The Osteen
Decision
The
Osteen Decision
July
17, 1998
Page 1 of 3 pages: |2|3|
Pages 1-29
Return to Report
IN THE UNITED STATES DISTRICT COURT
FOR
THE MIDDLE DISTRICT OF NORTH CAROLINA
WINSTON-SALEM
DIVISION
FLUE-CURED TOBACCO COOPERATIVE
STABILIZATION CORPORATION,
THE COUNCIL FOR BURLEY TOBACCO
INC.,
UNIVERSAL LEAF TOBACCO COMPANY
INCORPORATED,
PHILIP MORRIS INCORPORATED,
R.J. REYNOLDS TOBACCO COMPANY,
and
GALLINS VENDING COMPANY,
Plaintiffs,
V.
ace="Arial">
e="Arial">V.
ace="Arial">
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
and CAROL BROWNER, Administrator, Environmental
Protection Agency,
Defendants.
6:93CV00370
ORDER AND JUDGMENT
OSTEEN, District Judge
For the reasons set forth in the memorandum
opinion entered contemporaneously herewith,
IT IS ORDERED AND ADJUDGED that Plaintiffs'
Motion for Partial Summary Judgment is granted
[1171.
IT IS FURTHER ORDERED AND ADJUDGED that
Defendants' Cross Motion for Summary Judgment is
denied [1261. The court vacates Chapters 1-6 of
and the Appendices to EPA's Respiratory Health
Effects of Passive Smoking: Lung Cancer and other
Disorders, EPA/600/6-90/006F (December 1992).
To ripen its judgment for purposes of appellate
review, pursuant to Federal Rule of Civil
Procedure 54(b), the court finds there is no just
reason for delaying entry of judgment.
IT IS FURTHER ORDERED AND ADJUDGED that
Plaintiffs, Motion for Leave to File Supplement
Pleading under Rule 15(d) is granted (1201.
This the 17th day 1998.
[signed William L. Osteen]
United States District Judge
IN
THE UNITED STATES DISTRICT COURT
FOR
THE MIDDLE DISTRICT OF NORTH CAROLINA
WINSTON-SALEM
DIVISION
FLUE-CURED TOBACCO COOPERATIVE
STABILIZATION CORPORATION,
THE COUNCIL FOR BURLEY TOBACCO,
INC.,
UNIVERSAL LEAF TOBACCO COMPANY,
INCORPORATED,
PHILIP MORRIS INCORPORATED,
R.J. REYNOLDS TOBACCO COMPANY,
and
GALLINS VENDING COMPANY,
Plaintiffs,
V.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
and CAROL BROWNER, Administrator, Environmental
Protection Agency,
Defendants.
6:93CV00370
MEMORANDUM OPINION
OSTEEN, District Judge
This case is before the court on the parties'
cross motions for partial summary judgment on
Counts I-III of the Complaint. These counts raise
Administrative Procedure Act (APA) challenges to
EPA's report, Respiratory Health Effects of
Passive Smoking: Lung Cancer and Other Disorders,
EPA/600/6-90/006F, December 1992
(ETS Risk Assessment). EPA claims its authority
to conduct the ETS Risk Assessment derives from
the Radon Gas and Indoor Air Quality Research Act
of 1986, Pub. L. No. 99-499, 100 Stat. 1758-60
(1986) (Radon Research Act) (codified at 42
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 the
-----------------
1 Plaintiffs also allege that EPA's issuance of
the ETS Risk Assessment violated Plaintiffs, due
process rights. The court has stayed
consideration of the due process claims pending
resolution of the APA claims. See Flue-Cured
Tobacco Cooperative Stabilization Corp. v. EPA, 857
F. Supp. 1137 (M.D.N.C. 1994).
2
pleadings. For
the reasons stated herein, the court will enter
an order granting Plaintiffs' motions.
I. THE RADON RESEARCH ACT
The Radon Research Act was enacted by
Congress as Title IV of the Superfund Amendments
and Reauthorization Act of 1986 (SARA) and
codified with the Clean Air Act at 42 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
3
efforts relating to the improvement of indoor air
quality; and
(3) assess appropriate Federal Government actions
to mitigate the environmental and health risks
associated with indoor air quality problems.
