(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 U.S.C. 5 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 co
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 requirements; 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. EPA denies the
same and argues the administrative record (record) demonstrates reasoned
decision making. Plaintiffs have also filed a motion to supplement
|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).
pleadings. For the reasons stated herein, the
court will enter an order granting Plaintiffs' motions.
I. THE RADON
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 U.S.C. § 7401 note. The Act was
based on Congress' finding: "exposure to naturally occurring radon and indoor
air pollutants poses public health risk[s]," id. § 402(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 indoor environment;
(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 quality
(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 . . . .
. . . .
relating to the effects of indoor air pollution and radon on human
. . . .
(6) the dissemination of information to assure
the public availability of the findings of the activities under this
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. §
II. STANDARD OF REVIEW 2
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
|2 As this case involves review of
administrative agency action, the court will not conduct de novo review
but must review the record before EPA at the time EPA made its decision. For a
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
court to "hold unlawful and set aside agency
action . . . found to be . . . in excess of statutory jurisdiction, authority,
or limitations, or short of statutory right." 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 I
Inc., 467 U.S. 837,
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
The parties assert the plain language of the statute
determines whether EPA had authority to assess the risks of and 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 Toxic Substance Control Act prohibited EPA's risk assessment of
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]egulatory 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
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
EPA's Risk Assessment Guidelines state risk assessment
incorporates judgmental positions and the Agency's regulatory mission.
RiskAssessment 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 .3 3 Thus,
Plaintiffs conclude that EPA's guidelines and actions
demonstrate risk assessment is a regulatory, not research, tool.
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
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
Research Act. Included is evidence that EPA did
not conduct its risk assessment of radon under the authority of the Radon
Research Act. 4 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). 5
Plaintiffs argue EPA's
reliance on TSCA indicates EPA realizes the Radon Research Act does not
authorize risk assessments or carcinogenic classifications.
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
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
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.
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.
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
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 5 403(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.6 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.
|6 For example, if research
determines a pollutant harms human health by causing malignant tumors, it is
ipso facto a carcinogen. See Ted A. Loomis & A. Wallace Hayes,
Essentials of Toxicology 232-36 (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 toxins).
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 18.
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
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.' 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
|7 Standing upright is a component
of running. A prohibition on running is not also a prohibition on standing.
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. 8
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.8
|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.
B. EPA's Environmental Tobacco Smoke Activities
Do Not Constitute a Prohibited Regulatory Program Under the Radon Research Act.
Plaintiffs have shown that EPA aggressively disseminated
information, coordinated activities with government agencies and
non-governmental organizations, and promoted ETS regulation and prohibition.'
Plaintiffs argue EPA's conduct constitutes de facto regulatory activity in
violation of the Radon Research Act.
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 public
EPA's activities did not amount to formal
regulation, 10 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
C. The Toxic Substance Control Act's Prohibition With
Respect to Tobacco Does Not Apply to the Radon Research Act.
the Toxic Substance Control Act (TSCA), Congress authorized EPA to regulate
chemical substances presenting an
|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
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).
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 tobaccospecific 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, (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.) (.:A
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 9,310).
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
its 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 G11 (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
|11 Enclosure G: EPA Memorandum
from Gerald Yamada, Principal Deputy General Counsel, Designated Agency Ethics
Official, to Deputy Ethics Officials (April 24, 1992).
10,936). See 18 U.S.C. 202-09 (restrictions on
special government employees).
B. Neither the Science Advisory Board
Or Its Subcommittee Is the Representative Advisory Group Congress Mandated In
the Radon Research Act.
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 that 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
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 .--hat 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. 12
Black's Law Dictionary 1301 (6th ed. 1990). In contrast, EPA designed SAB to
|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).
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. 13 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 provided advice on the ETS Risk
Assessment provides further evidence of this incompatibility.
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.
|13 EPA may waive conflicts where
the interest affected is insubstantial or the need for the SGE's service
outweighs the conflict.
