The Precautionary Principle: Reasonable, Rational, and Responsible Evolutionary Not Revolutionary Ap

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The Precautionary Principle Reasonable,
Rational, and Responsible(Evolutionary Not
Revolutionary Approach)
Steven G. Gilbert, PhD, DABT www.asmalldoseof.org
LINK
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Risk Precaution
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FDA Precaution
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Benefits Risk
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Precautionary Principle

• Reasonable
• Rational
• Responsible

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Reasonable
Able to discourse or discuss matters ready of
tongue or speech sensible common sense sound
judgment
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Rational
Having the faculty of reasoning endowed with
reason coherent rational
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Responsible
Morally accountable for one's actions capable of
rational conduct answerable
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Child Health
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Lessons Learned

• Knowledge to policy
• Disease is money
• Externalize costs
• How to make money from prevention?

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Convergence of Issues

• Vision of Child Health
• Knowledge of Reproductive and Developmental
  Toxicology
• Policy Approach within an ethical framework
• Social responsibilities
• No technical solutions
• Restriction of freedoms
• Precautionary Principle

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Vision for Child Health
Children can develop and mature in an
environment that allows them to reach and
maintain their full potential.
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Human Environmental Health
Conditions that ensure that all living things
have the best opportunity to reach and maintain
their full genetic potential. S. Gilbert (1999)
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Socially responsible white guys?
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The First Bioethicist
Aldo Leopold
"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."
- Aldo Leopold, 1949, A Sand County Almanac
---------- 1887 - 1948 ----------
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Limits on Freedom
An ethic, ecologically, is a limitation on
freedom of action in the struggle for
existence Aldo Leopold
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The Commons
The Tragedy of the Commons By Garrett Hardin,
Science, 1968
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Technical Solutions
It is our considered professional judgment that
this dilemma has no technical solution. The
Tragedy of the Commons By Garrett Hardin,
Science, 1968
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Problems Solutions?

• Lead and kids
• Fetal alcohol syndrome
• Nuclear disarmament
• Bioterrorism
• Ocean Fisheries
• Persistent chemicals
• The Commons

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Rational
Having the faculty of reasoning endowed with
reason coherent rational
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Lessons Learned

• Thalidomide
• Ethanol (Alcohol)
• Methylmercury
• Lead
• PBDEs

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Thalidomide

• Introduced in 1956 as sedative (sleeping pill)
  and to reduce nausea and vomiting during
  pregnancy
• Withdrawn in 1961

• Discovered to be a human teratogen causing
  absence of limbs or limb malformations in
  newborns
• 5000 to 7000 infants effected
• Resulted in new drug testing rules

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What Is This?
(CH3-CH2-OH)
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FAS Child
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FAS FAE
Most common preventable cause of adverse CNS
development Fetal Alcohol Syndrome
(FAS) 4,000-12,000 infants per year in US Fetal
Alcohol Effect (FAE) 7,000-36,000 infants per
year in US 1 to 3 infants per 1,000 world wide??
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Policy Approaches

• 1981 - U.S. Surgeon General first advised that
  women should not drink alcoholic beverages during
  pregnancy.
• 1988 - U.S. requires warning labels on all
  alcoholic beverages sold in the United States.
• 1990 - U.S. Dietary Guidelines state that women
  who are pregnant or planning to become pregnant
  should not drink alcohol.
• 1998 - 19 states require the posting of alcohol
  health warning signs where alcoholic beverages
  are sold

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Mercury Toxicology
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Fetal Effects of MeHg
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The Mercury Cycle
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WA State Advisory
Limit the amount of canned tuna you eat, based on
your bodyweight. Guidelines are Women of
childbearing age should limit the amount of
canned tuna they eat to about one can per week
(six ounces.) A woman who weighs less than 135
pounds should eat less than one can of tuna per
week. Children under six should eat less than
one half a can of tuna (three ounces) per week.
Specific weekly limits for children under six
range from one ounce for a twenty pound child, to
three ounces for a child weighing about sixty
pounds.
http//www.doh.wa.gov/fish/FishAdvMercury.htm
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Ancient Awareness
"Lead makes the mind give way."
Greek Dioscerides - 2nd BC
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Lead In Homes
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Lead Health Effects

• Children more vulnerable than adults
• Orally consumed lead absorbed in place of calcium
• CHILDREN absorb 30-50 of oral lead
• ADULTS absorb 5-10 of oral lead
• Increased absorption during pregnancy
• Childhood effects
• Decreased intelligence (lower grades)
• Hyperactivity (higher school dropout rate)
• Growth retardation
• Effects at blood lead levels of 10 µq/dL

