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#6 -- Support Precaution for the Great Lakes, 5-Oct-2005

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Rachel's Precaution Reporter #6

"Foresight and Precaution, in the News and in the World"

Wednesday, October 5, 2005...........Printer-friendly version
www.rachel.org -- To make a secure donation, click here.
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Table of Contents...

You Can Support Precautionary Action for the Great Lakes
The U.S. and Canada are now reviewing the Great Lakes Water Quality
Agreement and will hold 14 public meetings and a Web Dialog this month
and next. This is a great opportunity to embed precautionary thinking
even more deeply into the restoration and protection of the Great
Lakes.
Principles for Review, Great Lakes Water Quality Agreement
These official guidelines for the review of the Great Lakes Water
Quality Agreement show that precaution is on the agenda for
discussion. Outspoken citizens can strengthen it.
In the U.S., Precaution Originated in the Great Lakes
The U.S. was first introduced to the precautionary principle by the
visionary leadership of conservative Republican Gordon Durnil who saw
that precautionary action is the only hope for restoring and
protecting the Great Lakes.
A Gender-bending Chemical Is Common in Cosmetics and Toys
Starting 30 years ago, studies in the Great Lakes began revealing
that gender-bending chemicals are changing the sexual characteristics
of wildlife. Now we know humans are affected as well.

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From: International Joint Commission, Oct. 5, 2005
[Printer-friendly version]

YOU CAN SUPPORT PRECAUTIONARY ACTION FOR THE GREAT LAKES

The International Joint Commission Invites Your Views at 14 Public
Meetings and a Web Dialog on the Future of the Great Lakes Water
Quality Agreement
.


The governments of the United States and Canada have asked the
International Joint Commission (IJC) to consult with the residents of
the Great Lakes and St. Lawrence River basin to find out their views
on what needs to be done to protect water quality in their area, and
on the future of the Great Lakes Water Quality Agreement.

First signed in 1972 and last amended nearly 20 years ago, the Water
Quality Agreement outlines the commitment of each country to restore
and maintain the chemical, physical and biological integrity of the
waters of the Great Lakes basin ecosystem, including the international
portion of the St. Lawrence River.

In the Agreement, the two governments commit to virtually eliminate
the input of persistent toxic substances. It has also resulted in
cooperation between the United States and Canada to limit the
discharge of nutrients and toxic substances into the waters, restore
degraded areas and undertake other joint activities designed to
improve water quality.

The governments intend to launch a review of the operation and
effectiveness of the Agreement in early 2006. The guidelines for the
review
process specify that a precautionary approach will be taken.
(See story in this issue of Rachel's Precaution Reporter.)

The International Joint Commission will hold 14 public meetings across
the Great Lakes and St. Lawrence River basin, conduct a Web Dialogue
and accept written and oral submissions until November 30. For more
information, call toll-free at 1-866- 813-0642 or check the IJC's web
site
.

Schedule of public meetings:

** Monday, October 17 at 7 p.m. in Montreal, Quebec, at City Hall, 275
Notre-Dame Street East

** Monday, October 24 at 7 p.m. in Duluth, Minnesota, at the Central
Hillside Community Center, 12 East 4th Street

** Tuesday, October 25 at 7 p.m. in Thunder Bay, Ontario, at City
Hall, 500 Donald Street East

** Thursday, October 27 at 7 p.m. in Sault Ste Marie, Ontario, in the
City Council Chamber at the Civic Centre, 99 Foster Drive

** Tuesday, November 1 at 7 p.m. in Bay City, Michigan, at City Hall,
301 Washington Avenue

** Tuesday, November 1 at 7 p.m. in Green Bay, Wisconsin, at the KI
Convention Center, 333 Main Street

** Wednesday, November 2 at 7 p.m. in Chicago, Illinois, in the Phelps
Auditorium at the Shedd Aquarium, 1200 South Lake Shore Drive

** Wednesday, November 2 at 3 p.m. in Detroit, Michigan, at the
Detroit Regional Chamber of Commerce, One Woodward Avenue, Suite 1900

** Wednesday, November 2 at 7 p.m. in Windsor, Ontario, at the Cleary
International Centre, 201 Riverside Drive West

** Thursday, November 3, at 7 p.m. in Cleveland, Ohio, in the Rotunda
of City Hall, 601 Lakeside Avenue

** Tuesday, November 8 at 7 p.m. in Quebec City, Quebec, at City Hall,
2 rue des Jardins

** Tuesday, November 8 at 7 p.m. in Midland, Ontario, in the Council
Chamber at the Municipal Building, 575 Dominion Avenue

** Wednesday, November 9 at 7 p.m. in Toronto, Ontario, at City Hall,
100 Queen Street West.

** Thursday, November 10 at 7:30 p.m. in Rochester, New York, in the
City Council Chambers at City Hall, 30 Church Street

Can't Attend? You can contribute online.

Or call toll-free 1-866-813-0642

Fax (613) 993-5583

Or write:

International Joint Commission
Great Lakes Regional Office (Canada)
100 Ouellette Ave., 8th Floor
Windsor, ON N9A 6T3

In the United States
P.O. Box 32869
Detroit, MI 48232

The deadline for comments is midnight, November 30, 2005

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From: International Joint Commission, Oct. 5, 2005
[Printer-friendly version]

PRINCIPLES FOR REVIEW, GREAT LAKES WATER QUALITY AGREEMENT

[RPR introduction: Here are the "principles" that the International
Joint Commission (IJC) recommends as a guide to the U.S. and Canada
when they review the Great Lakes Water Quality Agreement in 2006.

We have heard that the IJC and the governments of Canada and the U.S.
are particularly seeking testimony on the importance of human health
in carrying out the Great Lakes Water Quality Agreement. We hope
citizens will speak out loud and clear at the 14 public meetings
being held this month and next. (See previous story in this issue of
Rachel's Precaution Reporter). --RPR Editors]

The Parties [to the 1909 Boundary Waters Treaty, the U.S. and Canada]
are responsible for the overall review of the Great Lakes Water
Quality Agreement.

In the process of conducting the review, the International Joint
Commission recommends that the Parties adhere to the following
principles. It is recognized that "the Parties shall conduct a
comprehensive review of the operation and effectiveness of the
Agreement" (Article X.4). Consequently, for discussion purposes, the
principles were organized around "operation and effectiveness" and
"comprehensive".

I. Operation and Effectiveness

The process of conducting the review should be:

** Open and Transparent

To the extent practicable, deliberations related to the review should
be open and part of the public record.

** Inclusive

Solicit a full range of views and perspective throughout the [Great
Lakes] Basin through a variety of means (meetings, workshops,
websites, etc.). Engage a wide spectrum of groups and individuals,
including those who are not normally part of Agreement activities and
discussions. Is the Agreement meeting the needs of the people of the
Great Lakes basin?

** Ensure that the Review is Timely

Capitalize on the opportunity of wide-spread community support for a
review, the renewal of the Great Lakes Program in Canada and the
proposals for a Restoration Program in the U.S.

Timely onset of the review is as important as a reasonable time frame
for completing the review. It should be sufficiently long to obtain
necessary information and viewpoints, but sufficiently short to
minimize "burnout." A time period of 18-months is suggested.

** All Aspects of the Review Must be Binational

Workgroups or teams should normally have an equal number of members
from both countries. Consultations should allow equal opportunities
for the citizens of both countries to voice their opinions.

** Impartial

The review should be impartial and avoid conflict of interest.
Recognizing that all players in the Basin have a vested interest in
maintaining certain roles and responsibilities, care should be taken
to avoid having organizations alone review their own work.

II. Comprehensive

The process of reviewing the Agreement comprehensively will address,
by necessity, substantive issues within the Agreement. Principles for
guiding a comprehensive review should:

** Consider the Purpose of the Agreement First

In order for the review process to be most efficient, the purpose of
the Agreement should be confirmed before taking a more in-depth look
at the articles and annexes of the Agreement.

** Use Science and Science-Policy Linkages as the Basis for the Review

The review should be guided by the scientific evidence regarding what
action is needed to restore and maintain the chemical, physical and
biological integrity of the waters of the Great Lakes Basin Ecosystem.

In line with the Commission's Guiding Principles, the concept of
sustainable development, the ecosystem approach, virtual elimination
and zero discharge of persistent toxic substances should be affirmed.

Moreover, while the importance of a sound scientific basis for
conclusions and recommendations should be emphasized, it may sometimes
be necessary to adopt a precautionary approach and to act even in the
absence of a scientific consensus where prudence is essential to
protect the public welfare.

** Be Forward-Looking

Consider the relevance of existing articles and annexes, as well as
any new issues for possible additions that are aligned with the
Agreement purpose. The goals, objectives, and endpoints in the
Agreement should serve as drivers for action.

** Consider Governance

Consider governance roles, responsibilities, and relationships for
those implementing the Agreement, including the Parties' interactions
with First Nations, Tribes, States, Provinces, municipal and regional
governments, and non-governmental organizations, in order to maximize
a sense of ownership throughout the Great Lakes community. Consider
the roles and effectiveness of organizations created under, or
implementing, the Agreement (e.g., the IJC together with its Great
Lakes Regional Office, the Water Quality Board, the Science Advisory
Board, and the Binational Executive Committee.) Clarify, as necessary,
how the Agreement relates to other basin organizations, such as the
Commission on Economic Cooperation (CEC), Great Lakes Fishery
Commission (GLFC), Great Lakes Commission (GLC), and Council of Great
Lakes Governors (CGLG).

** Consider Accountability

Each element in the Agreement being reviewed should consider how
accountability to the public can be enhanced for Agreement
implementation by the Parties, states and provinces, as well as by
cooperating stakeholders in the Great Lakes basin.

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From: Seventh Biennial Report of the IJC, Jun. 15, 1994
[Printer-friendly version]

INTERNATIONAL JOINT COMMISSION SEVENTH BIENNIAL REPORT

[RPR introduction: In the U.S., precautionary thinking began in the
Great Lakes.

In 1978 the U.S. and Canada had signed a "Great Lakes Water Quality
Agreement
," binding both nations to "virtually eliminate persistent
toxic substances" from the Great Lakes ecosystem. In 1990, 1992, and
1994 the IJC described a "virtual elimination strategy" to get
persistent toxic chemicals out of the Great Lakes and keep them out.

During 1990-1994 the International Joint Commission (IJC) published
reports laying out a strategy for the "virtual elimination" of toxic
chemicals from the Great Lakes. The IJC is a government agency created
by the Boundary Waters Treaty of 1909 between the U.S. and Canada.

These early IJC reports started a revolution in thinking.

We believe these IJC reports of 1990, 1992, and 1994 are the
first time a U.S. government agency explicitly embraced a
precautionary approach. So you can hear the original language, here
is a portion of Chapter 3 from the 7th Biennial Report of the IJC
(1994)
.