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. Wood's 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 in the IAQC ETS reviews, transcripts, 14 nor does EPA assert or
direct the court's
See U.S. EPA SAB IAQC ETS
Review, I.SAB.16.1 & .2 (December 4 & 5, 1990) (transcript volumes I
& 11) (1990 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).
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 § 4 03(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
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
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 groups . . . 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. 15
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 that 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 §
|15 See 1990 IAQC Transcript at
11-38 (JA 8,803-30); 1992 IAQC Transcript at 16-29 (JA 11,655-668).
C. The Timing of Committee
EPA argues that § 403(c) is generally worded and does
not make the formation of a representative advisory committee a prerequisite
that must be satisfied before EPA can undertake a specific activity under the
Act. There is no evidence in the record, nor does EPA argue, that EPA
established the committee during or after any activity conducted under the Act.
Since the committee has not been established, EPA's argument about when it
could have sought the committee's assistance appears academic. However, for
purposes of fashioning a remedy, § 403(c) requires EPA to seek the
committee's assistance "in carrying out the research program . . . . Congress
intended consultation at least while EPA conducted research. ongoing
consultation requires more than post hoc consultation. See Morabito v. Blum,
528 F. Supp. 252, 264- 66 (S.D.N.Y. 1981) (Under the Social Security Act,
where consultation with a medical advisory committee is required, committee
input must be sought and received before action is taken.).
Consequences of EPA's Procedural Failure Plaintiffs argue EPA's actions
were unlawful and the ETS Risk Assessment must be set aside. EPA argues
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 them."
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. 16 A
congressional directive to consult an advisory committee is more than a
formality. The Court of Appeals for the District of Columbia emphasized the
significance of advisory committees in explaining the procedural requirements
within the Federal Coal Mine Health and Safety Act of 1969:
important aspect is the requirement of consultation with knowledgeable
representatives of federal and state government, industry and labor. This goes
far beyond the usual requirements of public notice and opportunity for comment
set forth in the Administrative Procedure Act, and represents the Congressional
answer to the fears expressed by industry and labor of the prospect of
unchecked federal administrative discretion in the field. These rather unique
requirements of the Act are an important part of the ultimate legislative
compromise, and must be given their due weight.
|16 Even so, the IAQC was a poor
proxy for industry representation. EPA sought parties near the "middle" of the
spectrum when establishing SAB panels and allegedly avoided representation from
either end of the spectrum. As a general rule, the tobacco industry occupies
that end of the spectrum contesting the carcinogenicity of ETS and EPA's
motives. A committee aspiring to represent the middle of the ETS debate
necessarily suppresses the tobacco industry's perspective. Further, industry's
ability to submit comments to a "neutral" committee, which itself had access to
EPA, is not equivalent to industry access to EPA.
Zeigler Coal Co. v. Klelppe, 536 F.2d 398, 403
(D.C. Cir. 1976). In National Constructors Ass'n v. Marshal, 581 F.2d 960
(D.C.Cir. 1978), the Secretary of Labor was obligated to establish and consult
with a specially constituted advisory committee when promulgating safety
standards. The Secretary failed to do so. The Marshal court rejected the
agency's effort to equate notice and comment with the required procedures and
concluded that "advisory committee consultation should, but in this case did
not, consist of something more than a . . . rest stop on the route between a
tentative proposal,. and the final promulgation Id. at 971.
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 "[aldministrative decisions should
be set aside . . . only for substantial procedural or substantive reasons as
mandated by statute Id. at 558, 98 S. Ct. at 1219.
Synthetic Organic Chem. Mfrs. Ass'n v. Brennan, 506 F.2d 385, 388-89 (3d
Cir. 1974), Congress gave the Secretary of Labor the option of requesting
recommendations from an advisory committee prior to promulgating certain rules.
If the Secretary used the committee, interested parties could submit their
comments about the rule after the committee issued its report. The dispute
before the Third Circuit arose when the Secretary consulted the committee but
published a proposed rule before the advisory committee submitted its report.
