. (Exxon Mobil, supra, 169 Cal.App.4th at p.1281.) “So long as OEHHA is

able to conclude on the basis of the authoritative body’s report and the underlying

scientific record that an authoritative body has identified a chemical as a reproductive

toxicant and that the identification takes the regulatory criteria into account, OEHHA

may list it pursuant to Regulations, section 25306.” (Ibid.; see also Western Crop, supra,

80 Cal.App.4th at p. 754 [“The clear implication” of Regulation 25306, subdivision (g) is

that OEHHA has the authority “to examine the record” relative to the authoritative

body’s report on the chemical “to determine whether there is substantial evidence that the

subdivision (g) criteria have been met”].) We do not find any provision in the regulations

51

that requires the authoritative body’s report to specifically state that “[s]tudies in

experimental animals indicate that there are sufficient data . . . indicating that an

association between adverse reproductive effects in humans and the toxic agent in

question is biologically plausible.” (Regs. § 25306, subd. (g)(2).) Consideration of the

“entire record” (Exxon Mobil, at p. 1282) before OEHHA includes consideration of

whether there are in that record “[s]tudies in experimental animals [that] indicate that

there are sufficient data, taking into account the adequacy of the experimental design and

other parameters such as, but not limited to, route of administration, frequency and

duration of exposure, numbers of test animals, choice of species, choice of dosage levels,

and consideration of maternal toxicity, indicating that an association between adverse

reproductive effects in humans and the toxic agent in question is biologically plausible.”

(Regs. § 25306, subd. (g); Exxon Mobil, at p. 1282.) Therefore, we turn to the record to

consider whether OEHHA’s determination that NTP considered criteria in subdivision (g)

and whether biological plausibility can be determined from the monograph and the

studies upon which it relied.

OEHHA referenced the studies in the monograph in its notice of intent to list

BPA. It stated the “studies were reviewed by OEHHA with regard to the criteria in the

regulation (Section 25306(g)(2)). Information reviewed in these studies included

experimental design, route administration, numbers of test animals, choice of species,

choice of dosage levels and maternal toxicity.”

Our own review of the monograph reveals that it discussed animal studies

involving rats, mice, and monkeys. In describing how it reached its conclusions in the

monograph, NTP stated: “Scientific decisions concerning health risks are generally

based on what is known as the ‘weight-of-evidence.’ ” “[I]n an effort to glean

information that might contribute to understanding the numerous reported effects of

[BPA], NTP evaluated many individual study reports. Attention was paid to issues of

sample size, control for litter effects, and various other aspects of experimental design;

52

however, experimental findings were initially evaluated in relation to their biological

plausibility and consistency across studies by multiple investigators. Studies were then

evaluated as to their adequacy of experimental design and the likelihood that any

inconsistent outcomes resulted from differences or shortcomings in experimental design.”

The monograph discussed route administration across different studies, specifically oral

administration versus subcutaneous administration, and how studies involving non-oral

administration should be interpreted. The monograph also discussed variations in doses

administered in different studies, and distinguished between low-dose and high-dose

studies. NTP dedicated a section of the monograph to discussion of the “impact of

limitations in experimental design” and how studies with such limitations should be

interpreted. (Capitalization omitted.) NTP observed that a number of the low-dose

studies had been characterized as having been “experimentally well-conducted,” and as

having “high utility.” The record amply supports OEHHA’s finding that the NTP took

into account parameters required by Regulation 25306, subdivision (g).

Additionally, as noted, consistent with Exxon Mobil, OEHHA applies the

generally accepted presumption of biological plausibility, where, “ ‘absent evidence to

the contrary, a chemical that causes developmental harm in experimental animals, will

cause similar harm in humans.’ ” (Exxon Mobil, supra, 169 Cal.App.4th at p. 1288.)21

Evidence to the contrary might include evidence that the animal has a particular physical

structure that is harmed but the same physical structure is not present in humans or

evidence the animal in question metabolizes the chemical differently than humans. No

21 Courts have recognized that human testing is unethical. (American Chemistry

Council, supra, 51 Cal.App.5th at p. 921; Exxon Mobil, supra, 169 Cal.App.4th at

p. 1289, citing Deukmejian, supra, 212 Cal.App.3d at p. 438, fn. 7.) Accordingly, the

principle of extrapolating from evidence effects in animals to humans “ ‘has been

accepted by all health and regulatory agencies, and is regarded widely by scientists in

industry and academia as a justifiable and necessary inference.’ ” (Deukmejian, at p. 438,

fn. 7.)

