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Date: 07-12-2020

Case Style:

American Chemistry Council v. Office of Environmental Health Hazard Assessment

Case Number: C079260

Judge: Raye, P.J.

Court: California Court of Appeals Third Appellate District on appeal from the Superior Court, County of Sacramento

Plaintiff's Attorney: Theodore Joseph Boutrous, Jr. and Robert Edward Dunn

Defendant's Attorney: Harrison M. Pollak

Description: Proposition 65, also known as the Safe Drinking Water and Toxic Enforcement
Act of 1986 (Health & Saf. Code, §§ 25249.5-25249.13), requires the Governor to
publish a “list of those chemicals known to the state to cause cancer or reproductive
toxicity.” (Health & Saf. Code, § 25249.8.) In 2013 the Carcinogen Identification
Committee (Committee) voted to list the chemical diisononyl phthalate (DINP) as a
cancer causing chemical. DINP is used to soften vinyl for use in flooring, wire
insulation, gloves, garden hoses, artificial leather, and roofing materials. The Committee
concluded DINP causes various types of cancer in animals and that the mechanisms by
2
which DINP causes cancer in animals are relevant to humans. Subsequently, the Office
of Environmental Health Hazard Assessment (OEHHA) added DINP to the Proposition
65 list. Plaintiff American Chemistry Council (Chemistry) challenged the action, arguing
it was arbitrary and capricious. The Chamber of Commerce of the United States filed an
amicus curiae brief in support of Chemistry. Chemistry appeals the trial court’s denial of
its petition for writ of mandate, arguing there is insufficient evidence that DINP causes
cancer in humans. We shall affirm the judgment.
FACTUAL AND PROCEDURAL BACKGROUND
Proposition 65 Process
Proposition 65 involves a two-step process. First, chemicals are placed on a list of
substances known to cause cancer or reproductive toxicity. (Health & Saf. Code,
§ 25249.8, subd. (a).)1
Second, the statute prohibits businesses from exposing
individuals to listed chemicals without providing a warning and from discharging listed
chemicals into sources of drinking water unless the business can establish that the
exposure or the discharge to drinking water is below the level that will pose no
significant risk. (§§ 25249.5, 25249.6, 25249.9, 25249.10, subd. (c).)
Chemicals must be listed under Proposition 65 if they are identified as causing
cancer or reproductive toxicity on the basis of animal studies. Proposition 65 “applies to
those chemicals which respected scientific agencies have already determined cause
cancer or reproductive toxicity in humans or animals.” (AFL-CIO v. Deukmejian (1989)
212 Cal.App.3d 425, 441.) Human testing is unethical, and because of the long latency
period of human cancers, waiting for human studies cannot adequately protect humans
from the risk of cancer. As a consequence, the principle of extrapolating from evidence
1
All further statutory references are to the Health and Safety Code unless otherwise
noted.
3
of cancer 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.’ ” (Id. at p. 438, fn. 7.)
OEHHA must list a chemical: (1) if the chemical is identified by reference in
certain Labor Code sections; (2) if a body considered authoritative by the group of
independent scientists known as the state’s qualified experts has formally identified the
chemical as causing cancer; (3) if a state or federal agency has formally required the
chemical to be labeled or identified as causing cancer (§ 25249.8, subds. (a), (b)); or (4)
upon review by the state’s qualified experts who, in their opinion, determine “the
chemical has been clearly shown through scientifically valid testing according to
generally accepted principles to cause cancer” (§ 25249.8, subd. (b)). This case involves
the fourth mechanism for identifying cancer causing chemicals.
Committee Composition and Guidance Criteria
Independent experts with degrees and research experience in various scientific
fields comprise the Committee. (Cal. Code Regs., tit. 27, § 25302, subd. (b)(1)(i), (ii).)
The Governor appoints the committee chairperson, who calls and presides over meetings,
designates an executive secretary, and designates subcommittees. (Cal. Code Regs.,
tit. 27, § 25302, subd. (c).) The chairperson possesses no special authority apart from
these administrative duties. The state’s qualified experts for the purpose of identifying
carcinogens are members of the Committee. (Cal. Code Regs., tit. 27, § 25302,
subd. (a).)
The Committee’s guidance criteria govern the review of a given chemical. Under
the criteria, the Committee uses a weight of evidence approach to evaluate the
information on any given chemical, including “all evidence bearing on the issue of
carcinogenicity shown through scientifically valid testing according to generally accepted
principles” of scientific inquiry.