The complainants "were not given adequate time to submit comments or to prepare
for the hearing after the committee's work was completed." Id. at 388.
The court remanded the standards to the agency with the directive to republish
them and follow the procedural requirements.
In Marshal, 581 F.2d
960, the agency was required to consult an advisory committee before
promulgating the disputed standards. The court found the agency greatly
deviated from required procedures and agency regulations by not meaningfully
consulting the committee. The court concluded that, had the agency abided by
its procedural requirements, the agency may have promulgated
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.
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
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
violation." The court is reluctant to characterize
EPA's procedural deficiency substantial where EPA would simply reproduce the
same ETS Risk Assessment at significant cost. In resolving the substantiality
of EPA's procedural defect, the court must inquire whether EPA's procedural
failure affected the Assessment. See Textile Workers Union of-America v.
Lincoln Mills of Alabama, 353 U.S. 448, 457, 77 S. Ct. 912, 918 (1957)
(Some federal law "lack[s] express statutory sanction but will be solved by
looking at the policy of -..'ie legislation and fashioning a remedy that will
effectuate that policy. The range of judicial inventiveness will be determined
by the nature of the problem."); United States v. Field, 193 F.2d 92, 96
(2nd Cir. 1951) ("'[I]t is fundamental that federal courts, in common with
other courts, have inherent power to do all things that are reasonably
necessary for the administration of justice, within the scope of their
|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
V. THE ENVIRONMENTAL TOBACCO SMOKE RISK
The court reviews the
performance of the ETS Risk Assessment to determine whether consultation with
the representative group would have likely produced a different result. 18 19.
Chapter 1 summarizes the claim that ETS is a Group A carcinogen that
causes approximately 3,000 lung cancer deaths per
|18 Plaintiffs initially argue
that had industry been consulted during the research process, EPA likely would
not have conducted a risk assessment and carcinogen classification. Plaintiffs'
argument depends on the ETS Risk Assessment being ultra vires. As
already addressed, risk assessment is incidental to gathering information,
researching, and disseminating the findings.
19 The parties' arguments
to the court address whether EPA's conduct was arbitrary and capricious and
whether the record demonstrates reasoned decision making. The court uses the
arguments to determine whether the Assessment would have been different had
industry (and state) representatives addressed their concerns directly to EPA.
The inquiry turns on the legitimacy of Plaintiffs, concerns.
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) 20 and ETS are not sufficiently similar. Specifically,
using "cigaretteequivalents" to correlate ETS exposure was not conducted for
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.
|20 Mainstream Smoke is the smoke
inhaled by the smoker.
ETS Risk Assessment at 2-7 thru 2-8. The report
then states that although ETS and MS are chemically similar, "ETS is rapidly
diluted into the environment, and consequently, passive smokers are exposed to
much lower concentrations of these agents than are active smokers." Id.
Chapter 3 establishes that ETS and MS are chemically similar
because: (a) ETS is composed of aged, diluted sidestream smoke (SS), 21 and
aged, diluted, exhaled MS, and (b) fifty-two of the 4,000+ characterized
chemical constituents of MS were found in SS, which include most of the
suspected carcinogens identified in Ms.
Chapter 4 states that the high
relative risks (RR) for lung cancer associated with active smoking along "with
no evidence of a threshold level of exposure," id. at 2-9, the chemical
similarity between MS and ETS, and corroborative evidence for the
carcinogenicity of tobacco smoke provided by animal bioassay and genotoxicity
studies "clearly establish the biological plausibility that ETS is also a human
lung carcinogen." Id. at 2- 9; see also 4-27 thru 4-29. EPA
asserts these observations
|21 Sidestream smoke is the smoke
emitted from a smoldering cigarette between puffs.
alone are sufficient to establish ETS as a Group A
carcinogen designation 22
Chapter 4 concludes with recognition that EPA
should examine the "vast body of epidemiologic data dealing specifically with
lung cancer and exposure to ETS." Id. at 4-29. The chapter concludes this data
should be examined: (1) to promote "the interest of weighing all the available
evidence, as recommended by EPA's [Risk Assessment Guidelines] (2) because SS
and MS rapidly dilute into the environment and ETS components change phase
distributions over time, which raises questions about the carcinogenicity of
ETS exposure under environmental conditions, and (3) since "active smoking data
do not constitute a good basis for quantitative estimation of the health
effects of passive
|22 A substance is categorized as
a Group A Human Carcinogen "only when there is sufficient evidence from
epidemiologic studies to support a causal association between exposure to the
agents and cancer." Risk Assessment Guidelines at 34,000.
