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Precautionary approaches to public health have a long history. The father of the precautionary approach is Hippocrates, who said "As to diseases make a habit of two things – to help, or at least, to do no harm" (Ref: Hippocrates in Epidemics). Precautionary actions have been a cornerstone of public health. For example, the physician John Snow mapped cases of London’s cholera epidemic of the mid-1800s. He observed that most cases of cholera were grouped around dwellings that used a certain well for drinking water. Until then it was thought that diseases were only transmitted in the air. The possibility of water transmission was hotly debated. While the organism that caused cholera was not identified for another 30 years, the removal of the handle at the Broad Street pump was a precautionary action by Dr. Snow that had a major impact on halting the 1854 cholera epidemic in the Soho district of London.

In more modern times, the origins of the Precautionary Principle can be traced to Germany’s emerging environmental movement of the 1970s. "Precautionary Principle" is actually the English translation of the German phrase "Vorsorgeprinzip," and the direct translation is "Foresight Principle" (Ref: Kreibel and Tickner, American Journal of Public Health, vol. 91, pp. 1351-55, 2001; and Tickner, Precaution and preventive public health policy (editorial), Public Health Reports, vol. 117. pp. 493-497, 2002).

There is no one definition of the Precautionary Principle. One of the early definitions was drafted in 1992 at the United Nations Rio Conference on the Environment and Development:

Definitions of the Precautionary Principle continued to evolve. A conference that had a major impact on redefining the Precautionary Principle was the 1998 Wingspread Conference held in Racine, Wisconsin. The 32 participants at the conference included scientists, lawyers, treaty negotiators and activists from the United States, Canada, and Europe. The participants drafted statements calling on policy makers, corporations, scientists, and communities to implement Precautionary Principles in making decisions affecting the environment. The principles they drafted at the end of the three-day conference included:

Recent Legislation in Canada based on Precautionary Policy Precautionary Framework Policy Passed

On August 5, 2003, the Canadian Cabinet formally approved policy that will apply the Precautionary Principle to all decisions made by federal policy makers that "carry a risk of serious or irreversible harm where there is a lack of scientific uncertainty" (Refs: http://www.pco-bcp.gc.ca and Menyasy, Canadian Government OKs formal approach for application of the Precautionary Principle, Environmental Reporter, vol. 34, pp. 1840-1841, 2003).

Introductory statements justifying this legislation included:

"
Governments can rarely act on the basis of full scientific certainty and cannot guarantee zero risk. Indeed, they are traditionally called upon and continue to address new or emerging risks…even though scientific information may be inconclusive, decisions will still have to be made as society expects risks to be addressed and managed and living standards enhanced."
Ref: Section 2.0, Context, Framework for the Application of Precaution in Science-based Decision Making about Risk, http://www.pco-bcp.gc.ca.

The precautionary framework is to be applied to federal domestic policies and laws in Canada, as well as to international agreements. The policy acknowledges that a precautionary approach is a legitimate method for decision-making. The framework embraces the Precautionary Principle by acknowledging that public involvement should be present in the scientific review and decision-making process. It stresses that scientific information is the basis of applying the Precautionary Principle. Science is not static. Policies and regulations may be modified as more information characterizing the risk becomes available (Ref: http://www.pco-bcp.gc.ca).

Québec Pesticide Laws

In July of 2002, Québec enacted a "Pesticide Management Code" which will phase out the use of certain pesticides on lawns in public and municipal areas. Restrictions will be extended to the private lawns of homeowners by 2005. The legislation will change requirements for training of persons working in retail pesticide sales, and will also broaden requirements that must be met for certification of farmers and forest managers who apply pesticides. The legislation will also specify which chemicals (called the "active ingredients") will be allowed for pest control inside and outside in elementary and secondary schools, and daycare centers (Ref: http://www.menv.gouv.qc.ca/index-en.htm press release dated 7/2/2003, on line version in French, released by Jean-Louis Laplante, Press Secretary, Canadian Cabinet of the Minister of State for Municipal Affairs, the Environment and Water).

Other cities in Canada, including Toronto, have recently passed laws restricting use of chemical insecticides and herbicides (weed killers) on lawns of private residences.

