Rachel's Precaution Reporter #6
Wednesday, October 5, 2005

From: International Joint Commission .....................[This story printer-friendly]
October 05, 2005


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.

[Rachel's introduction: 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.]

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


From: International Joint Commission .....................[This story printer-friendly]
October 5, 2005


[Rachel's introduction: 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.]

[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.


From: Seventh Biennial Report of the IJC .................[This story printer-friendly]
June 15, 1994


[Rachel's introduction: 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.]

[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


From: Wall Street Journal ................................[This story printer-friendly]
October 4, 2005


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

[Rachel's introduction: 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.]

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


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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