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
Id. at 33,999.
smoking because the relative uptake and deposition
between active and passive smokers of the agent(s) responsible for these
effects are not known Id.
Chapter 5 analyzes thirty-one
epidemiologic studies of nonsmoking women married to smoking spouses (spousal
smoking studies). Chapter 5 combines the spousal smoking studies data into six
statistical "meta-analysis" based on geographic origin. Chapter 5 also analyzes
high-exposure groups in the studies, conducts a trend analysis, and categorizes
studies into four tiers based on their perceived utility for assessing an
ETS/lung cancer association. The analysis within Chapter 5 utilizes one- tailed
tests of significance and 90% confidence intervals. "The justification for this
usage is based on the a priori hypothesis [from the theory of biological
plausibility] that a positive association exists between exposure to ETS and
lung cancer." Id. at 5-2.
Chapter 6 conducts an exposure
assessment in an attempt to quantify the threat posed by ETS. Chapter 6
concludes that MS and ETS are too dissimilar to use data about MS to assess the
risks of ETS exposure. Id. at 6-6. Chapter 6 thus bases its exposure
assessment on data from the spousal smoking studies and
asserts that ETS exposure causes approximately
3,000 nonsmoker lung cancer deaths each year."
The Addendum addresses
large U.S. spousal smoking studies published in 1992. It claims "these new
studies are generally consistent with this report's conclusions . . . . Id. at
ADD-1. Appendix A reviews the thirty-one spousal smoking studies and explains
how the studies were assigned to tiers based on their perceived utility.
Appendix B explains how EPA adjusted the data used in Chapter 5's meta-analysis
to address the effects of smoker misclassification bias.,
There are two
issues. The first is whether EPA's consulting a representative committee, on
which industry's concerns were represented during the research process, likely
would have caused EPA to change the conduct or conclusions of its ETS
assessment. The key to this determination is whether industry representatives
could have presented meritable criticism and advice. The second issue is
whether EPA's conduct was otherwise in accordance with the Radon Research
|23 Chapters 7 and 8 do not
involve the carcinogenicity of ETS.
B. Biological Plausibility
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.
out Chapter 3's similarity analysis is contradicted by the explanation at the
end of Chapter 4 for analyzing epidemiologic data. Specifically, "[t]he rapid
dilution of both SS and exhaled MS into the environment and changing phase
distributions of ETS components over time raise some questions about the
carcinogenic potential of ETS under actual environmental exposure conditions."
ETS Risk Assessment at 4-29.
in rejecting using a
"cigarette-equivalents" correlation, Chapter 2 states that although MS and ETS
are qualitatively similar, the absolute and proportional quantities of the
components, as well as their physical state, differ substantially. EPA also
rejects this equivalents analysis because it does not know which tobacco smoke
chemicals cause cancer nor the effect metabolic differences between active
passive smokers have on carcinogenicity. See
id. at 2-7 thru 2-9. Chapter 6 bases its rejection of an equivalents
analysis on the differences between MS and SS:
The basic assumption
of cigarette-equivalents procedures is that the lung cancer risks in passive
and active smokers are equivalently indexed by the common measure of exposure
to tobacco smoke, i.e., a common value of the surrogate measure of exposure in
an active and a passive smoker would imply the same lung cancer risk in both.
