The Osteen
Decision
The
Osteen Decision
July
17, 1998
Page 2 of 3
pages: |1|3|
pages 30-61
Return to Report
C. The
Timing of Committee Formation
EPA argues that § 403(c) is generally worded
and does not make the formation of a
representative advisory committee a prerequisite
that must be satisfied before EPA can undertake a
specific activity under the Act. There is no
evidence in the record, nor does EPA argue, that
EPA established the committee during or after any
activity conducted under the Act. Since the
committee has not been established, EPA's
argument about when it could have sought the
committee's assistance appears academic. However,
for purposes of fashioning a remedy, § 403(c)
requires EPA to seek the committee's assistance
"in carrying out the research program . . .
. Congress intended consultation at least while
EPA conducted research. ongoing consultation
requires more than post hoc consultation. See
Morabito v. Blum, 528 F. Supp. 252, 264- 66
(S.D.N.Y. 1981) (Under the Social Security Act,
where consultation with a medical advisory
committee is required, committee input must be
sought and received before action is taken.).
D. Consequences of EPA's Procedural Failure Plaintiffs
argue EPA's actions were unlawful and the ETS
Risk Assessment must be set aside. EPA argues
Plaintiffs
30
were not prejudiced "because EPA in fact
utilized extensive public participation and peer
review drawing upon all of the designated
constituencies in developing the ETS Risk
Assessment." (Conformed Mem. Sut; (Conformed
drawing upon all of the designated constituencies
in developing the ETS Risk Assessment."
(Conformed Mem. Sut; (Conformed Mem. Supp. EPA's
Cross Mot. Part. Summ. J. at 42-43.) Further in
its memorandum, however, EPA maintains it did
"not have an obligation to respond to public
comments in the same manner as in [an APA]
section 553 rulemaking," id. at 49,
and the court cannot require EPA to respond to
comments because "reviewing courts are
generally not free to impose additional
procedural requirements if the agencies have not
chosen to grant them." Id.
Even if EPA did provide a genuine opportunity
for comment and SAB review, the Agency was
required to carry out its research program with
the assistance of an advisory group of
representatives of the identified interests. EPA
may not rewrite the terms of the Radon Research
Act. See Environmental Defense Fund. Inc. v.
EPA, 636 F.2d 1267, 1283-84 (D.C. Cir. 1980)
(agency-created -de minimis" cutoff from
application of statute was struck down because
not in compliance with terms of statute); Alabama
Power Co. v. Costle, 636 F.2d 323, 365 (D.C.
Cir. 1979) (The agency is not "free to
ignore the plain meaning of the statute and to
substitute its policy judgment for that of
31
Congress."). When Congress requires specific
procedures, agencies may not ignore them or
fashion substitutes. 16 A congressional directive
to consult an advisory committee is more than a
formality. The Court of Appeals for the District
of Columbia emphasized the significance of
advisory committees in explaining the procedural
requirements within the Federal Coal Mine Health
and Safety Act of 1969:
The most important aspect is the requirement
of consultation with knowledgeable
representatives of federal and state government,
industry and labor. This goes far beyond the
usual requirements of public notice and
opportunity for comment set forth in the
Administrative Procedure Act, and represents the
Congressional answer to the fears expressed by
industry and labor of the prospect of unchecked
federal administrative discretion in the field.
These rather unique requirements of the Act are
an important part of the ultimate legislative
compromise, and must be given their due weight.
-----------------
16 Even so,
the IAQC was a poor proxy for industry
representation. EPA sought parties near the
"middle" of the spectrum when
establishing SAB panels and allegedly avoided
representation from either end of the spectrum.
As a general rule, the tobacco industry occupies
that end of the spectrum contesting the
carcinogenicity of ETS and EPA's motives. A
committee aspiring to represent the middle of the
ETS debate necessarily suppresses the tobacco
industry's perspective. Further, industry's
ability to submit comments to a
"neutral" committee, which itself had
access to EPA, is not equivalent to industry
access to EPA.
32
Zeigler Coal Co. v. Klelppe, 536 F.2d 398, 403
(D.C. Cir. 1976). In National Constructors Ass'n
v. Marshal, 581 F.2d 960 (D.C.Cir. 1978), the
Secretary of Labor was obligated to establish and
consult with a specially constituted advisory
committee when promulgating safety standards. The
Secretary failed to do so. The Marshal court
rejected the agency's effort to equate notice and
comment with the required procedures and
concluded that "advisory committee
consultation should, but in this case did not,
consist of something more than a . . . rest stop
on the route between a tentative proposal,. and
the final promulgation Id. at 971.
EPA relies on Vermont Yankee Nuclear Power
Corp. v. NRDC, 435 U.S. 519, 558, 98 S. Ct.
