IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
FLUE-CURED TOBACCO COOPERATIVE STABILIZATION CORPORATION,
THE COUNCIL FOR BURLEY TOBACCO,INC.,
UNIVERSAL LEAF TOBACCO COMPANY, INCORPORATED,
PHILIP MORRIS INCORPORATED,
R.J. REYNOLDS TOBACCO COMPANY,
and GALLINS VENDING COMPANY,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
and CAROL BROWNER, Administrator, Environmental Protection Agency,
ORDER AND JUDGMENT
OSTEEN, District Judge
For the reasons set forth in the memorandum opinion entered contemporaneously herewith,
IT IS ORDERED AND ADJUDGED that Plaintiffs' Motion for Partial Summary Judgment is granted .
IT IS FURTHER ORDERED AND ADJUDGED that Defendants' Cross Motion for Summary Judgment is denied . The court vacates Chapter 1-6 of and the Appendices to EPA's Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders, EPA/600/6-90/006F (December 1992). To ripen its judgment for purposes of appellate review, pursuant to Federal rule of Civil Procedure 54 (b), the court finds there is no just reason for delaying entry of judgment.
IT IS FURTHER ORDERED AND ADJUDGED that Plaintiffs' Motion for Leave to File Supplement Pleading under Rule 15(d) is granted .
This the 17th day July 1998.
United States District Judge
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
FLUE-CURED TOBACCO COOPERATIVE STABILIZATION CORPORATION,
THE COUNCIL FOR BURLEY TOBACCO,INC.,
UNIVERSAL LEAF TOBACCO COMPANY, INCORPORATED,
PHILIP MORRIS INCORPORATED,
R.J. REYNOLDS TOBACCO COMPANY,
and GALLINS VENDING COMPANY,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
and CAROL BROWNER, Administrator, Environmental Protection Agency,
OSTEEN, District Judge
This case is before the court on the parties' cross motions
for partial summary judgment on Counts I-III of the Complaint.
These counts raise Administrative Procedure Act (APA) challenges
to EPA's report, Respiratory Health Effects of Passive Smoking:
Lung Cancer and Other Disorders, EPA/600-6-90/006F, December 1992
(ETS Risk Assessment). EPA claims its authority to conduct the
ETS Risk Assessment derives from the Radon Gas and Indoor Air
Quality Research Act of 1986, Pub. L. No. 99--499, 100 Stat.
1758-60 (1986) (Radon Research Act) (codified at 42 USC. 7401
note (1994)). In the ETS Risk Assessment, EPA evaluated the
respiratory health effects of breathing secondhand smoke
(environmental tobacco smoke or ETS) and classified ETS as a
Group A carcinogen, a designation meaning there is sufficient
evidence to conclude ETS causes cancer in humans. Disputing the
Assessment, Plaintiffs argue: EPA exceeded its authority under
and violated the restrictions within the Radon Research Act; EPA
did not comply with the Radon Research Act's procedural
requirement; EPA violated administrative law procedure by making
a conclusion regarding ETS before it concluded its risk
assessment, and EPA's ETS Risk Assessment was not the result of
reasoned decision making.(FN1) EPA denies the same and argues the
administrative record (record) demonstrates reasoned decision
making. Plaintiffs have also filed a motion to supplement the
pleadings. For the reasons stated herein, the court will enter
an order granting Plaintiffs' motions.
THE RADON RESEARCH ACT
The Radon Research Act was enacted by Congress as Title IV of the Superfund Amendments and reauthorization Act of 1986 (SARA) and codified with the Clean Air Act at 42 USC. 7401 note. The act was based on Congress' finding: "exposure to naturally occurring radon and indoor air pollutants poses public health risk[s]," id. 492(2); "Federal radon and indoor air pollutant research programs are fragmented and underfunded," id. 402(3); and an "information base concerning exposure to radon and indoor air pollutants should be developed . . . ." Id. 402(4). The act provides
(a) Design of Program. - [The EPA] shall establish a research
program with respect to radon gas and indoor air quality. Such
program shall be designed to -
(1) gather data and information on all aspects of indoor air
quality in order to contribute to the understanding of health
problems associated with the existence of air pollutants in the
(2) coordinate Federal, State, local, and private research and
development efforts relating to the improvement of indoor air
(3) assess appropriate Federal government actions to mitigate
the environmental and health risks associated with indoor air
(b) Program requirements. - The research program required under this
section shall include -
(1) research and development concerning the identification,
characterization, and monitoring of the sources and levels of indoor air
pollution . . . .
. . . .
(2) research relating to the effects of indoor air pollution and radon
on human health;
. . . .
(6) the dissemination of information to assure the public availability
of the findings of the activities under this section.
Id. 403 (a) & (b). Congress also required a narrow construction of
the authority delegated under the Radon Research Act. Nothing in the
act "shall be construed to authorize the [EPA] to carry out any
regulatory program or any activity other than research, development, and
related reporting, information dissemination, and coordination
activities specified in [the Radon Research Act]." Id. 404.
The Act requires EPA to establish two advisory groups to assist EPA in
carrying out its statutory obligations under the Radon Research Act.
One of the advisory groups is to be a committee comprised of
representatives of federal agencies concerned with various aspects of
indoor air quality, and the other group is to be "an advisory group
comprised of individuals representing the States, the scientific
community, industry, and public interest organizations . . . ." Id.
403 (c). The Act requires EPA to submit its research plan to the EPA
Science Advisory Board which, in turn, would submit comments to
Congress. Id. 403(d).
II. STANDARD OF REVIEW (FN2)
Administrative agencies have no power to act beyond authority
conferred by Congress. See, e.g., Louisiana Public Serv. Comm'n
v. FCC, 476 U.S. 355, 374, 206 S. Ct. 1890, 1901, 90 L. Ed. 2d
369 (1986). Title 5 U.S.C. 706 (2) (C) requires the court to
"hold unlawful and set aside agency action . . . found to be
. . . in excess of statutory jurisdiction, authority, or
limitations, or short of statutory rights." The initial inquiry
for judicial review of agency action is "whether Congress has
directly spoken to the precise question at issue. If the intent
of Congress is clear, that is the end of the matter; for the
court, as well as the agency, must give effect to the
unambiguously expressed intent of Congress." Chevron, U.S.A.,
Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837,
842-43, 104 S. Ct. 2778, 2781, 81, L. Ed. 2d 694 (1984). "the
task of resolving the dispute over the meaning of [the statute]
begins where all such inquiries must begin: with the language of
the statute itself." United States v. Ron Pair Enter., Inc., 489
U.S. 235, 241, 109 S. Ct. 1026, 1030, 103 L. Ed. 2d 290 (1989)
(citations omitted). "The judiciary . . . is the final
authority on issues of statutory construction and will reject
administrative interpretations which are contrary to the clear
congressional intent." Adams v. Dole, 927 F.2d 771, 774 (4th
"[I]f the statute is silent or ambiguous with respect to the
specific issue, the question for the court is whether the
agency's answer is based on a permissible construction of the
statute." Chevron, 467 U.S. at 843, 104 S. Ct. at 2782. Courts
do not always abide by this Chevron deference. Although the
circuits appear divided, the majority of post-Chevron cases hold
no deference is accorded to an agency's view of a statute where
the statute does not confer rule making authority on the agency.
Compare Merck & Co. V. Kessler, 80 F.3d 1543, 1550 (Fed. Cir.
1996) (Chevron does not apply to interpretive rules); Atchison,
Topeka & Santa Fe Ry. V. Pena, 44 F. 3d 437, 441-42 (7th Cir.
1994) (en banc) (same), aff'd on other grounds sub nom.
Brotherhood of Locomotive Eng'rs v. Atchison, Topeka & Santa Fe
Ry., 116 S. Ct. 595 (1996) with Trans Union Corp. v. FTC, 81 F.
3d 228, 230-31 (D.C. Cir. 1996) (applying Chevron to
interpretive rule); Elizabeth Blackwell Health Ctr. For Women v.
Knoll, 61 F.3d 170, 182 (3d Cir. 1995) (same), cert. Denied, 116
S. Ct. 816 (1996). See Ronald M. Levin, Scope of Review
Legislation: The Lessons of 1995, 31 Wake Forest L. Rev. 647,
662-64 (1996). Another factor in determining an agency's
discretion in statutory interpretation is the specificity of
interpretation. Courts determine the general meaning of
legislation, whereas agencies are often better equipped to
determine interstitial meanings. John H. Reese, Administrative
Law Principles and Practice 709-713 (1995).
III. EPA's AUTHORITY UNDER THE RADON RESEARCH ACT
The parties assert the plain language of the statute determines
whether EPA had authority to assess the risks of an classify ETS.
The court agrees. However, the parties, reading the plain
language, come to opposite conclusions. Plaintiffs argue EPA
exceeded its statutory grant of authority under the Radon
Research Act by conducting a risk assessment, making a carcinogen
classification, and by engaging in de facto regulation.
Plaintiffs also argue the toxic Substance Control Act prohibited
EPA's risk assessment of ETS.
A. The Radon Research Act Authorizes EPA's Risk Assessment and
Classification of Environmental Tobacco Smoke.