At the time this report was written, the U.S. chairperson of the IJC
was Gordon Durnil, a strong environmentalist and conservative
Republican
.]

Excerpt from CHAPTER THREE (of the IJC's 7th Biennial Report, 1994)

Strategic Thinking and the Need for Further Change

Persistent Toxic Substances: The Commission's Position

As research findings demonstrate linkages between persistent toxic
substances and biological injury, they continue to reinforce the
Commission's conclusions, which are fundamental to its proposed policy
approach:

** persistent toxic substances are too dangerous to the biosphere and
to humans to permit their release in any quantity, and

** all persistent toxic substances are dangerous to the environment,
deleterious to the human condition, and can no longer be tolerated in
the ecosystem, whether or not unassailable scientific proof of acute
or chronic damage is universally accepted.

The Commission reiterates its stance that the very existence of human-
produced persistent toxic substances in the Great Lakes ecosystem is
inconsistent with maintaining the integrity of the ecosystem and hence
with the Purpose of the [1978 Water Quality] Agreement [between the
U.S. and Canada]. The Great Lakes Water Quality Board has confirmed
that the risks to humans are high, that there is a real probability of
substantial effects, and that such injury from certain persistent
toxic substances merits immediate measures to protect human health.

The characteristics of persistent toxic substances make them much less
amenable to traditional pollution control efforts such as discharge
limits to set acceptable levels in the environment, end-of-the-pipe
technology and disposal regulations.

The idea of a non-zero "assimilative" capacity in the environment or
in our bodies (and hence allowable discharges) for such chemicals is
no longer relevant. The Great Lakes Water Quality Board supports this
view, concluding that there is no acceptable assimilative capacity for
persistent, bioaccumulative toxic substances. It states, therefore,
that the only appropriate water quality objective is zero, even though
interim objectives may be needed.

Within the environment's carrying capacity for human activity, there
is no space for human loadings of persistent toxic substances. Hence,
there can be no acceptable loading of chemicals that accumulate for
very long periods, except that which nature itself generates.

Moreover, conventional scientific concepts of dose-response and
acceptable "risk" can no longer be defined as "good" scientific and
management bases for defining acceptable levels of pollution. They are
outmoded and inappropriate ways of thinking about persistent toxics.

The production and release of these substances into the environment
must, therefore, be considered contrary to the [1978 Water Quality]
Agreement legally, unsupportable ecologically and dangerous to health
generally. Above all, they are ethically and morally unacceptable.

The limits on allowable quantities of these substances entering the
environment must be effectively zero, and the primary means to achieve
zero should be the prevention of their production, use and release
rather than their subsequent removal.

Consequently, vigorous policy is needed to eliminate all persistent
toxic substances, except in very specialized, unavoidable, controlled
and hopefully temporary applications.

While a broad attack on these substances is required, we must begin
somewhere. The Commission has previously proposed beginning with
eleven Critical Pollutants* and still supports this approach. At the
same time, the Commission has concluded that organochlorines are a
major class of pollutants that should be addressed collectively due to
their large number and the egregious characteristics of many of them.

Precaution in the introduction and continued use of chemical
substances in commerce is a basic underpinning of the proposed virtual
elimination strategy. It is generally agreed, in principle, that the
burden of proof concerning the "safety" of chemicals should lie with
the proponent for the manufacture, import or use of at least
substances new to commerce in Canada and the United States, rather
than with society as a whole to provide absolute proof of adverse
impacts.

This principle should in the Commission's view, be adopted for all
human-made chemicals shown or reasonably suspected to be persistent
and toxic, including those already manufactured or otherwise in
commerce. The onus should be on the producers and users of any
suspected persistent toxic substance to prove that it is, in fact,
both "safe" and necessary, even if it is already in commerce. As one
participant at the October 1993 Biennial Meeting said, "Chemicals are
not innocent until proven guilty, people are."

Current Approaches

Canada's Environmental Protection Act provides for the review of
existing substances and control of dangerous substances, but its
implementation has been slow to address specific chemicals for
regulation. It also appears possible that legal challenges will
further render it ineffective in controlling persistent toxic
substances. Provincial action under Ontario's Municipal-Industrial
Strategy for Abatement (MISA) can also be used to eliminate discharges
of persistent toxic substances.

The United States Government has stated that available mechanisms can
be used to invoke regulatory action without definitive proof of a
causal relationship. However, the Toxic Substances Control Act, which
is used to screen the introduction of new chemicals, has to date
failed to screen out many chemicals. Among existing chemicals, it has
only limited the use and manufacture of PCBs. The Great Lakes Water
Quality Board concluded that the act has been rendered ineffective for
the timely control of existing chemicals.

The available approaches have not, in practice, been effective in
either country to screen a multitude of chemicals. A realistic review
of what chemicals have, in fact, been removed from commerce indicates
that the current approach does not provide an effective screening
process. Again, the Great Lakes Water Quality Board emphasized that
the problem lies not with the basic legislation, but with "significant
barriers to the effective implementation of this authority."

The basis for a precautionary approach and reverse onus can also be
found in the Agreement. It is the unequivocal statement of the Parties
to the Agreement that they intend to pursue an objective of virtual
elimination of inputs within a philosophy of zero discharge of
persistent toxic substances. These are forward-looking provisions,
even if they were focused at the time on regulatory and technological
solutions. However, society as a whole is beginning to realize the
importance and implications of this approach, as it come to grips with
the immensity of the persistent toxics problem. Even less well
advanced is a determination to implement virtual elimination
rigorously as a way to deal with persistent toxic substances.
Pollution prevention programs, while an important step forward, do not
necessarily enshrine this concept.

Weight of Evidence

The 1992 Biennial Report also urged adoption of a "weight of evidence"
approach to reaching conclusions on these issues. This approach takes
into account the cumulative weight of the many studies that address
the question of injury or the likelihood of injury to living
organisms. If, taken together, the amount and consistency of evidence
across a wide range of circumstances and/or toxic substances are
judged sufficient to indicate the reality or a strong probability of a
linkage between certain substances or class of substances and injury,
a conclusion of a causal relationship can be made.

This conclusion is made on the basis of common sense, logic and
experience as well as formal science. Once this point is reached, and
taking a precautionary approach, there can be no defensible
alternative to recommending that the input of those substances to the
Great Lakes be stopped. As noted above, the burden of proof must shift
to the proponent (manufacturer, importer or user) of the substance to
show that it does not or will not cause the suspected harm, nor meet
the definition of a persistent toxic substance.

The Commission's definition of "weight of evidence" is a pragmatic one
and not based on arbitrary rules or formulae. It is consistent with
the use of this term in science and law. The Commission's use of this
term has, however, generated considerable discussion and different
concepts from the perspective of various disciplines. Also, the
question of standard of evidence in this field is evolving. Scholars
and practitioners have been encouraged to consider more precise
definitions.

The Great Lakes Water Quality and Science Advisory Boards, and the two
federal governments in their responses to the 1992 Biennial Report,
have all accepted such an approach in principle. It is clear, however,
that in practice its application can result in different outcomes.
This appears to be the case with chlorine, because of different
standards of evidence or different levels of acceptable probability.
Governments, industry and other participants in the policy arena
should collaborate to codify a set of guidelines as to what factors
should be taken into account in weighing evidence.

Risk Assessment

Another relevant procedure is risk assessment. Clearly, the process of
assessing the relative risks to the environment and/or humans from
alternative actions is useful for some purposes. Both countries have
formal frameworks for risk assessment that are, by and large,
compatible, although some discrepancies in methodology exist and
improved integration of human health and environmental risks is
needed. Risk assessment is useful in decision-making, especially in
setting action priorities, but is not directly relevant to the basic
virtual elimination commitment. The Commission does not accept the
argument that the elimination of persistent toxic substances should be
subject to a risk-benefit calculation, as that is not the approach of
the [1978 Water Quality] Agreement.

When risk assessment is used to provide information, however, it is
important to pay careful attention to the communication of that risk
information to the public. Underlying assumptions and caveats, as well
as the question of different perceptions of risk across jurisdictional
boundaries, also must be communicated. Of specific concern is the lack
of uniformity in sport fishing advisories. The Great Lakes Water
Quality Board recommended collective effort among state and provincial
authorities to develop joint public advisories to ensure uniformity.
Furthermore, there is a lack of any public risk information in most
other circumstances.

A fuller accounting of environmental, economic and social values is
also needed when making decisions. At one level, the determination of
what natural resources are being used in human processes should be
part of economic accounting. Similarly, the ramifications of
"environmental" policy changes, which affect the amount of resources
available for production and consumption (including reduction of the
ability to pollute or use traditional technologies), must also be
taken into account.

In some cases, it will not be possible to eliminate substances in use
"overnight," especially if acceptable substitutes are not readily
available, as that could cause serious short-term economic and social
disruption. However, to continue to introduce new products without
this accounting, and to continue resisting a strategy that changes our
production and consumption habits and moves away from reliance on
persistent toxic substances, will be disastrous in the long term from
all perspectives. Again, a reasoned but sure process of transition,
and a new way of thinking about production and consumption decisions,
are needed.

In 1986, the World Health Organization used its definition of health
as a starting point for the Ottawa Charter for Health Promotion
(Ottawa Charter). It emphasizes the dependence of health on the
environment and identifies peace, shelter, food, education, income,
social justice, equity, the maintenance of a stable ecosystem and
sustainable resource development as components of health. It is not
sufficient for governments, industry and commerce to react only to
proven instances of injury. They also must provide a preventive
program to enhance personal and societal security against
unintentional intrusions on human health, at the same time other basic
needs and a high quality of life are met.

While not widely recognized in practice to date, this philosophy is
consistent with the ecosystem concept of the Great Lakes Water Quality
Agreement, as well as the sustainable development concept embraced by
the United Nations World Commission on Environment and Development
(Brundtland Report). This also has subsequently become the policy of
both federal and several state and provincial governments.

Just as human health is dependent on the absence of environmental
degradation, however, ecosystem integrity is dependent on more than
environmental quality. It also must include economic, social, cultural
and political dimensions, not the least of which is a healthy
population and healthy communities. The Commission has previously
observed that "long-term economic sustainability, including the
existence of a healthy and creative work force, depends on a healthy
environment. Paradoxically, a healthy environment depends on the
existence of vibrant local and regional economies."

Despite these efforts, an assessment of the overall policy response to
the environmental health studies and public concern to date must be
characterized as limited and disappointing. The mainstream response
from individuals in government, industry and elsewhere is to debate
the reality or magnitude of the risk to the health of humans and other
components of the ecosystem. Even if the issue is recognized, the
focus tends to be on setting priorities, developing lists, devoting
resources to avoid action and lobby against it, largely on the basis
of debatable short-term economic impacts, rather than on coming to
grips with and addressing the enormity of the problem.

