The Louisville Charter for Safer Chemicals  [Printer-friendly version]
May 15, 2005

ACT ON EARLY WARNINGS: LOUISVILLE CHARTER BACKGROUND PAPER #4

Act with foresight. Prevent harm when credible evidence exists that
harm is occurring or is likely to occur, even when some uncertainty
remains regarding the exact nature and magnitude of the harm.

[Rachel's introduction: The final draft of the Louisville Charter for
Safer Chemicals has now been published, along with six supporting
"background papers." This is paper #4. Hats off to Kathy Curtis of
Citizens' Environmental Coalition (Albany, N.Y.) who rode herd as
dozens of participants spent more than a year devising, honing and
polishing these important policy ideas.]

By Nancy Myers, Anne Rabe, and Katie Silberman

[RPR Introduction: The Louisville Charter for Safer Chemicals grew
out of a May, 2004, meeting of citizen-groups working to prevent
chemical harms; they then spent a year developing ideas for a better
U.S. chemicals policy. The Charter itself is supported by six
background papers. This is paper #4. Papers #1, #2, #3, #5,
and #6 are also available on the web, along with some background
on the Louisville Charter.

This background paper is also available in PDF format.

Abstract

Two conditions establish the threshold for protective action in the
presence of scientific uncertainty:

1. Credible evidence that a synthetic chemical can cause biological
changes that are known to result in unintended harmful outcomes to
human health or the environment in some cases.

2. The presence of such a chemical where it does not belong and where
it can cause damage to biological systems (such as human bodies).

Acting with foresight takes many forms. We must create and strengthen
human health and wildlife monitoring programs to detect and predict
harm; take steps to prevent, eliminate, and mitigate exposure when
credible evidence of harm is found; monitor novel technologies;
consider clusters of problems to be early warnings of harm; and open
toxic tort records. All action taken must be based on precautionary
definitions of "harm" and "credible evidence" and must include public
participation. Significant precautionary actions may be taken on the
state and local level in advance of a precautionary national chemicals
policy. [End of abstract.]

Introduction

Twenty-twenty hindsight tells us about the inadequacy of our ability
to detect and prevent chemical damage to biological systems. In case
after case, long periods of time have elapsed between the emergence of
the first credible scientific evidence that unintended harm was being
done to biological systems and the first action taken to address the
problem. DDT, benzene, asbestos, PCBs, and chlorofluorocarbons are
some of the best-known examples. In some cases, such as ozone-layer
damage, scientific intelligence systems failed -- harm was discovered
late because we didn't know what to look for, or we weren't looking
for harm at all. More often, however, the failures have come in
interpreting and acting upon emerging information. We have not heeded
early warnings and taken precautionary action.

Precautionary chemical policies do not stifle innovation. On the
contrary, exercising foresight implies an aggressive search for, and
transition to, safer substitutes. This kind of technological
innovation can help us get the benefits we seek with less harm to
human health and the environment. To prevent harm, chemical policies
should therefore include:

** Thorough measures to gather and evaluate evidence that a chemical
is likely to have harmful side effects;

** Specific thresholds and standards for acting to prevent harm; and

** The development of systems that avoid reliance on toxic chemicals.

A Precautionary Definition of Harm Sets the Terms for Protective
Action

Our chemical policy system must put the health of people and
ecosystems above all other considerations. This priority requires a
clear sense of when to act and what to do to prevent harm, even before
science can give definitive answers. This section describes the kind
of harm that biologically active chemicals can cause, scientific
uncertainty, and credible evidence of harm. These definitions help us
decide when and how to take protective action.

** Biologically Active Chemicals are Harmful

** Acting when Science is Uncertain

** Defining the "Credible Evidence of Harm" Threshold for Protective
Action

Biologically Active Chemicals are Harmful

At its simplest and least controversial, "harm" is damage to humans,
fish, wildlife, or ecosystems that may show up as

** acute toxicity, such as chemical poisoning causing death;

** cancer;

** reproductive impairment or failure, for example, resulting from
decreased sperm count;

** developmental abnormalities, such as birth defects or learning
disabilities;

** behavioral changes, such as attention deficit disorder;

** immune system alterations, such as autoimmunity or allergies;
disruption of biological signaling systems, such as changes in hormone
levels; or

** other manifestations of damage to biological systems that result in
disease or suboptimal functioning.

In this paper we will call chemicals capable of causing such harm, as
side effects to their intended use, biologically active chemicals.

