A Small Dose of ToxicologyAntioch & Prec Prin 09/10/05 A Small Dose of Precaution The Precautionary Principle, Ethics, and Society Antioch - Environmental

A Small Dose of Toxicology Antioch & Prec Prin 09/10/05

A Small Dose of Precaution

The Precautionary Principle, Ethics, and Society

Antioch - Environmental ScienceSeptember 10, 2005

Steven G. Gilbert, PhD, DABTwww.asmalldoseof.org LINK

Antioch & Prec Prin 09/10/05 A Small Dose of Toxicology

A Small Dose of Toxicology

See: www.asmalldoseof.org -- smdose


NW Public Health

See: http://healthlinks.washington.edu/nwcphp/nph/

nwph

Public Health and the Precautionary

Principle

By Steven G. Gilbert


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)


Precautionary Principle

"The Precautionary Principle": An ethical paradigm to protect human health and environmental health under conditions of uncertainty (but we know a lot).


Current Bioethical Issues

Check the local news paper Stem cells (state, national, international) Genetically Engineered Organisms Knowing your genes In vetro fertilization – choosing your child's

genes and characteristics Global warming Nanotechnology Environmental health Chemicals exposures – human health


Child Health


“Conditions that ensure that all living things have the best opportunity to reach and maintain their full genetic potential.”

S. Gilbert (1999)

Environmental & Human Health


Socially responsible white guys?


Socially Responsibility

What is social responsibility?

What are our responsibilities to society?


"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

The First Bioethicist

---------- 1887 - 1948 ----------

Aldo Leopold


“An ethic, ecologically, is a limitation on freedom of action in the struggle for

existence”Aldo Leopold

Limits on Freedom


“The Commons”

The Tragedy of the CommonsBy Garrett Hardin, Science, 1968


Technical Solutions

“It is our considered professional judgment that

this dilemma has no technical solution.”

The Tragedy of the CommonsBy Garrett Hardin, Science, 1968


Problems – Solutions?

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


Lessons Learned

Thalidomide Methylmercury Lead Ethanol (Alcohol) PBDEs


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


Fetal Effects of MeHg


The Mercury Cycle


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.

WA State Advisory

http://www.doh.wa.gov/fish/FishAdvMercury.htm


Lead In Homes


Agency Blood Lead Levels

60

40

3025

2015

10

20

10

20

30

40

50

60

Blo

od

Lea

d (

ug

/dl)

CDC1960

CDC1973

CDC1975

CDC1985

WHO1986

EPA1986

CDC1990

CDC2006?

Agency and Year

Acceptable Childhood Blood Lead Levels

Antioch & Prec Prin 09/10/05 A Small Dose of ToxicologyFAS Child


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??


• 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

Policy Approaches


Structure of PBDEs

X & Y are number of Bromine atomsCommon Penta, Octa, and Deca

PolyBrominated Diphenyl Ether

O

BrxBry


PBDEs in House Dust (ppb)

From EWG - Toxic Fire Retardants Contaminate American Homes - http://www.ewg.org/reports/inthedust/summary.php


PBDEs in Breast Milk (ppb)

From EWG - Toxic Fire Retardants in Breast Milk from American Mothers - http://www.ewg.org/reports/mothersmilk/es.php


Developmental Data

2863 above 1 Million pounds

78.2% no data

21.4% some data

12 or 0.4% good data

www.preventingharm.org


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

The Consequences


The challenge

To develop an individual and societal ethical framework for

decision making that supports the long term maintenance of a globally

sustainable ecology

Genomic and Ecological Bioethics


The challenge

“the knowledge of how to use knowledge for the social

good”

Knowledgeable Bioethics


“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.

Precautionary Principle


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)

Safety & Efficacy vs Harm


• Taking preventive action in the face of uncertainty

• Shifting the burden of proof/responsibility to the proponents of an activity

• Exploring a wide range of alternatives to possibly harmful actions

• Increasing public participation in decision making (environmental justice)

Wingspread Conference, 1998.

Central components


Improve decision making Promote integrated assessments Promote transparency Promote sharing of information Examine alternatives Examine uncertainties Encourage discussion among

stake holders

Purpose/Objectives


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 PP working group

Seattle Initiative


• Seattle Precautionary Principle White Paper (www.asmalldoseof.org)

• Inclusion of PP in Comp Plan Environment Element

(http://www.seattle.gov/dpd/Planning/Seattle's_Comprehensive_Plan/DPD_001178.asp) Link

Result of Effort


“Protecting Public Health by Adopting the Precautionary Principle as an Approach to Decision Making”

Resolution Submitted to Washington State Public Health Association

WSPHA Resolution


California

San Francisco Precautionary Purchasing Ordinance - June 2005

Resolution of the Marin county board of supervisors

“A resolution to continue to incorporate the precautionary principle in county operations.” Oct 2004

Oregon

Multnomah County, OR Resolution - September 2004 New York State Legislation - April 2005 Bill A07256 “To protect public health and the environment by establishing

a precautionary policy for state and local governments in New York State.” Bill A07257 “To establish a preference for the purchase of commodities,

services, and technologies by the State of New York that minimize

potential adverse impacts on public health and the environment.”

States in the US


Agreement Respecting Canada-wide Standards for Dioxins and Furans: Steel Manufacturing Electric Arc Furnaces

Pollution Prevention Strategy“In keeping with the Precautionary Principle as set out as guidance in the Canada-wide Standards Sub-agreement, and in consideration of the CWS principles of sound science, technical feasibility and socio-economic impacts, …..”http://www.ec.gc.ca/CEPARegistry/notices/NoticeText.cfm?intNotice=159&intDocument=939

Canada and PP


REACH -- Registration, Evaluation and Authorization of Chemicals

The two most important aims are to improve protection of human health and the environment from the hazards of chemicals and enhance the competitiveness of the EU chemicals industry.