Chemical and associated industries have an obligation to protect human
and other populations from the adverse effects of substances they
bring into existence and use. The Commission recognizes and
congratulates those industrial representatives who have responsibly
engaged in dialogue with the Commission and others, and have taken
pioneering steps to address these problems. It is important and
inevitable that the business sector act increasingly to lead rather
than resist a broad movement towards manufacturing processes that
eliminate the production and use of persistent toxic substances, and
that they embrace a new, ecosystemic approach to business and
governmental decision-making.

One progressive aspect of the Agreement and the Commission's work
pursuant to it has been the emergence of a Great Lakes-St. Lawrence
ecosystem "community" and numerous more specific communities-of-
interest under that umbrella. This development occurred first in the
community of scientists working across jurisdictions and disciplines
to enhance learning, understanding and the efficient use of resources.
In recent years, the active community of Great Lakes interests has
expanded greatly. A variety of new organizations have emerged over the
past decade focusing on regional concerns.

Several governmental institutions have evolved to address Great Lakes
ecosystem issues. This phenomenon has included a refocusing of the
Great Lakes Commission, the Great Lakes Fishery Commission and the
Council of Great Lakes Governors. A number of nongovernmental and
municipal organizations also have involved interested citizens and
specific interests. These citizens and organizations tend to begin at
a nontechnical level, but become increasingly more sophisticated in
knowledge and approach. A wide range of organizations fit this
description, such as Great Lakes United, the Council of Great Lakes
Industries and the International Great Lakes-St. Lawrence Mayors'
Conference, to name only a few examples.

The Commission encourages this process and its broadening to new areas
of the Great Lakes community of interest. Organizations whose mission
is to inform and activate the general public should strive to broaden
their membership and audience, by improving their media and public
affairs approaches and the coordination among organizations to ensure
consistent, accurate messages. All of these bodies have played an
important role, even if temporary, in the institutional component of
the Great Lakes ecosystem.

The voluntary sector is a key component in broadening Agreement
awareness and involvement. This sector needs to be encouraged within
the Great Lakes institutional mosaic, but the organizations and
movements involved, while enthusiastic, are often stymied by lack of
scientific data and interpretive skills. The Commission's Great Lakes
Science Advisory Board has emphasized that empowerment, participation
and involvement of the entire Great Lakes community in the achievement
of the goals of the Agreement is vital to its success.

Scientists should make themselves available to communicate with these
groups and with their local communities at large. Employers, whether
governments, private sector or academia, should permit and encourage
such mutually beneficial linkages. Universities, colleges and other
institutions of higher education in particular have a function in
supporting the wider Great Lakes community. Beyond their educational
roles, they can serve as catalysts to bring scientists, industries,
governments and citizens together to learn from one another and to
develop coordinated action plans....

Ecosystem Boundaries

Geographically, the Great Lakes ecosystem does not stop at the map
boundaries specified in the Agreement. Ecosystem boundaries are
neither fully jurisdictional, geophysical or even demographic in their
definition. They differ for the water, biological, atmospheric and
human dimensions of the ecosystem. The scope of an ecosystem's
boundaries can also differ depending on what economic, social or
political parameters are being considered.

Ecologically, the Great Lakes Basin Ecosystem clearly extends
downstream from the Agreement boundary at the end of the international
section of the St. Lawrence River, deep into Quebec and possibly to
the St. Lawrence estuary. There is evidence, for example, that
contaminants are passing downstream from the Cornwall-Massena area and
into the flesh of marine mammals and fish. This is a geographical and
ecological reality requiring that, at a minimum, concern and dialogue
should extend beyond the current "legal" Agreement boundaries. Whether
or not these formal boundaries of the Agreement merit reconsideration
at an appropriate time, from the Commission's ecosystemic standpoint,
the issue will eventually need to be addressed in some manner if a
fully ecosystemic approach is to be achieved.

In a number of ways, therefore, a significant modification of
institutions and attitudes is required to help resolve Great Lakes
Basin Ecosystem issues. The policy frameworks exist and are subscribed
to by both federal governments. This allows a new way of thinking and
mobilization of concern to move forward....

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

The Commission also believes that our two nations are still at a
turning point of opportunity. They can still make a difference. The
legacy we choose to leave for future generations can be either one of
diminished options and well-being, or an enhanced one. To choose the
latter, a strong, coordinated plan of action with target dates is
urgently needed. It should be designed to effect a new way of doing
business, and be based on the consideration of six basic principles:

Principle 1

The Governments of the United States and Canada, along with the
relevant states and provinces, should act decisively on the
commitments of the Great Lakes Water Quality Agreement wherein they
agreed that:

"The purpose of the Parties is to restore and maintain the chemical,
physical, and biological integrity of the waters of the Great Lakes
Basin Ecosystem," and

"The discharge of toxic substances in toxic amounts be prohibited and
the discharge of any or all persistent toxic substances be virtually
eliminated," within a philosophy of zero discharge.

It is the assumption of the Commission that the federal governments
continue to agree on this fundamental statement of intent upon which
the Commission builds its advice. Governments should also ensure that
their actions are coordinated through effectively functioning
mechanisms for consultation, cooperative research and common action.

Principle 2

Representatives of industry, when presented with evidence of ecosystem
health concerns about substances used in commerce, should react by
embracing open dialogue, data sharing and fact finding to resolve,
rather than deny, concerns and effect an orderly and timely transition
to those solutions.

Principle 3

Representatives of environmental and other organizations should offer
their expertise to help develop pragmatic solutions to the transition
issues that face governments, industries and their employees,
consumers and others in adopting preventive strategies.

Principle 4

While the scientific process should be value neutral, scientists
should be forthcoming in responses to public concerns and the
provision of current information about the health of the Great Lakes
ecosystem, especially as it relates to human health.

Principle 5

News media should review their policies about reporting on the
widespread use and effects of persistent toxic substances and evaluate
their responsibility to inform the public about them.

Principle 6

Citizens should constantly ask political, social and industrial
leaders about the effects of the use and discharge of pollutants on
this and future generations.

Gordon K. Durnil, Co-chairman
Claude Lanthier, Co-chairman
Hilary P. Cleveland, Commissioner
James A. Macaulay, Commissioner
Robert F. Goodwin, Commissioner
Gordon W. Walker, Commissioner

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From: Wall Street Journal, Oct. 4, 2005
[Printer-friendly version]

FROM AN INGREDIENT IN COSMETICS, TOYS, A SAFETY CONCERN

Male Reproductive Development Is Issue With Phthalates, Used in Host
of Products; Europe, Japan Restrict Them


By Peter Waldman

In the 12th week of a human pregnancy, the momentous event of gender
formation begins, as X and Y chromosomes trigger biochemical reactions
that shape male or female organs. Estrogens carry the process forward
in girls, while in boys, male hormones called androgens do.

Now scientists have indications the process may be influenced from
beyond the womb, raising a fresh debate over industrial chemicals and
safety. In rodent experiments, common chemicals called phthalates,
used in a wide variety of products from toys to cosmetics to pills,
can block the action of fetal androgens. The result is what scientists
call demasculinized effects in male offspring, ranging from
undescended testes at birth to low sperm counts and benign testicular
tumors later in life. "Phthalate syndrome," researchers call it.

Whether phthalates -- pronounced "thallets" -- might affect sexual
development in humans, too, is now a matter of hot dispute. Doses in
the rodent experiments were hundreds of times as high as the minute
levels to which people are exposed. However, last year, federal
scientists found gene alterations in the fetuses of pregnant rats that
had been exposed to extremely low levels of phthalates, levels no
higher than the trace amounts detected in some humans.

Then this year, two direct links to humans were made. First, a small
study found that baby boys whose mothers had the greatest phthalate
exposures while pregnant were much more likely than other baby boys to
have certain demasculinized traits. And another small study found that
3-month-old boys exposed to higher levels of phthalates through breast
milk produced less testosterone than baby boys exposed to lower levels
of the chemicals.

Scientists are raising questions about phthalates at a time when male
reproductive disorders, including testicular cancer, appear to be on
the rise in many countries. Seeking an explanation, European
endocrinologists have identified what some see as a human counterpart
to rodents' phthalate syndrome, one they call "testicular dysgenesis
syndrome." Some think it may be due in part to exposure to phthalates
and other chemicals that interfere with male sex hormones.

"We know abnormal development of the fetal testes underlies many of
the reproductive disorders we're seeing in men," says Richard Sharpe
of the University of Edinburgh in Scotland, a researcher on male
reproduction. "We do not know what's causing this, but we do know high
doses of phthalates induce parallel disorders in rats."

It isn't surprising to find traces of phthalates in human blood and
urine, because they are used so widely. Nearly five million metric
tons of phthalates are consumed by industry every year, 13% in the
U.S. They are made from petroleum byproducts and chemically known as
esters, or compounds of organic acid and alcohol. The common varieties
with large molecules are used to plasticize, or make pliable,
otherwise rigid plastics -- such as polyvinyl chloride, known as PVC
-- in things like construction materials, clothing, toys and
furnishings. Small-molecule phthalates are used as solvents and in
adhesives, waxes, inks, cosmetics, insecticides and drugs.

Users and producers of phthalates say they are perfectly safe at the
very low levels to which humans are exposed. Phthalates are among the
most widely studied chemicals and have proved safe for more than 50
years, says Marian Stanley of the American Chemistry Council, a trade
association.

She says studies suggest primates, including humans, may be much less
sensitive to phthalates than are rodents. She cites a 2003 Japanese
study of marmoset monkeys exposed to phthalates as juveniles, which
found no testicular effects from high doses. The study was sponsored
by the Japan Plasticizer Industry Association. Scientists involved in
a California regulatory review questioned the study and maintained it
didn't support the conclusion that humans are less sensitive to
phthalates than rodents are.

Ms. Stanley's conclusion: "There is no reliable evidence that any
phthalate, used as intended, has ever caused a health problem for a
human."

Societal Issue

The phthalate debate is part of the larger societal issue of what, if
anything, to do about minute, once-undetectable chemical traces that
some evidence now suggests might hold health hazards.

With much still unknown about phthalates, scientists and regulators at
the Environmental Protection Agency are moving cautiously. "All this
work on the effects of phthalates on the male reproductive system is
just five years old," says the EPA's leading phthalate researcher, L.
Earl Gray. "There appears to be clear disruption of the androgen
pathway, but how? What are phthalates doing?"

To Rochelle Tyl, a toxicologist who works for corporations and trade
groups studying chemicals' effects on animals, the broader question
is: "If we know something bad is happening, or we think we do, do we
wait for the data or do we act now to protect people?" Based on her
own studies of rodents, Dr. Tyl says it is still unclear whether low
levels of phthalates damage baby boys.

Some countries have acted. In 2003, Japan banned certain types of
phthalates in food-handling equipment after traces turned up in school
lunches and other foods.