1197, 1219, 55 L. Ed. 2d 460 (1978). In Vermont
Yankee, the agency complied with statutory
procedures, but the appeals court held the agency
should have done more. The Supreme Court
reversed, noting "we find absolutely nothing
in the relevant statutes to Justify what the
court did here." Id. at 557, 98 S. Ct. at
1218. In the present action, EPA violated a
statutory procedure.
At issue then is the proper remedy for agency
action that is procedurally deficient.
Specifically, the court must determine whether to
vacate the ETS Risk Assessment. In Vermont
Yankee,
33
the Court held "[aldministrative decisions
should be set aside . . . only for substantial
procedural or substantive reasons as mandated by
statute Id. at 558, 98 S. Ct. at 1219.
In Synthetic Organic Chem. Mfrs. Ass'n v.
Brennan, 506 F.2d 385, 388-89 (3d Cir. 1974),
Congress gave the Secretary of Labor the option
of requesting recommendations from an advisory
committee prior to promulgating certain rules. If
the Secretary used the committee, interested
parties could submit their comments about the
rule after the committee issued its report. The
dispute before the Third Circuit arose when the
Secretary consulted the committee but published a
proposed rule before the advisory committee
submitted its report. The complainants "were
not given adequate time to submit comments or to
prepare for the hearing after the committee's
work was completed." Id. at 388. The
court remanded the standards to the agency with
the directive to republish them and follow the
procedural requirements.
In Marshal, 581 F.2d 960, the agency was
required to consult an advisory committee before
promulgating the disputed standards. The court
found the agency greatly deviated from required
procedures and agency regulations by not
meaningfully consulting the committee. The court
concluded that, had the agency abided by its
procedural requirements, the agency may have
promulgated
34
different standards. Accordingly, the court
remanded the standards back to the agency for
consultation with the advisory committee. Because
the court also found the standards as promulgated
were not illegal and the administrative record
did not contain any glaring deficiencies, the
court ordered a minimum remand of ninety days
during which the standards would remain in
effect. If the committee recommended alteration,
the agency would have to reevaluate the
standards.
In Brennan and Marshal, the
agencies failed procedural requirements in the
process of promulgating agency standards. In both
Brennan and Marshal, the courts
remanded the disputed agency standards with
directives to comply with the procedural
directives. The Marshal decision left the
standards intact; the Brennan decision did
not.
This case is similar to Brennan and Marshal in
that the ETS Risk Assessment constitutes an
agency characterization promulgated without
adherence to statutory procedure. However, this
case is also unique. First, it is quite clear
that the ETS Risk Assessment consumed
significantly more resources than the
promulgation of standards in Brennan and Marshal.
Second, Congress' procedural requirements in
the Radon Research Act adhere to the research
process. Remanding the ETS Risk
35
Assessment for post hoc consultation could not
satisfy statutory requirements of consultation
during research.
To satisfy the Radon Research Act's procedural
requirements, the court would have to vacate the
Assessment. EPA could then conduct research on
ETS with the assistance of a representative
committee. However, in Vermont Yankee, the
Supreme Court advised that agency action should
be set aside only for substantial reason. By
itself, disregarding a statutory mandate to
establish and consult an advisory committee is
substantial. Again, EPA expended significant
resources over several years in producing an
assessment which claimed to deal with public
health and safety. The Assessment's subject
matter and EPA's expenditures raise the threshold
of what constitutes a substantial reason.
EPA's complete disregard of statutory procedure
and the potential waste of significant executive
branch resources dealing with health and safety
each suggest a different remedy. In resolving
this conflict, the court finds persuasive the
rationale underlying the District of Columbia's
remedy in Marshal. In addition to
enforcing Congress' directive, the remedy should
ameliorate the harm caused, or being caused, by
EPA's procedural
36
violation." The court is reluctant to
characterize EPA's procedural deficiency
substantial where EPA would simply reproduce the
same ETS Risk Assessment at significant cost. In
resolving the substantiality of EPA's procedural
defect, the court must inquire whether EPA's
procedural failure affected the Assessment. See
Textile Workers Union of-America v. Lincoln Mills
of Alabama, 353 U.S. 448, 457, 77 S. Ct. 912,
918 (1957) (Some federal law "lack[s]
express statutory sanction but will be solved by
looking at the policy of -..'ie legislation and
fashioning a remedy that will effectuate that
policy. The range of judicial inventiveness will
be determined by the nature of the
problem."); United States v. Field, 193
F.2d 92, 96 (2nd Cir. 1951) ("'[I]t is
fundamental that federal courts, in common with
other courts, have inherent power to do all
things that are reasonably necessary for the
administration of justice, within the scope of
their jurisdiction.,")
----------------
17 In deciding
whether procedural compliance could have produced
a different outcome, the Marshal decision
also distinguished agency action that violated
the law. EPA's procedural failure constitutes a
violation of the law. Where significant agency
resources are at stake, the court will not,
however, adopt a formal, bright line rule.