Plaintiffs concede EPA was authorized to conduct research on ETS
and indoor air quality but argue EPA's ETS carcinogen risk
assessment and carcinogen classification are regulatory
activities, not research activities. EPA's Guidelines for
Carcinogen Risk Assessment, 51 Fed. Reg. 33,992, 33,993 (1986)
(Risk Assessment Guidelines) state: "[r]regulatory decision
making involves two components: risk assessment and risk
management." See also, 60 Fed. Reg. 52,032, 52,034 (1995) (Risk
assessment is a component of the regulatory process.).
Plaintiffs also rely on the National Resource Council's (NRC)
Redbook which recognizes risk assessment as a distinct element of
the regulatory process. See NRC, Risk Assessment in the Federal
Government: Managing the Process 3 (1983) (NRC Redbook).
Plaintiffs argue that since risk assessment is a component of
regulatory activity, risk assessment is not authorized research
but rather proscribed regulatory activity.
EPA's Risk Assessment Guidelines state risk assessment
incorporates judgmental positions and the Agency's regulatory
mission. Risk Assessment Guidelines at 33,994. Plaintiffs also
offer evidence that EPA has promulgated regulations for every
other substance for which it has conducted a risk assessment and
classified the substance as a Group A carcinogen.(FN3) Thus
Plaintiffs conclude that EPA's guidelines and actions demonstrate
risk assessment is a regulatory, not research, tool.
In arguing EPA recognizes this distinction between risk
assessment and research, Plaintiffs offer evidence that EPA is
assessing the Risks of several other indoor air pollutants, none
of which are being conducted under the authority of the Radon
Research Act. Included is evidence that EPA did not conduct its
risk assessment of radon under the authority of the Radon
research Act.(FN4) Instead, EPA relied on the Toxic Substance
Control Act (TSCA), 15 U.S.C. 2601 et seq., which authorizes
EPA to describe "Action levels indicating the health risk
associated with different levels of radon exposure." TSCA
2663(b) (1).(FN5) Plaintiffs argue EPA's reliance on TSCA
indicates EPA realizes the Radon Research Act does not authorize
risk assessments or carcinogenic classifications.
EPA replies that the Radon Research Act provides a broad mandate
to conduct activities short of actual regulation. Upon a sparse
legislative record and subsequent congressional funding, EPA
urges that Congress intended the act to include ETS.
The Court is not persuaded by Plaintiffs' arguments or EPA's
reliance on what certain members of Congress intended. The plain
language of the statute is sufficient to resolve this dispute.
In the Radon Research Act, Congress directed EPA to gather
information on all aspects of indoor air quality, research indoor
pollutants' effects on health, characterize sources of pollution,
and disseminate the findings. Determining whether Congress
authorized risk assessments requires defining risk assessment.
"Risk assessment is the use of the factual base to define the
health effects of exposure of individuals or populations to
hazardous materials and situations." NRC Redbook, at 3. "[NRC]
use[s] risk assessment to mean the characterization of the
potential adverse health effects of human exposures to
environmental hazards." Id. at 18. "The qualitative assessment
or hazard identification part of risk assessment contains a
review of the relevant biological and chemical information
bearing on whether or not an agent may pose a carcinogenic
hazard." Risk Assessment Guidelines at 33,994.
Risk assessments include several elements: description of the
potential adverse health effects based on an evaluation of
results of epidemiologic, clinical, toxicologic, and
environmental research; extrapolation from those results to
predict the type and estimate the extent of health effects in
humans under given conditions of exposure; judgments as to the
number and characteristics of persons exposed at various
intensities and durations; and summary judgments on the existence
and overall magnitude of the public-health problem. Risk
assessment also includes characterization of the uncertainties
inherent in the process of inferring risk.
NRC Redbook, at 18.
In researching effects on health, EPA must assess whether
pollutants are hazardous to health. Researching whether
pollutants are hazardous to health necessarily entails assessing
the risk such pollutants pose to health. Thus, researching
health effects is indistinguishable from assessing risk to
health. Congress' directives to research the effects of indoor
air pollution on human health and disseminate the findings
encompass risk assessment as defined by NRC and explained by
EPA's Risk Assessment Guidelines.
The NRC explains "description of the potential adverse health
effects" is a component of risk assessment. Id. The Radon
Research Act requires researching pollutants' effects on health
and disseminating the findings. The mandate of the Act requires
more of EPA than merely describing effects. Congress intended
EPA to disseminate findings, or conclusions, based upon the
information researched and gathered. Utilizing descriptions of
health effects to make findings is risk assessment.
The Radon Research Act contains two independent directives which
authorize EPA to classify indoor pollutants as carcinogenic.
First, Congress required EPA to Characterize sources of indoor
air pollution. Radon Research Act 403(b) (1). Since they emit
gasses and particulates, burning cigarettes are a source of
indoor air pollutants. By determining whether these emissions
cause cancer in people exposed to burning cigarettes, EPA is
characterizing a source of indoor air pollution. Second,
Congress required EPA to determine indoor pollutants' effects on
health. Id. 403(b) (2). In determining whether health is
affected by a pollutant, the researcher must identify whether a
causal relationship exists between the pollutant and
deteriorating health. Put simply, the researcher must determine
how, if at all, a pollutant affects health. Once a researcher
has identified how a pollutant harms human health, the risk is
most often identified.(FN6) This is especially true regarding
carcinogens. The Radon Research Act's general language
authorizing EPA to characterize sources of pollutants, research
effects on health, and disseminate the findings encompasses
classifying pollutants based on their effects.
The court is not persuaded by Plaintiffs' evidence showing risk
assessment incorporates judgmental positions and an agency's
regulatory mission. Researching how a pollutant affects health
entails conducting risk assessment. Judgment and inference do
not automatically remove risk assessment from what constitutes
researching health effects. To the contrary, judgment and
inference inhere in the "use of [a] factual base to define the
health effects of exposure of individuals or populations to
hazardous materials and situations." NRC Redbook, at 3, 18, 28.
"Risk assessment . . . includes characterization of the
uncertainties inherent in the process of inferring risk." Id. at
The uncertainties inherent in risk assessment can be grouped in
two general categories: missing or ambiguous information on a
particular substance and gaps in current scientific theory. When
scientific uncertainty is encountered in the risk assessment
process, inferential bridges are needed to allow the process to
continue. . . . The judgments made by the scientist/risk
assessor for each component of risk assessment often entail a
choice among several scientifically plausible options; the
Committee has designated these inference options.
Id. at 28. In conducting a scientific inquiry into whether a
pollutant affects human health, a researcher will have to choose
inference options. In fulfilling its obligation under the Radon
Research Act, EPA must adopt inference options in conducting
research, characterizing, and making findings. Inference options
that are scientifically plausible and fundamentally fair are part
of risk assessment. EPA may conduct risk assessments under the
Radon Research Act so long as the assessments do not impede the
Act's general requirements of gathering all relevant information,
researching, and disseminating the findings.
The court disagrees with Plaintiffs' argument that risk
assessment constitutes a regulatory activity and is thus
prohibited under the Radon Research Act. Both the NRC's Redbook
and EPA's Risk Assessment Guidelines identify regulatory activity
as being comprised of two elements: risk assessment and risk
management. Prohibition of certain conduct does not include
prohibition of lesser included activities.(FN7) Prohibiting
conduct entails a prohibition against conducting the lesser
included activities in concert to arrive at the proscribed
result. Risk assessment is a component of regulation. Congress'
prohibition of regulation is not a prohibition against the
components comprising regulation. In the Radon Research Act,
Congress intended EPA to research, collect, and disseminate
information and findings on indoor air pollutants' effect on
health without engaging in regulating. Risk assessments are
incidental to researching effects on health, characterizing
sources of pollutants, and making findings. So long as
collecting and researching information and disseminating the
resulting information are EPA's lodestar, Congress' prohibiting
regulation under the Radon Research Act does not preclude risk
assessment. The court will review the ETS Risk Assessment to
determine whether EPA conducted its research activities in
accordance with the Act.
Finally, Plaintiffs' evidence of EPA's reliance on other statutes
for assessing risks of other indoor air pollutants is not
persuasive. In these statutes, Congress granted EPA regulatory
power over certain pollutants. EPA has since promulgated
regulations pursuant to these statutes. It is unremarkable that
when asked its authority to conduct elements of its regulatory
process from which regulation occurred, EPA cited the statutes
granting full regulatory power.
B. EPA's Environmental Tobacco Smoke Activities Do Not
Constitute a Prohibited Regulatory Program Under the Radon
Plaintiffs have shown that EPA aggressively disseminated
information, coordinated activities with government agencies and
non-governmental organizations, and promoted ETS regulation and
prohibition.(FN9) Plaintiffs argue EPA's conduct constitutes de
facto regulatory activity in violation of the Radon Research Act.
EPA's activities did not amount to formal regulation,(FN10) for
it issued no regulations and made no attempt to directly manage
ETS risks. EPA's activities constituted de facto regulatory
activity but were achieved through means authorized by Congress.
congress prohibited any regulatory program or activity "other
than research, development, and related reporting, information
dissemination, and coordination activities . . . ." Radon
Research Act 404 (emphasis added). EPA may be using its
authority under the Act more aggressively and effectively than
Congress had foreseen, however, such activities are within the
law as written. Removal of EPA's authority to engage in de facto
regulatory activity under the Radon Research Act requires an act
of Congress, not the court's judgment.
C. The Toxic Substance Control Act's Prohibition With Respect to
Tobacco Does Not Apply to the Radon Research Act.
In the Toxic Substance Control Act (TSCA), congress authorized
EPA to regulate chemical substances presenting an unreasonable
risk of injury to health or the environment. 15 U.S.C. 2605.