The European Union has recently banned some phthalates in cosmetics
and toys. In January, the European Parliament's public health
committee called for banning nearly all phthalates in household goods
and medical devices. In July, the full parliament asked the EU's
regulatory body, European Commission, to review a full range of
products "made from plasticised material which may expose people to
risks, especially those used in medical devices."

With the controversy particularly hot in Europe, the European market
for the most common phthalate plasticizer, diethylhexyl phthalate, or
DEHP, has fallen 50% since 2000, says BASF AG, the German chemical
giant. In response, BASF says it is ceasing production of DEHP in
Europe this month. A spokesman for the company says the cutback won't
affect its phthalate production in the U.S.

The U.S. doesn't restrict phthalates, and has lobbied the EU hard in
recent years not to burden manufacturers with new regulations on
chemicals. Still, a few companies, under pressure from health groups,
have agreed to abide by European standards in their products sold in
the U.S. Procter & Gamble Co. said last year it would no longer use
phthalates in nail polish. Last December, Unilever, Revlon Inc. and
L'Oreal SA's American unit promised to eliminate all chemicals banned
in European products from the same items in the U.S.

For medical bags and tubes, Baxter International Inc. pledged in 1999
to develop alternatives to phthalate-containing PVC, as did Abbott
Laboratories in 2003. (Abbott has since spun off its hospital-products
unit.) In a June study by Harvard researchers of 54 newborns in
intensive care, infants who'd had the most invasive procedures had
five times as much of the phthalate DEHP in their bodies -- as
measured in urine -- as did babies with fewer procedures.

Researchers aren't yet sure what this means. Another study by doctors
at the Children's National Medical Center in Washington, published
last year, found that 19 adolescents who'd had significant exposure to
phthalates from medical devices as newborns showed no signs of adverse
effects through puberty.

Kaiser Permanente, the big health-maintenance organization, promised
in 1999 to eliminate phthalates in hospital supplies. Demand from the
HMO has helped drive development of medical gloves that don't contain
phthalates, as well as non-PVC carpeting and a new line of phthalate-
free plastic handrails, corner guards and wall coverings.

In the early 1990s, the EPA set exposure guidelines for several types
of phthalates, based on studies that had been done decades earlier.
Since then, much more has been learned about them.

Consider dibutyl phthalate, which is used to keep nail polish from
chipping and to coat some pills. The EPA did a risk assessment of it
15 years ago, relying on a rodent study performed in 1953. The now
half-century-old study found a "lowest adverse-effect level" -- 600
milligrams a day per kilogram of body weight -- that killed half of
the rodents within a week.

A 2004 study of the same chemical, published in the journal
Toxicological Sciences, found far subtler effects, at far lower
exposures. It detected gene alteration in fetuses of female rats that
ingested as little as 0.1 milligram a day of the phthalate for each
kilogram of body weight. That dose is one six-thousandth of the 1953
"lowest adverse-effect" level.

It's also an exposure level found in some U.S. women, says Paul Foster
of the National Institute of Environmental Health Sciences, a co-
author of the gene study. So "now we're talking about 'Josephina Q.
Public' -- real women in the general population," he says. "The
comfort level is receding."

EPA Caution

Still, because researchers don't know the function of the genes that
were altered in the rat study, EPA experts say it's too early to base
regulatory decisions on such gene changes. "We're a long way, in my
opinion, from considering changes in gene expression as 'adverse' for
risk assessment," says the environmental agency's Dr. Gray.

Exxon Mobil Corp. and BASF dominate the $7.3 billion phthalates
market. An Exxon Mobil spokeswoman says risk assessments by government
agencies in Europe and the U.S. confirm "the safety of phthalates in
their current applications."

Phthalates are cheaper than most other chemicals that can soften
plastics. But a BASF press release says European manufacturers have
been replacing phthalates with plasticizers designed for "sensitive
applications such as toys, medical devices and food contact."

Makers of pills sometimes coat them with phthalates to make them
easier to swallow or control how they dissolve. A case study published
last year in the journal Environmental Health Perspectives said a man
who took a drug for ulcerative colitis, Asacol, for three months was
exposed to several hundred times as much dibutyl phthalate as the
average American. The drug's maker, Procter & Gamble, says it coats
the pill with the phthalate so it will stay intact until it reaches
inflamed colon areas. P&G says a daily dose of the drug has less than
1% of the 0.1 milligram of dibutyl phthalate per kilogram of body
weight that the EPA regards as a safe daily dose.

Sperm Count

Attributing health effects to specific industrial chemicals is a dicey
business. Scientists often look for associations: statistical
correlations that suggest, but don't prove, a possible causal link.

With phthalates, they've found a few. For instance, a 2003 study
divided 168 male patients at a fertility clinic into three groups
based on levels of phthalate metabolites in their urine. The study
found that men in the highest third for one of the phthalates were
three to five times as likely as those in the lowest third to have a
low sperm count or low sperm activity. Men highest in a different
phthalate also had more abnormally shaped sperm, according to the
study, which was done by researchers at the Harvard School of Public
Health and published in the journal Epidemiology.

The scientists now are extending the research to 450 men. In their
next paper, they're also planning to discuss a separate Swedish study,
of 245 army recruits, that found no link between phthalate exposure
and sperm quality.

The latest human study, on 96 baby boys in Denmark and Finland, found
that those fed breast milk containing higher levels of certain
phthalates had less testosterone during their crucial hormonal surge
at three months of age than baby boys exposed to lower levels.

Authors of the study, led by Katharina Main of the University of
Copenhagen and published Sept. 8 in Environmental Health Perspectives,
said their findings support the idea that the human testis is
vulnerable to phthalate exposure during development -- possibly even
more vulnerable than rodents' genitalia. They added, however, that
"before any regulatory action is considered, further studies on health
effects of [phthalates] are urgently needed" aimed at "verifying or
refuting our findings."

Physical Differences

A human study of 85 subjects published in June linked fetal exposure
to phthalates to structural differences in the genitalia of baby boys.

Researchers measured phthalate levels in pregnant women and later
examined their infant and toddler sons. For pregnant women who had the
highest phthalate exposure -- a level equivalent to the top 25% of
such exposure in American women -- baby sons had smaller genitalia, on
average. And their sons were more likely to have incompletely
descended testicles.

Most striking was a difference in the length of the perineum, the
space between the genitalia and anus, which scientists call AGD, for
anogenital distance. In rodents, a shortened perineum in males is
closely correlated with phthalate exposure. A shortened AGD also is
one of the most sensitive markers of demasculinization in animal
studies.

Males' perineums at birth are usually about twice as long as those of
females, in both humans and laboratory rodents. In this study, the
baby boys of women with the highest phthalate exposures were 10 times
as likely to have a shortened AGD, adjusted for baby weight, as the
sons of women who had the lowest phthalate exposures.

The length difference was about one-fifth, according to the study,
which was led by epidemiologist Shanna Swan of the University of
Rochester (N.Y.) School of Medicine and Dentistry and published in
Environmental Health Perspectives. Among boys with shorter AGD, 21%
also had incomplete testicular descent and small scrotums, compared
with 8% of the other boys.

Does it matter? The researchers intend to track as many of the boys as
possible into adulthood, to address a key question: Will they grow up
with lower testosterone levels, inferior sperm quality and higher
rates of testicular tumors, as do rats with phthalate syndrome?

When the boys are 3 to 5 years old, Dr. Swan plans to assess their
play behavior to see if exposure to phthalates appears associated with
feminized neurological development. She says such tests have shown
that little girls with high levels of androgens, or male hormones,
gravitate toward "masculine" play. But she says no one has studied
whether boys' play is affected by fetal exposure to chemicals that
block androgens.

"In rodents, the changes result in permanent effects. Future studies
will be necessary to determine whether these boys are also permanently
affected," Dr. Swan says.

She and others agree that a study of just 85 subjects needs to be
enlarged and repeated. She notes that although boys' genitalia were
affected in subtle ways, no substantial malformations or disease were
detected.

Some endocrinologists call this the first study to link an industrial
chemical measured in pregnant women to altered reproductive systems in
offspring. "It is really noteworthy that shortened AGD was seen," says
Niels Skakkebaek, a reproductive-disorder expert at the University of
Copenhagen, who wasn't an author of the study. "If it is proven the
environment changed the [physical characteristics] of these babies in
such an anti-androgenic manner, it is very serious."

Ms. Stanley of the American Chemistry Council doubts that any study
can "tease out" the cause of a human health condition, given the wide
variety of chemical exposures in people's lives. She notes that some
of the specific phthalates associated with reproductive changes in the
two human-baby studies haven't been linked to such changes in rodents.
So, she says, it's possible the changes in anogenital distance and
hormone levels may merely reflect normal variability.

Dr. Tyl, the chemical-industry toxicologist, says her own rat studies
confirm that AGD is very sensitive to phthalates. She says that in
rats that had very high phthalate exposures, a shortened AGD at birth
was closely associated with a number of serious reproductive disorders
later in life. However, in rats exposed to much lower doses of
phthalates, a shortened AGD at birth did not always lead to later
troubles. Many of these rats grew up to breed normally, she says,
despite their slightly altered anatomy.

Dr. Tyl suggests that the same may be true of humans. Dr. Swan's study
is "potentially important," Dr. Tyl says, because it suggests that "at
low levels of exposure, humans are responding" to phthalates. But it
remains quite possible, Dr. Tyl theorizes, that the boys with
shortened AGD will grow up normally. "At what point do changes like
this cross the line" to become dangerous, she asks. "We don't know
yet."

Write to Peter Waldman at peter.waldman@wsj.com

RELATED READING

See various studies related to phthalates:

Phthalate Exposure and Human Semen Parameters

Phthalate exposure and reproductive hormones in adult men

Dose-Dependent Alterations in Gene Expression and Testosterone
Synthesis in the Fetal Testes of Male Rats Exposed to Di (n-butyl)
phthalate

Analysis of Consumer Cosmetic Products for Phthalate Esters

Phthalate Exposure during Pregnancy and Lower Anogenital Index in
Boys: Wider Implications for the General Population?


Decrease in Anogenital Distance among Male Infants with Prenatal
Phthalate Exposure


Medications as a Source of Human Exposure to Phthalates

Human Breast Milk Contamination with Phthalates and Alterations of
Endogenous Reproductive Hormones in Three Months Old Infants


Follow-Up Study of Adolescents Exposed to Di(2-Ethylhexyl) Phthalate
(DEHP) as Neonates
on Extracorporeal Membrane Oxygenation (ECMO)
Support

Copyright 2005 Dow Jones & Company, Inc.

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Rachel's Precaution Reporter offers news, views and practical
examples of the Precautionary Principle, or Foresight Principle, in
action. The Precautionary Principle is a modern way of making
decisions, to minimize harm. Rachel's Precaution Reporter tries to
answer such questions as, Why do we need the precautionary
principle? Who is using precaution? Who is opposing precaution?