37
V. THE
ENVIRONMENTAL TOBACCO SMOKE RISK ASSESSMENT
A. Overview
The court reviews the performance of the ETS Risk
Assessment to determine whether consultation with
the representative group would have likely
produced a different result. 18 19.
Chapter 1 summarizes the claim that ETS is a
Group A carcinogen that causes approximately
3,000 lung cancer deaths per
----------------
18 Plaintiffs
initially argue that had industry been consulted
during the research process, EPA likely would not
have conducted a risk assessment and carcinogen
classification. Plaintiffs' argument depends on
the ETS Risk Assessment being ultra vires. As
already addressed, risk assessment is incidental
to gathering information, researching, and
disseminating the findings.
19 The parties' arguments to the court address
whether EPA's conduct was arbitrary and
capricious and whether the record demonstrates
reasoned decision making. The court uses the
arguments to determine whether the Assessment
would have been different had industry (and
state) representatives addressed their concerns
directly to EPA. The inquiry turns on the
legitimacy of Plaintiffs, concerns.
38
ETS Risk Assessment at 2-7 thru 2-8. The
report then states that although ETS and MS are
chemically similar, "ETS is rapidly diluted
into the environment, and consequently, passive
smokers are exposed to much lower concentrations
of these agents than are active smokers." Id.
at 2-8.
Chapter 3 establishes that ETS and MS are
chemically similar because: (a) ETS is composed
of aged, diluted sidestream smoke (SS), 21 and aged, diluted,
exhaled MS, and (b) fifty-two of the 4,000+
characterized chemical constituents of MS were
found in SS, which include most of the suspected
carcinogens identified in Ms.
Chapter 4 states that the high relative risks
(RR) for lung cancer associated with active
smoking along "with no evidence of a
threshold level of exposure," id. at
2-9, the chemical similarity between MS and ETS,
and corroborative evidence for the
carcinogenicity of tobacco smoke provided by
animal bioassay and genotoxicity studies
"clearly establish the biological
plausibility that ETS is also a human lung
carcinogen." Id. at 2-
9; see also 4-27 thru 4-29.
EPA asserts these observations
----------------
21 Sidestream smoke is the smoke emitted from a
smoldering cigarette between puffs.
40
alone
are sufficient to establish ETS as a Group A
carcinogen designation 22
Chapter 4 concludes with recognition that EPA
should examine the "vast body of
epidemiologic data dealing specifically with lung
cancer and exposure to ETS." Id. at 4-29.
The chapter concludes this data should be
examined: (1) to promote "the interest of
weighing all the available evidence, as
recommended by EPA's [Risk Assessment Guidelines]
(2) because SS and MS rapidly dilute into the
environment and ETS components change phase
distributions over time, which raises questions
about the carcinogenicity of ETS exposure under
environmental conditions, and (3) since
"active smoking data do not constitute a
good basis for quantitative estimation of the
health effects of passive
-----------------
22 A substance is categorized as a Group A Human
Carcinogen "only when there is sufficient
evidence from epidemiologic studies to support a
causal association between exposure to the agents
and cancer." Risk Assessment Guidelines at
34,000.
Three criteria must be met before a causal
association can be inferred between exposure and
cancer in humans: 1. There is no identified bias
that could explain the association. 2. The
possibility of confounding has been considered
and ruled out as explaining the association. 3.
The association is unlikely to be due to chance.
Id. at 33,999.
41
smoking
because the relative uptake and deposition
between active and passive smokers of the
agent(s) responsible for these effects are not
known Id.
Chapter 5 analyzes thirty-one epidemiologic
studies of nonsmoking women married to smoking
spouses (spousal smoking studies). Chapter 5
combines the spousal smoking studies data into
six statistical "meta-analysis" based
on geographic origin. Chapter 5 also analyzes
high-exposure groups in the studies, conducts a
trend analysis, and categorizes studies into four
tiers based on their perceived utility for
assessing an ETS/lung cancer association. The
analysis within Chapter 5 utilizes one- tailed
tests of significance and 90% confidence
intervals. "The justification for this usage
is based on the a priori hypothesis
[from the theory of biological plausibility] that
a positive association exists between exposure to
ETS and lung cancer." Id. at
5-2.
Chapter 6 conducts an exposure assessment in an
attempt to quantify the threat posed by ETS.
Chapter 6 concludes that MS and ETS are too
dissimilar to use data about MS to assess the
risks of ETS exposure. Id. at
6-6. Chapter 6 thus bases its exposure assessment
on data from the spousal smoking studies and
42
asserts that ETS exposure causes approximately
3,000 nonsmoker lung cancer deaths each
year."