4
At issue in the case before us is criterion No. 1D, which states the Committee will
“normally identify a chemical for listing” if “the weight of scientific evidence clearly
shows that [the] chemical causes invasive cancer in humans, or that it causes invasive
cancer in animals (unless the mechanism of action has been shown not to be relevant to
humans).” As the trial court aptly noted “This case is about that ‘unless.’ ”
Guidance criteria are not intended to be binding regulations or to be slavishly
followed. Instead, “these criteria are intended to give the Committee maximal flexibility
in evaluating all pertinent scientific information” and “are intended neither to limit the
scope of the Committee’s consideration of all appropriate cumulated scientific
information, nor to limit the use of best scientific judgment available at the time.” The
criteria require “scientific judgments which can only be based on experience . . . Thus,
few of the criteria are amenable to the use of absolute restrictions of either a quantitative
or qualitative nature.”
The Committee does not conduct independent scientific studies or experiments on
the carcinogenicity or toxicity of chemicals. Instead, OEHHA prepares a summary of the
current state the scientific evidence on the chemicals’ carcinogenicity, a hazard
identification document (HID). To prepare the HID, OEHHA reviews scientific literature
on the chemical and solicits information from the public. Once prepared, the HID is
released to the Committee and the public for a 45-day comment period. At the close of
the comment period, OEHHA provides the Committee with a copy of all comments and
supporting documents for review.
Consideration of DINP by the Committee
In 2009 the Committee began reviewing DINP when OEHHA asked it to rank a
set of chemicals for review. Chemistry and other entities submitted over 200 pages of
comments to support the argument that DINP should be ranked as no or low priority for
review. They argued the mechanism of carcinogenesis does not operate in humans.
5
However, the Committee voted on May 29, 2009, to rank DINP as a high priority
chemical for its review.
OEHHA issued a notice to interested parties on October 16, 2009, soliciting
information on the carcinogenicity of DINP. The public comment period lasted 60 days.
OEHHA, after reviewing the submitted material, prepared a 77-page HID. The HID
included the most current and pertinent information on the carcinogenicity of DINP,
including research and evidence on the mechanisms of action by which DINP operates.
The HID was not intended to be a comprehensive document citing every study, but a
“look at new more recent literature and thinking on those hypotheses.”
Although there were no human studies of the carcinogenicity of DINP, the HID
discussed 12 dietary carcinogenicity studies on laboratory animals. OEHHA provided
the studies to the Committee. No known carcinogenicity studies were omitted. The HID
referenced 114 documents and provided the documents to the Committee. Among the
documents were 32 referenced by Chemistry and others in response to the notice to
interested parties.
The HID summarized the 12 animal studies and noted three cancers seen at
statistically significantly levels: liver tumors, mononuclear cell leukemia, and kidney
tumors. Other rare or noncommon tumors were seen, but not at statistically significant
levels.
In addition, the HID noted that the mechanisms by which DINP induces tumors
are unknown. However, several studies identified possible mechanisms of action. These
include: activation of peroxisome proliferator activated receptors (PPAR), activation of
constitutive androstane receptor and pregnane X receptor, effects on steroidogenesis and
androgen-responsive tissues, tumor necrosis factor-alpha induction, and alpha 2uglobulin nephropathy.
OEHHA released the HID to the Committee on October 7, 2013, along with the
supporting documents. Concurrently, OEHHA released the HID to the public for a 45-
6
day comment period. When the comment period ended, OEHHA provided all public
comments and supporting documents to the Committee on November 20, 2013.
Meeting and Vote
On December 5, 2013, the Committee met to discuss and vote on DINP. Staff
counsel for OEHHA told the Committee that “there are certain criteria for listing
chemicals. And you have those criteria in front of you. You’re [sic] listing decisions
should be based on those criteria, and the discussions you have on those criteria.” In
addition, counsel stated the Committee was not obligated to render a decision that day,
and could ask OEHHA to provide further information.
As the meeting continued, the Committee heard testimony from OEHHA scientists
about DINP. The Committee also heard testimony from four people representing
Chemistry and others opposing listing DINP.
Following the presentations, the Committee questioned the presenters and
discussed the evidence before it. Members also discussed Chemistry’s argument that the
mechanism operating in animals is not relevant to humans.
At the conclusion of the presentation and discussion, the chairperson, Thomas
Mack, called for a vote by the Committee. Six members voted to identify DINP as
known to the state to cause cancer, one voted against, and one abstained. Following the
Committee’s vote, OEHHA added DINP to the Proposition 65 list on December 20,
2013.