We often include attacks on the precautionary principle because we
believe it is essential for advocates of precaution to know what
their adversaries are saying, just as abolitionists in 1830 needed
to know the arguments used by slaveholders.

Rachel's Precaution Reporter is published as often as necessary to
provide readers with up-to-date coverage of the subject.

As you come across stories that illustrate the precautionary
principle -- or the need for the precautionary principle --
please Email them to us at rpr@rachel.org.

Editors:
Peter Montague - peter@rachel.org
Tim Montague - tim@rachel.org

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:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Rachel's Precaution Reporter #6 "Foresight and Precaution, in the News and in the World" Wednesday, October 5, 2005...........Printer-friendly version www.rachel.org -- To make a secure donation, click here. ::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Table of Contents...

You Can Support Precautionary Action for the Great Lakes
The U.S. and Canada are now reviewing the Great Lakes Water Quality
Agreement and will hold 14 public meetings and a Web Dialog this month
and next. This is a great opportunity to embed precautionary thinking
even more deeply into the restoration and protection of the Great
Lakes.
Principles for Review, Great Lakes Water Quality Agreement
These official guidelines for the review of the Great Lakes Water
Quality Agreement show that precaution is on the agenda for
discussion. Outspoken citizens can strengthen it.
In the U.S., Precaution Originated in the Great Lakes
The U.S. was first introduced to the precautionary principle by the
visionary leadership of conservative Republican Gordon Durnil who saw
that precautionary action is the only hope for restoring and
protecting the Great Lakes.
A Gender-bending Chemical Is Common in Cosmetics and Toys
Starting 30 years ago, studies in the Great Lakes began revealing
that gender-bending chemicals are changing the sexual characteristics
of wildlife. Now we know humans are affected as well.

::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
From: International Joint Commission, Oct. 5, 2005
[Printer-friendly version]

YOU CAN SUPPORT PRECAUTIONARY ACTION FOR THE GREAT LAKES

The International Joint Commission Invites Your Views at 14 Public
Meetings and a Web Dialog on the Future of the Great Lakes Water
Quality Agreement
.


The governments of the United States and Canada have asked the
International Joint Commission (IJC) to consult with the residents of
the Great Lakes and St. Lawrence River basin to find out their views
on what needs to be done to protect water quality in their area, and
on the future of the Great Lakes Water Quality Agreement.

First signed in 1972 and last amended nearly 20 years ago, the Water
Quality Agreement outlines the commitment of each country to restore
and maintain the chemical, physical and biological integrity of the
waters of the Great Lakes basin ecosystem, including the international
portion of the St. Lawrence River.

In the Agreement, the two governments commit to virtually eliminate
the input of persistent toxic substances. It has also resulted in
cooperation between the United States and Canada to limit the
discharge of nutrients and toxic substances into the waters, restore
degraded areas and undertake other joint activities designed to
improve water quality.

The governments intend to launch a review of the operation and
effectiveness of the Agreement in early 2006. The guidelines for the
review
process specify that a precautionary approach will be taken.
(See story in this issue of Rachel's Precaution Reporter.)

The International Joint Commission will hold 14 public meetings across
the Great Lakes and St. Lawrence River basin, conduct a Web Dialogue
and accept written and oral submissions until November 30. For more
information, call toll-free at 1-866- 813-0642 or check the IJC's web
site
.

Schedule of public meetings:

** Monday, October 17 at 7 p.m. in Montreal, Quebec, at City Hall, 275
Notre-Dame Street East

** Monday, October 24 at 7 p.m. in Duluth, Minnesota, at the Central
Hillside Community Center, 12 East 4th Street

** Tuesday, October 25 at 7 p.m. in Thunder Bay, Ontario, at City
Hall, 500 Donald Street East

** Thursday, October 27 at 7 p.m. in Sault Ste Marie, Ontario, in the
City Council Chamber at the Civic Centre, 99 Foster Drive

** Tuesday, November 1 at 7 p.m. in Bay City, Michigan, at City Hall,
301 Washington Avenue

** Tuesday, November 1 at 7 p.m. in Green Bay, Wisconsin, at the KI
Convention Center, 333 Main Street

** Wednesday, November 2 at 7 p.m. in Chicago, Illinois, in the Phelps
Auditorium at the Shedd Aquarium, 1200 South Lake Shore Drive

** Wednesday, November 2 at 3 p.m. in Detroit, Michigan, at the
Detroit Regional Chamber of Commerce, One Woodward Avenue, Suite 1900

** Wednesday, November 2 at 7 p.m. in Windsor, Ontario, at the Cleary
International Centre, 201 Riverside Drive West

** Thursday, November 3, at 7 p.m. in Cleveland, Ohio, in the Rotunda
of City Hall, 601 Lakeside Avenue

** Tuesday, November 8 at 7 p.m. in Quebec City, Quebec, at City Hall,
2 rue des Jardins

** Tuesday, November 8 at 7 p.m. in Midland, Ontario, in the Council
Chamber at the Municipal Building, 575 Dominion Avenue

** Wednesday, November 9 at 7 p.m. in Toronto, Ontario, at City Hall,
100 Queen Street West.

** Thursday, November 10 at 7:30 p.m. in Rochester, New York, in the
City Council Chambers at City Hall, 30 Church Street

Can't Attend? You can contribute online.

Or call toll-free 1-866-813-0642

Fax (613) 993-5583

Or write:

International Joint Commission
Great Lakes Regional Office (Canada)
100 Ouellette Ave., 8th Floor
Windsor, ON N9A 6T3

In the United States
P.O. Box 32869
Detroit, MI 48232

The deadline for comments is midnight, November 30, 2005

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From: International Joint Commission, Oct. 5, 2005
[Printer-friendly version]

PRINCIPLES FOR REVIEW, GREAT LAKES WATER QUALITY AGREEMENT

[RPR introduction: Here are the "principles" that the International
Joint Commission (IJC) recommends as a guide to the U.S. and Canada
when they review the Great Lakes Water Quality Agreement in 2006.

We have heard that the IJC and the governments of Canada and the U.S.
are particularly seeking testimony on the importance of human health
in carrying out the Great Lakes Water Quality Agreement. We hope
citizens will speak out loud and clear at the 14 public meetings
being held this month and next. (See previous story in this issue of
Rachel's Precaution Reporter). --RPR Editors]

The Parties [to the 1909 Boundary Waters Treaty, the U.S. and Canada]
are responsible for the overall review of the Great Lakes Water
Quality Agreement.

In the process of conducting the review, the International Joint
Commission recommends that the Parties adhere to the following
principles. It is recognized that "the Parties shall conduct a
comprehensive review of the operation and effectiveness of the
Agreement" (Article X.4). Consequently, for discussion purposes, the
principles were organized around "operation and effectiveness" and
"comprehensive".

I. Operation and Effectiveness

The process of conducting the review should be:

** Open and Transparent

To the extent practicable, deliberations related to the review should
be open and part of the public record.

** Inclusive

Solicit a full range of views and perspective throughout the [Great
Lakes] Basin through a variety of means (meetings, workshops,
websites, etc.). Engage a wide spectrum of groups and individuals,
including those who are not normally part of Agreement activities and
discussions. Is the Agreement meeting the needs of the people of the
Great Lakes basin?

** Ensure that the Review is Timely

Capitalize on the opportunity of wide-spread community support for a
review, the renewal of the Great Lakes Program in Canada and the
proposals for a Restoration Program in the U.S.

Timely onset of the review is as important as a reasonable time frame
for completing the review. It should be sufficiently long to obtain
necessary information and viewpoints, but sufficiently short to
minimize "burnout." A time period of 18-months is suggested.

** All Aspects of the Review Must be Binational

Workgroups or teams should normally have an equal number of members
from both countries. Consultations should allow equal opportunities
for the citizens of both countries to voice their opinions.

** Impartial

The review should be impartial and avoid conflict of interest.
Recognizing that all players in the Basin have a vested interest in
maintaining certain roles and responsibilities, care should be taken
to avoid having organizations alone review their own work.

II. Comprehensive

The process of reviewing the Agreement comprehensively will address,
by necessity, substantive issues within the Agreement. Principles for
guiding a comprehensive review should:

** Consider the Purpose of the Agreement First

In order for the review process to be most efficient, the purpose of
the Agreement should be confirmed before taking a more in-depth look
at the articles and annexes of the Agreement.

** Use Science and Science-Policy Linkages as the Basis for the Review

The review should be guided by the scientific evidence regarding what
action is needed to restore and maintain the chemical, physical and
biological integrity of the waters of the Great Lakes Basin Ecosystem.

In line with the Commission's Guiding Principles, the concept of
sustainable development, the ecosystem approach, virtual elimination
and zero discharge of persistent toxic substances should be affirmed.

Moreover, while the importance of a sound scientific basis for
conclusions and recommendations should be emphasized, it may sometimes
be necessary to adopt a precautionary approach and to act even in the
absence of a scientific consensus where prudence is essential to
protect the public welfare.

** Be Forward-Looking

Consider the relevance of existing articles and annexes, as well as
any new issues for possible additions that are aligned with the
Agreement purpose. The goals, objectives, and endpoints in the
Agreement should serve as drivers for action.

** Consider Governance

Consider governance roles, responsibilities, and relationships for
those implementing the Agreement, including the Parties' interactions
with First Nations, Tribes, States, Provinces, municipal and regional
governments, and non-governmental organizations, in order to maximize
a sense of ownership throughout the Great Lakes community. Consider
the roles and effectiveness of organizations created under, or
implementing, the Agreement (e.g., the IJC together with its Great
Lakes Regional Office, the Water Quality Board, the Science Advisory
Board, and the Binational Executive Committee.) Clarify, as necessary,
how the Agreement relates to other basin organizations, such as the
Commission on Economic Cooperation (CEC), Great Lakes Fishery
Commission (GLFC), Great Lakes Commission (GLC), and Council of Great
Lakes Governors (CGLG).

** Consider Accountability

Each element in the Agreement being reviewed should consider how
accountability to the public can be enhanced for Agreement
implementation by the Parties, states and provinces, as well as by
cooperating stakeholders in the Great Lakes basin.

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From: Seventh Biennial Report of the IJC, Jun. 15, 1994
[Printer-friendly version]

INTERNATIONAL JOINT COMMISSION SEVENTH BIENNIAL REPORT

[RPR introduction: In the U.S., precautionary thinking began in the
Great Lakes.

In 1978 the U.S. and Canada had signed a "Great Lakes Water Quality
Agreement
," binding both nations to "virtually eliminate persistent
toxic substances" from the Great Lakes ecosystem. In 1990, 1992, and
1994 the IJC described a "virtual elimination strategy" to get
persistent toxic chemicals out of the Great Lakes and keep them out.

During 1990-1994 the International Joint Commission (IJC) published
reports laying out a strategy for the "virtual elimination" of toxic
chemicals from the Great Lakes. The IJC is a government agency created
by the Boundary Waters Treaty of 1909 between the U.S. and Canada.

