Common
Elements of the Precautionary Principle
- Establish goals and objectives.
- Take preventive action even in the face of uncertainty.
- Shift the burden of responsibility for establishing safety and
efficacy to the proponents of an activity
- Explore a wide range of alternative actions when harmful outcomes
are suspected.
- Encourage public participation in decision making.
Precautionary Principle: Reasonable, Rational,
and Responsible
(An Evolutionary, Not Revolutionary Approach to Decision-making)
Steven G. Gilbert
Based in part on Precautionary Principle talk December 6, 2005
Washington Health Legislative Conference - Health Or Health Care?
Seattle, WA
Introduction
The precautionary principle is a reasonable, rational, and responsible
approach to decision-making (Table 1). It provides a framework for
policy making that promotes human health, a sustainable environment,
and ensures that future generations of all species have an opportunity
to thrive.
But first, when you got in your car this morning did you think
about the relative benefits of driving your car to work, the store,
or errands as compared to the cost to the environment or risks to
your health should you get in an accident? Did you take the precautionary
action of wearing a seat belt to reduce the risk to your health
and safety? Did you think about walking or taking the bus, instead
of driving, to reduce air pollution?
Some of you are may take prescription drugs and are confident that
the benefits out weigh the risks of harm because trust that Food
and Drug Administration (FDA) has carefully reviewed the research
and approved the sale of those medications. The FDA takes a precautionary
approach when it approves drugs. It requires pharmaceutical companies
to demonstrate the efficacy and safety of their products before
they are put on the market. We expect that the companies that benefit
from the sale of their drugs should take on the responsibility for
demonstrating that the product meets certain standards of safety.
From tragic experience, we have learned that when this precautionary
process breaks down consumers suffer.
In contrast, we often do not take a precautionary approach to chemical
exposures to children. For example, while a nursing baby receives
the tremendous benefits of breast milk, they are often exposed to
a number of industrial chemicals that are present in the breast
milk. Often there is little information about potential for harmful
development effects of the industrial chemicals found in breast
milk. This raises a question: What is the equivalent seat belt for
our children’s health – is there a way to take precautionary
measures to protect our children’s health and intellectual
potential from the adverse affects of industrial chemicals?
We often take a precaution approach in our daily lives and we legislated
a mandatory precautionary approach for the sale of prescription
and over the counter drugs. The next evolution in the use of a precaution
approach is in the management of the use of industrial chemicals.
One of the most critical question is - What policy approach should
we use as a guideline in protecting future generations – our
children’s children? I believe it is reasonable, rational,
and responsible to use the precautionary principle, to learn from
our past experience and years of scientific developments, and initiate
a comprehensive and sustainable decision-making process.
Flavors of Precaution
The precautionary principle was defined at the Wingspread Conference
in 1998 as:
“When an activity raises threats of harm to human health
or the environment, precautionary measures should be take even if
some cause and effect relationships are not fully established scientifically.”
While the definitions of the precautionary principle come in a
number of flavors, all flavors have the same common elements. It
is the same with cars, some arrive at their destination more quickly,
some are more environmentally friendly, some might need more repair,
but all cars have basic identifiable elements, including seatbelts.
There are five elements that form the foundation of all versions
of the precautionary principle (Table 2).
The first common element is to have established goals and objectives.
Often objectives are broad, such as ensuring the health and well
being of future generations. More specific goals also might be established,
such as a list of health indicators or targets for health in local
growth plans. For example: ’by 2015 reduce the incidence of
childhood asthma by 50%’ or ‘by 2015 reduce the number
children with learning disabilities by 10%’ or ‘by 2015
reduce the rate of adult-onset diabetes by 10% through weight loss
programs.
The second common element is to take preventive action even in
the face of uncertainty. In the 1920’s the European League
of Nations banned the use of lead paint based upon data indicating
exposure to lead based paint could cause harmful health effects.
The United States government was slow to acknowledge the harmful
effects to children who were exposed to lead paint and delayed action
until 1971. Had the US government taken a more precautionary approach
and banned lead paint earlier, countless children could have been
spared the challenges of learning disability.
A third element includes shifting the burden of responsibility for
proving safety and efficacy to the proponents of an activity. This
suggests that those who benefit from the action have a obligation
of conducting the appropriate tests to ensure safety. For example,
pharmaceutical companies benefit from the development of new drugs
by making a profit when they sell a drug or medical device. Using
a precautionary approach the FDA requires that a company submit
data, paid for by the company, to demonstrate efficacy and safety
of the proposed product prior to marketing approval. The needs and
benefits of this precautionary approach is illustrated by the drug
thalidomide. In the 1950’s thalidomide was marketed, primarily
in Europe and Australia, as a sedative and anti-nausea drug for
pregnant women. Tragically, thalidomide caused a rare birth defect
when consumed by women during a specific period in pregnancy. Fortunately
thalidomide was not marketed in the United States because a woman
in the FDA questioned the safety data. The thalidomide experience
promoted Congress to increase the regulatory authority of the FDA
and require more testing of drugs prior to marketing approval. The
pharmaceutical companies assume the burden of responsibility to
demonstrate safety of their product in contrast to the limited requirements
placed on industrial chemical producers to demonstrate the safety
of their products.