Trial Court’s Decision
Chemistry filed suit against OEHHA, challenging the listing of DINP. In denying
Chemistry’s petition for writ of mandate, the court stated Chemistry would be entitled to
a writ if it “could prove the [Committee’s] decision was based on an incorrect
interpretation of the law. [Chemistry] fails to make this showing.”
7
The court rejected Chemistry’s argument that the HID was incomplete, noting the
document discussed a number of studies relied on by Chemistry in support of its
argument that animal cancers were not relevant to humans. In addition, OEHHA
accompanied submission of the HID with voluminous materials relating to DINP’s
carcinogenicity. These documents included studies in support of Chemistry’s argument
that the mechanism operative in rats did not apply to humans. Chemistry members also
spoke at length at the public meeting, arguing against the listing.
Chemistry also claimed the Committee lacked adequate time to review this
voluminous information. The court found “absent evidence to the contrary, the court will
assume the [Committee] reviewed sufficient evidence to come to an informed decision.
(Evid. Code, § 664.)”
Chemistry argued the studies demonstrated that the mechanisms that cause cancer
in rodents, such as PPAR, do not operate in humans. The court disagreed: “[S]ome of
the studies [Chemistry] cites are less categorical than it suggests. For example, the ILSA
Health and Environmental Sciences Institute concluded ‘it is unlikely that peroxisome
proliferators are carcinogenic to humans under anticipated conditions and levels of
exposure, although their carcinogenic potential cannot be ruled out under extreme
conditions of exposure.’ ” The court found it clear that the Committee considered the
very evidence Chemistry accused it of disregarding. Committee members discussed the
issue of mechanistic data and its relevance to humans, stated they understood the issue,
and “considered, and wrestled with” the evidence of mechanism.
Finally, the court addressed Chemistry’s contention that Mack incorrectly outlined
the guidance criteria, invalidating the entire Committee review process. After carefully
reviewing the comments Chemistry posits as incorrect interpretations of the law, the
court determined Mack’s statements were susceptible to several alternative
interpretations.
8
More importantly, the court noted, the Committee members had the guidance
criteria in front of them and were twice instructed to follow those criteria. In order to
find the Committee’s decision arbitrary and capricious, “the court would have to assume
the remaining [Committee] members followed Mack’s rather garbled and possibly
erroneous interpretation of the law rather than the guidance criteria they were instructed
to follow. The court cannot make this assumption.” The court denied the petition.
DISCUSSION
Standard of Review
In order to overturn OEHHA’s listing of DINP, Chemistry must show OEHHA’s
action is “inconsistent with the governing statute, section 25249.8.” (Western Crop
Protection Assn. v. Davis (2000) 80 Cal.App.4th 741, 757.) A review of OEHHA’s
scientific analysis regarding a chemical’s listing under Proposition 65 requires deference:
“ ‘ “[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 Corp. v.
Office of Environmental Health Hazard Assessment (2009) 169 Cal.App.4th 1264, 1277
(Exxon).)
We defer to the agency’s authority and presumed expertise and do not reweigh the
evidence or substitute our judgment for that of the agency. If the agency has adequately
considered all relevant factors and demonstrated a rational connection between those
factors, the choice made, and the purposes of the statute, we will uphold the decision.
We set aside the decision only if it was arbitrary, capricious, or entirely lacking in
evidentiary support. (Exxon, supra, 169 Cal.App.4th at p. 1277.)
The Committee’s Decision
At the conclusion of the review process, six of the Committee’s eight scientists
found DINP causes several types of invasive cancers in laboratory animals and the
9
evidence was not sufficient to show that all of the possible mechanisms underlying these
cancers are not relevant to humans. Consequently, OEHHA added DINP to the list of
chemicals known to the state to cause cancer.
On appeal, Chemistry challenges the decisionmaking process, focusing on several
comments made by the chairperson, Mack. Chemistry contends Mack incorrectly
instructed the Committee that the evidence of mechanism was irrelevant and directed the
Committee to apply a different standard of his own creation. According to Chemistry, “it
is clear that the instructions so infected the [Committee’s] deliberations that the decision
to list DINP was arbitrary and capricious.”
Preliminarily we note, as the trial court observed, the Committee never explained
the basis for its determination, and never explained how it evaluated the evidence on
whether animal studies were relevant to humans. An administrative body making a
quasi-legislative decision such as the one before us is not generally required to either
make findings or explain how the evidence supports its decision. (Fullerton Joint Union
High School Dist. v. State Bd. of Education (1982) 32 Cal.3d 779, 787.) As a
consequence the trial court found: “[T]he lack of findings or an explanation may make it
difficult for [Chemistry] to show the [Committee’s] decision was arbitrary or capricious.