Acting when Science is Uncertain

Although biologically active chemicals can cause harm, identifying
harm may still be controversial because linking harmful outcomes in
specific individuals or communities to specific chemicals that may
have caused them is often difficult or impossible. Here are some
reasons why:

** The earliest manifestations of damage may lie within "normal
variability" of individuals or populations. For example, individuals
or populations may have reduced brain or reproductive function as the
result of chemical exposures, although measures of their neurological
or reproductive function may still lie within "normal" ranges;

** The earliest manifestations of damage are sometimes not, in
themselves, easily classified as harmful. For example, a chemical
exposure may alter levels of hormones or other systemic substances in
an organism. These changes may increase the risk of a variety of
adverse effects, but the effects themselves are non-specific and not
easily linked to the original exposure;

** A long latent period may follow early manifestations of altered
biological functioning before more obvious and conclusive evidence of
harm emerges. For instance, some cancers have latency periods of up to
40 years;

** The manifestations of harm are often not unique to a single
specific cause. For example, diet, exercise, genetics, high blood
pressure, exposure to air pollutants, some industrial chemicals, and
cigarette smoking can all contribute to heart disease. These factors
act alone and in many different combinations to increase risk.
Defining the contribution of any one of them to the ultimate risk of
heart disease in an individual or population is filled with
uncertainty.

By convention, scientific certainty is generally considered to be
established when an assertion is considered "true" with at least 95%
likelihood or when a number of strict criteria that establish
causation have been met. These requirements translate into "beyond a
reasonable doubt." It is, however, difficult to draw conclusions about
cause and effect relationships in complex biological systems without
acknowledging some degree of uncertainty. Factors that influence
uncertainty include the following.

** Lack of data -- temporary, reducible uncertainties (which may, for
example, be addressed by requiring comprehensive safety data for all
chemicals, another key action item of the Louisville Charter).

** System complexity -- interacting variables, cumulative impacts,
delayed effects, or the difficulty of extrapolating from controlled
conditions to real-world conditions. These uncertainties may be
reducible, but reaching certainty may never be possible.

** Ignorance -- we often do not know how much we do not know,
especially where novel and emerging technologies are concerned.
Novelty itself must be considered a risk factor, because harmful
effects of new technologies may not be detected or predicted by tests
developed for older technologies. Emerging technologies require
special scrutiny, both pre-market and post-market.

** Controversies and conflicts influence scientific opinion and
investigations, for example:

** Conflicting values, especially regarding what constitutes harm;

** Economic pressures within the scientific community;

** Economic pressures from industry to discourage health and
environmental investigations.

Defining the "Credible Evidence of Harm" Threshold for Protective
Action

Despite the difficulties posed by scientific uncertainty, we do know
enough to act when we have credible evidence that harm is occurring or
likely to occur from biologically active chemicals. Credible evidence
of harm includes any or some combination of the following:

** well-established, independent scientific evidence of harm to human
health or ecosystems;

** emerging scientific evidence of harm to human health or ecosystems;

** verifiable evidence of altered functioning of exposed organisms,
including damage to DNA, biological systems, or cellular function;

** results of comprehensive or partial testing and controlled
observations, including animal studies;

** observations from formal health, environmental, or wildlife
monitoring;

** epidemiological evidence;

** health surveys or verifiable observations of and by workers;

** observations by medical personnel;

** observations, experience, or community health surveys by people
living near industrial facilities, waste sites, or other sources of
contamination;

** extrapolation from existing, well-established scientific evidence
on existing substances to new substances with similar structures and
physico-chemical properties; and

** predictive models based on empirical data.

The duty to consider all relevant information from multiple sources is
a fundamental principle of science. The best scientists keep their
minds open to all relevant information, including factors that lie
outside the scope of their investigations. Yet, when science is
translated to policy, this aspect of scientific learning is often
forgotten or ignored. Too often, policy makers have looked to science
for precision without taking into account the skepticism and
uncertainty embedded in science itself -- the hesitance to draw hard
and fast conclusions -- and the continuing curiosity that is essential
to scientific investigations. People who are not technical experts,
especially people living in communities disproportionately affected by
chemical contamination, may have an even keener sense than experts do
of what must be considered, and they can provide relevant information.

