Philip Morris
Flue-Cured Tobacco Cooperative Stabilization Corporation, Plaintiffs, V. United States Environmental Protection Agency, Defendants. Memorandum Opinion. 6:93cv00370
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- Osteen, W.L.
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- Bailey, L.
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- Browner, C.
- Cronan
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- Derosa, C.
- Farland, W.H.
- Flaak, R.
- Flamm
- Fontham
- Franz, D.R.
- Glass, L.
- Gori
- Hammond
- Harvey, T.
- Hayes, A.W.
- Kabat, G.C.
- Lautenberg
- Levin, R.M.
- Loomis, T.A.
- Luken
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- Ouaratino
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- Reese, J.H.
- Reilly, W.K.
- Rosenberg, W.G.
- Sullivan, L.W.
- Surgeon General
- Todhunter
- Woods
- Wynder, E.L.
- Xxkeith
- Yamada, G.
- Barnes, D.G.
- Master ID
- 2081323141/3234
Related Documents: - Date Loaded
- 15 Aug 2002
- UCSF Legacy ID
- ymx65c00
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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
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
' Standing upright is a component of running. A
prohibition on running is not also a prohibition on standing.
15
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[s1," 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
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
Rv., 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
II I. 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 .1-3 Toxic Substance Control
Act prohibited EPA's risk assessmqnt 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)
N
(Risk assessment is a component of the regulatory process.). p~p
8 ~
CA
0
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 researcl. olan to the EPA Science
Advisory Board which, in turn, would submit comments to Congress.
Id. § 403(d).
11. STANDARD OF REVIEW2
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
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 1,.ealth. Once a researcher
has identified how a pollutant harms human health, the risk is
most often identified.b 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 SAMA 399 (1997)
(discussing botulinum toxins).
13
(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. § 7401
note (1994)). In the ETS Risk Assessment, EPA evaluated the
respiratory health effects of breathing secondhand smoke
(environmental tobacco smoke or ETS) and classified ETS as a
Group A carcinogen, a designation meaning there is sufficient
evidence to conclude ETS causes caz.-,er 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.l EPA denies the same and argues the
administrative record (record) demonstrates reasoned decision
making. Plaintiffs have also filed a motion to supplement the
' 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 Corn. v. EPA, 857 F. Supp. 1137 (M.D.N.C. 1994).
2
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. ''TYe qualitative assessment
or hazard identification part of zisk 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 THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF NORTH CAROLINA
WINSTON-SALEM DIVISION
FLUE-CURED TOBACCO COOPERATIVE )
STABILIZATION CORPORATION, ) 4
THE COUNCIL FOR BURLEY TOBACCO, )
INC., '~
UNIVERSAL LEAF TOBACCO COMPANY,
INCORPORATED, ) ,
PHILIP MORRIS INCORPORATED, )
R.J. REYNOLDS TOBACCO COMPANY, )
and )
GALLINS VENDING COMPANY, )
)
)
Plaintiffs,
)
I
!2
v. ) 6:93CV00370
)
UNITED STATES ENVIRONMENTAL }
PROTECTION AGENCY, and )
CAROL BROWNER, Administrator, )
Environmental Protection )
Agency, )
)
Defendants. )
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, ResQiratory Health Effects of Passive Smoking:
Lung Cancer and Other Disorders, EPA/600/6-90/006F, December 1992
Q