This difficulty is then compounded by the fact that, absent evidence to the contrary, the
court must presume the [Committee] properly performed its duties. (Evid. Code, § 664.)
Here, the primary evidence to the contrary consists of the transcript of the public hearing.
But at no point during that hearing did the [Committee] clearly explain its views on the
evidence on human relevance.” As the trial court recognized, we are left with the
presumption that the Committee properly performed its duties and the burden is on
Chemistry to show the Committee’s decision is arbitrary, capricious, or without
evidentiary support.
At the hearing, OEHHA’s staff counsel informed the Committee that its listing
decision should be based on the published criteria for listing, a copy of which was
10
provided to each member. Counsel stated, “you have those criteria in front of you.
You’re [sic] listing decisions should be based on those criteria.” Under the criteria
provided to the Committee, they were directed to identify a chemical for listing if the
weight of scientific evidence shows it causes invasive cancer in animals “unless the
mechanism of action has been shown not to be relevant to humans.” Subsequently,
counsel reminded the Committee “if the weight of scientific evidence clearly shows that
certain chemicals cause invasive cancer . . . in animals, unless a mechanism of action has
been shown not to be relevant to humans, the Committee will normally identify the
chemical for listing.”
Juxtaposed against these correct statements of the decisionmaking process are
comments by chairperson Mack, which Chemistry argues directed the Committee to
“ignore the mechanistic data, contrary to the published Criteria,” advice which tainted the
voting process.
The parties focus on two statements made by Mack towards the end of the hearing.
In the first Mack stated:
“My own view is that I wish the proposition had been worded a little bit better. I
wish it had said in humans, but it didn’t say in humans. And that means that we’re left
either pretending that we’re the Supreme Court, and we can interpret and make law, or
we can simply be technologists and apply the rules that we’re given. And I think we’re --
my own position is we’re stuck with the latter.
“So the question to me is does this stuff cause cancer? And I have to rely upon the
dose response relationships. And I actually am moved by the number of cancers which
pop up, in an unusual circumstance, including the kidney, the pancreatic islet cell and the
leukemia. I understand completely points that [Committee member] David [Eastmond]
11
has made about – and that the regulated community has made about the mechanism
issue.[2]
“And I wouldn’t be a bit surprised to find in the long run that each of these tumor
frequencies can be explained by mechanisms that are not pertinent in humans.
“But my gut response right now is that that can’t be an assumption I can make.
And so my inclination is to make the judgment on the basis of whether or not the cancers
that are caused in mice are invasive and truly malignant. And I presume that that’s -- not
presume. I know that that’s the case.”
We read Mack’s comments as acknowledging that listing might not be appropriate
in the “long run” (the future) if the scientific evidence reveals DINP-caused tumors can
be explained by mechanisms not relevant to humans. However, “right now” (presently)
Mack cannot assume “the number” of “invasive and truly malignant” cancers which “pop
up, in unusual circumstances” were caused by a mechanism that is not relevant to
humans. Mack did not misstate the law in his comment.
After Mack’s statement, Committee member Duncan Thomas quoted from the
guidelines: “As I read the guidelines that says that if it causes invasive cancer in animals
parenthesis, unless the mechanism of action has been shown not to be relevant in
humans.” He continued: “[W]e clearly show that the PPAR alpha mechanism is not
relevant in humans, but that’s not the only possible mechanism, that there are others
about which we are simply unsure. And so the possibility that it’s relevant [in humans]
still stands . . . .”
Mack then made the second statement:
2
David Eastmond discussed the evidence concerning the relevance of animal studies to
humans. Eastmond concluded “When you get this many [tumor types], it really is very
difficult not to list it.” But he also stated: “I’m right now not convinced to list, just
simply because I see enough weaknesses on each of these that I don’t feel real confident.”
12
“Having -- being the person who wrote those guidelines, I have to try and describe
to you the reason why that verbiage was put in there. Can you picture a circumstance
where there’s extremely good epidemiologic data suggesting that there is no effect on
humans, a carcinogenic effect? And, at the same time, there is one or two animal studies
with liver cancer in rates, in which there is a marginally increased effect.
“And I think the point of that mechanistic inclusion in the criteria document is
thinking about that rather than this. Here we’re in a situation where there is no
epidemiologic data. We have to go solely on the animal data.”