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Agency Blood Lead Levels
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Structure of PBDEs
PolyBrominated Diphenyl Ether
X Y are number of Bromine atoms Common Penta,
Octa, and Deca
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PBDEs in House Dust (ppb)
From EWG - Toxic Fire Retardants Contaminate
American Homes - http//www.ewg.org/reports/inthed
ust/summary.php
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PBDEs in Breast Milk (ppb)
From EWG - Toxic Fire Retardants in Breast Milk
from American Mothers - http//www.ewg.org/reports
/mothersmilk/es.php
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PBDEs In Milk Fat
(adapted from Northwest Environmental Watch, 2004)
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Developmental Data
2863 above 1 Million pounds
12 or 0.4 good data
21.4 some data
78.2 no data
www.preventingharm.org
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The Consequences

• Nearly 12 million children (17) under age 18 in
  the US suffer from one or more developmental
  disabilities
• Learning disabilities 5-10 of kids in public
  school
• ADHD 3-6 of all school kids, maybe higher

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Estimated Costs - National
Estimated Costs of Pediatric Disease of
Environmental Origin, United States,1997
(billions)
(From Environmental Pollutants and Disease in
American Children, Landrigan, Schechter, et.al.,
2002)
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Estimated Costs - Washington
Diseases and disabilities (asthma, cancer, lead
exposure, birth defects, and neurobehavioral
effects) attributable to environmental
contaminants.
Disease/Disability (2004 million)
Kate Davies Economic costs of diseases and
disabilities attributable to environmental
contaminants in Washington State. Antioch
University Seattle 2005. http//washington.chenw.o
rg/pdfs/EnvironmentalCosts.pdf
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Precautionary Principle
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. Wingspread Conference, 1998.
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Central components

• Setting goals (Health indicators)
• Taking preventive action in the face of
  uncertainty
• Shifting the burden of responsibility to the
  proponents of an activity (Who benefits?)
• Exploring a wide range of alternatives to
  possibly harmful actions (Is it necessary?)
• Increasing public participation in decision
  making (transparency of information
  environmental justice)

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Seattle Initiative

• City Comprehensive Plans
• Every citizen of Seattle has an equal right to a
  healthy and safe environment.
• Seattle sees the Precautionary Principle approach
  as its policy framework to develop laws for a
  healthier and more just Seattle.
• Seattle Precautionary Principle White Paper
  (www.asmalldoseof.org)
• Seattle PP working group CHE-WA

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Asthma Diabetes
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Overweight Obese
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Knowledge - Responsibility

• Children have a right to a safe, fair and healthy
  environment
• Ethical Responsibility to share and use of
  knowledge
• Duty to promote health and well being of children
• Thoughtful public health advocate

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Conclusion
The Precautionary Principle is part of the
evolution in our thinking and decision making
toward ensuring human and environmental health.
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Precautionary Principle

• Reasonable
• Rational
• Responsible

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Reasonable

• Able to discourse or discuss matters
• 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

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Rational

• Having the faculty of reasoning
• 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

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Responsible

• Morally accountable for one's actions
• Ethical responsibility and duty to prevent harm
• Responsibility to promote human and environmental
  health
• The proponents of an action are responsible for
  demonstrating safety

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The Potential of Children
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Additional Information

• A Small Dose of Toxicology (www.asmalldoseof.org)
• The Science and Environmental Health Network
  (SEHN) (www.sehn.org)
• Late lessons from early warnings the
  precautionary principle 1896-2000 European
  Environment Agency
• Ethical, legal, and social issues our children's
  future. Steven G. Gilbert. Neurotoxicology,
  26(4), pp 521-530, 2005.

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Questions or Comments?
Download Presentation from www.asmalldoseof.org
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Authorship Information
This presentation is supplement to A Small
Dose of Toxicology
For Additional Information Contact Steven G.
Gilbert, PhD, DABT E-mail smdose_at_asmalldoseof.org
Web www.asmalldoseof.org
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Socially Responsible
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A Small Dose of Toxicology
See www.asmalldoseof.org -- smdose
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NW Public Health
Public Health and the Precautionary Principle By
Steven G. Gilbert
See http//healthlinks.washington.edu/nwcphp/nph/
nwph
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Doubt / Uncertainty
"Doubt is our product since it is the best means
of competing with the 'body of fact' that exists
in the mind of the general public. 1969 an
executive at Brown Williamson owned by R. J.
Reynolds Tobacco Company (Doubt Is Their Product
by David Michaels in Scientific American, June
15, 2005)
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New Mexico Precaution

• NEW MEXICO CREATES A PRECAUTIONARY PRINCIPLE TASK
  FORCE
• In New Mexico, the state Environment Department
  and the state Department of Health have formed a
  joint task force to study the precautionary
  principle. The task force will advise the
  Governor and the Executive Branch on the
  potential and practice of implementing the
  principle in New Mexico. Findings and
  recommendations are due in
• October 2006

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Safety Efficacy vs Harm

• FDA regulations of Drugs (1938)
• FDA regulations of Dietary Supplements (Dietary
  Supplement Health and Education Act of 1994
  (DSHEA))
• Ephedra present an unreasonable risk of illness
  or injury (Dec, 2003)