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Post: Immediate action needed to prevent 'industrial manslaughterPosted by Sharon on 9/17/08
Immediate action needed to prevent 'industrial
manslaughter,'
says expert
Dr. Jeanne Stellman tells presidential panel that many
chemicals remain unregulated
Jeanne Mager Stellman, PhD, professor and chair of
environmental and occupational health sciences at SUNY
Downstate Medical Center, told the President's Cancer Panel
that government policy and a 'lack of the will to prevent
occupational disease, death and disability' are responsible
for the failure to control cancer-causing chemicals in the
workplace. Meeting in East Brunswick, New Jersey on Sep 16,
the panel heard Dr. Stellman say that decades have been
wasted examining the problem of carcinogens while not doing
enough to stem their threat to public health.
Dr. Stellman attributed the successful campaign to remove
the threat of asbestos more to health advocates such as the
late Irving Selikoff and trade unions rather than to
government action. PCBs, on the other hand – while widely
considered hazardous – are still a major threat to workers
because few have championed efforts to control them and the
government has not followed its own mandates to protect the
public.
Dr. Stellman said, 'While we as a society have been
debating and delaying and have been occupying ourselves
with setting up straw man arguments about incidence and
attributable risk, more and more chemicals have been
introduced into commerce and have remained largely
unmonitored and unregulated.'
Dr. Stellman told the panel that the time for discussion is
past if we are to stop 'ongoing industrial manslaughter.'
###
The full text of Dr. Stellman's testimony follows:
'Delusions, Illusions and Ongoing Neglect of Hazard
Recognition, Regulation and Control of Industrial
Carcinogens'
A Presentation to the President's Cancer Panel
September 16, 2008
East Brunswick, New Jersey
Jeanne Mager Stellman, PhD
Professor & Chair, Environmental and Occupational Health
Sciences
SUNY-Downstate Medical Center, Brooklyn NY
Professor Emeritus, Mailman School of Public Health
Columbia University, New York, NY
In collaboration with
Steven D. Stellman, PhD MPH
Professor, Department of Epidemiology
Mailman School of Public Health
Columbia University
I wish to thank the President's Cancer Panel for this
opportunity to address it on environmental cancers
associated with industrial and manufacturing exposures. The
Panel's day has been framed by a series of questions on the
current state of governmental regulation, inspection,
control and overall policy with regard to carcinogens; on
resources allocated to recognition of cancer hazards, and
on social and policy barriers to carrying out research and
developing effective cancer control policy
These questions are, of course, more or less rhetorical.
Indeed, each of us on the day's panels can most probably
reach into our file drawers and pull out papers and
presentations we have given in the 1970's, 1980's, 1990's
and 2000's addressing these very issues. The only
substantive differences in content would be that the number
of potential chemical exposures has grown – as has the
knowledge gap about the hazards associated with these
chemicals and the dearth of appropriate standards to ensure
that hazardous exposures are controlled.
Regulation: The National Cancer Panel need not call upon
outside experts to confirm the federal government's own
findings that fewer that 2% of chemicals on the market have
been tested for carcinogenicity (NIOSH, 2007) or that a
significant number of agents that have been identified as
carcinogens by the Environmental Protection Agency, the
International Agency for Research on Cancer (IARC) and the
National Toxicology Program (NTP) are unregulated by the
Occupational Safety and Health Administration (OSHA)
(http://www.epa.gov/tri/chemical/OSHA/carcinog.pdf). My
colleague Dr. Franklin Mirer will present some of these
data on specific OSHA standards in more detail in today's
panel presentations.
Or consider another example. The National Institute for
Occupational Safety and Health (NIOSH) is mandated to
provide technical assistance to OSHA and the Mine Safety
and Health Administration in developing its standards. The
National Cancer Panel does not need independent scientists
to report back NIOSH's own performance in this regard. This
is a graph of the publication rate for criteria documents,
special hazard reviews and joint occupational health
documents produced with other countries. Criteria Documents
are developed to provide the basis for comprehensive
occupational safety and health standards. These documents
generally contain a critical review of the scientific and
technical information available on the prevalence of
hazards, the existence of safety and health risks, and the
adequacy of methods to identify and control hazards. The
downward trend of publication and dismal production rate
needs no advanced statistical interpretation: neither OSHA
standards-setting nor NIOSH advice-giving is occurring.