The Commission’s White Paper on the Strategy for a future Chemicals Policy was adopted in on 13 February 2001.

A Precautionary approach

REACH-European Union


REACH -- Registration, Evaluation and Authorization of Chemicals

Initially regulate High Production Volume (HPV) chemicals - produced or imported above 1,000 metric tons.

Total world wide production of chemicals 400 million metric tons per year or $1.6 Trillion

To be introduced into European Parliament late this year.

REACH


• 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

Knowledge - Responsibility


The Potential of Children


Additional Information

The Science and Environmental Health Network (SEHN) (www.sehn.org)

Late lessons from early warnings: the precautionary principle 1896-2000 – European Environment Agency (free)

Garrett Hardin - The Tragedy of the Commons (Science, 1968)

Ethics and Environmental Health – Mini Monograph - Environmental Health Perspectives (November 2003)

Ethical, legal, and social issues: our children's future. Steven G. Gilbert. Neurotoxicology, 26/4 pp 521-530, 2005.

Public Health and the Precautionary Principle. Steven G. Gilbert. NW Public Health, Spring 2005. http://healthlinks.washington.edu/nwcphp/nph/


Ethics and the Precautionary Principle

Questions or Comments?

Download Presentation from www.asmalldoseof.org


Authorship Information

For Additional Information ContactSteven G. Gilbert, PhD, DABT

E-mail: [email protected]: www.asmalldoseof.org

This presentation is supplement to “A Small Dose of Toxicology”


Socially Responsible


Scientific Process

VariabilityUncertainty


• Statistical

• Model

• Fundamental

Types of Uncertainty


• Easiest to examine & reduce

• Not knowing the exact value of a variable (inter and intra subject variance)

• Sample size

Statistical Uncertainty

Reducing Variability


• Not fully understanding the relations between variables (mechanism of action)

• Which variables are most important (high dose vs low dose)

Model or System Uncertainty


• Not knowing the right questions to ask

• Most sensitive end point

• “we don’t know what we don’t know”

Fundamental Uncertainty


• Dose Response Issues

• Higher metabolic rate

• Different nutritional requirements

• Rapidly dividing & migrating cells

• Immature organs

Susceptibility of Children


"Biology combined with diverse humanistic knowledge forging a

science that sets a system of medical and environmental

priorities for acceptable survival.“Global Bioethics (1988)

Bioethics

-------- 1911 - 2001 --------

Van Rensselaer Potter


Fetal Alcohol Effect (FAE)

Milder form of FAS

7,000-36,000 infants per year in US

1 to 3 infants per 1,000 world wide??

CharacteristicsGrowth deficiency

Learning dysfunctionNervous systems disabilities


WHO Vision for Child Health

A World Fit for Children • Promoting healthy lives• Providing quality education• Protecting against abuse,

exploitation and violence• Combating HIV/AIDS.

http://www.unicef.org/why/why_worldgoals.html


CDC Vision for Child Health

“Environmental Health at CDC strives to promote health and quality of life by preventing or controlling those diseases or deaths that result from interactions between people and their environment.”

http://www.cdc.gov/node.do?id=0900f3ec8000e044


• 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

Convergence of Issues


American Academy of Pediatrics

Mission and vision

To attain optimal physical, mental and social health and well-being for all infants, children, adolescents and young adults.

http://www.aap.org/member/memcore.htm


American Academy of Pediatrics

The APA goes on to state: “To this purpose, the AAP and its members dedicate their efforts and resources.

The vision: 1) to advocate for infants, children, adolescents, and young adults and provide for their care; 2) to collaborate with others to assure child health; and ….

http://www.aap.org/member/memcore.htm


“Children can develop and mature in an

environment that allows them to reach and maintain their full

potential.”

Vision for Child Health


"All scientific work is incomplete - whether it be observational or experimental. All scientific work is liable to be upset or modified by advancing knowledge. That does not confer upon us a freedom to ignore the knowledge we already have or postpone the action that it appears to demand at a given time. "

Sir Austin Bradford Hill (1965)

Sir Austin Bradford Hill


1. Strength of association

2. Consistency of findings

3. Biological gradient

4. Temporal sequence

5. Biologic or theoretical plausibility

6. Coherence with established knowledge

7. Specificity of association

Sir Austin Bradford Hill (1965)

Determining Causation


The citizen toxicologist is a thoughtful advocate for human and environmental health, who strives to share their scientific knowledge with the public, speaking to public interests rather than private or special interests.

Citizen Toxicologist

Socially Responsible Toxicologist


• Testifying

• Writing review papers

• K-12 class room teaching

• Adding expertise to community groups

• Education

• Mentoring

• Speakers Bureau

Socially Responsible Actions


• Forum in which to discuss the ethical implications of results from our science as well as the resulting legal and social implications.

• 2005 SOT meeting – workshop on Conflict of Interest

SOT - ELSI Specialty Section

http://www.toxicology.org/memberservices/specsection/specsection.html


1) Respect - for the needs and rights of this and future generations as well as others who cannot speak for themselves

2) Humility - towards the natural world and our ability to understand it through science

3) Democracy - giving people a voice in matters that affect their lives

4) Responsibility - government’s public trust responsibility to manage the commonwealth for this and future generations.

- Individuals’ including industry, obligation to take responsibility for their actions in the world.

Values of the precautionary principle

Documents

A Small Dose of ToxicologyAntioch & Prec Prin 09/10/05 A Small Dose of Precaution The Precautionary Principle, Ethics, and Society Antioch - Environmental