(b) Program requirements. - The research program
required under this section shall include -
(1) research and development concerning the
identification, characterization, and monitoring
of the sources and levels of indoor air pollution
. . . .
. . . .
(2) research relating to the effects of indoor
air pollution and radon on human health;
. . . .
(6) the dissemination of information to assure
the public availability of the findings of the
activities under this section.
Id. 403(a) & (b). Congress also required a
narrow construction of the authority delegated
under the Radon Research Act. Nothing in the act
"shall be construed to authorize the [EPA]
to carry out any regulatory program or any
activity other than research, development, and
related reporting, information dissemination, and
coordination activities specified in (the Radon
Research Act]." Id. § 404.
4
The Act requires
EPA to establish two advisory groups to
assist EPA in carrying out its statutory
obligations under the Radon Research Act. one of
the advisory groups is to be a committee
comprised of representatives of federal agencies
concerned with various aspects of indoor air
quality, and the other group is to be "an
advisory group comprised of individuals
representing the States, the scientific
community, industry, and public interest
organizations . . . ... Id. § 403(c). The
Act requires EPA to submit its research plan to
the EPA Science Advisory Board which, in turn,
would submit comments to Congress. Id. §
403(d).
II. STANDARD OF REVIEW 2
Administrative agencies have no power to act
beyond authority conferred by Congress. See,
e.g., Louisiana Public Serv. Comm'n v. FCC, 476
U.S. 355, 374, 206 S. Ct. 1890, 1901, 90 L. Ed.
2d 369 (1986). Title 5 U.S.C. § 706(2)(C)
requires the
----------------
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 review).
5
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,
842-43, 104 S. Ct. 2778, 2781, 81, L. Ed. 2d 694
(1984). -The task of resolving the dispute over
the meaning of [the statute] begins where all
such inquiries must begin: with the language of
the statute itself." United States v. Ron
Pair Enter., Inc., 489 U.S. 235, 241, 109 S. Ct.
1026, 1030, 103 L. Ed. 2d 290 (1989) (citations
omitted). "The judiciary . . . is the final
authority on issues of statutory construction and
will reject administrative interpretations which
are contrary to the clear congressional
intent." Adams v. Dole, 927 F.2d 771,
774 (4th
Cir. 1991).
"[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
6
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).
7
III. EPA's AUTHORITY UNDER THE RADON RESEARCH
ACT
The parties assert the plain language of the
statute determines whether EPA had authority to
assess the risks of 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
ETS.
A. The Radon Research Act Authorizes EPA's
Risk Assessment and Classification of
Environmental Tobacco Smoke.
Plaintiffs concede EPA was authorized to
conduct research on ETS and indoor air quality
but argue EPA's ETS carcinogen risk assessment
and carcinogen classification are regulatory
activities, not research activities. EPA's Guidelines
for Carcinogen Risk Assessment, 51 Fed. Reg.
33,992, 33,993 (1986) (Risk Assessment
Guidelines) state: "[r]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 process.).
8
Plaintiffs also
rely on the National Resource Council's (NRC)
Redbook which recognizes risk assessment as a
distinct element of the regulatory process. See
NRC, Risk Assessment in the Federal
Government; Managing the Process 3 (1983)
(NRC Redbook). Plaintiffs argue that since risk
assessment is a component of regulatory activity,
risk assessment is not authorized research. but
rather proscribed regulatory activity.
EPA's Risk Assessment Guidelines state risk
assessment incorporates judgmental positions and
the Agency's regulatory mission. 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.
In arguing EPA recognizes this distinction
between risk assessment and research, Plaintiffs
offer evidence that EPA is assessing the risks of
several other indoor air pollutants, none of
which are being conducted under the authority of
the Radon
----------------
3
See Assessing the Effects of-Environmental
Tobacco Smoke: Hearing on S. 262 and S. 1680
Before the Subcomm. on Clean Air and Nuclear Reg.
of the Sen. Comm. on Env't and Public Works,
103d Cong. 177, 204-05 (1994) (Browner Hearing
Responses).