TSCA does not authorize EPA to regulate tobacco products. Id.
2602(2) (B) (iii). Some in congress have attempted to repeal the
tobacco exemption for the purpose of providing EPA with authority
to regulate tobacco smoke under TSCA. See 136 Cong. Rec. E2223,
E2224 (daily ed. June 28, 1990) (statement of Rep. Luken). More
recently, a bill was introduced to amend TSCA "to protect the
public from health hazards caused by exposure to [ETS]." S. 1680,
103d Cong., 1st Sess., 139 Cong. Rec. S16222 (daily ed. Nov. 18,
1993). Both bills were introduced after the enactment of the
Radon Research Act, and neither passed. Plaintiffs argue the
specific language in TSCA, regarding tobacco, takes precedence
over the general conflicting language of the Radon Research Act.
The court does not find the conflict Plaintiffs' argument
presumes. In the TSCA, Congress directed EPA to prohibit, limit,
and regulate the manufacture, processing, or distribution of
hazardous chemical substances. Congress exempted tobacco from
TSCA's regulatory reach. The Radon Research Act contains no
regulatory authority. Compare TSCA 2605 (EPA's requirements in
regulating manufacturing, processing, and distribution of
hazardous chemical substances), with Radon Research Act 404 (no
regulatory authority except research, development, dissemination,
and coordination regarding indoor air pollutants).
To the extent the Radon Research Act authorizes de facto
regulatory activity, Congress simply excluded tobacco from the
definition of chemical substance as used in the TSCA chapter.
See TSCA 2602 (definitions "As used in this chapter").
Congress' defining "chemical substance" under the TSCA to exclude
tobacco does not mean Congress conclusively removed tobacco from
EPA's jurisdiction. It means Congress removed tobacco from the
authority granted to EPA under TSCA. Congress did not so limit
the definition of "indoor air pollutant" under the Radon Research
Act. See generally Coyne Beahm, Inc. V. FDA, 966 F. Supp. 1374,
1379-80 (M.D.N.C. 1997) (declining to infer preemption of FDA
authority to regulate tobacco products from other tobacco-specific legislation or Congress' failure to act). There being
no conflict between the statutes and finding Congress' TSCA
restriction by definition inapplicable to the Radon Research Act,
Plaintiffs' argument fails.
IV. EPA's PROCEDURAL REQUIREMENTS UNDER THE RADON RESEARCH ACT
Plaintiffs argue EPA failed to establish and consult the advisory
group mandated by the Radon Research Act, therefore, EPA's
conduct under the Act was unlawful and must be vacated. EPA
responds by arguing it satisfied its procedural requirements by
consulting the EPA science Advisory Board (SAB). EPA states it
formed an advisory group within SAB which included
representatives of all the statutorily identified constituencies.
EPA further argues that even if it did not satisfy the Radon
Research Act's procedural requirements: (1) the Act speaks in
general terms and committee formation was not a prerequisite to
research activity under the Act, and (2) Plaintiffs were not
prejudiced because EPA utilized public participation and peer
review procedures in developing the ETS Risk Assessment. In
reply, Plaintiffs analyze SAB and the members of the board which
reviewed the ETS Risk Assessment.
"[T]he SAB is an independent group of non-Federal government
scientists and engineers who are mandated through the
Environmental Research, Development and Demonstration Act of 1978
to provide advice to the EPA administrator on technical aspects
of issues confronting the Agency." EPA Memorandum from William
K. Reilly, Administrator, to Congressman Thomas J. Bliley, Jr.,
U.S. House of Representatives 1 (Oct. 11, 1990) (Reilly Mem.)
(JA 9,310). See also, 42 U.S.C. 4365 (statute authorizing
SAB). "The objective of the Board is to provide independent
advice . . . . The Board will review scientific issues, provide
independent scientific and technical advice on EPA's major
programs and perform special assignments . . . ." SAB Charter
3, reprinted in, EPA, U.S. Environmental Protection Agency
Advisory Committees 137 (July 1994) (JA 3,445). "[T]he Board
augments its standing committee membership with the inclusion of
subject-matter experts('consultants') to provide special insights
on particular issues. In identifying appropriate consultants,
the [SAB] . . . solicits names of candidates from a variety of
public and private sources, which generally include the Agency
and the affected parties." Reilly Mem. At 2 (JA 9,311). SAB
then attempts to select experts from "either side of the middle
of the spectrum of views in the technical community, with few, if
any coming from either end of the spectrum." Id. at 1 (JA
In 1986, congress passed the Radon Research Act which required
that EPA "establish . . . an advisory group comprised of
individuals representing the States, the scientific community,
industry, and public interest organizations to assist [EPA] in
carrying out the research program for . . . indoor air quality."
Radon Research Act 403(c). The Act also required EPA to submit
research plan to SAB. Id. 403(d). In response, "the SAB
established the Indoor Air Quality/Total Human Exposure Committee
(IAQC) as the forum in which the SAB would consider indoor air
issues." Reilly Mem. At 1 (JA 9,310).
An EPA Ethics Advisory sent to IAQC draws the distinction between
"representatives" on advisory committees and "Special Government
Employees." EPA Memorandum from Robert Flaak, Assistant Staff
Director, SAB, to IAQC at Enclosure G(FN11) (June 17, 1992) (JA
10,938-40) (Flaak Mem.). Representatives are those who "appear
in a representative capacity to speak for firms or an industry .
. . or for any other recognizable group . . . ," whereas "Special
Government Employees" do not. Id. (JA 10,940). Another
attachment, captioned "Procedures for Public Disclosures at SAB
Meetings," states the IAQC panel members were serving as Special
Government Employees, not as representatives: "SAB members and
consultants (M/Cs) carry our [sic] their duties as Special
Government Employees (SGE's) and are subject to the COI [conflict
of interest] regulations." Id. at Enclosure F (JA 10,936). See
18 U.S.C. 202-09 (restrictions on special government
B. Neither the Science Advisory Board Or Its Subcommittee Is the
Representative Advisory Group Congress Mandated In the Radon
The language used in the Radon Research Act, the nature of SAB,
and the composition of the IAQC which reviewed the ETS Risk
Assessment, demonstrate the EPA failed to comply with the
procedural requirements set forth by Congress. In 403(c) of
the Radon Research Act, Congress clearly requires EPA to
establish a representative advisory group to assist EPA in
carrying out research programs conducted under the Act. The
group is to be comprised of representatives from the states,
scientific community, industry, and public interest
organizations. In the following paragraph, 403(d), Congress
requires that EPA submit its research plan "to the EPA Science
Advisory Board . . .," which would then submit its comments to
Congress. "Where congress includes particular language in one
section of a statute but omits it in another section of the same
Act, it is generally presumed that Congress acts intentionally
and purposely in the disparate inclusion or exclusion." Brown v.
Gardner, 513 U.S. 115, 120, 115 S. Ct. 552, 556, 130 L. Ed. 2d
462 (1994) (citation omitted). The presumption is strengthened
where, as here, the disparate language is used within the same
section. Had Congress meant SAB when requiring a representative
advisory group, Congress would have specified SAB as it did in
the subsequent paragraph. Further, 403(c) calls upon EPA to
establish the advisory group. In 1977, Congress mandated
creation of SAB, and EPA complied. Congress' use of "establish
suggests that EPA should create a group. Congress would not
likely direct EPA to establish what already exists. A closer
examination of SAB verifies the court's statutory construction.
Congress directed EPA to establish and consult a representative
group to assist EPA in conducting research under the Radon
Research Act. To "represent" or be a "representative," one must
possess the ability to "speak or act with authority on behalf
of," or "act as [a] substitute or agent" for the person or
interest represented.(FN12) Black's Law Dictionary 1301 (6th ed.
1990). In contrast, EPA designed SAB to provide independent
advice. EPA designated SAB employees as special government
employees (SGE's), meaning the employees are temporarily
appointed, "as contrasted with members who are designated as
'representatives' . . . ." Flaak Mem. At Enclosure G (JA 10,938).
SGE's may not participate in matters that affect their employers'
financial interests.(FN13) Id. (JA 10,939). Congress' requiring
a collegium of representatives is incompatible with SAB's
independent and aspiringly neutral composition. Both the role
Congress assigned to each group and the composition of the group
that provide advice on the ETS Risk Assessment provides further
evidence of this incompatibility.
Congress set forth in 403(d) a role for the SAB that tracks the
SAB's traditional mission: providing independent scientific
review and comment on EPA's plan for implementing the research
program. In contrast, 403(c) charged the advisory group with
representing specified constituencies and providing assistance to
EPA in carrying out the research program. Those are two
different roles for two different groups.
The IAQC group that provided advice to EPA on the ETS Risk
Assessment was not the representative body required by 403(c).
See ETS Risk Assessment at xviii-xx. In the ETS Risk Assessment,
EPA lists nine members of IAQC who participated in the reviews of
two review drafts. Seven of the members are listed as university
professors or members of schools, one was listed as a scientist
in a national laboratory, and one was a state employee. Of the
nine consultants involved, seven were employed by universities,
and two by special interest groups. EPA claims that one of the
listed members, Dr. Woods, represented industry. However, this
is not possible since Dr. Woods left industry for employment with
a university almost a year before the first draft of the ETS Risk
Assessment was made available for review by IAQC. See JA 7,063-73 (Dr. Woods' curriculum vita). EPA further asserts that two
other individuals represented industry. The ETS Risk Assessment
IAQC listing does not contain the names of these individuals.