53

evidence “to the contrary” sufficient to rebut the presumption has been identified by

ACC.22

Additionally, statements in the monograph which touch on the subject do not

refute biological plausibility, and, if anything, support it. The monograph stated that

BPA can “possibly” affect human development or reproduction. OEHHA stated in a

response to comments during the administrative process: “That conclusion is equivalent

to concluding that such effects are biologically plausible in humans.” We agree. If there

was evidence to the contrary sufficient to rebut the presumption of biological plausibility,

this “possibility” would not exist. The monograph also stated, “Although there is no

direct evidence that exposure of people to [BPA] adversely affects reproduction or

development, studies with laboratory rodents show that exposure to high dose levels of

[BPA] during pregnancy and/or lactation can reduce survival, birth weight, and growth of

offspring early in life, and delay the onset of puberty in males and females.” (Italics

added.) Noting the absence of “direct evidence,” and then immediately segueing into the

animal evidence findings suggests that that animal testing results are indirect or

circumstantial evidence of reproductive toxicity in humans. It can be reasonably inferred

from this that there is insufficient evidence to rebut the presumption and, again, ACC has

identified no such evidence. The monograph continued: “Recognizing the lack of data

on the effects of [BPA] in humans and despite the limitations in the evidence for ‘low’

dose effects in laboratory animals . . . , the possibility that [BPA] may alter human

development cannot be dismissed.” (Italics added.) OEHHA stated in response to

comment the aforementioned statement “represents NTP’s conclusion that developmental

22 Regarding metabolism, OEHHA stated, in response to comments during the

administrative process, that it “reviewed the discussion of metabolism in the NTP-

CERHR document and did not find any information that conflicted with NTP’s

conclusion that BPA ‘possibly’ could affect human reproduction or development.” Nor

have we.

54

toxicity of BPA is biologically plausible in humans.” Again, we agree because if there

were evidence sufficient to rebut the presumption of biological plausibility, there would

be no such possibility.

At oral argument, ACC focused on Figure 2a in the monograph, which is labeled,

“The weight of evidence that [BPA] causes adverse developmental or reproductive

effects in humans” and states, regarding developmental and reproductive toxicity:

“Insufficient evidence for conclusion.” But this conclusion as summarized in Figure 2a

does not explain that conclusion and does not exclude biological plausibility. The text of

the monograph explains: “In the case of [BPA], evidence from a limited number of

studies in humans exposed to [BPA] is not sufficient to reach conclusions regarding

possible developmental or reproductive hazard. In contrast, there is a large literature of

laboratory animal studies.” (Italics added.) It further stated: there “is also insufficient

evidence from studies in humans to determine if [BPA] does or does not cause

developmental toxicity when exposure occurs prenatally or during infancy and

childhood.” (Italics added.) As the italicized text reveals, it appears the conclusion

summary in Figure 2a that there was “[i]nsufficient evidence for conclusion” was based

on the limited number of human studies. Thus, that conclusion does not mean NTP

found that biological plausibility could not be determined from experimental animal

studies.

Our conclusion in this regard is buttressed by other text in the monograph. For

example, the monograph stated: “The NTP concurs with the CERHR Expert Panel on

[BPA] that the results of neurological and behavioral studies of exposures of laboratory

animals to [BPA] during development raise questions about possible risks to human

development.” (Italics added.) The monograph continued: “The conclusion of

similarities between exposures of certain human populations and laboratory animals

treated with ‘low’ doses of [BPA] is supported by multiple approaches. For this reason,

the possibility that human development may be altered by [BPA] at current exposure

55

levels cannot be dismissed.” (Italics added.) Again, if there was evidence to the contrary

sufficient to rebut the presumption of biological plausibility, there would be no possible

“risks to human development” and the possibility that human development may be

altered by BPA at current exposure levels could be dismissed.

Additionally, NTP in the monograph’s conclusions expressed “some concern for

exposures in fetuses, infants, and children based on a number of laboratory animal studies

reporting that ‘low’ level exposure to [BPA] during development can cause changes in

the brain and behavior. [T]he NTP has some concern for exposures to these populations

based on effects on the prostate gland observed in laboratory animals.” The monograph

acknowledged the need for further study, and then stated: “because these effects in

animals occur at [BPA] exposure levels similar to those experienced by humans, the

possibility that [BPA] may alter human development cannot be dismissed.” (Italics

added.) Again, no such possibility would exist if there was evidence sufficient to rebut

the presumption of biological plausibility.

While these statements cannot be characterized as categorically stating there is an

established association between adverse reproductive effects in humans and BPA, they do

not undermine the conclusion, and in fact support the conclusion, that such an association

is biologically plausible by suggesting the absence of sufficient contrary evidence to

rebut the presumption of biological plausibility.

In addressing the presumption of biological plausibility, ACC seeks to distinguish

the instant case from Exxon Mobil, where the court recognized the presumption in

connection with reproductive toxicity. It asserts that, in Exxon Mobil, OEHHA did not

resort to “speculation,” like ACC asserts OEHHA does here. This is because in Exxon

Mobil, the NTP “expressly stated that ‘ “the NTP judges the scientific evidence sufficient

to conclude that DIDP is a developmental toxicant and could adversely affect human

development . . . .” ’ ” However, in the monograph here, the NTP did conclude that BPA

could possibly affect human development and reproduction, and further stated,

56

“[r]ecognizing the lack of data on the effects of [BPA] in humans and despite the

limitations in the evidence for ‘low’ dose effects in laboratory animals . . . , the possibility

that [BPA] may alter human development cannot be dismissed.” (Italics added.) While

less direct than the statements in the Exxon Mobil monograph, these statements, along

with the presumption of biological plausibility, provide support for a finding that “an

association between adverse reproductive effects in humans and the toxic agent in

question is biologically plausible.” (Regs. § 25306, subd. (g)(2).)