This assumption may not be tenable, however, as MS and SS differ in the
relative composition of carcinogens and other components identified in tobacco
smoke and in their physicochemical properties in general; the lung and systemic
distribution of chemical agents common to MS and SS are affected by their
relative distribution between the vapor and particle phases, which differs
between MS and SS and changes with SS as it ages. Active and passive smoking
also differ in characteristics of intake . . . which may affect deposition and
systemic distribution of various tobacco smoke components as well. Id. at 6-6.
EPA further revealed that such differences affect carcinogenicity: "Pipe and
cigar smokers, who inhale less deeply than cigarette smokers, have lower risks
of lung cancer than cigarette smokers."
Id. at 4-10.
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
risk that are not fully understood." Kenneth G.
Brown, Draft Report Responses to Public Comments on the First
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
[a]lthough it would be of interest to know more about the
physicochemical properties of ETS, the distribution of exposure concentration,
exposure duration, and other characteristics, these things do not need to be
fully understood to conclude that
ETS is a carcinogen . . . . If the
unknown characteristics regarding the properties of ETS or exposure to ETS
nullified the carcinogenic potential in fresh sidestream smoke, then we would
not expect to see an association of ETS exposure with increased lung cancer, as
the study data indicate.
|Id., Response To 3.1.2, at
14 (JA 6,455).
Plaintiffs assert EPA's statements impact EPA's
biological plausibility analysis. Regarding EPA's a priori hypothesis,
Plaintiffs conclude: (1) ETS cannot be a known carcinogen if dilution and aging
raise unresolved questions about its potential carcinogenicity, and (2) ETS and
MS are not "sufficiently similar" carcinogens if they are "vastly dissimilar"
as to exposure.
Plaintiffs next point to comments submitted by
scientists 24 and by the tobacco industry citing scientific literature 21 that
reject EPA's similarity conclusions. Plaintiffs contend EPA selectively cites
or ignores certain studies, depending on whether the Agency is explaining or
disclaiming similarities between ETS and MS. Plaintiffs also point out that
none of the eleven U.S. epidemiologic studies analyzed in the ETS Risk
Assessment, as reported by their authors, shows an overall statistically
significant association between ETS and lung cancer.
argue EPA failed to identify the criteria used to determine chemical
similarity. Plaintiffs insist the criteria EPA-used to analyze similarity must
be precise for two reasons. First, at different times in the same ETS Risk
Assessment, EPA concluded that MS and ETS are similar,
|24 See, e.g., Comments of
Cronan (JA 6,188); Comments of Gori (JA 10,839); Comments of Todhunter (JA
10,072); Comments of Flamm (JA 10,633-34); Comments of Newell (JA 10,660-61);
Comments of Reasor (JA 10,786).
25 See, e.g., Comments of The
Tobacco Institute (JA 9,537-38, 9,543); Comments of Reasor (JA 10,789-90);
Comments of R.J. Reynolds (JA 5,841-58); Comments of Philip Morris (JA 10,012,
dissimilar, and of indeterminate similarity . 26
Second, EPA's chemical similarity analysis is inconsistent with the Agency's
prior risk assessment practices. See Risk Assessment Guidelines at
33,992 (listing "consistency of carcinogen risk assessments" as an EPA goal).
Plaintiffs then provide evidence that., previously, EPA did not classify agents
in Group A because they contain the same constituents as other Group A
carcinogens. See Tennessee Gas Pipelines Co. v. F.E.R.C., 926 F.2d 1206,
1211 (D..C. Cir. 1991) (When an agency decision is inconsistent with prior
decisions, it must explain the change.).
As their final argument against
EPA's biological plausibility hypothesis, Plaintiffs dispute EPA's
conclusion that ETS exposure causes lung cancer because "[a] clear dose-
response relationship exists between lung cancer and amount of exposure [to
MS], without any evidence of a threshold level." ETS Risk Assessment at 4-1.