The individuals are not listed on the IAQC ETS reviews'
transcripts,(FN14) nor does EPA assert or direct the court's
attention to evidence that these individuals provided any
participation in the ETS Risk Assessment.
EPA points out that some panelists were associated with
organizations that had received some industry funding pursuant to
contract. That does not convert those individuals into industry
representatives under 403(c). EPA also urges that one of the
panelists was selected as a consultant on the recommendation of
the tobacco industry. Appropriately, EPA does not attempt to
argue that one becomes a member or representative of industry
upon a recommendation by industry.
EPA confirmed IAQC's independence from outside interests. When
he was preparing the panel for the second public meeting on the
draft ETS Risk Assessment, the SAB assistant director included in
his transmittal letter a reminder to panel members of their
conflict of interest and disclosure obligations:
An area of potential sensitivity in our public meetings is the
nature of your interactions with both the Agency and outside
interests on a particular matter. At the beginning of the
meeting, I will ask each person on the Committee to voluntarily
discuss any such areas they wish to identify. . . . Issues of
concern can include the extent to which you or your organization
have received (or will receive) professional or personal benefits
from any individuals, organizations or group . . . representing
any viewpoint concerning the issue(s) under consideration at this
meeting. Flaak Mem. At 3. At both IAQC public reviews, no one
admitted representing industry or any other 403(c)
constituency.(FN15) This result was in accordance with SAB's
designed purpose and the EPA ethics advisory sent to IAQC.
After reviewing the Radon Research Act, analyzing the SAB, and
reviewing the actual composition of the IAQC, the court has found
no evidence that the IAQC involved with the ETS Risk Assessment
satisfied 403(c) of the Radon Research Act. EPA's procedures,
guidelines, and conduct in the ETS Risk Assessment clearly
demonstrate the SAB and IAQC are independent bodies. EPA's
argument that IAQC was a representative body is without merit.
IAQC's membership did not include individuals from industry or
representatives from more than one state. No members were
invited to represent or admitted to representing any
constituency. Rather, EPA's regulations prohibited parties with
meaningful outside interests from participating. Accordingly,
EPA failed to comply with the requirements of 403(c).
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
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 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. 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
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 Congress."). When
Congress requires specific procedures, agencies may not ignore
them or fashion substitutes.(FN16)
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.
Zeigler Coal Co. v. Kleppe, 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
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,
the Court held "[a]dministrative 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 ad
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
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
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
violation.(FN17) 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 the 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 F2d 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
V. THE ENVIRONMENTAL TOBACCO SMOKE RISK ASSESSMENT
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.(FN18) The court
also reviews the record to determine whether EPA conducted the
Assessment in accordance with the Radon Research Act, aside from
procedural defects. Plaintiffs contest the validity of Chapters
3, 4, and 5 of the final ETS Risk Assessment. A brief overview
of the Assessment will elucidate the arguments.(FN19)
Chapter 1 summarizes the claims that ETS is a Group A carcinogen
that causes approximately 3,000 lung cancer deaths per year among
nonsmokers. Chapter 2 provides an introduction and overview.
EPA states the study was conducted in accordance with its Risk
Assessment Guidelines. The report explains EPA did not use its
Guidelines for Health and Risk Assessment of Chemical Mixtures
because mainstream smoke (MS)(FN20) and ETS are not sufficiently
similar. Specifically, using "cigarette-equivalents" to
correlate ETS exposure was not conducted for several reasons.
Although MS and ETS are qualitatively similar with respect to
chemical composition (i.e., they contain most, if not all, of the
same toxicants and carcinogens), the absolute and proportional
quantities of the components, as well as their physical state,
can differ substantially . . . . Furthermore, it is not known
which of the chemicals in tobacco smoke are responsible for its
carcinogenicity. Clearly, the comparison of a small number of
biomarker measures cannot adequately quantify differential
distributions of unknown carcinogenic compounds.
Another area of uncertainty in the "cigarette-equivalents"
approach relates to potential metabolic differences between
active and passive smokers. . . . Because of these
uncertainties, the data from active smoking are more appropriate
for qualitative hazard identification than for quantitative dose-response assessment. ETS Risk Assessment at 2-7 through 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
Chapter 3 establishes that ETS and MS are chemically similar
because: (a) ETS is composed of aged, diluted sidestream smoke
(SS),(FN21) 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
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
alone are sufficient to establish ETS as a Group A carcinogen
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
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.
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
asserts that ETS exposure causes approximately 3,000 nonsmoker
lung cancer deaths each year.(FN23)
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
smokers 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.
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
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
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 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
Is. 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
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
Plaintiffs next point to comments submitted by scientists(FN24)
and by the tobacco industry citing scientific literature(FN25)
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
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, dissimilar, and of
indeterminate similarity.(FN26) 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 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 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
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
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
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)
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-à-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 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 that 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 is 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 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 Plaintiff's 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 make 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
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 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 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
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 1983)." 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
developed by the NRC (1983) is usually preferred." Id. Neither
the Assessment or the administrative record explains why
physicochemical inquires 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 EP A 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 led to
a conclusion that ETS is not a Group A carcinogen.(FN28) It 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.(FN29) Nor did the
scientists on IAQC's final review panel identify the criteria
used to determine similarity.(FN30) EPA's citations reveal only
summaries of dings on MS-SS similarities and ETS
The record does not support EPA's arguments that EPA took MS-ETS
differences into account and, despite them, concluded ETS is a
known human carcinogen because nonsmokers are exposed to and
absorb carcinogens. EPA conceded that dilution, aging, and
exposure characteristics fundamentally distinguish ETS from
mainstream smoke, and "raise . . . questions about the
carcinogenic potential of ETS." ETS Risk Assessment at 2-7 thru
2-8, 4-29, 6-6. See also Draft Responses at 14-16 (JA 6,455-57).
The record does not explain how, after raising these questions,
EPA could classify ETS a known human carcinogen based on
similarities between SS and MS. The record also fails to explain
whether or how EPA determined that, because some components of
ETS may be absorbed, questions raised in other areas of the
assessment about the carcinogenic potential of ETS were no longer
Finally both sides cite two independent studies on ETS, done by
third parties, to support their arguments. Both sides often lay
claim to the same studies. The studies predominantly contain
information useful to both sides, and often conflict with one
another. The court finds one review particularly relevant, a
review conducted within EPA on the ETS Risk Assessment. EPA's
Risk Criteria Office, a group of EPA risk assessment experts,
concluded that EPA failed to reasonably explain how all relevant
data on ETS, evaluated according to EPA Risk Assessment
Guidelines' causality criteria, can support a Group A
classification. Acting Director Chris DeRosa advised EPA that
the evidence "support[ed] the conclusion that ETS be classified
as a Group B1 carcinogen."(FN32) EPA Toxicologist Larry Glass
concluded, "it is recommended that the [epidemiological] evidence
be summarized as being limited . . . . This would classify ETS
into a weight-of-the-evidence Group B1."(FN33) Office Director
Terry Harvey also concluded that the ETS Classification's
analysis violated EPA's Risk Assessment Guidelines: "[l]ike it
or not, EPA should live within its own categorization framework
or clearly explain why we chose not to do so."(FN34)
In summary, Plaintiffs raise legitimate questions not addressed
in the record regarding EPA's bioplausibility theory. If
confronted by a representative committee that voiced industry
concerns, EPA would likely have had to resolve these issues in
the record. It is not clear whether EPA could have or can do so.
These issues are more than periphery. If EPA's a priori
hypothesis fails, EPA has no justification for manipulating the
Agency's standard scientific methodology.
C. EPA's Choice of Epidemiological Studies
By the time EPA released the ETS Risk Assessment in 1993, 33
studies had analyzed the lung cancer risk of nonsmoking females
marred to smoking spouses, 12 studies had analyzed the risk of
females exposed to ETS in the workplace, and 13 studies had
analyzed the risk of females exposed to ETS in childhood. Six of
the 58 analyses (10.3%) reported a statistically significant
association between ETS exposure and lung cancer for nonsmoking
females; two of 13 analyses for male nonsmokers were significant.
EPA chose 31 of the 33 studies done on nonsmoking females married
to smoking spouses. Of the 33 studies completed in 1993, three
large U.S. studies were not completed at the time EPA conducted
its second IAQC review. EPA used interim results from one of the
three, the Fontham study, and did not include the other two in
its overall assessment. EP A did not draw its conclusions
directly from the 31 studies it chose. Instead, EPA pooled the
results of the studies and arranged the data into categories by
geographic region and exposure level. EPA then organized and
analyzed the studies by the quality of their methodology. This
technique of synthesizing findings across related studies is
known as meta-analysis.
The Risk Assessment gives short notice to why the childhood or
workplace studies were no evaluated. The assessment states,
[t]he use of a more homogenous group allows more confidence in
the results of combined study analyses. . . . Some [studies]
also provide information on childhood and/or workplace exposure,
but there is far less information on these exposure; therefore,
in order to develop one large database for analysis, only the
female exposures from spousal smoking are considered.
ETS Risk Assessment at 5-1. The Assessment's overview explains
only that childhood and workplace studies are fewer, represent
fewer cases, and are generally excluded from APA's analysis. Id.
at 1-8. The Addendum mentions the two large U.S. female
nonsmoker studies but does not explain why the two were excluded
but the Fontham study included.