These early IJC reports started a revolution in thinking.

We believe these IJC reports of 1990, 1992, and 1994 are the
first time a U.S. government agency explicitly embraced a
precautionary approach. So you can hear the original language, here
is a portion of Chapter 3 from the 7th Biennial Report of the IJC
(1994)
.

At the time this report was written, the U.S. chairperson of the IJC
was Gordon Durnil, a strong environmentalist and conservative
Republican
.]

Excerpt from CHAPTER THREE (of the IJC's 7th Biennial Report, 1994)

Strategic Thinking and the Need for Further Change

Persistent Toxic Substances: The Commission's Position

As research findings demonstrate linkages between persistent toxic
substances and biological injury, they continue to reinforce the
Commission's conclusions, which are fundamental to its proposed policy
approach:

** persistent toxic substances are too dangerous to the biosphere and
to humans to permit their release in any quantity, and

** all persistent toxic substances are dangerous to the environment,
deleterious to the human condition, and can no longer be tolerated in
the ecosystem, whether or not unassailable scientific proof of acute
or chronic damage is universally accepted.

The Commission reiterates its stance that the very existence of human-
produced persistent toxic substances in the Great Lakes ecosystem is
inconsistent with maintaining the integrity of the ecosystem and hence
with the Purpose of the [1978 Water Quality] Agreement [between the
U.S. and Canada]. The Great Lakes Water Quality Board has confirmed
that the risks to humans are high, that there is a real probability of
substantial effects, and that such injury from certain persistent
toxic substances merits immediate measures to protect human health.

The characteristics of persistent toxic substances make them much less
amenable to traditional pollution control efforts such as discharge
limits to set acceptable levels in the environment, end-of-the-pipe
technology and disposal regulations.

The idea of a non-zero "assimilative" capacity in the environment or
in our bodies (and hence allowable discharges) for such chemicals is
no longer relevant. The Great Lakes Water Quality Board supports this
view, concluding that there is no acceptable assimilative capacity for
persistent, bioaccumulative toxic substances. It states, therefore,
that the only appropriate water quality objective is zero, even though
interim objectives may be needed.

Within the environment's carrying capacity for human activity, there
is no space for human loadings of persistent toxic substances. Hence,
there can be no acceptable loading of chemicals that accumulate for
very long periods, except that which nature itself generates.

Moreover, conventional scientific concepts of dose-response and
acceptable "risk" can no longer be defined as "good" scientific and
management bases for defining acceptable levels of pollution. They are
outmoded and inappropriate ways of thinking about persistent toxics.

The production and release of these substances into the environment
must, therefore, be considered contrary to the [1978 Water Quality]
Agreement legally, unsupportable ecologically and dangerous to health
generally. Above all, they are ethically and morally unacceptable.

The limits on allowable quantities of these substances entering the
environment must be effectively zero, and the primary means to achieve
zero should be the prevention of their production, use and release
rather than their subsequent removal.

Consequently, vigorous policy is needed to eliminate all persistent
toxic substances, except in very specialized, unavoidable, controlled
and hopefully temporary applications.

While a broad attack on these substances is required, we must begin
somewhere. The Commission has previously proposed beginning with
eleven Critical Pollutants* and still supports this approach. At the
same time, the Commission has concluded that organochlorines are a
major class of pollutants that should be addressed collectively due to
their large number and the egregious characteristics of many of them.

Precaution in the introduction and continued use of chemical
substances in commerce is a basic underpinning of the proposed virtual
elimination strategy. It is generally agreed, in principle, that the
burden of proof concerning the "safety" of chemicals should lie with
the proponent for the manufacture, import or use of at least
substances new to commerce in Canada and the United States, rather
than with society as a whole to provide absolute proof of adverse
impacts.

This principle should in the Commission's view, be adopted for all
human-made chemicals shown or reasonably suspected to be persistent
and toxic, including those already manufactured or otherwise in
commerce. The onus should be on the producers and users of any
suspected persistent toxic substance to prove that it is, in fact,
both "safe" and necessary, even if it is already in commerce. As one
participant at the October 1993 Biennial Meeting said, "Chemicals are
not innocent until proven guilty, people are."

Current Approaches

Canada's Environmental Protection Act provides for the review of
existing substances and control of dangerous substances, but its
implementation has been slow to address specific chemicals for
regulation. It also appears possible that legal challenges will
further render it ineffective in controlling persistent toxic
substances. Provincial action under Ontario's Municipal-Industrial
Strategy for Abatement (MISA) can also be used to eliminate discharges
of persistent toxic substances.

The United States Government has stated that available mechanisms can
be used to invoke regulatory action without definitive proof of a
causal relationship. However, the Toxic Substances Control Act, which
is used to screen the introduction of new chemicals, has to date
failed to screen out many chemicals. Among existing chemicals, it has
only limited the use and manufacture of PCBs. The Great Lakes Water
Quality Board concluded that the act has been rendered ineffective for
the timely control of existing chemicals.

The available approaches have not, in practice, been effective in
either country to screen a multitude of chemicals. A realistic review
of what chemicals have, in fact, been removed from commerce indicates
that the current approach does not provide an effective screening
process. Again, the Great Lakes Water Quality Board emphasized that
the problem lies not with the basic legislation, but with "significant
barriers to the effective implementation of this authority."

The basis for a precautionary approach and reverse onus can also be
found in the Agreement. It is the unequivocal statement of the Parties
to the Agreement that they intend to pursue an objective of virtual
elimination of inputs within a philosophy of zero discharge of
persistent toxic substances. These are forward-looking provisions,
even if they were focused at the time on regulatory and technological
solutions. However, society as a whole is beginning to realize the
importance and implications of this approach, as it come to grips with
the immensity of the persistent toxics problem. Even less well
advanced is a determination to implement virtual elimination
rigorously as a way to deal with persistent toxic substances.
Pollution prevention programs, while an important step forward, do not
necessarily enshrine this concept.

Weight of Evidence

The 1992 Biennial Report also urged adoption of a "weight of evidence"
approach to reaching conclusions on these issues. This approach takes
into account the cumulative weight of the many studies that address
the question of injury or the likelihood of injury to living
organisms. If, taken together, the amount and consistency of evidence
across a wide range of circumstances and/or toxic substances are
judged sufficient to indicate the reality or a strong probability of a
linkage between certain substances or class of substances and injury,
a conclusion of a causal relationship can be made.

This conclusion is made on the basis of common sense, logic and
experience as well as formal science. Once this point is reached, and
taking a precautionary approach, there can be no defensible
alternative to recommending that the input of those substances to the
Great Lakes be stopped. As noted above, the burden of proof must shift
to the proponent (manufacturer, importer or user) of the substance to
show that it does not or will not cause the suspected harm, nor meet
the definition of a persistent toxic substance.

The Commission's definition of "weight of evidence" is a pragmatic one
and not based on arbitrary rules or formulae. It is consistent with
the use of this term in science and law. The Commission's use of this
term has, however, generated considerable discussion and different
concepts from the perspective of various disciplines. Also, the
question of standard of evidence in this field is evolving. Scholars
and practitioners have been encouraged to consider more precise
definitions.

The Great Lakes Water Quality and Science Advisory Boards, and the two
federal governments in their responses to the 1992 Biennial Report,
have all accepted such an approach in principle. It is clear, however,
that in practice its application can result in different outcomes.
This appears to be the case with chlorine, because of different
standards of evidence or different levels of acceptable probability.
Governments, industry and other participants in the policy arena
should collaborate to codify a set of guidelines as to what factors
should be taken into account in weighing evidence.

Risk Assessment

Another relevant procedure is risk assessment. Clearly, the process of
assessing the relative risks to the environment and/or humans from
alternative actions is useful for some purposes. Both countries have
formal frameworks for risk assessment that are, by and large,
compatible, although some discrepancies in methodology exist and
improved integration of human health and environmental risks is
needed. Risk assessment is useful in decision-making, especially in
setting action priorities, but is not directly relevant to the basic
virtual elimination commitment. The Commission does not accept the
argument that the elimination of persistent toxic substances should be
subject to a risk-benefit calculation, as that is not the approach of
the [1978 Water Quality] Agreement.

When risk assessment is used to provide information, however, it is
important to pay careful attention to the communication of that risk
information to the public. Underlying assumptions and caveats, as well
as the question of different perceptions of risk across jurisdictional
boundaries, also must be communicated. Of specific concern is the lack
of uniformity in sport fishing advisories. The Great Lakes Water
Quality Board recommended collective effort among state and provincial
authorities to develop joint public advisories to ensure uniformity.
Furthermore, there is a lack of any public risk information in most
other circumstances.

A fuller accounting of environmental, economic and social values is
also needed when making decisions. At one level, the determination of
what natural resources are being used in human processes should be
part of economic accounting. Similarly, the ramifications of
"environmental" policy changes, which affect the amount of resources
available for production and consumption (including reduction of the
ability to pollute or use traditional technologies), must also be
taken into account.

In some cases, it will not be possible to eliminate substances in use
"overnight," especially if acceptable substitutes are not readily
available, as that could cause serious short-term economic and social
disruption. However, to continue to introduce new products without
this accounting, and to continue resisting a strategy that changes our
production and consumption habits and moves away from reliance on
persistent toxic substances, will be disastrous in the long term from
all perspectives. Again, a reasoned but sure process of transition,
and a new way of thinking about production and consumption decisions,
are needed.

In 1986, the World Health Organization used its definition of health
as a starting point for the Ottawa Charter for Health Promotion
(Ottawa Charter). It emphasizes the dependence of health on the
environment and identifies peace, shelter, food, education, income,
social justice, equity, the maintenance of a stable ecosystem and
sustainable resource development as components of health. It is not
sufficient for governments, industry and commerce to react only to
proven instances of injury. They also must provide a preventive
program to enhance personal and societal security against
unintentional intrusions on human health, at the same time other basic
needs and a high quality of life are met.

While not widely recognized in practice to date, this philosophy is
consistent with the ecosystem concept of the Great Lakes Water Quality
Agreement, as well as the sustainable development concept embraced by
the United Nations World Commission on Environment and Development
(Brundtland Report). This also has subsequently become the policy of
both federal and several state and provincial governments.

Just as human health is dependent on the absence of environmental
degradation, however, ecosystem integrity is dependent on more than
environmental quality. It also must include economic, social, cultural
and political dimensions, not the least of which is a healthy
population and healthy communities. The Commission has previously
observed that "long-term economic sustainability, including the
existence of a healthy and creative work force, depends on a healthy
environment. Paradoxically, a healthy environment depends on the
existence of vibrant local and regional economies."