EPA's "no threshold" finding means EPA
|26 See Dithiocarbamate Task
Force v. EPA, 98 F.3d 1394, 1404-05 (D.C. Cir. 1996) (vacating EPA's
listing of a carbamate as a "K waste" because EPA could not employ a highly
discretionary and unarticulated "environmental concern" standard and then fail
to explain why that carbamate failed to meet that standard); see also Toler
v. Eastern Assoc. Coal Co., 43 F.3d 109, 115-16 (4th Cir. 1995) (review of
denial of medical benefits, requiring an ALJ to identify specific and
persuasive reasons to justify seemingly paradoxical reasoning).
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
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 33,992.)
EPA explains that its biological
plausibility findings rest on three considerations. First, active smoking
causes lung cancer in humans, and MS is chemically similar to ETS. Second,
considerable evidence exists that nonsmokers exposed to ETS absorb and
metabolize significant amounts of ETS, including
carcinogenic compounds. Third, laboratory studies
show ETS can cause cancer in animals and damage DNA, which scientists recognize
as being an instrumental mechanism for cancer development. Further, EPA argues
that its bioplausibility theory alone need not be sufficient to support the
Assessment's conclusion, because the theory is confirmed by the findings from
the epidemiologic studies.
EPA defends its Chapter 3 findings of
chemical similarity by stating *the Agency never suggested ETS and MS are
identical compounds. Rather, EPA found that ETS and MS are similar in some
respects and can be compared in terms of carcinogenicity. Differences between
the compounds were not disregarded by the Agency. EPA cites to the many
portions in the ETS Risk Assessment where EPA discusses the dissimilarities
between MS and
|27 EPA also relies upon IAQC's
There are substantial differences in the relative composition
of the smoke formed between mainstream and sidestream smoke. . . . but there is
no reason to suppose that the qualitative toxicities of ETS and MS are
substantively different. In comparing these two agents the differences are
largely ones of dose and duration of exposure rather than fundamental
differences in the toxicity or carcinogenicity of the agent in
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
|27 ( ...
EPA, An SAB Report: Review of Draft Passive Smoking
Health Effects Document, EPA/SAB/IAQC/93/003, at 11, November 20,
in the risk assessment process is a qualitative
determination as to whether a substance is carcinogenic. See Risk
Assessment Guidelines at 33,993 ("The hazard identification component
qualitatively answers the question of how likely an agent is to be a human
carcinogen."). EPA asserts that if the substance is identified as a hazard, the
second question is a quantitative assessment as to how dangerous a carcinogenic
substance is to humans. See id. (Quantitative risk assessment is a
general term to describe all or parts of dose-response assessment, exposure
assessment, and risk characterization.).
EPA also claims it explained
four criteria for finding MS and ETS chemically similar: (1) the process
resulting in the generation of MS and SS; (2) the identity of toxins and
carcinogens in the two substances; (3) the relative toxicity and
carcinogenicity of SS and MS per cigarette smoke; and (4) the demonstrated
exposure to and absorption by the body of significant levels of carcinogens and
other toxins. In response to the charge that it changed its approach in
evaluating biological plausibility vis-a-vis other Group A carcinogen
determinations, EPA states risk assessments are conducted on a case-by-case
basis. Thus, comparison to other EPA Group A determinations are not relevant.
EPA then re-explains the basis
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.
the epidemiologic studies reviewed in Chapter 4 establish MS as a human
carcinogen. In defense of chemical similarity, EPA recites the similarities
between SS and MS. Both compounds contain the same carcinogenic compounds,
moreover, EPA asserts "there is voluminous record evidence demonstrating that
SS is more toxic per cigarette smoked than the carcinogenic MS."
(Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at 62.)
recognizing that ETS is rapidly diluted into the environment, EPA explains that
it analyzed the extent to which nonsmokers actually absorb and metabolize ETS.