Canadian Healthy Lawn Program

The healthy lawn program was developed through collaboration between Health Canada’s Pest Management Regulatory Agency and provincial and territorial governments in Canada. The goal of the program, featured on-line at www.healthylawns.net, is to promote the use of integrated pest management techniques to reduce reliance on the use of pesticides to control lawn problems.

The Wingspread Conference added the elements of reversing the burden of proof (the "polluter pays" principle), as well as the importance of open dialogue and the democratic process in decision-making. Another new concept was the full exploration of alternatives. The importance of planning and considering alternatives in the decision making process is closer to the original German concept of the "foresight" principle.

Scientists use a variety of tools to predict hazards in people. One example of harm or irreversible damage detected in laboratory animals before there was "proof" of harm in humans was data on the chemical vinyl chloride. Years before a similar type of liver tumor was observed in plastic manufacturing workers exposed to high levels of vinyl chloride, a rare type of liver tumor was identified in controlled laboratory animal studies (Ref: Rosner and Markowitz, Industry challenges to the principle of prevention in public health: the precautionary principle in historical perspective, Public Health Reports, vol. 117, pp. 501-512, 2002).

The National Toxicology Program still oversees a variety of short and long-term studies in laboratory animals used to identify potential chemical hazards in humans. Of the 509 chemicals tested so far, eight percent (or 42) have been identified as causing mammary (breast) tumors in control laboratory animal cancer bioassays.

While the Precautionary Principle has been getting a lot of attention recently, landmark environmental legislation enacted in the 1970s in the United States used a precautionary approach. For instance, the Occupational Safety and Hazard Administration (OSHA) attempted to regulate levels of benzene in the workplace because it was suspected of causing a rare type of leukemia. In the case Industrial Union, OSHA was sued over the proposed regulation. The US Supreme Court ruled in favor of OSHA, supporting precautionary action in light of scientific uncertainty, stating:

A second example is a court ruling in the case of the Ethyl Corporation vs. the US Environmental Protection Agency (EPA). The "ethyl" stood for "tetra ethyl lead," the additive that had been added to gasoline since 1922. The EPA’s phase out of lead in gasoline in the 1970s was based on concerns that ethyl lead as a fuel additive caused "significant" harm to those who were exposed to it, especially children. In 1976, the majority opinion of the court ruled in favor of the EPA stating:

Policy makers and regulatory agencies in the United States have had a strong history of precautionary approaches to protect public health even when there is scientific uncertainty of a cause and effect. Unfortunately for our nation’s children, the phase out of lead in gasoline was too long in coming. From 1922 to 1985 more than 15.5 billion pounds of lead was used as a gasoline additive in the United States. With the phase out of lead in gasoline in the 1970-80s, lead levels in air had been reduced by 80 percent by the 1990s. But lead still persists in soil since it does not degrade. Public health scientists had testified and protested the use of lead in gasoline as early as 1925. One of the leading public health scientists of that time, Dr. Thompson of the US Public Health Service had stated, "…lead has no business in the human body … everyone agrees lead is an undesirable hazard and the only way to control it is to stop its use by the public." (Refs: Rosner and Markowitz, Industry challenges to the principle of prevention in public health: the precautionary principle in historical perspective, Public Health Reports, vol. 117, pp. 501-512, 2002, and http://www.uwsp.edu/geo/courses/geog100/Lead-Science.htm).

Nearly 60 years later we are still struggling with how very low levels of lead affect the body’s immune system and cognitive development in children. However, the push to use lead in gasoline in the 1920s was made under the guise of the global competitiveness and industrial supremacy of the United States. We, our children, and generations to come, will pay the price for the decision to use lead in gasoline for more than 50 years.

For the protection of our children’s health, the American Public Health Association (APHA) affirmed its endorsement of the Precautionary Principle as a cornerstone of public health. In a 2000 policy statement, the APHA encouraged governments, the private sector and health professionals to promote and use the Precautionary Principle to protect the health of developing children (Ref: APHA Policy Statements adopted Nov. 15, 2000, American Journal of Public Health, vol. 91, pp 476, and 495-496, 2001).