In its first review, IAQC stated that one of four criteria
necessary to conduct a meta-analysis is a "precise definition of
criteria used to include (or exclude) studies." EPA, An SAB
Report: Review of Draft Environmental Tobacco Smoke Health
Effects Document, EPA/SAB/IAQC/91/007 at 32-33 (1991) (SAB 1991
Review) (JA 9,497-98). Regarding the studies chosen for the ETS
Risk Assessment, IAQC stated,
[s]pecific criteria for including studies was not provided. The
importance of this was reinforced at the Committee meeting when a
reanalysis was presented on a different set of studies than those
in the report. This resulted in a change in the overall risk
estimate. Decisions as to study inclusion should be made prior
to analysis, based on clearly stated criteria. It is also
desirable to evaluate the impact on conclusions of closely
related, but excluded, studies.
Id. at 33 (first emphasis added) (JA 9,498). In its 1992
review, neither EPA or IAQC addressed again the criteria used to
determine which studies were included in the meta-analysis. IAQC
stated that the combination of studies used provided a
scientifically defensible basis for estimating the relative risk
of lung cancer associated with ETS among American women who have
never smoked cigarettes. IAQC also supported EPA's general meta-analysis categorization of the studies which EPA had chosen. See
EPA, An SAB Report: Review of Draft Passive Smoking Health
Effects Document, EPA/SAB/IAQC/93/003 at 3-4, 22 (1992) (IAQC
review which EPA now misrepresents as a full explanation of EPA's
database choice with express IAQC support) (JA 12,207-08,
Plaintiffs contest that EPA excluded studies and data on
workplace and childhood exposure to ETS, as well as the "two
largest and most recent" U.S. spousal smoking studies, because
inclusion would have undermined EPA's claim of a causal
association between ETS exposure and lung cancer.(FN35)
(Conformed Mem. Supp. Pls.' Mot. Summ. J. at 66.) In its
memorandum before this court, EPA offers four reasons for
excluding the workplace and childhood data.
"First, such data are less extensive and therefore less
reliable." (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J.
at 88.) EPA's three citations to the record to not support this
assertion. All three citations state there is less information
in the disputed studies. One of Dr. Brown's draft responses also
calls the disputed studies inadequate, without reason or
explanation. IAQC also recognized the disputed studies contained
less information, however, IAQC concluded "the report should
review and comment on the data that do exist . . . ." SAB 1991
Review at 5 (JA 9,470). The court has also found no record
support or reason for the assertion that smaller studies are less
reliable for purposes of meta-analysis. The purpose of meta-analysis is utilization of smaller studies.
Similarly, EPA's second assertion that workplace studies were
excluded because of potential confounders is without record
support. As evidence explaining why EPA excluded workplace
studies from the meta-analysis, EPA cites IAQC's 1991 Review
discussing limitation on EPA's reliance on spousal smoking as an
indicator of ETS exposure. IAQC discussed that the structure of
peoples' homes, where they live and work, the climate, and even
parental influences impact spousal assessments. SAB 1991 Review
at 30. The report cited by EPA does not state workplace data
should be disregarded. If at all relevant, the discussion now
cited by EPA supports the opposite conclusion.
EPA also claims that workplace exposure data were disregarded
because only two studies made an attempt to classify by amount of
exposure. Again, EPA's explanation appears nowhere in that
portion of the Risk Assessment cited by the Agency. Further,
EPA's explanation appears targeted only at workplace data
contained within the spousal smoking studies and does not address
the Agency's decision to disregard workplace and childhood
exposure data reported outside spousal studies.
EPA's final proffer is that childhood studies rely upon distant
memories and more limited lifetimes exposure. Again, the record
does not reveal that EPA used this as a selection criteria.
Rather, and assessment on ETS and lung cancer on which EPA now
relies states, "No consistent association has been reported for
lung cancer and exposure to ETS in childhood, which might be
expected to exert a greater effect . . . . Of course, recall of
ETS exposure in childhood is more difficult than recall of such
exposure in adulthood." E.L. Wynder & G. C. Kabat, Environmental
Tobacco Smoke and Lung Cancer: A Critical Assessment, ORD.C.1
S59-1 (JA 5,020). Nowhere in the Assessment is there a
suggestion that childhood exposure data should be ignored.
EPA claims it excluded the latest two U.S. spousal smoking
studies because they were submitted after the close of the
comment period, and EPA already had a considerable database. EPA
claims the Fontham study was used because it published interim
results, was the largest U.S. ETS study, and its methodology was
superior to any other study. The record contains discussion of
the Fontham study, even testimony by Dr. Fontham. However, the
evidence is not relevant to Plaintiffs' assertion. There being
no indication of study criteria, it is no possible to determine
whether o why the Fontham study was "superior." Even if EPA
provided criteria, comparison would not be possible since EPA
provides no discussion on the two U.S. spousal studies excluded.
In summary, EPA's claim of having clearly established criteria is
without merit. See Bowen v. Georgetown University Hosp., 488
U.S. 204, 212, 109 S. Ct. 468, 474, 102 L. Ed. 2d 493 (1988)
("The courts may not accept appellate counsel's post hoc
rationalizations for agency [orders]."); American Trucking Ass'n
v. Federal Highway Admin., 51 F.3d 405, 411 (4th Cir. 1995) (If
agency action is to withstand judicial review, the agency's
"actual reasoning . . . must prove reasonable, not the post hoc
rationalization devised during litigation.").
EPA's study selection is disturbing. First, there is evidence in
the record supporting the accusation that EPA "cherry picked" its
data. Without criteria for pooling studies into a meta-analysis,
the court cannot determine whether the exclusion of studies
likely to disprove EPA's a priori hypothesis was coincidence or
intentional. Second, EPA's excluding nearly half of the
available studies directly conflicts with EPA's purported purpose
for analyzing the epidemiological studies and conflicts with
EPA's Risk Assessment Guidelines. See ETS Risk Assessment at 4-29 ("These data should also be examined in the interest of
weighing all the available evidence, as recommended by EPA's
carcinogen risk assessment guidelines (U.S. EPA, 1986a) . . . ."
(emphasis added)). Third, EPA's selective use of data conflicts
with the Radon Research Act. The Act states EPA's program shall
"gather data and information on all aspects of indoor air quality
. . . ." Radon Research Act 403(a) (1) (emphasis added). In
conducting a risk assessment under the Act, EPA deliberately
refused to assess information on all aspects of indoor air
At the outset, the court concluded risk assessments were
incidental to collecting information and making findings. EPA
steps outside the court's analysis when information collection
becomes incidental to conducting a risk assessment. In making a
study choice, consultation with an advisory committee voicing
these concerns would have resulted, at a minimum, in a record
that explained EPA's selective use of available information.
From such record, a reviewing court could then determine whether
EPA "cherry picked" its data, and whether EPA exceeded its
D. EPA's Epidemiologic Methodology
Plaintiffs raise a list of objections asserting that EPA deviated
from accepted scientific procedure and its own Risk Assessment
Guidelines in a manner designed to ensure a preordained outcome.
Given the ETS Risk Assessment shortcomings already discussed, it
is neither necessary or desirable to delve further into EPA's
epidemiological web. However, two of Plaintiffs' arguments
require mention.(FN36) The first contention is EPA switched,
without explanation, from using standard 95% confidence intervals
to 90% confidence intervals to enhance the likelihood that its
meta-analysis would appear statistically significant. This shift
assisted EPA in obtaining statistically significant results.
Studies that are not statistically significant are "null
studies"; they cannot support a Group A classification. See
Brock v. Merrell Dow Pharm., Inc., 874 F.2d 307, 312 (5th Cir.
1989) ("If the confidence interval is so great that it includes
the number 1.0, then the study will be said to show no
statistically significant association between the factor and the
EPA used a 95% confidence interval in the 1990 Draft ETS Risk
Assessment, but later switched to a 90% confidence interval.
Most prominently, this drew criticism from IAQC's epidemiologist,
who was also a contributor to the ETS Risk Assessment:
The use of 90% confidence intervals, instead of the
conventionally used 95% confidence intervals, is to be
discouraged. It looks like a[n] attempt to achieve statistical
significance for a result which otherwise would not achieve
Geoffrey Kabat, Comments on EPA's Draft Report: "Respiratory
Health Effects of Passive Smoking: Lung Cancer and Other
Disorders", II.SAB.9.15 at 6 (July 28, 1992) (JA 12,185).
Plaintiffs argue that established epidemiologic practice is to
use 95% confidence intervals. As evidence, Plaintiffs point out
EPA's prior risk assessments, including the 1990 ETS draft,
consistently used 95% confidence intervals, as did previous ETS
analyses by IARC, NRC, and the Surgeon General.
ETS Risk Assessment Chapter 5 states:
throughout this chapter, one-tailed tests of significance
(p=0.05) are used, which increases the statistical ability
(power) to detect an effect. The 90% confidence intervals used
for the analyses performed are consistent with the use of the
one-tailed test. The justification for this usage is based on
the a priori hypothesis . . . that a positive association exists
between exposure to ETS and lung cancer.
ETS Risk Assessment at 5-2. Before this court, EPA explains the
"use of the 95 percent confidence interval with the one-tailed
test . . . would have produced an apparent discrepancy: study
results that were statistically significant using the standard p-value of .05 might nevertheless have a 95 percent confidence
interval that included a relative risk of 1." (Conformed Mem.