First, EPA examined the extent of nonsmokers, actual exposure to ETS in a
variety of indoor environments. The studies EPA reviewed showed measurable
carcinogens and toxins in ETS at levels that varied but consistently exceeded
background levels. Second, EPA reviewed biomarker studies which showed at least
some of the carcinogens in ETS are absorbed by the body at a higher rate than
nicotine. The human carcinogen 4-aminobiphenyl (4-ABP), which is emitted at
concentrations 31 times greater in SS than MS, was present in the blood of
nonsmokers exposed to ETS in
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
EPA asserts that Plaintiffs, arguments are simply attacks on
the uncertainties inherent in the risk assessment process. A risk assessment,
by its very nature, is not a final determination about the health effects of a
substance but is instead an assessment that makes the best judgments possible
based upon the available evidence. Ethyl Corp. v. EPA, 541 F.2d 1, 24
(D.C. Cir. 1976). In conducting risk assessments, an agency must adopt
inference options and point out where evidence and scientific knowledge are
incomplete. NRC Redbook, at 18, 28.
Finally, EPA defends its
determination that there is no safe level of exposure to MS by referring to
several studies that found a risk of lung cancer at the lowest levels of
exposure to MS. EPA also relies upon SAB's finding it plausible that prolonged
inhalation of ETS results in some increase of lung cancer. Finally, EPA asserts
the record rebuts Plaintiffs, argument that nonsmokers are exposed only to
small amounts of ETS.
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
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
the court to any evidence within the record
explaining, how SS condensate demonstrates similarities between MS and
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
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
analysis. However, for purposes of EPA's
bioplausibility theory, neither the ETS Risk Assessment or administrative
record demonstrates a difference or attempt the explanation which EPA now
offers the court. Quantity versus quality may be a relevant distinction in
certain situations, e.g., the amount of arsenic naturally occurring in an
apple. Plaintiffs assert that since ETS is a gas, considering the evidence
regarding ETS' physicochemical properties and the characteristics of the
particles and gases comprising ETS is necessary to determine the quality of
ETS. This suggests an analytical process combining qualitative and quantitative
analysis, which is also what EPA's Risk Assessment Guidelines
EPA's Risk Assessment Guidelines do not support the Agency's
argument that risk assessment is a bifurcated, quantitative then qualitative,
analysis. To the contrary, "[r]isk assessment includes one or more of the
following components: hazard identification, dose-response assessment,
exposure assessment, and risk characterization (NRC "Risk Assessment Guidelines
at 33,993 (emphasis added). "[Q]uantitative risk assessment has been used as an
inclusive term to describe all or parts of dose- response assessment, exposure
assessment, and risk characterization. . . . [However,] the more explicit
developed by the NRC (1983) is usually
preferred." Id. Neither the Assessment or the administrative record explains
why physicochemical inquiries require a bifurcated analysis instead of a
combined analysis as per the Guidelines, or why MS and ETS are similar for
purposes of hazard identification, but not for purposes of quantitative risk
assessments. Since Chapter 2 found ETS and MS not sufficiently similar, Chapter
3 found them similar, and Chapter 6 found them dissimilar, EPA apparently used
a different risk assessment methodology for each chapter. Again, neither the
Assessment nor the record explains the risk assessment components used in the
different chapters, why methodologies varied between chapters, or why ETS and
MS were or were not similar using each methodology.
The court is faced
with the ugly possibility that EPA adopted a methodology for each chapter,
without explanation, based on the outcome sought in that chapter. This
possibility is most potent where EPA rejected MS-ETS similarities to avoid a
"cigarette- equivalents" analysis in determining carcinogenicity of ETS
exposure. Use of cigarette-equivalents analysis may have lead to a conclusion
that ETS is not a Group A carcinogen."
|28 [S]ome persons suggest a
is striking that MS and ETS were similar only
where such a conclusion promoted finding ETS a carcinogen.
assertion that "EPA did explain the numerous criteria it used in assessing
similarity . . . " (Conformed Mem. Supp. EPA's Cross Mot. Part. Summ. J. at
73), is without merit. EPA merely parrots the findings made in Chapter 3 of the
ETS Risk Assessment. The record presents no evidence of EPA establishing
similarity criteria before the Assessment .29 Nor did
|28 ... continued)
"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
See Portland Cement Ass'n v.