We must increase our understanding of complex biological systems and,
in the absence of complete understanding, do what we can to protect
the integrity of such systems, including human bodies. We must keep
alert to the political and social influences on our knowledge, the
limits of that knowledge, and the potential costs, including the human
health costs, of transgressing those limits.

When do we know enough to act? To sum up, two conditions provide
credible evidence of harm in cases of scientific uncertainty on
biologically active chemicals. These conditions establish the
threshold for various kinds of protective action.

1. Credible evidence that a synthetic chemical can cause biological
changes that are known to result in unintended harmful outcomes in
some cases.

2. The presence of such a chemical where it does not belong and where
it can cause damage to biological systems (such as human bodies).

The best way to protect the health of people and ecosystems is through
chemical policies that regulate the production and use of all
biologically active chemicals, remove those chemicals from where they
can cause damage, and treat untested chemicals as potentially
dangerous. And because it is impossible to predict all side effects of
synthetic substances, giving priority to the health and well-being of
humans and the environment means monitoring presence and effects of
chemicals in the real world even after a full safety-testing regime is
in place.

Acting to Prevent Harm On the State & Federal Level

We can act to prevent harm from chemicals through a wide variety of
measures, some of which we describe below and many of which are
described in other parts of the Charter.

** How Taking Precautionary Action Relates to Other Charter Reforms

** Create and Strengthen Health & Environmental Programs to Detect and
Predict Possible Harm

** Take Action when Credible Evidence of Harm is Found

** Monitor Novel Technologies

** Consider Clusters of Health Problems to Be Early Warnings

** Open Toxic Tort Records

How Taking Precautionary Action Relates to Other Charter Reforms

Reform #1: Require Safer Substitutes: A precautionary chemical regime
encourages the development of innovative, safer technologies. The
principles of green chemistry and requirements for safer substitutes
are the positive side of a precautionary approach. Inherently safer
chemistry is the goal of this Charter. The preventive actions
recommended in this background paper must be accompanied by incentives
and requirements for safer substitutes.

Reform #2: Phase Out Persistent, Bioaccumulative, or Highly Toxic
Chemicals. Acting with foresight requires collecting enough
information to make informed choices and exercising our moral capacity
to make just choices. When it becomes clear that chemicals in use are
persistent, bioaccumulative, or highly toxic -- that is, we know they
are harming our bodies, and especially our children's bodies -- then
it becomes necessary to make a societal choice to phase them out.
Especially in cases where safer alternatives are available, the phase-
out of uniquely harmful chemicals becomes a moral choice for society.

Recommendation #3: Give the Public and Workers the Full Right-To-Know.
Acting with foresight means both having enough information to know
that a product or practice is harmful, as well as acting on that
information. By definition, that means that the public and workers
must have full right-to-know about the toxicity of substances to which
we are exposed. Without knowing the potential harm of exposures, we
cannot judge whether we should take action to prevent further harm.
Therefore, full right-to-know is essential for implementing a
precautionary framework.

Recommendation #5: Require Comprehensive Safety Data. The adoption of
a comprehensive safety-testing regime for all chemicals entering or
remaining on the market is essential. The procedures and requirements
described in the background paper for Recommendation #5 would provide
much of the evidence we need to decide whether a chemical should or
should not be on the marketplace or whether any restrictions should be
placed on its use. But additional measures will be needed in the
interim, before all chemicals have been tested, and even after this
regime is in place, especially where novel technologies are concerned.

Recommendation #6: Take Immediate Action to Protect Communities and
Workers. The recommendation to "act on early warnings" detailed in
this paper rests on one fundamental fact: tens of thousands of
community members and workers have spoken of harm for years -- quite
literally while the body count piles up -- before being taken
seriously by those with decision-making power. While data gathering
and considered decision-making processes are both crucial to
preventing harm, these steps must not stand in the way of taking
immediate action to protect our health. The earliest warnings of harm
must be heeded.