The Addendum addresses large U.S. spousal smoking
studies published in 1992. It claims "these
new studies are generally consistent with this
report's conclusions . . . . Id. at ADD-1.
Appendix A reviews the thirty-one spousal smoking
studies and explains how the studies were
assigned to tiers based on their perceived
utility. Appendix B explains how EPA adjusted the
data used in Chapter 5's meta-analysis to address
the effects of smoker misclassification bias.,
There are two issues. The first is whether EPA's
consulting a representative committee, on which
industry's concerns were represented during the
research process, likely would have caused EPA to
change the conduct or conclusions of its ETS
assessment. The key to this determination is
whether industry representatives could have
presented meritable criticism and advice. The
second issue is whether EPA's conduct was
otherwise in accordance with the Radon Research
Act.
----------------
23
Chapters 7 and 8 do not involve the
carcinogenicity of ETS.
43
B.
Biological Plausibility
1. Industry Criticism
Plaintiffs argue EPA's "biological
plausibility" analysis is flawed because the
Agency disregarded evidence that MS and ETS are
not similar, failed to identify the criteria used
in equating MS and ETS, and disregarded evidence
that MS has a no- effect threshold. The
importance of Plaintiffs, arguments is that the
biological plausibility analysis establishes
Chapter 5's "a priori hypothesis" that
ETS is a Group A carcinogen. EPA uses this
hypothesis to justify the use of one-tailed
significance tests, which the Agency in turn
relies upon to switch from a 95% to 90%
confidence interval.
Plaintiffs assert the record does not explain why
EPA ignored record evidence and EPA's own
findings in the chemical similarity analysis of
Chapter 3. Plaintiffs point out that EPA analyzed
the similarity of MS and ETS three times and
reached three different conclusions. Chapter 6
establishes ETS and MS were too dissimilar to use
MS data to establish the carcinogenic risk of
ETS, and Chapter 2 states the similarity of ETS
to MS was too indeterminate to assess risk
according to EPA's Guidelines for the Health
Risk Assessment of Chemical-Mixtures. Chapter
3, however, uses the chemical similarities of ETS
and MS to
44
establish ETS as a known human carcinogen.
Plaintiffs argue Chapter 3's similarity analysis
fails for three reasons: (1) the chapter ignored
Assessment findings about the differences between
MS and ETS; (2) EPA ignored evidence rejecting
any chemical similarity; and (3) EPA did not
define the criteria used to reach conclusions
about the similarity/dissimilarity/indeterminacy
of MS and ETS.
Plaintiffs point out Chapter 3's similarity
analysis is contradicted by the explanation at
the end of Chapter 4 for analyzing epidemiologic
data. Specifically, "[t]he rapid dilution of
both SS and exhaled MS into the environment and
changing phase distributions of ETS components
over time raise some questions about the
carcinogenic potential of ETS under actual
environmental exposure conditions." ETS Risk
Assessment at 4-29.
in rejecting using a
"cigarette-equivalents" correlation,
Chapter 2 states that although MS and ETS are
qualitatively similar, the absolute and
proportional quantities of the components, as
well as their physical state, differ
substantially. EPA also rejects this equivalents
analysis because it does not know which tobacco
smoke chemicals cause cancer nor the effect
metabolic differences between active and
45
passive smokers have on carcinogenicity. See
id. at 2-7 thru 2-9. Chapter 6 bases its
rejection of an equivalents analysis on the
differences between MS and SS:
The basic assumption of cigarette-equivalents
procedures is that the lung cancer risks in
passive and active smokers are equivalently
indexed by the common measure of exposure to
tobacco smoke, i.e., a common value of the
surrogate measure of exposure in an active and a
passive smoker would imply the same lung cancer
risk in both. This assumption may not be tenable,
however, as MS and SS differ in the relative
composition of carcinogens and other components
identified in tobacco smoke and in their
physicochemical properties in general; the lung
and systemic distribution of chemical agents
common to MS and SS are affected by their
relative distribution between the vapor and
particle phases, which differs between MS and SS
and changes with SS as it ages. Active and
passive smoking also differ in characteristics of
intake . . . which may affect deposition and
systemic distribution of various tobacco smoke
components as well. Id. at 6-6. EPA further
revealed that such differences affect
carcinogenicity: "Pipe and cigar smokers,
who inhale less deeply than cigarette smokers,
have lower risks of lung cancer than cigarette
smokers."
Id. at 4-10.
