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of Environmental and Health Sciences, assessed BPA as being qualify as suitable for consideration, the National Institute
of intermediate concern for human health, on the third level of Environmental and Health Sciences sponsored a meeting
of their five-level scale. The panel voiced “some concern in 2009 of BPA researchers at which common protocols
for effects on brain, behavior, and prostate gland in fetuses, were established. Further, the agency devoted $30 million
infants, and children at current human exposures,” and wrote in 2011–2013 to BPA research to stimulate studies using
that “the possibility that bisphenol A may alter human devel- these protocols, generate additional information, and better
opment cannot be dismissed.” inform future panels about potential health impacts of BPA
The regulatory challenges faced with endocrine disrup- on humans. Because ratings like this heavily influence regu-
tors such as BPA were highlighted in this review. Initially, latory decisions, such as the one issued by the FDA in 2012
the panel deemed 80 studies appropriate for informing pol- opting not to restrict BPA use in food packaging (p. 378),
icy on regulating BPA, 70% of which were from academic initiatives like these can broaden the scientific studies used
laboratories (many of which found adverse effects of BPA to evaluate threats to public health.
on organisms) rather than industry laboratories (which typi-
cally found no effects of BPA). Shortly thereafter, the panel
received a 93-page letter from the American Chemistry Coun-
cil contending that many of the studies had flaws that made Risk management combines science
them unsuitable for informing regulatory policy. One com- and other social factors
mon criticism advanced in the letter was that academic studies
did not follow Good Laboratory Practice (GLP), which is part Accurate risk assessment is a vital step toward effective risk
of the protocols adopted by regulatory agencies around the management, which consists of decisions and strategies to
world to evaluate potentially toxic substances. After consider- minimize risk (Figure 14.18). In most nations, risk management
ing these concerns, the panel eliminated many academic stud- is handled largely by federal agencies. In the United States,
ies from consideration, reducing academic studies to a mere these include agencies such as the FDA, the EPA, and, the
30% of the studies being considered. Given this pool of stud- Centers for Disease Control and Prevention (CDC). In risk
ies to consider, the panel failed to rate any impacts of BPA management, scientific assessments of risk are considered in
as of “Concern for Adverse Impact” or “Serious Concern for light of economic, social, and political needs and values. Risk
Adverse Impact.” managers assess costs and benefits of addressing risk in vari-
Scientists argued that as a federal agency regulating ous ways with regard to both scientific and nonscientific con-
potentially toxic substances, the panel is expected to con- cerns before making decisions on whether and how to reduce
sider both GLP and non-GLP studies in its deliberations. or eliminate risk.
Also, they contended, very rigid GLP methods were not In environmental health and toxicology, comparing
always appropriate for chemicals such as BPA that show costs and benefits (p. 164) can be difficult because the ben-
unusual dose-response curves. To aid efforts to standardize efits are often economic, whereas the costs often pertain to
research protocols and produce more studies that would health. Moreover, economic benefits are generally known,
Scientific results Political, social,
and measurement economic, and
of probability ethical considerations
Risk Risk Policy
assessment management CHAPTER 14 • Envi R onm E n TA l H EA lTH A nd T o xi C ology
Scientific data on Information, opinion, and lobbying from
Hazard Toxicity Extent of Private Industry and Nonprofit
identification character- exposure citizens manufacturing interest
ization groups
Figure 14.18 The first step in addressing the risk of an environmental hazard is risk assessment.
Once science identifies and measures risks, then risk management can proceed. In this process,
economic, political, social, and ethical issues are considered in light of the scientific data from risk assessment.
The consideration of all these types of information is intended to result in policy decisions that minimize the risk
of the environmental hazard. 399
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