Supp. EPA's Cross Mot. Part. Summ. J. at 96.)
Plaintiffs' second methodological argument requiring comment
states, EPA based ETS' Group A classification in large part on a
resulting relative risk of on 1.19, without adequately explaining
why the Agency had required every other Group A carcinogen to
exhibit a much higher relative risk, or why it had recently found
relative risks of 2.6 and 3.0 insufficient to classify other
agents in Group A. All of the 15 chemicals or mixtures
previously classified by EPA as Group A carcinogens have higher
relative risks than ETS. See, e.g., ETS Risk Assessment at 4-15,
16 & 22 (Risk assessments on cigarette smoking demonstrate
relative risks between 7 and 14.9 for lung cancer, and relative
risks between 26 and 60 for undifferentiated carcinoma.); see
also EPA Review Draft, Evaluation of the Potential
Carcinogenicity of electromagnetic Fields, EPA/600/6-901/005B at
6-2 (October 1990) (JA 1,562) (declining classifying EMF as
carcinogenic for lack of strong association with cancer where
relative risks in studies seldom exceeded 3.0). IAQC
epidemiologist Dr. Kabat observed, "An association is generally
considered weak if the odds ratio [relative risk] is under 3.0
and particularly when it is under 2.0, as is the case in the
relationship of ETS and lung cancer." E.L. Wynder & G.C. Kabat,
Environmental Tobacco Smoke and Lung Cancer: A Critical
Assessment, I.SAB.7.1 at 6 (JA 7,216).
EPA responds that the most impressive evidence from the
epidemiologic studies is the consistent results of many studies
showing increased risk, and the dose-response relationships
showing the most risk to the most exposed nonsmokers. EPA
explains that ETS' diluted concentration in the atmosphere
accounts for the low strength of association.
The record and EPA's explanations to the court make it clear that
using standard methodology, EPA could not produce statistically
significant results with its selected studies. Analysis
conducted with a .05 significance level and 95% confidence level
included relative risks of 1. Accordingly, these results did not
confirm EPA's controversial a priori hypothesis. In order to
confirm its hypothesis, EPA maintained its standard significant
level but lowered the confidence interval to 90%. This allowed
EPA to confirm its hypothesis by finding a relative risk of 1.19,
albeit a very weak association.
EPA's conduct raises several concerns besides whether a relative
risk of 1.19 is credible evidence supporting a Group A
classification. First, with such a weak showing, if even a
fraction of Plaintiffs' allegations regarding study selection or
methodology is true, EPA cannot show a statistically significant
association between ETS and lung cancer.
Second, the court's conclusions regarding EPA's motive for
reducing the confidence level are based upon EPA's litigation
explanations and circumstantial evidence from the record. EPA
does not provide explanation in the ETS Risk Assessment or
administrative record. When an agency changes its methodology
mid-stream, as EPA did here, it has an obligation to explain why.
See Western States Petroleum Ass'n v. EPA, 87 F.3d 280, 284 (9th
Cir. 1996) ("EPA may not depart, sub silento, from its usual
rules of decision to reach a different, unexplained result in a
single case.'"); Natural Resources Defense Council, Inc. v. EPA,
859 F.2d 156, 205-11 (D.C. Cir. 1988) (invalidating an EPA rule
because EPA failed to explain its mid-proceeding switch on the
utility of an upset defense); see also Motor Vehicle mfrs. Ass'n
of U.S., Inc. v. EPA, 768 F.2d 385, 399 (D.C. Cir. 1985) (EPA
failed to explain why it departed from "established specific
statistical criteria for determining whether a fuel will cause a
vehicle to exceed emission standards . . . .").
Finally, when an agency conducts activities under an act
authorizing information collection and dissemination of findings,
the agency has a duty to disseminate the findings made. EPA did
not disclose in the record or in the Assessment: its inability
to demonstrate a statistically significant relationship under
normal methodology; the reasoning behind adopting a one-tailed
test, or that only after adjusting the Agency's methodology could
a weak relative risk be demonstrated. Instead of disclosing
information, the Agency withheld significant portions of its
findings and reasoning in striving to confirm its a priori
E. Summary of the Assessment and Record
In reviewing the parties' arguments, the court has given the
benefit of many doubts to EPA by allowing the Agency to adopt
third party statements, such as IAQC reviews, as Agency
reasoning. EPA, the decision make, not IAQC, the independent
advisor, has the duty to demonstrate reasoned decision making on
the record. See SEC v. Chenery Corp., 332 U.S. 194, 196, 67 S.
Ct. 1575, 1577, 91 L. Ed. 1995 (1947) ("[A] reviewing court, in
dealing with a determination or judgment which an administrative
agency alone is authorized to make, must judge the propriety of
such action solely by the grounds invoked by the agency."); Motor
Vehicle Mfr. Ass'n of the United States v. State Farm Mut. Auto.
Ins. Co., 463 U.S. 29, 50, 103 S. Ct. 2856, 2870, 77 L. Ed. 2d
443 (1993) ([A]n "agency's action must be upheld, if at all, on
the basis articulated by the agency itself."); see also H.R. Rep.
No. 95-722, 95th Cong., 1st Sess., 16 (1977), reprinted in 1977
U.S.C.C.A.N. 3283, 3295 (JA 652-53) (The SAB "is intended to be
advisory only. The Administrator will still have the
responsibility for making the decisions required of him by
law."). If EPA's appendages speak on behalf of the
Administrator, the opposing conclusions reached between IAQC and
the EPA Risk Criteria Office would demonstrate schizophrenia.
Even allowing EPA the benefit of now adopting IAQC reasoning, the
record does not provide answers to Plaintiffs' questions.
EPA determined it was biologically plausible that ETS causes lung
cancer. In doing so, EPA recognized problems with its theory,
namely the dissimilarities between MS and ETS. In other areas of
the Assessment, EPA relied on these dissimilarities in justifying
its methodology. EPA did not explain much of the criteria and
assertions upon which EPA's theory relies. EPA claimed selected
epidemiologic studies would affirm its plausibility theory. The
studies EPA selected did not include a significant number of
studies and data which demonstrated no association between ETS
and cancer. EPA did not explain its criteria for study
selection, thus leaving itself open to allegations of "cherry
Using its normal methodology and its selected studies, EPA did
not demonstrate a statistically significant association between
ETS and lung cancer. This should have caused EPA to reevaluate
the inference options used in establishing its plausibility
theory. A risk assessment is supposed to entail the best
judgment possible based upon the available evidence. See Ethyl,
541 F.2d at 24. Instead, EPA changed its methodology to find a
statistically significant association. EPA claimed, but did not
explain how, its theory justified changing the Agency's
methodology. With the changed methodology and selected studies,
EPA established evidence of a weak statistically significant
association between ETS and lung cancer.
VI. MOTION TO SUPPLEMENT THE PLEADINGS
Plaintiffs have moved to supplement the pleadings pursuant to
Fed. R. Civ. P. 15(d). Plaintiffs' Supplemental Pleading seeks
declaratory and injunctive relief against EPA relating to the
Agency's alleged unlawful efforts to regulate indoor air, tobacco
products, and smoking, as documented in August 1996 by EPA's
The Supplemental Pleading contains two counts. Supplemental
Count I alleges EPA illegally funds and controls a private entity
that drafts indoor air ventilation standards that are adopted in
state and local building codes. Count I also alleges additional
ultra vires regulatory activities by EPA in regard to indoor air
and smoking through the Agency's regional offices and third
parties. Supplemental Count II seeks relief from these alleged
activities pursuant to the Administrative Procedure Act's bar on
agency actions "in excess of statutory jurisdiction, authority,
or limitations, or short of statutory right." 5 U.S.C.
706(2)(C). Plaintiffs' proposed supplemental pleading does not
affect briefing or the court's consideration of summary judgment
on Counts I, II, and III. EPA responds that the proposed
supplemental pleading is untimely and unrelated to the Complaint
and will delay the conclusion of the case.
Fed. R. Civ. P. 15(d) allows a party with leave of court to file
a supplemental pleading "setting forth transactions or
occurrences or events which have happened since the date of the
pleadings sought to be supplemented." Courts apply the rule
liberally to allow new claims and allegations to be added to a
suit. See, e.g., Ouaratino V. Tiffany & Co., 71 F.3d 58, 66 (2d
Cir. 1995); Gillihan v. Shillinger, 872 F.2d 935, 941 (10th Cir.
1989); Keith v. Volpe, 858 F.2d 467, 474 (9th Cir. 1988). In
reversing a district court's decision that refused leave to file
a supplemental pleading, the Fourth Circuit found that
supplemental pleadings so enhanced the efficient administration
of justice that they should be allowed as a matter of course:
[Supplemental pleadings are] a useful device, enabling a court to
award complete relief, or more nearly complete relief, in one
action, and to avoid the cost, delay and waste of separate
actions which must be separately tried and prosecuted. So useful
they are and of such service in the efficient administration of
justice that they ought to be allowed as of course, unless some
particular reason for disallowing them appears, though the court
has the unquestioned right to impose terms upon their allowance
when fairness appears to require them.