In a draft response to comments, Kenneth Brown,
the primary author of Chapters 5 and 6, and
Appendices C and D, rejects using a
cigarette-equivalents analysis because
"there are differences between active and
passive smoking that may affect carcinogenic
46
risk that are not fully understood." Kenneth
G. Brown, Draft Report Responses to Public
Comments on the First
EPA Draft Risk Assessment of ETS with Discussion
of Revisions that Appear in the Second Draft
Report, Response To Comment 3.1.4, at 16
(June 1992) (JA 6,457) (Draft Responses). The
author agrees "that active and passive
smoking are vastly dissimilar with regard to
exposure," id., and states,
[a]lthough it would be of interest to know
more about the physicochemical properties of ETS,
the distribution of exposure concentration,
exposure duration, and other characteristics,
these things do not need to be fully understood
to conclude that
ETS is a carcinogen . . . . If the unknown
characteristics regarding the properties of ETS
or exposure to ETS nullified the carcinogenic
potential in fresh sidestream smoke, then we
would not expect to see an association of ETS
exposure with increased lung cancer, as the study
data indicate.
Id., Response To 3.1.2, at 14 (JA
6,455).
Plaintiffs assert EPA's statements impact EPA's
biological plausibility analysis. Regarding EPA's
a priori hypothesis, Plaintiffs conclude:
(1) ETS cannot be a known carcinogen if dilution
and aging raise unresolved questions about its
potential carcinogenicity, and (2) ETS and MS are
not "sufficiently similar" carcinogens
if they are "vastly dissimilar" as to
exposure.
47
Plaintiffs next point to comments submitted by
scientists 24 and by the tobacco industry citing
scientific literature 21 that reject EPA's similarity
conclusions. Plaintiffs contend EPA selectively
cites or ignores certain studies, depending on
whether the Agency is explaining or disclaiming
similarities between ETS and MS. Plaintiffs also
point out that none of the eleven U.S.
epidemiologic studies analyzed in the ETS Risk
Assessment, as reported by their authors, shows
an overall statistically significant association
between ETS and lung cancer.
Plaintiffs also argue EPA failed to identify the
criteria used to determine chemical similarity.
Plaintiffs insist the criteria EPA-used to
analyze similarity must be precise for two
reasons. First, at different times in the same
ETS Risk Assessment, EPA concluded that MS and
ETS are similar,
----------------
24 See,
e.g., Comments of Cronan (JA 6,188); Comments
of Gori (JA 10,839); Comments of Todhunter (JA
10,072); Comments of Flamm (JA 10,633-34);
Comments of Newell (JA 10,660-61); Comments of
Reasor (JA 10,786).
25 See, e.g., Comments of The Tobacco
Institute (JA 9,537-38, 9,543); Comments of
Reasor (JA 10,789-90); Comments of R.J. Reynolds
(JA 5,841-58); Comments of Philip Morris (JA
10,012, 10,024).
48
dissimilar,
and of indeterminate similarity . 26 Second, EPA's chemical similarity
analysis is inconsistent with the Agency's prior
risk assessment practices. See Risk
Assessment Guidelines at 33,992 (listing
"consistency of carcinogen risk
assessments" as an EPA goal). Plaintiffs
then provide evidence that., previously, EPA did
not classify agents in Group A because they
contain the same constituents as other Group A
carcinogens. See Tennessee Gas Pipelines Co.
v. F.E.R.C., 926 F.2d 1206, 1211 (D..C. Cir.
1991) (When an agency decision is inconsistent
with prior decisions, it must explain the
change.).
As their final argument against EPA's biological
plausibility hypothesis, Plaintiffs dispute EPA's
conclusion that ETS exposure causes lung
cancer because "[a] clear dose- response
relationship exists between lung cancer and
amount of exposure [to MS], without any evidence
of a threshold level." ETS Risk Assessment
at 4-1. EPA's "no threshold" finding
means EPA
----------------
26 See Dithiocarbamate Task Force v. EPA, 98
F.3d 1394, 1404-05 (D.C. Cir. 1996) (vacating
EPA's listing of a carbamate as a "K
waste" because EPA could not employ a highly
discretionary and unarticulated
"environmental concern" standard and
then fail to explain why that carbamate failed to
meet that standard); see also Toler v. Eastern
Assoc. Coal Co., 43 F.3d 109, 115-16 (4th
Cir. 1995) (review of denial of medical benefits,
requiring an ALJ to identify specific and
persuasive reasons to justify seemingly
paradoxical reasoning).
49
purported to find no concentration level at which
MS ceases to be carcinogenic. This finding was
critical because Plaintiffs assert that
nonsmokers are exposed to only minute
concentrations of ETS. If EPA had found a
threshold for exposure to MS, then one would have
to be established for ETS. Evidence of an MS
exposure threshold would jeopardize EPA's
biological plausibility analysis since ETS is
substantially more dilute than MS. Plaintiffs
point to comments and evidence in the record of
thresholds in human, animal, and genotoxicity
studies. Again, Plaintiffs point to EPA's
selective use of studies and failure to consider
or respond to contrary evidence.