A fourth element encourages the exploration of a wide range of
alternative actions when harmful outcomes are suspected. An initial
question might be: Is it activity/chemical/ procedure really necessary?
Or is a substitute as effective? A good example of exploring alternative
actions is the use of integrated pest management instead of using
pesticides. A number of schools systems are implementing integrated
pest management policies to reduce or illuminate the use of pesticides
around schools.
A final and fifth element common to definitions of the precautionary
principle encourages public participation in decision making. It
is essential that all stake holders have not only an opportunity
to but the means to participate in discussions and the decision
making process. The proponents of a product, process, or activity
must provide complete and accurate information and work with all
parties to ensure adequate understanding of its implications. While
this may seem costly and time consuming the beginning it almost
inevitably saves time and money and always produces the best results.
A reasonable approach
The precautionary principle is reasonable; it provides a comprehensive
and inclusive approach to decision-making that incorporates a vision
of human and environmental health and quality of life. This vision
of human and environmental health strives to “ensure that
all living things have the best opportunity to reach and maintain
their full genetic potential.ii” One might also consider this
vision of human and environmental health as supporting the achievement
of our “God-given potential” for “genetic potential”
depending on ones perspective. Part of being reasonable is encouraging
a discussion and consideration of our values. This definition of
human health is particularly relevant to our children, who need
an environment free from exposure to compounds that rob them of
their intellectual potential such as lead, mercury and PCBs. Furthermore,
the salmon of the world need clean and open streams in which to
express their future generations.
The precautionary principle is reasonable because; it encourages
participation of a broad range of stakeholders including business,
government, non-profit organizations, health-affected groups, and
most importantly the general public. Providing a healthy environment
for humans and other species is best accomplished by a broad community
of stakeholders working together to seek solutions. This starts
by sharing information and respecting each other’s values.
All stakeholders need access to technical information, and all need
to be helped to understand the issues.
The precautionary principle emphasizes prevention and consideration
of future generations. It is just common sense to prevent disease
and promote healthy conditions. Waiting to treat disease or cleaning
up toxic spills is more expensive, time consuming, and is often
disabling, and often does not even work.
A rational approach
The precautionary principle is rational and logical approach to
decision-making. We have considerable scientific knowledge and experience
that allow us to make good judgments even with uncertain or incomplete
information. We have enough information, in many cases, to rationally
consider alternatives, even when there may be some uncertainty or
incomplete information. As many CEOs know, there is never enough
information, but business doesn’t stop. CEOs must and do make
good and rational decisions even with incomplete information. There
needs to a shift in emphasis from increasing revenue and profits
to consideration of human and environmental health.
In the fields of biological and toxicological sciences we have
seen rapid advances that provide much of the knowledge we need to
prevent harm. A rational person or community takes action based
on an assessment of the facts combined with knowledge and experience
to support the greatest good for that community. True, we must constantly
review new information and update our decisions, but we should not
wait for the perfect information. What we do know from toxicological
sciences is that the developing organism is very sensitive to the
effects of environmental contaminants and adverse effects are discovered
at lower and lower levels of exposure. Here are a few examples documenting
the lessons learned where the rational application of the precautionary
principle would have benefited human health.
Fetal alcohol syndrome is characterized by facial deformities and
severe learning disabilities that result from alcohol consumption
during pregnancy. This condition and the sensitivity of the developing
organism were well described by researchers in the early 1970s.
It took almost 10 years after this scientific information was available
for the U.S. Surgeon General to advise women to avoid consuming
alcohol during pregnancy. Several more years passed before warning
labels were required on alcohol beverages. Scientists continue to
learn about the fetal affects of maternal alcohol consumption and
recognize that even small amount during pregnancy can result in
milder forms of learning disabilities, or Fetal Alcohol Effect.
But despite the new evidence, it was rational to act before this
latest information was available. Prevention is a reasoned approach.
Two thousand years ago it was known that “Lead makes the
mind give way”. Despite this knowledge lead was added to paint
and, in the 1920s, to gasoline. As early as the 1920s the European
League of Nations, despite some uncertainty about the health effects
of lead exposure, chose to ban lead-based paint. Unfortunately the
United States did not ban lead-based paint until 1971, resulting
in the contamination of countless homes. Millions of children were
exposed to harmful levels of lead because of this delay in action.