These data are complemented by an ever shrinking number of
papers on cancer regulation and carcinogen policies, as I
easily observed in a straightforward recent Medline search
on the topic.
Prevalence of problem: Continuing in the same vein of 'Why
are we still asking these questions?' we would respectfully
suggest that further erudite discussions as to the precise
percentage of cancer deaths attributable to exposures to
carcinogens found in industrial and manufacturing
situations are simply not needed. These arguments have been
raging for decades now, following the publication of Doll
and Peto's provocative assessment of attributable risk ,
which many considered a serious undercount. The fact is
that a significant number of annual deaths in the United
States – and of course around the world as we export our
hazards to developing nations -- are caused by
environmental pollutants and industrial chemicals (see ACS
Facts and Figures, 2006 for example) and these cancers (and
associated diseases) are, for the most part, completely
preventable.
Furthermore, our technical ability to actually resolve the
question of the exact percentage of deaths attributable to
industrial and environmental chemicals is extremely
limited. Following is a brief summary of factors limiting
our ability to estimate true risk ratios and even to
identify all industrial carcinogens:
1. Latency between exposure and onset poses a daunting
challenge to associating cause and effect. It is the rare
workplace/industrial situation in which exposures do not
change over time; where sufficiently accurate data on
exposure scenarios are available to calculate a dose-
response relationship; or even where the population at risk
can be completely identified. Even in situations in which
there is complete cooperation from the relevant employers
assembling and following up on the study populations is
extremely difficult.
2. The statistical power to observe an effect is limited.
The expected rates of cancer require many person-years of
observation and the exposures need to be sufficiently high
to elicit a statistically observable effect. Without super-
exposures of large populations, most occupational and
environmental cancers will go undetected (particularly if
they are never the subject of studies).
3. Competitive risk also limits the ability to identify –
and hence control and regulate – carcinogens in the
workplace or the general environment. Most carcinogens are
associated with other toxic effects, many of which may
manifest themselves many years before cancer develops, and
many of these illnesses are themselves fatal. Silica is a
prime example of such an agent.
4. Complex mixtures and exposures: Workplace environments
are characterized by complex mixtures making substance-by-
substance studies and regulations impractical. IARC has
recognized this for many years and its monograph series and
studies in general have evolved into monographs that deal
with exposure situations and scenarios rather than single
substances. Such an approach in incommensurate with the
standards-making approach as it has been practiced in the
past. (It is difficult to generalize about recent standards-
making – as it doesn't seem to happen any more.)
5. The heterogeneity of the workforce further complicates
studies. The development of cancer is assuredly
attributable to both individual susceptibilities as well as
exposures to industrial carcinogens and various behavioral
factors. This multiple causation further limits the
statistical power to observe an effect.
As a result of these methodological constraints, very few
chemical carcinogens are actually 'known' and classified as
such. Many of the 'known' carcinogens arise from peculiar
circumstances that made their 'discovery' possible. For
example, asbestos is associated with a rare tumor,
mesothelioma. Asbestos is used by specialized workers,
insulators, where it is their major exposure. Also, by good
chance, many insulators belonged to a trade union and that
union maintained records whereby they could identify their
members over many years. The extreme rates of lung cancer
observed among cigarette smoking workers also improved
statistical power immensely. But these factors alone would
not have been sufficient to lead to our understanding about
the cancer risks associated with asbestos and to the
widespread control of asbestos that now exists. The
dedication and skill of E. Cuyler Hammond and his co-
workers at the American Cancer Society (ACS), the power and
wealth of the ACS and its interest in pursuing the
research, and the extraordinary relationship between Irving
J. Selikoff and the trade unions, coupled with his
charismatic leadership qualities and tireless energy,
combined to largely eradicate this blight on human health.
By contrast, consider polychlorinated biphenyls (PCBs),
which are classified by IARC and NTP as probable human
carcinogens, but for which few human studies are conclusive
and OSHA does not regulate as a carcinogen. The paucity of
human data is attributable to the complexity of the
exposures, the ill-defined workgroups and undoubtedly to
the sheer absence of will to carry out the appropriate
studies. Not every substance or exposure circumstance is
fortunate enough to have an Irving Selikoff, Cuyler Hammond
or large organization interested in pursuing studies.