2. EPA's Response
In response to Plaintiffs, claim that EPA
failed to respond to certain public comments, EPA
asserts that it did not have an obligation to
respond to public comments in the same manner as
in formal rulemaking. EPA further reminds that it
is not the province of the court to impose
additional procedural requirements outside those
mandated by Congress.
In assessing the health risk of ETS, EPA claims
it used a "total weight of the
evidence" approach, see Risk
Assessment Guidelines at 33,996, 33,999-34,000,
and the Agency's conclusions
50
rely upon all of the available evidence, not on
any single analysis or theory. EPA offers two
reasons the ETS Risk Assessment is unique. First,
the database of evidence concerning ETS is large
and derived from human data. "The use of
human evidence eliminates the uncertainties that
normally arise when one has to base hazard
identification on the results of high-dose animal
experiments." ETS Risk Assessment at 2-7.
Second, the evidence consists of exposure at
environmental levels people are exposed to in
everyday life. EPA states such data are rare in
risk assessments and obviate the need to
extrapolate a response from high to low
exposures. The available data being unique, EPA
asserts "the guidelines themselves stress
that risk analysis is not subject to hard and
fast rules, but rather must be 'conducted on a
case-by- case basis, giving consideration to all
relevant scientific information.'"
(Conformed Mem. Supp. EPA's Cross Mot. Part.
Summ. J. at 47; quoting Risk Assessment
Guidelines at 33,992.)
EPA explains that its biological plausibility
findings rest on three considerations. First,
active smoking causes lung cancer in humans, and
MS is chemically similar to ETS. Second,
considerable evidence exists that nonsmokers
exposed to ETS absorb and metabolize significant
amounts of ETS, including
51
carcinogenic compounds. Third, laboratory studies
show ETS can cause cancer in animals and damage
DNA, which scientists recognize as being an
instrumental mechanism for cancer development.
Further, EPA argues that its bioplausibility
theory alone need not be sufficient to support
the Assessment's conclusion, because the theory
is confirmed by the findings from the
epidemiologic studies.
EPA defends its Chapter 3 findings of chemical
similarity by stating *the Agency never suggested
ETS and MS are identical compounds. Rather, EPA
found that ETS and MS are similar in some
respects and can be compared in terms of
carcinogenicity. Differences between the
compounds were not disregarded by the Agency. EPA
cites to the many portions in the ETS Risk
Assessment where EPA discusses the
dissimilarities between MS and
----------------
27 EPA also relies upon IAQC's finding:
There are substantial differences in the relative
composition of the smoke formed between
mainstream and sidestream smoke. . . . but there
is no reason to suppose that the qualitative
toxicities of ETS and MS are substantively
different. In comparing these two agents the
differences are largely ones of dose and duration
of exposure rather than fundamental differences
in the toxicity or carcinogenicity of the agent
in question.
(continued...
52
EPA asserts
the Assessment specifically discusses dilution in
ambient air, aging, and exposure characteristics.
Review of EPA's citations reveals very limited
discussion. The discussions primarily admit that
these are areas of uncertainty. See ETS
Risk Assessment at 3-10 ("Detailed chemical
characterizations of ETS emissions . . . are
limited. As a result, the impact on ETS of
factors such as the rapid dilution of SS
emissions, adsorption and remission of
contaminants, and exhaled MS is not well
understood."); see also id. at 3-12
(ETS concentration is the result of a complex
interaction of at least 13 variables; studies
show large variations in contaminant
concentrations.). EPA asserts that despite these
uncertainties, nonsmokers, lungs are nevertheless
exposed to and absorb contaminants, including
carcinogens, and that exposure can be at
significant levels relative to active smokers.
EPA characterizes Plaintiffs, contrasting the
Agency's differing conclusions on ETS-MS
similarities as nothing more than obfuscating the
differences between qualitative and quantitative
assessments. EPA claims the first issue (hazard
identification)
-----------------
27 ( ... continued)
EPA, An SAB Report: Review of Draft Passive
Smoking Health Effects Document, EPA/SAB/IAQC/93/003,
at 11, November 20, 1992.
53
in the risk assessment process is a qualitative
determination as to whether a substance is
carcinogenic. See Risk Assessment
Guidelines at 33,993 ("The hazard
identification component qualitatively answers
the question of how likely an agent is to be a
human carcinogen."). EPA asserts that if the
substance is identified as a hazard, the second
question is a quantitative assessment as to how
dangerous a carcinogenic substance is to humans. See
id. (Quantitative risk assessment is a
general term to describe all or parts of
dose-response assessment, exposure assessment,
and risk characterization.).