The principles and actions described in this section complement all
these actions but apply especially to:

** Taking action in conditions of uncertainty;

** Gathering early warnings of harm; and

** Bridging the gap between the present and future. Many of the
principles and actions described here may be implemented immediately
and serve as a bridge to a chemical regime based on comprehensive
safety testing and inherently safer technologies.

Create and Strengthen Health and Environmental Programs to Detect and
Predict Possible Harm

1. Comprehensive safety testing of all synthetic chemicals is the most
important system for detecting and predicting possible harm. (See the
Charter's 5th recommendation)

2. Expand and Strengthen State and Federal Health Monitoring Programs.
The Centers for Disease Control (CDC), National Institute of
Occupational Safety & Health (NIOSH), and public and occupational
health agencies at the state and local levels should broaden the scope
of systems monitoring exposures, including body burdens, of chemicals
to include all known biologically active chemicals used in products
and manufacturing processes. In the period before full safety testing,
these agencies must also be alert for the presence of any untested
synthetic chemicals. The CDC and NIOSH should establish monitoring
standards and ensure that all state and local agencies are conducting
monitoring in a consistent manner, with public input and annual
reports available to the public.

2. Monitoring should be expanded to include breast milk, infant
meconium or cord blood, and other appropriate biological tests. (The
goal of biomonitoring is to identify the nature and degree of
exposures at various life stages and in various communities.
Biological sampling methods will vary, depending on the
physicochemical properties of the substances of interest. Pilot
testing will help determine the size and scope of ongoing monitoring
programs.) Breastfeeding advocates and community members should
participate in monitoring breast milk and infant meconium or cord
blood. When breast milk is tested, support systems and information on
the health benefits of breastfeeding over formula feeding should be
offered to women who are tested and to low income communities where
breastfeeding rates may be below the national average.

2. Health effects, disease, and disability tracking can be pursued
separately from exposure monitoring. Examples include environmental
health tracking, state-wide cancer and birth defect registries,
community-focused epidemiology, and community health surveys.

2. The CDC and NIOSH should issue a comprehensive annual report
summarizing monitoring data from federal, state, and local
investigations. Exposure monitoring data should be systematically
integrated with health effects data in order to identify potential
correlations early and to trigger follow up investigations. Findings
of credible evidence of harm should be reported immediately to
appropriate Early Warning Committees or other authorities for action
(see number 4 below). Advisory Committees need to be established,
where they are not already in place, to provide public input to
federal and state agencies conducting such monitoring programs.

3. Early Warning Committees. Every state should have an Early Warning
Committee of health, environmental, and wildlife experts. Committees
should include county and state environmental and health department
staff; representatives of community, environmental, health, and
occupational safety & health organizations; and health practitioners
experienced in environmental health issues. At the federal level, a
major interagency task force could be established including
representatives of Health & Human Services (HHS), Environmental
Protection Agency (EPA), U.S. Fish & Wildlife Service, National
Institute of Occupational Safety & Health (NIOSH), and CDC, as well as
representatives of health, environmental, conservation, occupational
safety & health, and community organizations.

2. The state Early Warning Committees would ideally serve as channels
both for reporting emerging problems and acting upon them. The
committees would report immediately to the national interagency Early
Warning Task Force any health or environmental monitoring finding of
credible evidence of harm. The reports and subsequent action
recommendations of these state committees would be the authoritative
trigger for timely health-protective action by the appropriate state
and federal agencies and/or industry. The national interagency Task
Force would coordinate the state committees and ensure that consistent
action is taken to address similar problems in different regions.