Shortly afterward Mack reiterated: “Did you hear what I said about why the panel
-- why we wrote those criteria? We wrote them for the circumstance in which there is a
conflict between human epidemiologic data and information from animals. And, in any
case, I don’t think we can discuss it any further. We have to take a vote now.
“So if you’ll permit me, we’ll go ahead and do that.”
Chemistry argues Mack’s statement again misstated the law to the Committee.
We agree Mack’s statement is confusing enough to be susceptible to several
interpretations. It might be interpreted to state that the guidance criteria require listing
based on animal studies alone, even if epidemiological studies show no effect on humans,
unless there is additional evidence showing the mechanism of action in animals has no
relevance to humans. This would allow a chemical to be listed even though studies on
humans showed it did not cause cancer in humans, which runs afoul of the criteria.
However, Mack’s comments can also be read to state that, in the absence of human
studies, the Committee must rely on animal studies. Mack earlier told the Committee “in
the absence of epidemiologic information, we’re stuck making decisions about animal
data.” This is not an incorrect statement of the law.
Mack’s comments lacked clarity, but any ambiguity cannot be considered in
isolation. The Committee had before it the guidance criteria, which Chemistry does not
dispute state the law accurately. Committee members, made up of independent experts,
13
were twice instructed to follow the criteria. Based on the totality of the circumstances
surrounding the decision, we cannot find the Committee’s decision was arbitrary and
capricious. We cannot assume Committee members failed to follow the criteria they
were instructed to follow and instead were led astray by Mack’s somewhat confusing and
possibly erroneous interpretation.
In the absence of evidence to the contrary, we must presume the Committee
properly carried out its obligation and followed its own guidance criteria. Again, the
question before us is not whether the record establishes the Committee complied with
requirements, but whether the evidence establishes the agency failed to comply. (Evid.
Code, § 664; City of Sacramento v. State Water Resources Control Bd. (1992)
2 Cal.App.4th 960, 976.)
Adequacy of the HID
Chemistry acknowledges OEHHA based its decision to list DINP on the
Committee’s recommendation, but argues OEHHA preluded the Committee from
considering all relevant factors by issuing a “biased, incomplete and misleading HID.”
Chemistry also faults OEHHA’s allowing only two weeks for the Committee to consider
opposing comments and 7,000 pages of scientific studies. After painstakingly setting
forth the alleged omissions, Chemistry states the “only plausible explanation for the
HID’s many inaccuracies is agency bias in favor of listing.”
The scientific evidence collected by OEHHA revealed DINP causes three types of
cancer in rodents: kidney tumors, liver tumors, and mononuclear cell leukemia. Some
evidence suggests the mechanism of action of these three cancers is not relevant to
humans because the cancers occur in rodents through a mechanism that does not occur in
humans or because of physiological differences between rodents and humans.
Chemistry cites authority stating we must ensure that the agency has
“ ‘ “ ‘ “adequately considered all relevant factors.” ’ ” ’ ” (Exxon, supra,
14
169 Cal.App.4th at p. 1277.) Chemistry also notes the Committee’s own guidance
criteria require it to consider “all evidence bearing on the issue of carcinogenicity shown
through scientifically valid testing according to generally accepted principles” of
scientific inquiry. Since the Committee failed to consider the evidence showing DINP
was not a human carcinogen, Chemistry argues its decision to list DINP is arbitrary and
capricious.
Chemistry mounts a multiprong attack on the alleged HID failures: omission of
primate studies; omission and mischaracterization of critical toxicity reviews;
mischaracterization of evidence regarding kidney tumors; mischaracterization of
evidence regarding liver tumors; mischaracterization of evidence regarding mononuclear
cell leukemia; and mischaracterization of evidence of pancreatic, testicular, and uterine
tumors. According to Chemistry, the record is clear that the HID presented a misleading
picture of the science and biased the Committee in favor of listing DINP.
However, our review of the record reveals the Committee considered much of the
evidence Chemistry accuses it of ignoring. Chemistry faults the HID for failing to
adequately discuss studies showing that kidney tumors, liver tumors, and leukemia
observed in rodents are not relevant in humans. However, one of Chemistry’s members
submitted extensive comments to OEHHA reviewing and discussing these other studies.
This critique explained in great detail the studies Chemistry claims reveal DINP caused
animal cancers are not relevant to humans. The additional materials were provided to
the Committee prior to the meeting. Chemistry addressed the Committee at the public
meeting and provided a detailed explanation of their view that the rodent studies were not
relevant to humans.