9
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.
EPA replies that the Radon Research Act provides
a broad mandate to conduct activities short of
actual regulation. Upon a sparse legislative
record and subsequent congressional funding, EPA
urges that Congress intended the act to include
ETS.
The court is not persuaded by Plaintiffs,
arguments or EPA's reliance on what certain
members of Congress intended. The plain language
of the statute is sufficient to resolve this
dispute. In the Radon Research Act, Congress
directed EPA to gather information on all aspects
of indoor air quality, research indoor
----------------
4
See Browner Hearing Responses at 190-92.
5 Plaintiffs
also provide evidence that EPA did not include
the ETS project when providing Congress with a
listing of Agency research activity.
10
pollutants'
effects on health, characterize sources of
pollution, and disseminate the findings.
Determining whether Congress authorized risk
assessments requires defining risk assessment.
"Risk assessment is the use of the factual
base to define the health effects of exposure of
individuals or populations to hazardous materials
and situations." NRC Redbook, at 3. -[NRC]
use[s] risk assessment to mean the
characterization of the potential adverse health
effects of human exposures to environmental
hazards." Id. at 18. "The
qualitative assessment or hazard identification
part of risk assessment contains a review of the
relevant biological and chemical information
bearing on whether or not an agent may pose a
carcinogenic hazard." Risk Assessment
Guidelines at 33,994.
Risk assessments include several elements:
description of the potential adverse health
effects based on an evaluation of results of
epidemiologic, clinical, toxicologic, and
environmental research-* extrapolation from those
results to predict the type and estimate the
extent of health effects in humans under given
conditions of exposure; judgments as to the
number and characteristics of persons exposed at
various intensities and durations; and summary
judgments on the existence and overall magnitude
of the public-health problem. Risk assessment
also includes characterization of the
uncertainties inherent in the process of
inferring risk.
NRC Redbook, at 18.
11
In researching effects on health, EPA must assess
whether pollutants are hazardous to health.
Researching whether pollutants are hazardous to
health necessarily entails assessing the risk
such pollutants pose to health. Thus, researching
health effects is indistinguishable from
assessing risk to health. Congress, directives to
research the effects of indoor air pollution on
human health and disseminate the findings
encompass risk assessment as defined by NRC and
explained by EPA's Risk Assessment Guidelines.
The NRC explains "description of the
potential adverse health effects" is a
component of risk assessment. Id. The Radon
Research Act requires researching pollutants,
effects on health and disseminating the findings.
The mandate of the Act requires more of EPA than
merely describing effects. Congress intended EPA
to disseminate findings, or conclusions, based
upon the information researched and gathered.
Utilizing descriptions of health effects to make
findings is risk assessment.
The Radon Research Act contains two independent
directives which authorize EPA to classify indoor
pollutants as carcinogenic. First, Congress
required EPA to characterize sources of indoor
air pollution. Radon Research Act 5 403(b)(1).
Since they emit gasses and particulates, burning
cigarettes are a
12
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).
13
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.
The uncertainties inherent in risk assessment
can be grouped in two general categories: missing
or ambiguous information on a particular
substance and gaps in current scientific theory. When
scientific uncertainty is encountered in the risk
assessment process, inferential bridges are
needed to allow the process to continue . . . .
The judgments made by the scientist/risk assessor
for each component of risk assessment often
entail a choice among several scientifically
plausible options; the Committee has designated
these inference options.
Id. at 28. In conducting a scientific
inquiry into whether a pollutant affects human
health, a researcher will have to choose
inference options. In fulfilling its obligation
under the Radon
14
Research Act, EPA must adopt inference options in
conducting research, characterizing, and making
findings. Inference options that are
scientifically plausible and fundamentally fair
are part of risk assessment. EPA may conduct risk
assessments under the Radon Research Act so long
as the assessments do not impede the Act's
general requirements of gathering all relevant
information, researching, and disseminating the
findings.
The court disagrees with Plaintiffs' argument
that risk assessment constitutes a regulatory
activity and is thus prohibited under the Radon
Research Act. Both the NRC's Redbook and EPA's
Risk Assessment Guidelines identify regulatory
activity as being comprised of two elements: risk
assessment and risk management. Prohibition of
certain conduct does not include prohibition of
lesser included activities.' 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.
