The U.S. Environmental Protection Agency (EPA)defines risk
as “the chance of harmful effects to human health or to ecological systems resulting
from exposure to an environmental stressor,” with a stressor being “any
physical, chemical, or biological entity that can induce an adverse response.”
Risk assessment, then, is a scientific process of quantifying and
characterizing the nature of health risks to humans or to the environment, and
risk management is the process which determines the best methods for protecting
public and environmental health from these risks (EPA Risk Assessment website, last visited 30 April
2012).
Following the previous discussion on standards, it is clear
that many of the same limitations to the development of adequate standards
apply to the risk assessment process. Risks can only be characterized and
quantified to the extent that we have scientific data available. As data are
often either lacking or limited by available technologies, risk assessment and
management are necessarily iterative processes. Moeller uses the nuclear
accident at Three Mile Island as an example, as it helped to highlight
deficiencies in previous risk assessment methodologies and led to improvements
in the process.
There is also considerable overlap between the concepts of
standards and risk assessment/risk management. In essence, risk assessment is
an integral part of the process of developing standards, as it helps to
determine and quantify threshold exposure levels. The development of standards,
in turn, is part of the process of risk management, because the standards
provide the necessary benchmarks for determining mitigation and enforcement
needs.
The EPA lists related, but slightly different, steps for
assessing risks to human health vs. to ecological systems. Both begin with what
they refer to as the planning and scoping process, which is essentially the
preparatory background research needed. For human health risk assessments, the
steps are then hazard identification, dose-response assessment, exposure
assessment, and risk characterization. In the case of ecological risks, the
steps are problem formulation, analysis, and risk characterization.
In either situation, the risk characterization cannot be
considered static, as new or ongoing research may reveal previously
unrecognized effects, or even the presence of unrecognized confounders which
have falsely inflated the apparent risk. In essence, the iterative process is
that of the Plan-Do-Check-Act cycle of continuous quality control (ISO website, last visited 30 April 2012).The planning
process and the assessment steps previously mentioned correspond to the Plan
and Do phases of the cycle, respectively. The Check phase is one of determining
how well the risk has been quantified/characterized and what deficiencies exist
in the currently available data, and the Act phase is one of determining how to
address these deficiencies for the next iteration of the cycle.
Although risk management is also an iterative process, it
relies on far more than just the scientific and methodological considerations
of risk assessment. Risk management must also take into account the feasibility
of control measures, socioeconomic factors and political considerations.
Additionally, risk management must factor in the potential impact of
alternatives to the risk being considered. For instance, if the exposure of interest
is the product or by-product of an industrial process, risk management must
also consider the potential risks of pushing industry toward alternate
processes, the product or by-products of which may pose equal or greater risks
that the primary agent of concern.
Risk management is also not wholly dependent upon the
existence of well-characterized or quantified risk. The Precautionary Principle
is that of instituting control measures when there is evidence of serious
damage to human health or the environment, even though the risk may not yet be
well quantified. As the United Nations’ 1992 Rio Declaration stated, “[L]ack of
full scientific certainty shall not be used as a reason for postponing
cost-effective measures to prevent environmental degradation.” This principle
is, of course, highly subject to interpretation, and is not an acceptable
substitute for a proper risk assessment. It does, however, provide a rational
basis for instituting an initial risk management program until an apparent risk
can be more accurately assessed.
Because risk management is also an inherently
politically-charged process, as well, risk communication is an extremely
important component of the process for developing consensus among shareholder
groups, including the media, the general public, and policymakers. Although
communication needs to be scientifically-based, it should also take into
consideration the target audience, as non-technical audiences are likely to
lose or misinterpret the intended message when highly technical language is
used (FDA website, last visited 30 April 2012).
An example of a situation in which good risk communication was
likely important in shaping policy was the passage in Maine last year of a ban
on the sale in the state of reusable food containers made with plastics
containing bisphenol A (BPA). BPA is used to harden some plastics by increasing
crosslinking between polymer chains and is also used in the lining of food cans
and in some types of paper. Although it has been known to possess some
estrogenic properties since 1936, BPA was grandfathered in as an existing
chemical under the 1976 Toxic Substances Control Act and industries were
allowed to continue using it without safety testing (Flint, et al., 2012).
Although BPA does not bioaccumulate at a level that reaches
the EPA’s threshold for concern, several studies have documented detrimental
effects in some wildlife species at levels of contamination which are known to
occur in the environment. These include the brown trout, which is an important
game fish in the state. Additionally, there is growing evidence that it may
increase infertility risks in women and may increase the risk of
estrogen-responsive tumors, such as meningioma (Ehrlich, et al., 2012, and
Duan, et al., 2012). Although this represents only a tiny fraction of the
available data, the governor stated at a press conference that he didn’t see
that there was any greater risk than women growing “little beards”.
Given that the governor’s party controls both branches of the
state legislature and the fact that both branches voted overwhelmingly in favor
of the ban, it is clear that the potential risks of BPA were communicated to
them sufficiently to garner broad bipartisan support for the measure. Of
course, there still remains the question of whether the ban will a) adequately
reduce levels of BPA contamination, and b) avoid increasing levels of other,
potentially more damaging, substitutes for BPA remains to be seen. With ongoing
iteration of the assessment and management processes, though, and with good
risk communication, there is at least some hope that these risks can be
mitigated.
REFERENCES
Moeller, D.W. Environmental Health, Fourth Edition. Harvard
University Press. 2011.
Flint, S., et al. “Bisphenol A exposure, effects, and policy: a
wildlife perspective”. Journal of Environmental Management. 104(2012):
19-34. doi: 10.1016/j.jenvman.2012.03.021
Ehrlich, S., et al. “Urinary bisphenol A concentrations and
implantation failure among women undergoing in vitro fertilization”. Environmental
Health Perspectives. E-pub, http://dx.doi.org/10.1289/ehp.1104307
Duan, B., et al. “The relationship between urinary bisphenol A
levels and meningioma in Chinese adults”. International Journal of Clinical
Oncology. E-pub, doi: 10.1007/s10147-012-0408-6