PU Rachel's Precaution Reporter #17
DA December21, 2005

HD Precautionary Principle: Reasonable, Rational, and Responsible

An Evolutionary, Not Revolutionary, Approach to Decision-making

CM Using examples from modern life (chemicals in breast milk, toxic
lead in paint, fetal alcohol syndrome, and toxic flame retardants),
toxicologist {Steve Gilbert} presents five common elements to a
precautionary approach. We successfully apply precaution in the
pharmaceutical industry without bringing it to a halt, so why can't we
apply it to industrial chemicals that cause cancer, brain damage, a
myriad of other health effects, and environmental damage?

UR

AU By {Steven G. Gilbert}

Introduction

The precautionary principle is a reasonable, rational, and responsible
approach to decision-making. 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 readers may take prescription drugs, confident that the benefits
outweigh the risks of harm because you trust that the 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 precautionary 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 precautionary approach is in the management of the use of
industrial chemicals. One of the most critical questions 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."[2]

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.

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
U.S. government taken a more precautionary approach and banned lead
paint earlier, countless children could have been spared the
challenges of learning disabilities.

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 are 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 prompted 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 products 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 the 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
eliminate 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 in 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."[3] 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 one's
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
for 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 be 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 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 amounts 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 safe 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/deciliter to 2 mcg/deciliter.

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 unintended
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 likely to help ensure an
environment that will help them reach and maintain their full
potential.[3] Part of being responsible is encouraging 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."[4]
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 enacted 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.[5] 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 of 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 responsibility 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 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 evolutionary not a revolutionary
approach to our decision-making processes.

*  *  *

REASONABLE
(Able to discourse or discuss matters; ready of tongue or
speech; sensible; common sense; sound judgment)[6]:
** 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)[6]:
** 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)[6]:
** Ethical responsibility and duty to prevent harm
** Responsibility to promote human and environmental health
** The proponents of an action are responsible for demonstrating
safety

Steven G. Gilbert, Ph.D., can be reached at the Institute of
Neurotoxicology & Neurological Disorders, 8232 14th Ave NE Seattle, WA
98115; Tel. 206-527-0926; Fax: 206-525-5102; Email: sgilbert@innd.org
Web: www.asmalldoseof.org ("A Small Dose of Toxicology")

==============

[1] This essay was originally presented in part at the Washington
Health Legislative, Seattle, WA, December 6, 2005.

[2] Carolyn Raffensperger and Joel Tickner (Eds.), (1999), Protecting
Public Health & the Environment: Implementing the Precautionary
Principle. Washington, DC: Island Press.

[3] Steven G. Gilbert, Ethical, legal, and social issues: our
children's future. Neurotoxicology, Vol. 26/4 pp 521-530, 2005. (doi
10.1016/j.neuro.2004.12.006).

[4] Aldo Leopold, (1949), A Sand County Almanac.

[5] Garrett Hardin, (1968), The tragedy of the commons. The population
problem has no technical solution; it requires a fundamental extension
in morality. Science, 162(859), 1243-1248.

[6] Oxford English Dictionary.

{1} http://www.powells.com/biblio/71-0415311683-0

{2} http://www.powells.com/biblio/71-0415311683-0