Examples of federal landmark legislation using a precautionary approach include the Food, Drug and Cosmetic Act. This law requires pharmaceutical manufacturers to demonstrate safety of the drug prior to market approval by the Food and Drug Administration (FDA). The 1970 Occupational Safety and Health Act requires employers to provide workplaces free from recognized hazards (Ref: Mayer et al., Moving further upstream: from toxics reduction to the precautionary principle, Public Health Reports, vol. 117, pp. 574-586, 2002).

The EPA requires pesticide manufacturers to submit the results of animal cancer bioassays prior to registration approval to determine if the pesticide is a cancer hazard. Unfortunately, there is a lack of transparency in this process. The cancer bioassay reports are submitted to the EPA, but remain the property of the manufacturer. The results of the reports are rarely published in the open scientific literature, and often can only be obtained though the tedious process of a Freedom of Information Act request. But since proprietary (trade secret) information can be found in the reports, the manufacturer retains the right to edit (black out) parts before they are released if copies are requested under the Freedom of Information Act. While some requests have quick turnaround of one to three months, BCERF staff have waited up to 18 months to get copies of reports evaluating the cancer causing potential of certain pesticides.

Instead of requiring individual risk assessments to be done for each air pollutant, the revised 1990 Clean Air Act amendment states that maximum controls must be used for a list of 180 chemicals unless there is proof that they are harmless. (Refs: Harremoës [editor], Late lessons from early warnings; the precautionary principle 1896-2000, European Environment Agency, Report no. 22, 2001; and Goldstein, The precautionary principle also applies to public health actions, American Journal of Public Health, vol. 91, 1358-1361, 2001).

The Massachusetts Toxic Use Reduction legislation is another example of a success story at the state level. This act has lead to a 75 percent reduction in chemical emissions, a 57 percent reduction in chemical waste, and a $15 million savings to the industry. (Ref: Tickner, Precaution and preventative public health policy, Public Health Reports, vol. 117, pp. 493-497, 2002).

Legislation creating a policy framework for precautionary action has also been enacted in some municipalities. On June 17, 2003, the San Francisco Board of Supervisors formally adopted the Precautionary Principle for managing environmental issues. Several elements, including taking anticipatory action to prevent harm, community right to know, assessment of the full range of alternatives, cost accounting, and a participatory decision making process, were cited in the policy statement. (Ref: Environmental Code and Precautionary Principle Policy, File no. 030422, Ordinance No. 171-03, San Francisco Board of Supervisors, June 17, 2003; http://sfgov.org/site/uploadedfiles/bdsupvrs/ordinances03/o0171-03.pdf;

While the European Union is currently embracing the Precautionary Principle more fully, there are examples of when the United States took precautionary action before Europe. For instance, the United States banned chloroflurocarbons in aerosols in 1977 because of concerns of how this chemical affected the ozone layer. European Nations followed suit several years later. The United States also banned DES as a growth promoter in beef in 1979, 10 years before a similar ban in Europe.

But more recently we are lagging behind Europe. A class of chemicals called polybrominated diphenylethers (PBDEs) has been banned in Sweden. These flame retardants are widely used in carpets, furniture foam, and plastics (including plastic computer casings). PBDEs can range from five to 30 percent by weight of these products. As the fibers and plastics degrade the dust containing the chemical is inhaled and concentrates in body fat. PBDEs have been found globally in marine life from the North Atlantic, to harbor seals in the San Francisco Bay area. PBDEs have been widely detected in air, drinking water, and food in Europe. Few studies have been done on food levels in the United States. Sweden, with an extensive human breast milk banking system, detected an alarming rise in levels of PBDE in the breast milk of European women in recent years. The United States does not have a national breast milk bank, but very high levels of PBDEs – more than 10 times higher than detected in Europe – have been found in women from the San Francisco Bay area. Sweden banned PBDEs based on the chemicals’ persistency in the environment, bioaccumulative properties, and the availability of alternatives. No similar ban has been enacted in the United States. Recently, scientists have also shown that PBDEs can support the growth of estrogen-dependent breast tumor cells in the laboratory (Refs: Darnerund et al., Environmental Health Perspectives, 109 [Supplement 1]:49-68, 2001; Christensen and Platz, Journal of Environmental Monitoring, 3:543-7, 2001; She et al., Chemosphere 46:697-707, 2002; McDonald, Chemosphere 46:745-55, 2002; Wenning, Chemosphere 46:779-96, 2002; and Hooper and She, Environmental Health Perspectives, vol. 111, pp. 109-114, 2003).