Indeed, just the opposite in general occurs: there are
often massive roadblocks to assembling study populations,
obtaining accurate data on exposures and obtaining medical
data. These roadblocks themselves require a separate and
lengthy presentation, beyond the time and space allotted
here.
What sorts of standards do we need? The General Duty Clause
of the United States Occupational Safety and Health Act
states: 29 U.S.C. § 654, 5(a)1: Each employer shall furnish
to each of his employees employment and a place of
employment which are free from recognized hazards that are
causing or are likely to cause death or serious physical
harm to his employees.' Thus we suggest that all
carcinogens that currently are rated as known or probable
by recognized agencies (e.g. IARC, NTP, EPA) are already
regulated by OSHA under the General Duty Clause and
exposure to them should be limited to the lowest detectable
amount feasible. That the general duty clause is, in fact,
virtually never applied to industrial carcinogen exposure
is not a matter of science but of policy and lack of the
will to prevent occupational disease, death and disability.
Next, since it is the job of OSHA to develop workplace
guidance that assists employers and employees in fulfilling
their obligations under the general duty to provide a
workplace free from recognizable hazard, we suggest that
OSHA, with the advice of NIOSH and other technical
agencies, undertake extensive process management standards-
making similar to its Process Safety Management of Highly
Hazardous Chemicals standard or its Hazardous Waste
Operations and Emergency Response (HAZWOPER) standard or
the OSHA Lab standard. These standards take into
consideration the realities of complex working environments
and seek to control processes rather than target individual
bad actors. Control of a hazard at the source is a prime
principle of industrial hygiene, as is substitution of less
hazardous substances for known toxic agents. Mandating
control of exposure situations and processes, rather than
engaging in the long and clearly unsuccessful process of
individual standards-making is consistent with the IARC
approach of recent years, which has largely dealt with
exposure situations and mixtures and not with individual
substances. Indeed, the epidemiology and the industrial
hygiene constraints described above mandate such an
approach. In the case of vinyl chloride, OSHA adopted a
stringent standard that led the chemical processing
industry to develop scrubbing techniques for ridding
product of unreacted monomer and of introducing mechanical
cleaning mechanisms. These standard process techniques by
and large led to vinyl chloride exposure levels below those
mandated by OSHA and similar processing could be used to
prevent exposure to other highly reactive monomers.
Indeed, the generalization of process controls to other
chemically similar products makes scientific sense and is
completely consistent with trends in the drug and chemical
industries where structure-activity-relationships (SAR) are
key to product development initiatives. Principles of SAR
should be applied to untested chemical compounds and those
chemicals with properties similar to known toxic agents
should, by analogy, be considered potentially toxic and
controlled through appropriate process management
techniques. For example, all alkylating agents, like
ethylene oxide, should be considered carcinogenic until
proven otherwise.
Finally, it is fatuous to believe that regulatory decisions
are based on science alone. Advocacy is the key to
regulation and control and to funding of scientific
studies. It is not a coincidence that the decrease in
carcinogen-control regulations, studies and government
publications corresponds to the rapid shrinkage of the
United States' industrial workforce and their
representation by trade unions. Control of second-hand
environmental tobacco smoke has come from public advocacy.
Indeed, OSHA withdrew from its role of protecting workers
from second-hand smoke and other serious problems of indoor
air quality and has withdrawn its own indoor air quality
regulatory proposals .
Thus, while we applaud the National Cancer Panel for
directing its attention to this too long neglected topic
and for framing the issues as insightfully as it has, we
believe that the time for discussion is long past. While we
as a society have been debating and delaying and have been
occupying ourselves with setting up strawman arguments
about incidence and attributable risk, more and more
chemicals have been introduced into commerce and have
remained largely unmonitored and unregulated. We hope that
the resurgence of interest in this topic may be a harbinger
to a new future in which we will not continue to remain
bystanders to ongoing industrial manslaughter.
Public release date: 16-Sep-2008
Contact: Jeanne Stellman
jeanne.stellman@downstate.edu
718-483-3928
SUNY Downstate Medical Center
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Immediate action needed to prevent 'industrial manslaughter, 9/17/08, by Sharon.
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