Despite these efforts, an assessment of the overall policy response to
the environmental health studies and public concern to date must be
characterized as limited and disappointing. The mainstream response
from individuals in government, industry and elsewhere is to debate
the reality or magnitude of the risk to the health of humans and other
components of the ecosystem. Even if the issue is recognized, the
focus tends to be on setting priorities, developing lists, devoting
resources to avoid action and lobby against it, largely on the basis
of debatable short-term economic impacts, rather than on coming to
grips with and addressing the enormity of the problem.

Chemical and associated industries have an obligation to protect human
and other populations from the adverse effects of substances they
bring into existence and use. The Commission recognizes and
congratulates those industrial representatives who have responsibly
engaged in dialogue with the Commission and others, and have taken
pioneering steps to address these problems. It is important and
inevitable that the business sector act increasingly to lead rather
than resist a broad movement towards manufacturing processes that
eliminate the production and use of persistent toxic substances, and
that they embrace a new, ecosystemic approach to business and
governmental decision-making.

One progressive aspect of the Agreement and the Commission's work
pursuant to it has been the emergence of a Great Lakes-St. Lawrence
ecosystem "community" and numerous more specific communities-of-
interest under that umbrella. This development occurred first in the
community of scientists working across jurisdictions and disciplines
to enhance learning, understanding and the efficient use of resources.
In recent years, the active community of Great Lakes interests has
expanded greatly. A variety of new organizations have emerged over the
past decade focusing on regional concerns.

Several governmental institutions have evolved to address Great Lakes
ecosystem issues. This phenomenon has included a refocusing of the
Great Lakes Commission, the Great Lakes Fishery Commission and the
Council of Great Lakes Governors. A number of nongovernmental and
municipal organizations also have involved interested citizens and
specific interests. These citizens and organizations tend to begin at
a nontechnical level, but become increasingly more sophisticated in
knowledge and approach. A wide range of organizations fit this
description, such as Great Lakes United, the Council of Great Lakes
Industries and the International Great Lakes-St. Lawrence Mayors'
Conference, to name only a few examples.

The Commission encourages this process and its broadening to new areas
of the Great Lakes community of interest. Organizations whose mission
is to inform and activate the general public should strive to broaden
their membership and audience, by improving their media and public
affairs approaches and the coordination among organizations to ensure
consistent, accurate messages. All of these bodies have played an
important role, even if temporary, in the institutional component of
the Great Lakes ecosystem.

The voluntary sector is a key component in broadening Agreement
awareness and involvement. This sector needs to be encouraged within
the Great Lakes institutional mosaic, but the organizations and
movements involved, while enthusiastic, are often stymied by lack of
scientific data and interpretive skills. The Commission's Great Lakes
Science Advisory Board has emphasized that empowerment, participation
and involvement of the entire Great Lakes community in the achievement
of the goals of the Agreement is vital to its success.

Scientists should make themselves available to communicate with these
groups and with their local communities at large. Employers, whether
governments, private sector or academia, should permit and encourage
such mutually beneficial linkages. Universities, colleges and other
institutions of higher education in particular have a function in
supporting the wider Great Lakes community. Beyond their educational
roles, they can serve as catalysts to bring scientists, industries,
governments and citizens together to learn from one another and to
develop coordinated action plans....

Ecosystem Boundaries

Geographically, the Great Lakes ecosystem does not stop at the map
boundaries specified in the Agreement. Ecosystem boundaries are
neither fully jurisdictional, geophysical or even demographic in their
definition. They differ for the water, biological, atmospheric and
human dimensions of the ecosystem. The scope of an ecosystem's
boundaries can also differ depending on what economic, social or
political parameters are being considered.

Ecologically, the Great Lakes Basin Ecosystem clearly extends
downstream from the Agreement boundary at the end of the international
section of the St. Lawrence River, deep into Quebec and possibly to
the St. Lawrence estuary. There is evidence, for example, that
contaminants are passing downstream from the Cornwall-Massena area and
into the flesh of marine mammals and fish. This is a geographical and
ecological reality requiring that, at a minimum, concern and dialogue
should extend beyond the current "legal" Agreement boundaries. Whether
or not these formal boundaries of the Agreement merit reconsideration
at an appropriate time, from the Commission's ecosystemic standpoint,
the issue will eventually need to be addressed in some manner if a
fully ecosystemic approach is to be achieved.

In a number of ways, therefore, a significant modification of
institutions and attitudes is required to help resolve Great Lakes
Basin Ecosystem issues. The policy frameworks exist and are subscribed
to by both federal governments. This allows a new way of thinking and
mobilization of concern to move forward....

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

The Commission also believes that our two nations are still at a
turning point of opportunity. They can still make a difference. The
legacy we choose to leave for future generations can be either one of
diminished options and well-being, or an enhanced one. To choose the
latter, a strong, coordinated plan of action with target dates is
urgently needed. It should be designed to effect a new way of doing
business, and be based on the consideration of six basic principles:

Principle 1

The Governments of the United States and Canada, along with the
relevant states and provinces, should act decisively on the
commitments of the Great Lakes Water Quality Agreement wherein they
agreed that:

"The purpose of the Parties is to restore and maintain the chemical,
physical, and biological integrity of the waters of the Great Lakes
Basin Ecosystem," and

"The discharge of toxic substances in toxic amounts be prohibited and
the discharge of any or all persistent toxic substances be virtually
eliminated," within a philosophy of zero discharge.

It is the assumption of the Commission that the federal governments
continue to agree on this fundamental statement of intent upon which
the Commission builds its advice. Governments should also ensure that
their actions are coordinated through effectively functioning
mechanisms for consultation, cooperative research and common action.

Principle 2

Representatives of industry, when presented with evidence of ecosystem
health concerns about substances used in commerce, should react by
embracing open dialogue, data sharing and fact finding to resolve,
rather than deny, concerns and effect an orderly and timely transition
to those solutions.

Principle 3

Representatives of environmental and other organizations should offer
their expertise to help develop pragmatic solutions to the transition
issues that face governments, industries and their employees,
consumers and others in adopting preventive strategies.

Principle 4

While the scientific process should be value neutral, scientists
should be forthcoming in responses to public concerns and the
provision of current information about the health of the Great Lakes
ecosystem, especially as it relates to human health.

Principle 5

News media should review their policies about reporting on the
widespread use and effects of persistent toxic substances and evaluate
their responsibility to inform the public about them.

Principle 6

Citizens should constantly ask political, social and industrial
leaders about the effects of the use and discharge of pollutants on
this and future generations.

Gordon K. Durnil, Co-chairman
Claude Lanthier, Co-chairman
Hilary P. Cleveland, Commissioner
James A. Macaulay, Commissioner
Robert F. Goodwin, Commissioner
Gordon W. Walker, Commissioner

Return to Table of Contents

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From: Wall Street Journal, Oct. 4, 2005
[Printer-friendly version]

FROM AN INGREDIENT IN COSMETICS, TOYS, A SAFETY CONCERN

Male Reproductive Development Is Issue With Phthalates, Used in Host
of Products; Europe, Japan Restrict Them


By Peter Waldman

In the 12th week of a human pregnancy, the momentous event of gender
formation begins, as X and Y chromosomes trigger biochemical reactions
that shape male or female organs. Estrogens carry the process forward
in girls, while in boys, male hormones called androgens do.

Now scientists have indications the process may be influenced from
beyond the womb, raising a fresh debate over industrial chemicals and
safety. In rodent experiments, common chemicals called phthalates,
used in a wide variety of products from toys to cosmetics to pills,
can block the action of fetal androgens. The result is what scientists
call demasculinized effects in male offspring, ranging from
undescended testes at birth to low sperm counts and benign testicular
tumors later in life. "Phthalate syndrome," researchers call it.

Whether phthalates -- pronounced "thallets" -- might affect sexual
development in humans, too, is now a matter of hot dispute. Doses in
the rodent experiments were hundreds of times as high as the minute
levels to which people are exposed. However, last year, federal
scientists found gene alterations in the fetuses of pregnant rats that
had been exposed to extremely low levels of phthalates, levels no
higher than the trace amounts detected in some humans.

Then this year, two direct links to humans were made. First, a small
study found that baby boys whose mothers had the greatest phthalate
exposures while pregnant were much more likely than other baby boys to
have certain demasculinized traits. And another small study found that
3-month-old boys exposed to higher levels of phthalates through breast
milk produced less testosterone than baby boys exposed to lower levels
of the chemicals.

Scientists are raising questions about phthalates at a time when male
reproductive disorders, including testicular cancer, appear to be on
the rise in many countries. Seeking an explanation, European
endocrinologists have identified what some see as a human counterpart
to rodents' phthalate syndrome, one they call "testicular dysgenesis
syndrome." Some think it may be due in part to exposure to phthalates
and other chemicals that interfere with male sex hormones.

"We know abnormal development of the fetal testes underlies many of
the reproductive disorders we're seeing in men," says Richard Sharpe
of the University of Edinburgh in Scotland, a researcher on male
reproduction. "We do not know what's causing this, but we do know high
doses of phthalates induce parallel disorders in rats."

It isn't surprising to find traces of phthalates in human blood and
urine, because they are used so widely. Nearly five million metric
tons of phthalates are consumed by industry every year, 13% in the
U.S. They are made from petroleum byproducts and chemically known as
esters, or compounds of organic acid and alcohol. The common varieties
with large molecules are used to plasticize, or make pliable,
otherwise rigid plastics -- such as polyvinyl chloride, known as PVC
-- in things like construction materials, clothing, toys and
furnishings. Small-molecule phthalates are used as solvents and in
adhesives, waxes, inks, cosmetics, insecticides and drugs.

Users and producers of phthalates say they are perfectly safe at the
very low levels to which humans are exposed. Phthalates are among the
most widely studied chemicals and have proved safe for more than 50
years, says Marian Stanley of the American Chemistry Council, a trade
association.

She says studies suggest primates, including humans, may be much less
sensitive to phthalates than are rodents. She cites a 2003 Japanese
study of marmoset monkeys exposed to phthalates as juveniles, which
found no testicular effects from high doses. The study was sponsored
by the Japan Plasticizer Industry Association. Scientists involved in
a California regulatory review questioned the study and maintained it
didn't support the conclusion that humans are less sensitive to
phthalates than rodents are.

Ms. Stanley's conclusion: "There is no reliable evidence that any
phthalate, used as intended, has ever caused a health problem for a
human."

Societal Issue

The phthalate debate is part of the larger societal issue of what, if
anything, to do about minute, once-undetectable chemical traces that
some evidence now suggests might hold health hazards.

With much still unknown about phthalates, scientists and regulators at
the Environmental Protection Agency are moving cautiously. "All this
work on the effects of phthalates on the male reproductive system is
just five years old," says the EPA's leading phthalate researcher, L.
Earl Gray. "There appears to be clear disruption of the androgen
pathway, but how? What are phthalates doing?"