New Amsterdam Casualty Co. v. Waller, 323 F.2d 20, 28-29 (4th
Cir. 1963). "While some relationship must exist between the
newly alleged matters and the subject of the original action,
they need not all arise out of the same transaction." Keith, 858
F.2d at 474. A supplemental pleading may state a new cause of
action so long as the matters have some relation to the claim set
forth in the original pleading. Rowe v. United States Fidelity
and Guaranty Co., 421 F.2d 937, 943 (4th Cir. 1970). A court may
in its discretion deny leave to file a supplemental pleading
where it finds undue delay, bad faith, dilatory tactics, undue
prejudice to the opposing party, or futility. Ouarantino, 71
F.3d at 66.
EPA first asserts Plaintiffs' proposed supplementation is
untimely because the events relevant to the new allegations
occurred prior to Plaintiffs' agreeing to the joint motion to
establish a briefing schedule for summary judgment. The new
allegations do not, however, affect the disposition or scheduling
of the court's summary judgment analysis or decision. Further,
the court notes EPA's Inspector General's report was not
announced or otherwise disseminated by EPA. Approximately seven
months after the report was issued, Plaintiffs sought permission
to file the Supplemental Pleading. Seven months is not an
unreasonable amount of time for multiple plaintiffs to learn of
EPA's alleged activities, investigate, develop, and agree upon a
complex legal claim.
EPA next argues Plaintiffs' new allegations are not sufficiently
related to the Complaint. EPA states the Complaint challenges
EPA's ETS Risk Assessment, whereas the proposed Supplemental
Pleading challenges EPA's involvement with a private entity.
There are several reasons why the Complaint and proposed
Supplemental Pleading are sufficiently related. First, both
involve EPA's authority under the Radon Research Act.
Specifically, both the Complaint and Supplemental Pleading
involve EPA's authority to conduct regulatory activities under
the Act. In deciding the parties' motions for summary judgment,
the court has become familiar with the outer limits of EPA's
authority under the Radon Research Act. Second, ETS is the
object of EPA's alleged regulatory attention in each set of
allegations. As a result, EPA's conduct as alleged in the
Supplemental Pleading causes the very harm for which Plaintiffs
seek a remedy in the Complaint. Third, the court finds probable
that EPA premises its involvement with private organizations, as
alleged in the Supplemental Pleading, on the Agency's conclusions
in the ETS Risk Assessment. Fourth, the court, in resolving this
case, has become familiar with many organizations EPA has worked
with in conducting the ETS Risk Assessment and in establishing de
facto regulatory activities under the Radon Research Act.
Clearly, the Supplemental Pleading has some relation to the
The impact supplementing the pleadings would have in concluding
the case concerns the court. EPA has spent years formulating and
litigating the ETS Risk Assessment. Since EPA has been
aggressively coordinating with and assisting regulatory programs
based upon its ETS Risk Assessment, the court believes EPA
desires a final resolution to Plaintiffs' original claims. EPA
indicates such, stating "EPA wishes to conclude this case
challenging its ETS Risk Assessment." (Defs.' Resp. Pls." Mot.
Supplemental Pleading at 5.) Supplementing the pleadings with
new causes of action would significantly delay final judgment
being entered in this case. As a general rule, such delay would
prevent the parties from exercising their rights to appeal.
For nearly five years, the parties have disputed the validity of
EPA's ETS Risk Assessment. Based upon the Assessment's
conclusions, EPA is involved with other government and private
entities. Resolving Plaintiff's new allegations may entail
pretrial motions and discovery, possibly prolonging the case for
years. There is no just reason for so delaying final judgment
regarding EPA's ETS Risk Assessment. However, Plaintiffs' new
allegations are significantly related to the Complaint.
Precedent as well as principles of judicial economy and justice
urge the court to allow Plaintiffs' motion. To cure this
dilemma, the court will allow Plaintiffs to serve their
supplemental pleading and will sua sponte make an express
direction for the entry of judgment regarding the parties'
motions for summary judgment. Accordingly, the court's judgment
will be certified for review pursuant to Fed. R. Civ. P. 54(b).
Though the court creates the possibility of the parties'
appealing separately under the Complaint and Supplemental
Pleading, there is little risk an appellate court would be faced
with redundant issues. Plaintiffs' Supplemental Pleading,
although related to the issues raised in the Complaint, is
factually and legally independent from the issues raised in the
Complaint. EPA will have 20 days after service of the
Supplemental Pleading to respond.
In 1988, EPA initiated rafting policy-based recommendations about
controlling ETS exposure because EPA believed ETS is a Group A
carcinogen. See, e.g., EPA Memorandum from William K. Reilly,
Administrator, to Congressman Thomas J. Bliley, Jr., U.S. House
of Representatives 1 (March 24, 1992) (JA 6,374; 6,380-82)
(Reilly Mem. II) (EPA began drafting a policy guide recommending
workplace smoking bans before drafting the ETS Risk Assessment.)
Rather than reach a conclusion after collecting information,
researching, and making findings, EPA categorized ETS as a "known
cause of cancer" in 1989. EPA, Indoor Air Facts No. 5
Environmental Tobacco Smoke, ANR-445 (June 1989) (JA 9,409-11).
EPA's Administrator admitted that EPA "managed to confuse and
anger all parties to the smoking ETS debate . . . ." EPA
Memorandum from William K. Reilly, Administrator, to Secretary
Louis W. Sullivan 2 (July 1991) (JA 6,754). The Administrator
also conceded, "[B]eginning the development of an Agency risk
assessment after the commencement of work on the draft policy
guide gave the appearance of . . . policy leading science . . .
." Reilly Mem. II at 1 (JA 6,391).
In conducting the Assessment, EPA deemed it biologically
plausible that ETS was a carcinogen. EPA's theory was premised
on the similarities between MS, SS, and ETS. In other chapters,
the Agency used MS and ETS dissimilarities to justify
methodology. Recognizing problems, EPA attempted to confirm the
theory with epidemiologic studies. After choosing a potion of
the studies, EPA did not find a statistically significant
association. EPA then claimed the bioplausibility theory,
renominated the a priori hypothesis, justified a more lenient
methodology. With a new methodology, EPA demonstrated from the
selected studies a very low relative risk for lung cancer based
on ETS exposure. Based on its original theory and the weak
evidence of association, EPA concluded the evidence showed a
causal relationship between cancer and ETS. The administrative
record contains glaring deficiencies.
The Radon Research Act authorizes information collection,
research, industry inclusion, and dissemination of findings.
Whether these actions authorize risk assessments is a matter of
general and interstitial statutory construction. So long as
information collection on all relevant aspects of indoor air
quality, research, and dissemination are the lodestars, the
general language of the Radon Research Act authorizes risk
assessments as they are defined by NRC and explained in EPA's
Risk Assessment Guidelines.
It is clear that congress intended EPA to disseminate findings
from the information researched and gathered. In this case, EPA
publicly committed to a conclusion before research had begun;
excluded industry by violating the Act's procedural requirements;
adjusted established procedure and scientific norms to validate
the Agency's public conclusion, and aggressively utilized the
Act's authority to disseminate findings to establish a de facto
regulatory scheme intended to restrict Plaintiffs' products and
to influence public opinion.(FN38) In conducting the ETS Risk
Assessment, EPA disregarded information and made findings on
selective information; did not disseminate significant
epidemiologic information; deviated from its Risk Assessment
Guidelines; failed to disclose important findings and reasoning;
and left significant questions without answers. EPA's conduct
left substantial holes in the administrative records. While so
doing, EPA produced limited evidence, then claimed the weight of
the Agency's research evidence demonstrated ETS causes cancer.
Gathering all relevant information, researching, and
disseminating findings were subordinate to EPA's demonstrating
ETS a Group carcinogen. EPA's conduct transgressed the general
meaning of the Radon Research Act's operative language. Further,
to the extent EPA's conduct in this matter entailed interstitial
construction of the Act, the court affords no deference to EPA.
Congress did not delegate rule making or regulatory authority to
EPA under the Act. EPA's conduct of the ETS Risk Assessment
frustrated the clear Congressional policy underlying the Radon
Research Act. See 131 Cong. Rec. S7035 (May 23, 1985) (purpose
of the Act is to provide clear, objective information about
indoor air quality).
EPA also failed the Act's procedural requirements. In the Radon
Research Act, Congress granted EPA limited research authority
along with an obligation to seek advice from a representative
committee during such research. Congress intended industry
representatives to be at the table and their voices heard during
the research process. EPA's authority under the act is
contingent upon the Agency hearing and responding to the
represented constituents' concerns. The record evidence is
overwhelming that IAQC was not the representative body required
under the Act. Had EPA reconciled industry objections voiced
from a representative body during the research process, the ETS
Risk Assessment would very possibly not have been conducted in
the same manner nor reached the same conclusions.
Because EPA exceeded its authority under the Radon Research Act
and also failed the Act's procedural requirements, the court will
direct the entry of judgment in favor of Plaintiffs' motion for
summary judgment and vacate Chapters 1 thru 6 of and the
Appendices to EPA's Respiratory Health Effects of Passive
Smoking: Lung Cancer and Other Disorders, EPA/600/6-90/006F
(December 1992). To ripen its judgment for purposes of appellate
review pursuant to Fed. R. Civ. P. 54(b), the court will make an
express determination that there is no just reason for delay.
Accordingly, the court need not address Plaintiffs' remaining
arguments, Counts II, III, and IV of the Complaint. The court
will also grant Plaintiffs' Motion to Supplement the Pleading.
An order and judgment in accordance with this memorandum opinion
will be filed contemporaneously herewith.
This the 17th day July 1998.