EPA also claims it explained four criteria for
finding MS and ETS chemically similar: (1) the
process resulting in the generation of MS and SS;
(2) the identity of toxins and carcinogens in the
two substances; (3) the relative toxicity and
carcinogenicity of SS and MS per cigarette smoke;
and (4) the demonstrated exposure to and
absorption by the body of significant levels of
carcinogens and other toxins. In response to the
charge that it changed its approach in evaluating
biological plausibility vis-a-vis other Group A
carcinogen determinations, EPA states risk
assessments are conducted on a case-by-case
basis. Thus, comparison to other EPA Group A
determinations are not relevant. EPA then
re-explains the basis
54
for its plausibility hypothesis and states no
other EPA Group A determination involves
comparison with a substance whose carcinogenicity
is as potent and as well documented as MS.
EPA asserts the epidemiologic studies reviewed in
Chapter 4 establish MS as a human carcinogen. In
defense of chemical similarity, EPA recites the
similarities between SS and MS. Both compounds
contain the same carcinogenic compounds,
moreover, EPA asserts "there is voluminous
record evidence demonstrating that SS is more toxic
per cigarette smoked than the carcinogenic
MS." (Conformed Mem. Supp. EPA's Cross Mot.
Part. Summ. J. at 62.)
In recognizing that ETS is rapidly diluted into
the environment, EPA explains that it analyzed
the extent to which nonsmokers actually absorb
and metabolize ETS. First, EPA examined the
extent of nonsmokers, actual exposure to ETS in a
variety of indoor environments. The studies EPA
reviewed showed measurable carcinogens and toxins
in ETS at levels that varied but consistently
exceeded background levels. Second, EPA reviewed
biomarker studies which showed at least some of
the carcinogens in ETS are absorbed by the body
at a higher rate than nicotine. The human
carcinogen 4-aminobiphenyl (4-ABP), which is
emitted at concentrations 31 times greater in SS
than MS, was present in the blood of nonsmokers
exposed to ETS in
55
concentrations of one-tenth to one-fifth of that
found in active smokers. These studies lead EPA
to conclude that nonsmokers exposed to ETS absorb
and metabolize ETS, including carcinogenic
compounds.
EPA asserts that Plaintiffs, arguments are simply
attacks on the uncertainties inherent in the risk
assessment process. A risk assessment, by its
very nature, is not a final determination about
the health effects of a substance but is instead
an assessment that makes the best judgments
possible based upon the available evidence. Ethyl
Corp. v. EPA, 541 F.2d 1, 24 (D.C. Cir.
1976). In conducting risk assessments, an agency
must adopt inference options and point out where
evidence and scientific knowledge are incomplete.
NRC Redbook, at 18, 28.
Finally, EPA defends its determination that there
is no safe level of exposure to MS by referring
to several studies that found a risk of lung
cancer at the lowest levels of exposure to MS.
EPA also relies upon SAB's finding it plausible
that prolonged inhalation of ETS results in some
increase of lung cancer. Finally, EPA asserts the
record rebuts Plaintiffs, argument that
nonsmokers are exposed only to small amounts of
ETS.
56
3. Analysis
EPA offers three assertions as the
foundation for its biological plausibility
hypothesis. Plaintiffs contest EPA's first
assertion that MS and ETS are similar. In support
of its second assertion, EPA points to evidence
in the record that some components of ETS are
absorbed by nonsmokers. EPA does not, however,
direct the court to evidence in the record
demonstrating that the observed absorption of ETS
constituents answers the questions of
carcinogenicity raised elsewhere in EPA's
analysis.
There is limited evidence in the record
supporting EPA's final basis for its plausibility
hypothesis. The animal laboratory studies used by
EPA present some evidence supporting EPA's
hypothesis. EPA conducted no animal lifetime
inhalation studies of ETS but did conduct
cigarette smoke inhalation studies on Syrian
golden hamsters. The studies detected no evidence
of lung cancer but did detect evidence of cancer
of the upper larynx and a dose- response
relationship. The record does not state whether
the substance analyzed, air-diluted cigarette
smoke (1:15), replicated MS, SS, or ETS. The
remaining studies, upon which EPA relies, involve
analysis of SS condensates from smoking machines.
The Assessment does not explain, nor does EPA
direct
57
the court to any evidence within the record
explaining, how SS condensate demonstrates
similarities between MS and ETS.
The court is disturbed that EPA and Kenneth Brown
buttress the bioplausibility theory with the
epidemiology studies. EPA's theory must be
independently plausible. EPA relied upon
similarities between MS and ETS to conclude that
it is biologically plausible that ETS causes
cancer. EPA terms this theory its "a
priori hypothesis" in justifying Chapter
5's methodology. Chapter 5's methodology allowed
EPA to demonstrate a statistically significant
association between ETS exposure and lung cancer.