15
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.
16
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.
----------------
9
See, e.g., Summary of EPA Draft Conclusions and
SAB Review, Steven Bayard, EPA ETS Project
Manager, ORD Q.9 at 1 (April 4, 1991) (Joint
Appendix (JA) 6,700) ("EPA has no regulatory
authority on ETS, but is coordinating with OSHA
which does have regulatory authority in the
workplace."); EPA Memorandum from William G.
Rosenberg, Assistant Administrator for Air and
Radiation, to Erich W. Bretthauer, Assistant
Administrator for Research and Development at 1
(Oct. 7, 1991) (JA 6,696-97) (urging expedition
of ETS study; local, state and federal agency
projects awaiting its issuance); EPA Memorandum
from William G. Rosenberg, Assistant
Administrator for Air and Radiation, to Donald G.
Barnes, Director, Science Advisory Board (June
28, 1991), and attached ETS Technical Compendium,
Draft (May 1991) at 2 (JA 6,755- 56, 6,758)
(intended to help state legislators ban smoking
in workplaces, restaurants, and public places).
17
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
judgment.
C. The Toxic Substance Control Act's
Prohibition With Respect to Tobacco Does Not
Apply to the Radon Research Act.
In the Toxic Substance Control Act (TSCA),
Congress authorized EPA to regulate chemical
substances presenting an
-----------------
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 motions.
18
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
19
regulatory authority except research,
development, dissemination, and coordination
regarding indoor air pollutants).
To the extent the Radon Research Act authorizes
de facto regulatory activity, Congress simply
excluded tobacco from the definition of chemical
substance as used in the TSCA chapter. See TSCA
§ 2602 (definitions "As used in this
chapter"). Congress, defining "chemical
substance" under the TSCA to exclude tobacco
does not mean Congress conclusively removed
tobacco from EPA's jurisdiction. it means
Congress removed tobacco from the authority
granted to EPA under TSCA. Congress did not so
limit the definition of "indoor air
pollutant" under the Radon Research Act. See
generally Coyne Beahm, Inc. v. FDA, 966 F.
Supp. 1374, 1379-80 (M.D.N.C. 1997) (declining to
infer preemption of FDA authority to regulate
tobacco products from other 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,
20
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.
A. Background
"[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
21
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
22
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 (JA
----------------
11 Enclosure
G: EPA Memorandum from Gerald Yamada, Principal
Deputy General Counsel, Designated Agency Ethics
Official, to Deputy Ethics Officials (April 24,
1992).
23
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 v.
24
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 provide independent
----------------
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).
25
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.
Congress set forth in § 403(d) a role for the
SAB that tracks the SAB's traditional mission:
providing independent scientific review and
comment on EPA's plan for implementing the
research program. In contrast, § 403(c) charged
the advisory group with representing specified
constituencies and providing assistance to EPA in
carrying out the research program. Those are two
different roles for two different groups.
----------------
13 EPA may
waive conflicts where the interest affected is
insubstantial or the need for the SGE's service
outweighs the conflict.
26
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
----------------
14
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).
27
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 industry.
EPA confirmed IAQC's independence from outside
interests. When he was preparing the panel for
the second public meeting on the draft ETS Risk
Assessment, the SAB assistant director included
in his transmittal letter a reminder to panel
members of their conflict of interest and
disclosure obligations:
An area of potential sensitivity in our public
meetings is the nature of your interactions with
both the Agency and outside interests on a
particular matter. At the beginning of the
meeting, I will ask each person on the Committee
to voluntarily discuss any
such areas they wish to identify. . . . Issues of
concern can include the extent to which you or
your organization have received (or will receive)
professional or personal benefits from any
individuals, organizations or groups . . .
representing any viewpoint concerning the
issue(s) under consideration at this meeting.
28
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 §
403(c).
----------------
15 See 1990
IAQC Transcript at 11-38 (JA 8,803-30); 1992 IAQC
Transcript at 16-29 (JA 11,655-668).
29
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