4. Expand & Strengthen State and Federal Environmental and Fish &
Wildlife Monitoring Programs. The Environmental Protection Agency
(EPA), U.S. Fish & Wildlife Service, and environmental agencies at the
state and local levels should broaden the scope of monitoring fish,
wildlife, and environmental contamination of air, soil, and water
(groundwater and drinking water including private wells) to:

** include all known biologically active chemicals used in products
and manufacturing processes and,

** in the period before full safety testing, to be alert for the
presence of any untested synthetic chemicals.

2. The EPA and U.S. Fish & Wildlife Service should establish
monitoring standards and ensure that all agencies are conducting
monitoring in a consistent manner, with public input and annual
reports available to the public. These agencies should issue a
comprehensive annual report summarizing monitoring data from federal,
state, and local investigations. Findings of credible evidence of
harm, integrating exposure data with effects data, should be reported
immediately to the Early Warning Committee for action. Advisory
Committees need to be established, where they are not already in
place, to provide public input to federal and state agencies
conducting such monitoring programs.

5. Redirect the Public Research Agenda. While narrowly focused
scientific research produced breathtaking advances of many kinds in
the past two hundred years, failure to give equal attention to
consequences, side effects, and the complex interactions of multiple
chemical exposures and other health factors has resulted in untold,
unintended harm to people, fish, wildlife and the environment. In the
Twenty-First Century it is no longer appropriate for science and
technology to continue to produce innovations in a vacuum of knowledge
about such consequences.

2. Public funding, therefore, must shift to science investigating
complex biological systems and relationships; broad, long-range
effects in biological systems; factors that promote public health and
a healthy environment; and inherently safer technologies. This should
be established as a priority by the president, governors of states,
and federal and state legislatures. Advisory committees should be
formed to direct funding to research in every institution where such
committees do not already exist at the federal and state level,
including the National Institutes of Health (NIH), National Institute
of Environmental Health Sciences (NIEHS), National Institute of
Occupational Safety & Health (NIOSH), and state-sponsored
universities.

Take Action when Credible Evidence of Harm Is Found.

When credible evidence of harm is found that a chemical is
biologically active and can cause harm in people, fish and wildlife,
or the soil, air, and water, timely action should be taken to prevent
harm. Such action may include, but is not limited to:

** Widespread distribution of a public health or environmental warning
advising people to avoid exposure; and

** Steps to prevent, eliminate, and mitigate exposure, such as:

** use restrictions,

** timely transition to safer alternatives,

** phase-out of manufacture and use of the hazardous chemical,
technology, or practice,

** healthcare consultations and assistance,

** wildlife restoration, and

** timely cleanup of any contaminated soil or water.

Monitor Novel Technologies

Novel chemicals and quasi-chemical technologies (for example,
converging technologies at the nano scale) may have properties and
unintended effects that may not be revealed even under a comprehensive
safety-testing regime. The EPA must therefore authorize review of
novel products and technologies through a democratic process such as
an Advisory Committee including experts from a wide range of
scientific, health, and nonscientific disciplines (including ethics)
and representative, potentially impacted citizens.

Such a panel would determine whether:

** the evidence is adequate to make a reasonable judgment;

** the product or technology is needed for an important societal
function;

** the product or technology threatens public health, the environment,
or another highly valued aspect of our common enterprise;

** safer alternatives are available; and

** whether there are other relevant questions that cannot be answered
to public satisfaction by scientists, manufacturers, or regulators
alone.

The results of these deliberations and recommendations could (do you
want to say "should") be provided to EPA (and any other relevant
oversight agency) and would be prioritized and given weight in the
body of evidence as EPA and other agencies determine public policy,
permitting, regulations, and legal action regarding the novel
technology.

Performance bonds should be considered for all new and emerging
chemicals and technologies in the absence of ways to test and
understand their biological and geological behavior. For instance,
bonds could be posted for certain potentially hazardous chemicals or
technologies, based on a full-cost accounting of possible impacts.

Note that these requirements for novel technologies would be in
addition to meeting requirements for comprehensive safety testing.
There is no body of evidence without such testing.

Consider Clusters of Health Problems to Be Early Warnings

The impacted public should not have to prove harm before action is
taken when:

** any body burden or other information shows elevated levels, in a
specific population, of biologically active substances including
synthetic chemicals and pollutants such as mercury and lead; or

** apparently higher incidences of unusual cancers, birth defects,
poisonings, or other diseases or disorders appear in a population.

The question should not be whether a cluster of elevated body burdens
or unusual diseases is statistically significant before action is
taken. Rather, the question should be whether any of the occurrences
are preventable. With the appearance of clusters, both the public and
private sector must act immediately to reduce contributing exposures
to the extent possible.