ACC argues that the dosages administered to laboratory animals is far in excess of

the highest estimated daily intake BPA in children, adults or workers, essentially arguing

that biological plausibility has not been established because humans are not exposed to

such dosages. ACC focuses on the fact that “choice of dosage” is listed as a factor for

consideration in Regulation 25306, subdivision (g)(2). (See fn. 14, ante.) But OEHHA

did “take into account” the parameters listed in that provision, including “choice of

dosage,” so there was no abuse of discretion. As for the issue of whether humans are

exposed to BPA at levels high enough to pose a risk, as we have said, that is a matter to

be addressed in the second step of Proposition 65, which allows businesses the

opportunity to prove no significant risk at certain levels of exposure. (§25249.10, subd.

(c); see fn. 12, ante; Exxon Mobil, supra, 169 Cal.App.4th at pp. 1291-1292.)

Lastly, ACC cites various reports by various governmental bodies around the

world indicating BPA is safe for humans for various uses.23 Again, this information is

23 These agencies include the United States Food and Drug Administration (FDA), the

European Food Safety Authority, Health Canada, Japan’s National Institute of Advanced

Industrial Science and the World Health Organization. According to ACC, the FDA

stated in 2008 “an adequate margin of safety exists for BPA at current levels of exposure

from food contact uses, for infants and adults.” ACC asserts that in 2013, the FDA

stated: “ ‘Based on FDA’s ongoing safety review of scientific evidence, the available

information continues to support the safety of BPA for the currently approved uses in

food containers and packaging.’ ” In 2014, according to ACC, the FDA concluded that

57

pertinent to Proposition 65’s second step allowing businesses to prove BPA presents an

insignificant risk. It does not establish that OEHHA abused its discretion in listing BPA

in Proposition 65’s first step related to hazard identification.

In light of the presumption of biological plausibility applied to reproductive

toxicants (Exxon Mobil, supra, 169 Cal.App.4th at p. 1288), the foregoing statements in

the monograph from which biological plausibility can be inferred based on the

presumption, and OEHHA’s determination as to NTP’s consideration of the parameters

required by subdivision (g) of Regulation 25306, we conclude that OEHHA’s

determination as to biological plausibility was reasonable and not “arbitrary, capricious,

or entirely lacking in evidentiary support.” (Id. at p. 1277.) We thus conclude OEHHA

did not abuse its discretion in concluding there was sufficient data in the monograph and

“FDA’s current perspective, based on its most recent safety assessment, is that BPA is

safe at the current levels occurring in foods.” ACC also asserts that in 2015, the FDA’s

Acting Chief Scientist advised OEHHA that the FDA, based on a four-year assessment of

over 300 scientific studies, “reaffirm FDA’s determination that BPA is safe provided that

it is used in accordance with our regulations.” But we note that not only was the 2015

declaration not part of the administrative record here, but also that it was apparently

rejected by DART-IC because that body concluded BPA is a female reproductive

toxicant in the administrative process for which that declaration was submitted. (See fn.

4, ante.) Also, NRDC points out that many government agencies have actually banned

BPA for various usages. According to NRDC, Canada and the European Union have

banned the use of BPA in infant feeding bottles. Connecticut and Vermont banded BPA

in all reusable food and beverage containers. California, Delaware, Illinois, Maine,

Maryland, Massachusetts, Minnesota, Nevada, New York, Washington, and Wisconsin

have banned the use of BPA in certain products intended for children. ACC

acknowledges these bans, but asserts “each and every one of these bans has been the

result of political lobbying by the NRDC and/or like-minded groups, not impartial

science. As such, these politically motivated bans do not support any listing here.” We

need not consider these arguments, which might be pertinent to the second step in

Proposition 65, because here we address only the first step, hazard identification, based

on the monograph, not the second step, which includes an opportunity for businesses to

show the risk to humans is insignificant.

58

the studies upon which the monograph was based indicating that an association between

adverse reproductive effects in humans and BPA was biologically plausible.

D. Conclusion

We conclude that OEHHA did not abuse its discretion in listing BPA based on the

monograph. Therefore, we conclude that the trial court did not abuse its discretion in

denying ACC the relief requested in the amended complaint.

DISPOSITION

Our previously issued stay is vacated and the judgment is affirmed. Respondents

shall recover their costs on appeal. (Cal. Rules of Court, rule 8.278(a)(1), (2).)

/s/

MURRAY, J.

We concur:

/s/

BLEASE, Acting P. J.

/s/

DUARTE, J.

59