The HID itself does discuss some of the issues Chemistry claims it ignores. The
HID discusses a study that reported no human counterpart to rodent leukemia.
Regarding another study cited, HID stated: “It has also been suggested that rat and
mouse liver tumors induced by PPAR agonists are not relevant to human cancer risk
15
assessment because of differences in activation characteristics between rodent and human
PPAR.” The HID discussed another study that found “The protein 2u-globulin is
specific to male rats, and some renal tubule cell tumors induced by agents that induce
2u-globulin accumulation in male rat renal tubules have been suggested to be not
relevant to human cancer risk assessment.”
Nor did the subsequent discussion of the HID by Committee members reveal a
monolithic approach to the conflicting evidence. Committee members acknowledged
struggling with the question of whether the evidence that DINP caused cancer in animals
was relevant to humans. Committee member Joseph Landolph stated “I struggle with the
issue of the relevance to human tumors.” The key issue, according to Committee
member Peggy Reynolds, “is really whether the mechanism of action has been shown to
be relevant in humans.” Committee member Eastmond agreed, stating, “The key
question now becomes are those [cancers] relevant to humans?” Committee member
Jason Bush revealed: “I guess what I’m wrestling with is whether this is meaningful for
humans?” Chairperson Mack summed up the members concerns: “I understand
completely the points . . . the regulated community has made about the mechanism
issue.”
The Committee did not disregard evidence presented by Chemistry regarding
mechanism. Chemistry submitted studies and offered arguments disputing the relevance
of rodent studies to humans. The HID included studies cited by Chemistry and members
of the Committee admitted struggling over the issue. We cannot find the HID presented a
biased view of the relevant data.
In a related argument, Chemistry contends the time period allowed for the
Committee to review the voluminous underlying toxicity reviews and scientific studies
“was patently inadequate” and as a result the Committee’s understanding of the state of
the science regarding DINP was shaped by the HID’s inaccurate summary of the
evidence. The trial court rejected this argument: “Absent evidence to the contrary, the
16
court will assume the [Committee] reviewed sufficient evidence to come to an informed
decision. (Evid. Code, § 664.)”
OEHHA provided the HID to the Committee on October 7, 2013, along with
references cited in the document and including 32 documents submitted by the industry.
On November 20, 2013, OEHHA gave additional documents submitted by the industry in
response to the HID to the Committee. The meeting took place two weeks later on
December 5, 2013.
At the beginning of the meeting, OEHHA’s staff counsel informed the Committee
they did not have to vote that day and could request additional time. Four industry
members were given 30 minutes to present arguments against listing DINP. Committee
members followed up with questions for the presenters. At the conclusion of the
questioning, Mack allowed industry members to provide further comment. The record
reveals the Committee review was not rushed and did not render the Committee’s
decision arbitrary and capricious.
Negative Consequences of Listing
Finally, Chemistry contends the Committee’s decision to list DINP carries with it
serious consequences. The listing may cause manufacturers to replace DINP with other
chemicals that are less safe, not as well studied, and less effective. In addition, “The
listing will lead to an increase in unnecessary warnings on consumer products, because
manufacturers can insulate themselves from enforcement litigation by applying warnings
to any product containing DINP. (§ 25249.6.) The overuse of Proposition 65 warnings
will cause individuals to become desensitized to legitimate warnings that are supported
by scientific evidence, completely undermining Proposition 65’s value and purpose.”
Amicus curiae Chamber of Commerce of the United States of America echoes this
argument in its brief. Chemistry also warns of “a barrage of harmful and costly
litigation” filed by “bounty hunters” against manufacturers who use DINP.
17
We note these objections to the consequences of the Committee’s decision do not
address the propriety of the decision itself. Consequences do not bear on OEHHA’s
discretion to list DINP.
In addition, the decision to list a chemical does not determine whether or not a
warning is required. Under Proposition 65, a business can avoid providing a warning if it
can prove that the exposure caused by its product is below the level that will have “no
significant risk.” (§ 25249.10, subd. (c).) OEHHA’s decision requires listing DINP.
Subsequently, Chemistry will have the opportunity to prove it is exempt from the
Proposition 65 requirements because a specific exposure that it causes is below the level
that will have no significant risk. (Exxon, supra, 169 Cal.App.4th at p. 1291.)

Outcome: The judgment is affirmed. OEHHA shall recover costs on appeal. (Cal. Rules of
Court, rule 8.278(a)(1) & (2).)

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