Open Toxic Tort Records

Too often, relevant information about toxic chemicals and health
effects has been sealed in protective orders issued by courts in
specific cases. In exchange for a generous settlement, plaintiffs and
their attorneys may agree to keep secret certain information that is
detrimental to a defendant. But this secrecy means the offenses may be
repeated and other victims may suffer in apparent isolation. In order
to protect the public, court records, including settlements, should be
opened for all toxic tort cases.

On the Local Level: Supporting Communities to Take Action

Although there are many opportunities for progress on the state and
national level, many communities are making the strategic choice to
focus their efforts locally. Local work is less dependent on the
politics of the current White House or State House, can be more
grounded in community experience, and can lead to more direct
accountability from local elected officials.

Several communities have incorporated the precautionary principle into
local law in order to provide explicit authority to act on early
warnings. The cities and counties of San Francisco, Berkeley, and
Marin County CA; Portland OR; Seattle WA; and Buffalo, NY have all
passed precautionary principle laws or ordinances. The University of
California, Berkeley, is developing recommendations, under the mandate
of the California legislature, to give state agencies explicit
authority to act on early warnings and take precautionary action.
Bills directing state agencies to take precautionary action when
credible evidence of harm is found have also been introduced in the
New York State Assembly and Senate. In addition, precautionary laws on
specific chemicals such as PBDE flame retardants have passed or are
pending in many states.

For decades, communities have been acting with foresight to heed early
warnings if laws and regulations are not protecting people and the
environment. For instance, in the last thirty years communities have
prevented harm and stopped exposures to toxic and radioactive
chemicals from hazardous technologies and practices, despite gaps in
federal or state protective policies and enforcement. Grassroots
groups have shut down or halted the siting of hundreds of medical,
solid, and hazardous waste incinerators; nuclear power plants; and
hazardous and radioactive waste landfills.

Recently many of these actions have been based explicitly on the
precautionary principle. For example, people in Denton, TX, advocated
for a policy to reduce pesticide use in parks, and, in the process,
discovered a new, safer product (corn gluten as an herbicide) that a
local business could produce. San Francisco, CA, Buffalo, NY, and
several other cities are setting up programs to purchase healthier,
less toxic products such as vehicles that burn cleaner fuels and
products without persistent bioaccumulative toxic chemicals. Citizens
in Georgia are calling on officials to act on early warnings by
preventing the siting of an elementary school between hazardous waste
sites, and investigating nuclear contamination in counties surrounding
a weapons manufacturing plant.

None of these communities or local authorities waited for state or
federal authorities to act before taking the initiative to prevent
harm. In the suburbs of Pittsburgh, PA, a school superintendent
explained his decision to switch away from using harmful pesticides on
the school playing fields this way: "If there's a chance that
something I'm doing is hurting kids, and there are safer alternatives
available, then why would I do it? I may not be as zealous as some,
but I think I know right from wrong."

Policies and programs that support community involvement in taking
local precautionary action are needed. For instance, technical
assistance grants, meaningful community participation plans, and
Advisory Committees that truly represent impacted communities are
needed at every level of government. Non-profit groups can provide
resources and model policies, share successful strategies, offer
guidance on fundraising, and otherwise support an expansion of
community-based precautionary actions around the country.

Background Paper #1: Require Safer Substitutes and Solutions

Background Paper #2: Phase Out Persistent, Bioaccumulative, or Highly
Toxic Chemicals

Background Paper #3: Give the Public and Workers the Full Right-to-
Know and Participate

Background Paper #4: Act with Foresight

Background Paper #5: Require Comprehensive Safety Data for All
Chemicals

Background Paper #6: Take Immediate Action to Protect Communities and
Workers

Nancy Myers
Science and Environmental
Health Network
nancy@sehn.org
http://www.sehn.org

Anne Rabe
BE SAFE Center for Health,
Environment & Justice
annerabe@msn.com
http://www.besafenet.com

Katie Silberman
Science and Environmental
Health Network*
katie@sehn.org
http://www.sehn.org

* Katie Silberman was associated with the Center for Environmental
Health when this paper was written.