See Federal Judicial Center, Reference Manual
on Scientific Evidence 154-55, (1994)
(Narrowing the confidence intervals makes it more
likely that a study will be found to be
statistically significant.). Chapter 5's analysis
rests on the validity of the biological
plausibility theory. It is circular for EPA to
now argue the epidemiology studies support the
Agency's a priori theory. Without the
theory, the studies would likely have done no
such thing.
The record also does not support EPA's argument
that contrasting EPA's three positions on ETS-MS
similarities constitutes obfuscation. EPA's Risk
Assessment Guidelines establish a distinction
between qualitative and quantitative
58
analysis. However, for purposes of EPA's
bioplausibility theory, neither the ETS Risk
Assessment or administrative record demonstrates
a difference or attempt the explanation which EPA
now offers the court. Quantity versus quality may
be a relevant distinction in certain situations,
e.g., the amount of arsenic naturally occurring
in an apple. Plaintiffs assert that since ETS is
a gas, considering the evidence regarding ETS'
physicochemical properties and the
characteristics of the particles and gases
comprising ETS is necessary to determine the
quality of ETS. This suggests an analytical
process combining qualitative and quantitative
analysis, which is also what EPA's Risk
Assessment Guidelines suggest.
EPA's Risk Assessment Guidelines do not support
the Agency's argument that risk assessment is a
bifurcated, quantitative then qualitative,
analysis. To the contrary, "[r]isk
assessment includes one or more of the following components:
hazard identification, dose-response
assessment, exposure assessment, and risk
characterization (NRC "Risk Assessment
Guidelines at 33,993 (emphasis added).
"[Q]uantitative risk assessment has been
used as an inclusive term to describe all or
parts of dose- response assessment, exposure
assessment, and risk characterization. . . .
[However,] the more explicit terminology
59
developed by the NRC (1983) is usually
preferred." Id. Neither the Assessment or
the administrative record explains why
physicochemical inquiries require a bifurcated
analysis instead of a combined analysis as per
the Guidelines, or why MS and ETS are similar for
purposes of hazard identification, but not for
purposes of quantitative risk assessments. Since
Chapter 2 found ETS and MS not sufficiently
similar, Chapter 3 found them similar, and
Chapter 6 found them dissimilar, EPA apparently
used a different risk assessment methodology for
each chapter. Again, neither the Assessment nor
the record explains the risk assessment
components used in the different chapters, why
methodologies varied between chapters, or why ETS
and MS were or were not similar using each
methodology.
The court is faced with the ugly possibility that
EPA adopted a methodology for each chapter,
without explanation, based on the outcome sought
in that chapter. This possibility is most potent
where EPA rejected MS-ETS similarities to avoid a
"cigarette- equivalents" analysis in
determining carcinogenicity of ETS exposure. Use
of cigarette-equivalents analysis may have lead
to a conclusion that ETS is not a Group A
carcinogen." It
-----------------
28 [S]ome persons suggest a dosimetric approach
(continued...
60
is striking
that MS and ETS were similar only where such a
conclusion promoted finding ETS a carcinogen.
EPA's assertion that "EPA did explain the
numerous criteria it used in assessing similarity
. . . " (Conformed Mem. Supp. EPA's Cross
Mot. Part. Summ. J. at 73), is without merit. EPA
merely parrots the findings made in Chapter 3 of
the ETS Risk Assessment. The record presents no
evidence of EPA establishing similarity criteria
before the Assessment .29 Nor did the
-----------------
28 ...
continued)
(called "cigarette-equivalents" in the
Report) to estimate lung cancer risk from ETS
exposure from data on active smoking. An average
ETS exposure is determined to be equivalent to
actively smoking some percentage of one cigarette
per day. Extrapolating downward on a
does-response [sic] curve for active smoking at
that level suggests a "negligible" lung
cancer risk.
Kenneth G. Brown, Draft Report Responses to
Public Comments on the First EPA Draft Risk
Assessment of ETS with Discussion of Revisions
that Appear in the Second Draft Report, Comment
3.1.4, at 15 (June 25, 1992) (JA 6,456) (Draft
Responses). Dr. Brown's response does not rebut
the asserted consequences of a cigarette
equivalents analysis.
29
See Portland Cement Ass'n v. Ruckelshaus, 486
F.2d. 375, 395 (D.C. Cir. 1973) ("A
troublesome aspect of this case is the
identification of what, in fact, formed the basis
for the standards promulgated by EPA - a question
that must be probed prior to consideration of
whether the basis or bases for the standards is
reliable."); see also Independent U.S.
Tanker Owners Comm. v. Lewis,, 690 F.2d 908,
920 (D.C. Cir. 1982) (noting that when agency
action is undertaken prior to disclosure of the
basis (continued...
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