United States District Judge FOOTNOTES
(1) Plaintiffs also allege that EPA's issuance of the ETS Risk Assessment violated
Plaintiffs' due process rights. The court has stayed consideration of the due process
claims pending resolution of the APA claims. See Flue-Cured Tobacco Cooperative
Stabilization Corp. v. EPA, 857 F. Supp. 1137 (M.D.N.C. 1994).
(2) As this case involves review of administrative agency action, the court will not
conduct de novo review but must review discussion on the scope of review, see Flue-Cured Tobacco Cooperative Stabilization
Corp. v. EPA, No. 6:93CV00370 at 16-20
(M.D.N.C. May 23, 1995) (Memorandum Opinion discussing summary judgment on
scope of review).
(3) See Assessing the Effects of Environmental Tobacco Smoke: Hearing on S. 262 and
S. 1680 Before the Subcomm. On Clean Air and Nuclear Reg. Of the Sen. Comm. On
Env't and Public Works, 103d Cong. 177, 204-05 (1994) (Browner Hearing Responses).
(4) See Browner Hearing Responses at 190-92.
(5) Plaintiffs also provide evidence that EPA did not include the ETS project when
providing Congress with a listing of Agency research activity.
(6) For example, if research determines a pollutant harms human health by causing
malignant tumors, it is ipso facto a carcinogen. See Ted. Al. Loomis & A. Wallace
Hayes, Essentials of Toxicology 2323-36 (4th ed. 1996) (tests for carcinogenicity). If
research determines the pollutant causes blockage of neurotransmissions, it is ipso facto a
neurotoxin. See David R. Franz, et al., Clinical Recognition and Management of Patients
Exposed to Biological Warfare Agents, 278 JAMA 399 (1997) (discussing botulinum
(7) Standing upright is a component of running. A prohibition on running is not also a
prohibition on standing.
(8) Even if it were persuasive evidence that EPA interpreted the Radon Research Act to
exclude risk assessment, the court makes its determination based upon the language
Congress used, not agency interpretation.
(9) See, E.G., Summary of EPA Draft Conclusions and SAB Review, Steven Bayard,
EPA ETS Project Manager, ORD Q.9 at 1 (April 4, 1991) (Joint Appendix (JA) 6,700)
("EPA has no regulatory authority on ETS, but is coordinating with OSHA which does
have regulatory authority in the workplace."); EPA Memorandum from William G.
Rosenberg, Assistant Administrator for Air and Radiation, to Erich W. Bretthauer,
Assistant Administrator for Research and Development at 1 (Oct. 7, 1991) (JA 6,696-97)
(Urging expedition of ETS study; local, state and federal agency projects awaiting its
issuance); EPA Memorandum from William G. Rosenberg, Assistant Administrator for
Air and Radiation, to Donald G. Barnes, Director, Science Advisory Board (June 28,
1991), and attached ETS Technical Compendium, Draft (May 1991) at 2 (JA 6,755-56,
6,758) (intended to help state legislators ban smoking in workplaces, restaurants, and
(10) Plaintiffs also seek leave to supplement the pleadings, claiming EPA is
promulgating indoor air regulations by funding and controlling a private entity that drafts
indoor air ventilation standards that are adopted in state and local building codes. The
court does not consider these allegations in ruling on the parties' summary judgment
(11) Enclosure G: EPA Memorandum from Gerald Yamada, Principal Deputy General
Counsel, Designated Agency Ethics Official, to Deputy Ethics Officials (April 24, 1992).
(12) The legislative history supports this common sense interpretation of "represent."
Senator Lautenberg, one of the sponsors of the bill that became the Radon Research Act,
said the Advisory Committee was to be "a blue ribbon advisory committee, composed of
members" of the specified constituencies. 131 Cong. Rec. S11684 (daily ed. Sept. 18,
1985) (JA 657).
(13) EPA may waive conflicts where the interest affected is insubstantial or the need for
the SGE's service outweighs the conflict.
(14) See U.S. EPA SAB IAQC ETS Review, I.SAB.16.1 & .2 (December 4 & 5, 1990)
(transcript volumes I & II) (199) IAQC Transcript) (JA 8,793 9,213); U.S. EPA SAB
IAQC ETS Review Panel, II.SAB.8.1 & .2 (July 21 & 22, 1992) (transcript volumes I &
II) (1992 IAQC Transcript) (JA 11,641-12,105).
(15) See 1990 IAQC Transcript at 11-38 (JA 8,803-30); 1992 IAQC Transcript at 16-29
(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, the industry's ability
to submit comments to a "neutral" committee, which itself had access to EPA, is not
equivalent to industry access to EPA.
(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.
(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.
(20) Mainstream smoke is the smoke inhaled by the smoker.
(21) Sidestream smoke is the smoke emitted from a smoldering cigarette between puffs.
(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.
(23) Chapters 7 and 8 do not involve the carcinogenicity of ETS.
(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).
(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
(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 substantially 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.
EPA, An SAB Report: Review of Draft Passive Smoking Health Effects Document,
EPA/SAB/IAQC/93/003, at 11, November 20, 1992.
(28) [S]ome persons suggest a dosimetric approach (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 of the action, "[t]here is an
overwhelming institutional bias in favor of justifying the result in any way possible.")
(30) The data in Chapter 3 "do not . . . adequately support the conclusion that the two are
chemically similar. . . . [T]he data that are in there, speaking as a chemist, they simply
don't make the case." 1992 IAQC Review at II-41 (Dr. Daisey) (JA 11,969). "That also
brings you to an issue of what you mean by 'chemically similar,' which is not so simple to
discuss. . . . [P]erhaps we don't have to consider it. But in a broader sense, the chapter
often talks about sort of vague quantitative terms . . . ." Id. at II-43 (JA 11,971). "What
does it mean? What is the test for chemical similarity?" Id. at II-51 (Dr. Hammond) (JA
11,979). "[T]he data . . . simply do not demonstrate that they are similar. There are
simply not enough data. . . . [Y]ou're not going to have that data, and even if you did,
you'd have to decide on criteria for what constitutes similarity and what does not
constitute similarity." Id. at II-77 (Dr. Daisey) (JA 12,005).
(31) Instead of explaining the criteria used to make findings, EPA's citations reveal more
uncertainty. "Standardized testing protocols for assessing the physical and chemical
nature of SS emissions . . . do not exist, and data on SS are not as extensive as those for
MS emissions." ETS Risk Assessment at 3-2.
Although ETS is a major source of indoor air contaminants, the actual contribution of
ETS to indoor air is difficult to assess due to the background levels of many contaminants
contribute from a variety of other indoor and outdoor sources. Relatively few of the
individual constituents of the ETS mix have been identified and characterized. In
addition, little is known about the role of individual ETS constituents in eliciting the
adverse health and nuisance effects observed.
Id. at 3-18.
(32) EPA Memorandum from Chris DeRosa, Acting Director Environmental Criteria and
Assessment Office, to William H. Farland, Director, Office of Health and Environmental
Assessment (OHEA) 1 (April 27, 1990) (JA 6,651).
(33) Id. at 4-5 (JA 6,654-55). The same author recognizes "tremendous scientific,
regulatory, and political ramifications of categorizing a substance as a Group A
carcinogen. . . . [G]iven the inherent limitations of the data, and the comparative novelty
of the approach used to interpret the date I would recommend that this approach not be
used as the basis of a Group A classification." Id. at 4 (JA 6,654).
(34) EPA Memorandum from Terry Harvey, Director, Environmental Criteria and
Assessment Office, to Linda Bailey, Technical Information Staff, OHEA 2 (March 24,
1992) (emphasis added) (JA 6,661).
(35) Plaintiffs also argue EPA included workplace data that affirmed the Agency's a
priori hypothesis. The court does not find it necessary to reach the merits of this
(36) The court finds it unnecessary to resolve Plaintiffs' remaining methodological
contentions: (1) EPA inexplicably departed from its stated procedure for selecting risk
estimates from the spousal smoking studies when that allowed the Agency to increase its
summary risk estimate for particular studies; (2) EPA did not include certain studies and
data in its meta-analysis in order to exclude the possibility that confounders explain the
association between ETS and cancer; (3) EPA adopted statistical testing methods rejected
by epidemiologists, ignored the possibility that more than one confounder interacting
jointly could explain the claimed association, and inconsistently interpreted the results of
confounding analysis to promote finding an association; (4) EPA switched from a peer-reviewed methodology to an unpublished one in excluding
study bias as an explanation
for the claimed association; and (5) to create critical ETS dose-response evidence, EPA
inexplicably used a trend analysis that included unexposed (i.e., control) subjects, in
violation of EPA's Risk Assessment Guidelines and standard epidemiologic practice.
(37) EPA Office of Inspector General, EPA's Relationship with the American Society of
Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE), Audit Report No.
E1FAF5-13-0075-6100228 (August 14, 1996).
(38) Given the holdings in United States v. Lopez, 514 U.S. 549, 115 S. Ct. 1624 (1995) and United States v. Hartsell, 127 F.3d 343 (4th Cir. 1997), and argument may exist concerning where the federal government derives the authority to regulate indoor air quality, a patently intrastate environmental concern. Being neither interstate or commercial, it is unclear where indoor air finds a nexus with the instrumentalities of interstate commerce and how it substantially affects interstate commercial transactions. The Complaint does not raise these concerns. Since the court is granting Plaintiffs the complete relief requested, it is unnecessary to reach these issues.