Ruckelshaus, 486 F.2d. 375, 395 (D.C. Cir. 1973) ("A troublesome aspect of
this case is the identification of what, in fact, formed the basis for the
standards promulgated by EPA - a question that must be probed prior to
consideration of whether the basis or bases for the standards is reliable.");
see also Independent U.S. Tanker Owners Comm. v. Lewis,, 690 F.2d 908,
920 (D.C. Cir. 1982) (noting that when agency action is undertaken prior to
disclosure of the basis (continued...
scientists on IAQC's final review panel identify
the criteria used to determine similarity. 30 EPA's citations reveal only
summaries of findings on MS-SS similarities and ETS biomarkers. 31
|29 ( continued) 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 Re I view at 11-41 (Dr Daisey) (JA 11,969). "That also brings
you to an issue sue 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 11-43 (JA 111,971). "What does it ;mean? What is the test for
chemical similarity?" Id. at 11-51 (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 ever if you did, you'd:
have to decide on criteria for what constitutes similarity and what does not
constitute similarity." Id. at 11-77 (Dr. Daisey) (JA 12,005).
Instead of explaining the criteria used to make findings, EPA's citations re I
veal more uncertainty. "Standardized testing protocols for assessing the
physical End 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
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
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 relevant. Finally, both sides
cite to independent studies on ETS, done by third parties, to support their
arguments. Both sides often lay claim to the same studies. The studies
|31 ( ... continued) eliciting
the adverse health and nuisance effects observed.
Id. at 3-18.
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."
32 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 Bl." 33 Office Director
Terry Harvey also concluded that the ETS Classification's analysis violated
EPA's Risk Assessment Guidelines: ,[l]ike it or
|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 data I would recommend that this approach
not be used as the basis of a Group A classification." Id. at 4 (JA
EPA should live within its own categorization
framework or clearly explain why we chose not to do so." 34
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
C. EPA's Choice of Epidemiological
By the time EPA released the ETS Risk Assessment in 1993, 33
studies had analyzed the lung cancer risk of nonsmoking females married 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
|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)
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. EPA 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 not evaluated. The
[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 exposures; therefore, in order to develop one
large database for analysis, only the female exposures from spousal smoking are
ETS Risk Assessment at 5-1. The Assessment's overview
explains only that childhood and workplace studies are fewer,
fewer cases, and are generally excluded from EPA'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 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
[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.
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
of lung cancer associated with ETS among American
women who have never smoked cigarettes. IAQC also supported EPA's general
metaanalysis categorization of the studies which EPA had chosen. 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, 12,226).
Plaintiffs contest that EPA exculded
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. 35 (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 do not support
|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 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
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 limitations 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
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 lifetime
exposure. Again, the record does not reveal that EPA used this as a selection
criteria. Rather, an 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 not possible to determine whether or 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
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 statutory authority.
D. EPA's Epidemiologic
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." The first contention
|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
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 disease.").
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
|36 ( ... continued) 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
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 significance.
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
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
Plaintiffs, second methodological argument requiring comment
states, EPA based ETS' Group A classification in large part on a resulting
relative risk of only 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/600/6901/005B 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
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
significance 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
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
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 maker, 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
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
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 picking."
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
VI. MOTION TO SUPPLEMENT THE
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 Inspector General."
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
|37 EPA Office of Inspector
General, EPA's Relation hip with the American Society of Heating,
Refrigerating, and Air-Conditioning Engineers (ASHRAE), Audit Report No.
E1FAF513-0075-6100228 (August 14, 1996).
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., Quaratino 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 efficient administration of
justice that they should be allowed as a matter of
(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. Quaratino, 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
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 Complaint.
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
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 Plaintiffs' 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
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.
EPA initiated drafting 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).
conducting the Assessment, EPA deemed it biologically plausible that ETS was a
carcinoqen. 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 portion 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 88
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
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
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." In
conducting the ETS Risk Assessment, 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 record.
While so doing, 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
A 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
|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), an 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 or 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.
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
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
This the 17th day July 1998.
[Signed] William L.
United States District Judge
END OF DOCUMENT