To Rochelle Tyl, a toxicologist who works for corporations and trade
groups studying chemicals' effects on animals, the broader question
is: "If we know something bad is happening, or we think we do, do we
wait for the data or do we act now to protect people?" Based on her
own studies of rodents, Dr. Tyl says it is still unclear whether low
levels of phthalates damage baby boys.

Some countries have acted. In 2003, Japan banned certain types of
phthalates in food-handling equipment after traces turned up in school
lunches and other foods.

The European Union has recently banned some phthalates in cosmetics
and toys. In January, the European Parliament's public health
committee called for banning nearly all phthalates in household goods
and medical devices. In July, the full parliament asked the EU's
regulatory body, European Commission, to review a full range of
products "made from plasticised material which may expose people to
risks, especially those used in medical devices."

With the controversy particularly hot in Europe, the European market
for the most common phthalate plasticizer, diethylhexyl phthalate, or
DEHP, has fallen 50% since 2000, says BASF AG, the German chemical
giant. In response, BASF says it is ceasing production of DEHP in
Europe this month. A spokesman for the company says the cutback won't
affect its phthalate production in the U.S.

The U.S. doesn't restrict phthalates, and has lobbied the EU hard in
recent years not to burden manufacturers with new regulations on
chemicals. Still, a few companies, under pressure from health groups,
have agreed to abide by European standards in their products sold in
the U.S. Procter & Gamble Co. said last year it would no longer use
phthalates in nail polish. Last December, Unilever, Revlon Inc. and
L'Oreal SA's American unit promised to eliminate all chemicals banned
in European products from the same items in the U.S.

For medical bags and tubes, Baxter International Inc. pledged in 1999
to develop alternatives to phthalate-containing PVC, as did Abbott
Laboratories in 2003. (Abbott has since spun off its hospital-products
unit.) In a June study by Harvard researchers of 54 newborns in
intensive care, infants who'd had the most invasive procedures had
five times as much of the phthalate DEHP in their bodies -- as
measured in urine -- as did babies with fewer procedures.

Researchers aren't yet sure what this means. Another study by doctors
at the Children's National Medical Center in Washington, published
last year, found that 19 adolescents who'd had significant exposure to
phthalates from medical devices as newborns showed no signs of adverse
effects through puberty.

Kaiser Permanente, the big health-maintenance organization, promised
in 1999 to eliminate phthalates in hospital supplies. Demand from the
HMO has helped drive development of medical gloves that don't contain
phthalates, as well as non-PVC carpeting and a new line of phthalate-
free plastic handrails, corner guards and wall coverings.

In the early 1990s, the EPA set exposure guidelines for several types
of phthalates, based on studies that had been done decades earlier.
Since then, much more has been learned about them.

Consider dibutyl phthalate, which is used to keep nail polish from
chipping and to coat some pills. The EPA did a risk assessment of it
15 years ago, relying on a rodent study performed in 1953. The now
half-century-old study found a "lowest adverse-effect level" -- 600
milligrams a day per kilogram of body weight -- that killed half of
the rodents within a week.

A 2004 study of the same chemical, published in the journal
Toxicological Sciences, found far subtler effects, at far lower
exposures. It detected gene alteration in fetuses of female rats that
ingested as little as 0.1 milligram a day of the phthalate for each
kilogram of body weight. That dose is one six-thousandth of the 1953
"lowest adverse-effect" level.

It's also an exposure level found in some U.S. women, says Paul Foster
of the National Institute of Environmental Health Sciences, a co-
author of the gene study. So "now we're talking about 'Josephina Q.
Public' -- real women in the general population," he says. "The
comfort level is receding."

EPA Caution

Still, because researchers don't know the function of the genes that
were altered in the rat study, EPA experts say it's too early to base
regulatory decisions on such gene changes. "We're a long way, in my
opinion, from considering changes in gene expression as 'adverse' for
risk assessment," says the environmental agency's Dr. Gray.

Exxon Mobil Corp. and BASF dominate the $7.3 billion phthalates
market. An Exxon Mobil spokeswoman says risk assessments by government
agencies in Europe and the U.S. confirm "the safety of phthalates in
their current applications."

Phthalates are cheaper than most other chemicals that can soften
plastics. But a BASF press release says European manufacturers have
been replacing phthalates with plasticizers designed for "sensitive
applications such as toys, medical devices and food contact."

Makers of pills sometimes coat them with phthalates to make them
easier to swallow or control how they dissolve. A case study published
last year in the journal Environmental Health Perspectives said a man
who took a drug for ulcerative colitis, Asacol, for three months was
exposed to several hundred times as much dibutyl phthalate as the
average American. The drug's maker, Procter & Gamble, says it coats
the pill with the phthalate so it will stay intact until it reaches
inflamed colon areas. P&G says a daily dose of the drug has less than
1% of the 0.1 milligram of dibutyl phthalate per kilogram of body
weight that the EPA regards as a safe daily dose.

Sperm Count

Attributing health effects to specific industrial chemicals is a dicey
business. Scientists often look for associations: statistical
correlations that suggest, but don't prove, a possible causal link.

With phthalates, they've found a few. For instance, a 2003 study
divided 168 male patients at a fertility clinic into three groups
based on levels of phthalate metabolites in their urine. The study
found that men in the highest third for one of the phthalates were
three to five times as likely as those in the lowest third to have a
low sperm count or low sperm activity. Men highest in a different
phthalate also had more abnormally shaped sperm, according to the
study, which was done by researchers at the Harvard School of Public
Health and published in the journal Epidemiology.

The scientists now are extending the research to 450 men. In their
next paper, they're also planning to discuss a separate Swedish study,
of 245 army recruits, that found no link between phthalate exposure
and sperm quality.

The latest human study, on 96 baby boys in Denmark and Finland, found
that those fed breast milk containing higher levels of certain
phthalates had less testosterone during their crucial hormonal surge
at three months of age than baby boys exposed to lower levels.

Authors of the study, led by Katharina Main of the University of
Copenhagen and published Sept. 8 in Environmental Health Perspectives,
said their findings support the idea that the human testis is
vulnerable to phthalate exposure during development -- possibly even
more vulnerable than rodents' genitalia. They added, however, that
"before any regulatory action is considered, further studies on health
effects of [phthalates] are urgently needed" aimed at "verifying or
refuting our findings."

Physical Differences

A human study of 85 subjects published in June linked fetal exposure
to phthalates to structural differences in the genitalia of baby boys.

Researchers measured phthalate levels in pregnant women and later
examined their infant and toddler sons. For pregnant women who had the
highest phthalate exposure -- a level equivalent to the top 25% of
such exposure in American women -- baby sons had smaller genitalia, on
average. And their sons were more likely to have incompletely
descended testicles.

Most striking was a difference in the length of the perineum, the
space between the genitalia and anus, which scientists call AGD, for
anogenital distance. In rodents, a shortened perineum in males is
closely correlated with phthalate exposure. A shortened AGD also is
one of the most sensitive markers of demasculinization in animal
studies.

Males' perineums at birth are usually about twice as long as those of
females, in both humans and laboratory rodents. In this study, the
baby boys of women with the highest phthalate exposures were 10 times
as likely to have a shortened AGD, adjusted for baby weight, as the
sons of women who had the lowest phthalate exposures.

The length difference was about one-fifth, according to the study,
which was led by epidemiologist Shanna Swan of the University of
Rochester (N.Y.) School of Medicine and Dentistry and published in
Environmental Health Perspectives. Among boys with shorter AGD, 21%
also had incomplete testicular descent and small scrotums, compared
with 8% of the other boys.

Does it matter? The researchers intend to track as many of the boys as
possible into adulthood, to address a key question: Will they grow up
with lower testosterone levels, inferior sperm quality and higher
rates of testicular tumors, as do rats with phthalate syndrome?

When the boys are 3 to 5 years old, Dr. Swan plans to assess their
play behavior to see if exposure to phthalates appears associated with
feminized neurological development. She says such tests have shown
that little girls with high levels of androgens, or male hormones,
gravitate toward "masculine" play. But she says no one has studied
whether boys' play is affected by fetal exposure to chemicals that
block androgens.

"In rodents, the changes result in permanent effects. Future studies
will be necessary to determine whether these boys are also permanently
affected," Dr. Swan says.

She and others agree that a study of just 85 subjects needs to be
enlarged and repeated. She notes that although boys' genitalia were
affected in subtle ways, no substantial malformations or disease were
detected.

Some endocrinologists call this the first study to link an industrial
chemical measured in pregnant women to altered reproductive systems in
offspring. "It is really noteworthy that shortened AGD was seen," says
Niels Skakkebaek, a reproductive-disorder expert at the University of
Copenhagen, who wasn't an author of the study. "If it is proven the
environment changed the [physical characteristics] of these babies in
such an anti-androgenic manner, it is very serious."

Ms. Stanley of the American Chemistry Council doubts that any study
can "tease out" the cause of a human health condition, given the wide
variety of chemical exposures in people's lives. She notes that some
of the specific phthalates associated with reproductive changes in the
two human-baby studies haven't been linked to such changes in rodents.
So, she says, it's possible the changes in anogenital distance and
hormone levels may merely reflect normal variability.

Dr. Tyl, the chemical-industry toxicologist, says her own rat studies
confirm that AGD is very sensitive to phthalates. She says that in
rats that had very high phthalate exposures, a shortened AGD at birth
was closely associated with a number of serious reproductive disorders
later in life. However, in rats exposed to much lower doses of
phthalates, a shortened AGD at birth did not always lead to later
troubles. Many of these rats grew up to breed normally, she says,
despite their slightly altered anatomy.

Dr. Tyl suggests that the same may be true of humans. Dr. Swan's study
is "potentially important," Dr. Tyl says, because it suggests that "at
low levels of exposure, humans are responding" to phthalates. But it
remains quite possible, Dr. Tyl theorizes, that the boys with
shortened AGD will grow up normally. "At what point do changes like
this cross the line" to become dangerous, she asks. "We don't know
yet."

Write to Peter Waldman at peter.waldman@wsj.com

RELATED READING

See various studies related to phthalates:

Phthalate Exposure and Human Semen Parameters

Phthalate exposure and reproductive hormones in adult men

Dose-Dependent Alterations in Gene Expression and Testosterone
Synthesis in the Fetal Testes of Male Rats Exposed to Di (n-butyl)
phthalate

Analysis of Consumer Cosmetic Products for Phthalate Esters

Phthalate Exposure during Pregnancy and Lower Anogenital Index in
Boys: Wider Implications for the General Population?


Decrease in Anogenital Distance among Male Infants with Prenatal
Phthalate Exposure


Medications as a Source of Human Exposure to Phthalates

Human Breast Milk Contamination with Phthalates and Alterations of
Endogenous Reproductive Hormones in Three Months Old Infants


Follow-Up Study of Adolescents Exposed to Di(2-Ethylhexyl) Phthalate
(DEHP) as Neonates
on Extracorporeal Membrane Oxygenation (ECMO)
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