In addition, the cost of demonstrating that low levels of lead exposure
result in reduced IQ and learning deficits was borne by the taxpayers
not by the industries that benefited from the sale of lead-based
paint. Continued research on the health effects of lead has demonstrated
that there are no save levels of lead exposure for the developing
infant. We have enough scientific information to make a rational
and reasoned decision that lead exposure is harmful and must be
eliminated. The U.S. Center for Disease Control and Prevention (CDC)
has failed to act on this information and lower the acceptable blood
lead level from 10 mcg/dL to 2 mcg/dL.
A more recent example of a failure to have a rational approach
to prevent unnecessary exposure of children to potentially harmful
chemicals involves brominated flame retardants (PBDEs). These chemicals
are widely used in consumer products to prevent or retard fire,
clearly a desirable action. PBDEs are used in foam rubber cushions
and mattress, so you are probably sleeping on several pounds of
PBDEs. The problem is that these compounds do not stay in the product,
but show up in household dust and ultimately the food supply. PBDEs
have been found in women’s breast milk and result in un-intended
exposures to their babies. The PBDE manufacturers and distributors
have not demonstrated that these chemicals will not harm the environment
or cause adverse health effects. In contrast to the precautionary
measure taken when introducing new medicines, we take few precautionary
measures when introducing and using industrial chemicals.
These brief examples illustrate that knowledge is available to
make rational decisions with regard to exposure to harmful chemicals.
The challenge is to act on that information. Even when there is
some uncertainty about the potential effects, we know from experience
that even small amounts of chemicals can be harmful and that a precautionary
approach is a rational approach.
A responsible approach
Our ethical responsibility to our children, the offspring of other
species, and to future generations requires a precautionary approach.
It is the strategy that will be most like to help ensure an environment
that will help them reach and maintain their full potential . Part
of being responsible is encouraging a consideration of our personal
and national values.
America’s first bioethicist Aldo Leopold wrote in 1949: "A
thing is right when it tends to preserve the integrity, stability,
and beauty of the biotic community. It is wrong when it tends otherwise."
Exposing our children to the harmful effects of industrial chemicals
reduces their integrity, stability, and beauty as well as their
potential to succeed and live healthy, fruitful lives. Leopold went
on to say: “An ethic, ecologically, is a limitation on freedom
of action in the struggle for existence”. Leopold recognized
that certain constrains on our freedom may be necessary to achieve
a healthy outcome for the society. Laws requiring the use of seatbelts
or limits on fishing restrict our freedoms but were in acted to
promote a greater community good.
Garrett Hardin in his 1968 paper, The Tragedy of the Commons, recognized
that many problems of society have no technical solutions, but must
be managed to achieve the desired outcome. There is no technical
solution to fetal alcohol syndrome once the child is affected. The
only solution is the elimination of alcohol during pregnancy –
or prevention. Technological advances have lead to over fishing
the oceans; the most responsible way to control over fishing is
to restrict unlimited freedom to fish – or prevention. The
idea that there are “no technical” solutions does not
mean that technology is not necessary but rather that we often know
what to do but for a variety for reasons to not take action. For
example, we know what to do about lead based paint but do not employ
the resources.
An important element of the precautionary principle is that the
proponents of an activity must take responsible to demonstrate that
their chemical or product is safe and effective. Those who benefit
from the activity must assume responsibility for the harm their
product might cause. We have applied this concept successfully in
drug development and we could easily apply this experience to industrial
chemicals.
Conclusion
The precautionary principle is a reasonable, rational, and responsible
approach to protecting the health and potential of our children.
The most critical question is - What policy approach do we adapt
to protect the future generations – our children’s children?
The current system of evaluating the safety of industrial chemicals
is clearly not working. The precautionary principle offers a more
comprehensive approach to ensuring quality human and environmental
health by employing a series of elements that engage all stakeholders.
The precautionary principle is an evolution not a revolutionary
approach to our decision-making processes.
Table 1. Precautionary Principle: Reasonable, Rational, and Responsible
Reasonable (Able to discourse or discuss matters; ready of tongue
or speech; sensible; common sense; sound judgment)v • Comprehensive
and inclusive decision making approach
• Brings stakeholders together
• Emphasizes prevention rather than treatment
• Encourages sharing of information
• Considers future generations of humans and other species
Rational (Having the faculty of reasoning; endowed with reason;
coherent; rational) • Decisions based on scientific knowledge
and experience
• We have the knowledge and experience to prevent harm to
future generations
• Uncertainty is not a reason to delay action to ensure human
and environmental health
Responsible (Morally accountable for one's actions; capable of
rational conduct; answerable)v • Ethical responsibility and
duty to prevent harm
• Responsibility to promote human and environmental health
• The proponents of an action are responsible for demonstrating
safety
Table 2. Common Elements of the Precautionary Principle
Element
1 Establish goals and objectives.
2 Take preventive action even in the face of uncertainty.
3 Shift the burden of responsibility for establishing safety and
efficacy to the proponents of an activity
4 Explore a wide range of alternative actions when harmful outcomes
are suspected.
5 Encourage public participation in decision making.
Notes:
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