Decision has far-reaching implications
Written By: Environment & Climate News staff
Published In: Environment News
Publication Date: September 1, 1998
Publisher: The Heartland Institute
In one of the most embarrassing setbacks for EPA in recent memory, a
federal judge has thrown out the agency�s landmark 1993 risk assessment
linking secondhand smoke to cancer.
The ruling, handed down July 17, invalidated EPA research linking exposure
to secondhand smoke, also known as environmental tobacco smoke (ETS), to
3,000 cancer deaths each year. The agency�s ETS risk assessment was
subsequently challenged by tobacco industry officials who feared--quite
rightly, as it turned out--that the agency�s findings would be used to
justify smoking bans in public places. Tobacco companies argued that EPA
cherry-picked data and ignored standard scientific and statistical
practices to reach its conclusions, an opinion shared by a large number of
independent scientists.
The new court ruling could have a profound effect on the risk assessments
and other scientific reviews periodically released by the federal
government. If allowed to stand, the decision will establish a precedent
that risk assessments are subject to judicial review in instances where
they have a regulatory impact. That prospect is nothing short of a
nightmare for federal agencies unaccustomed to seeing their scientific
pronouncements challenged in court.
In his blistering 92-page decision, Judge William Osteen of the Middle
District of North Carolina essentially vindicated those who had accused EPA
of manipulating data in order to reach a preconceived conclusion. Osteen
ruled that EPA had violated provisions of the 1986 Radon Gas and Indoor Air
Quality Act, under which the agency determined that exposure to ETS is
hazardous.
�EPA publicly committed to a conclusion before research had begun; excluded
industry by violating the Act�s procedural requirements; adjusted
established procedure and established 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 Plaintiff�s products and to influence public opinion,� Osteen
wrote.
Among other things, the Act requires that a broad-based, stakeholder
advisory panel--one that includes the participation of affected
industries--be convened to review the findings of EPA research alleging a
substance is dangerous to human health. Judge Osteen noted, however, that
the tobacco industry had been excluded from the secondhand smoke panel.
�Findings Based on Selective Information�
Osteen added that EPA�s findings were based on insufficiently rigorous
statistical tests and were therefore invalid. EPA, he noted, �disregarded
information and made findings based on selective information . . . ;
deviated from its risk assessment guidelines; failed to disclose important
[opposition] findings and reasoning; and left significant questions without
answers.�
Osteen�s ruling isn�t expected to have much impact on smoking bans already
in place. (Some California communities might be an exception, where bans on
smoking in bars are immensely unpopular with patrons and owners.) But the
ruling is certain to discourage lawsuits aimed at recovering damages for
people claiming to have been harmed by exposure to ETS. Plaintiffs will no
longer be able to cite EPA�s now-discredited risk assessment to buttress
their claims.
No Choice but to Appeal
Although legal observers agree Osteen�s ruling is likely to be upheld by a
higher court, EPA has little choice but to appeal. Risk assessments are the
foundation of the agency�s regulatory action. To have one of its
high-profile risk assessments invalidated by a federal judge for violating
standard scientific and statistical practices is nothing short of an
humiliation for EPA. It raises serious questions about the science
underlying other EPA regulatory decisions, including last year�s
controversial decision to tighten standards for particulate matter and
ground-level ozone. That action is also being challenged in court, with a
ruling expected in the next twelve months.
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