A precautionary approach does not mean that regulated chemicals are no longer studied. Indeed, as more information on risk is gathered, policies may be reevaluated. For instance, the European Union’s program on characterizing whether endocrine disrupting chemicals affect the health of humans and animals is called the CREDO program: Cluster of Research on Endocrine Disruption in Europe. One of the gaps they will fill will be to better characterize health risks posed by PBDEs and other flame-retardants (Ref: Lorenz et al., E.U. shifts endocrine disrupter research into overdrive, Science, vol. 300, p. 1069, 2003).

The European Union is considering enacting a policy evaluating the risks of new and old chemicals. The proposed policy is called REACH, which stands for Registration, Evaluation, and Authorization for Chemicals. In December 2002, the Danish Minister for the Environment presented an overview of the proposed policy as a part of an endocrine disruption scientific conference that was held in Copenhagen, Denmark. I had the pleasure of hearing the Danish minister’s talk. The REACH program has also been described in a recent articles by Michael Rogers, a policy advisor to the European Commission (Refs: Rogers et al., Risk analysis under new uncertainty, the precautionary principle, and the new EU chemicals strategy, Regulatory Toxicology and Pharmacology, vol. 37, pp. 370-381, 2003; and Rogers, The European Commission’s white paper "Strategy for a Future Chemicals Policy": a review, Risk Analysis, vol. 23, pp. 381-388, 2003). This legislation would require European Union members to "act as one" to register new and existing chemicals that are produced at over one ton per year, all endocrine disruptors and POPs chemicals (persistent environmental pollutants). Information on uses, toxicity data, production, and preliminary risk assessments would be included in the registration database. Full risk assessments would be required on all high volume chemicals produced at more than 100 tons annually, and also on lower volume chemicals of concern. Authorities would use the registration and risk assessment information to make decisions on whether to authorize the continued/future use of the chemical or not. What is remarkable about this proposed legislation is that both new and existing chemicals would be held to the same standard. Even though the legislation is not finalized, many industries in Europe are already pooling resources to start conducting the risk assessment on many of the high production chemicals (see Lowenberg, E.U. starts a chemical reaction, Science, vol. 300. p. 405, 2003).

To what extent heavy lobbying by both environmentalists and the European chemical industry will affect the final form of the proposed REACH legislation remains to be seen. A September 25, 2003 article by Andrew Osborn, in the British newspaper The Guardian, suggested that a new draft of the proposed REACH legislation being circulated in Brussels may require testing far fewer chemicals than was mandated in earlier drafts (The Guardian, http://www.guardian.co.uk/business/story/0,3604,1049170,00.html). Many aspects of this proposed legislation are being hotly debated in Europe, including its complex implementation, benefits to the environment, and potential impact on the European chemical industry.


	The Precautionary Principle Thus Far: Where It’s Been, Where It’s Heading
	As a tool of public policy-making, the Precautionary Principle has evolved considerably since its earliest incarnations. Its history and current status can be summarized as follows:
	* It was used extensively in United States environmental decision-making in the 1970s. * It has been and continues to be the cornerstone of the public health system. * It is already being used as a cornerstone of environmental decision-making in European nations – especially Denmark, Sweden, and Germany – as well as in Canada (see side-bar article). * It can be used to enhance collection of cancer risk information on high production volume chemicals. * It must be science-based. * It does not eliminate the need for risk assessments. * It is enhanced by public participation. * It requires transparency of data on health risks of chemicals. * It has spurred a debate on whether the principle should embrace the "polluter pays" directive, which places the responsibility for providing risk assessment information with industry. Some advocates of precaution believe that evaluations by independent agencies and researchers are also important.

Of concern is how to deal with the "polluter pays" concept. Environmental groups and some scientists are very cautious of industry-conducted risk assessments because of potential conflicts of interest. How transparent (i.e. how available) will the reports generated by industry be to any interested party? We already have problems with accessibility to the results of pesticide cancer bioassays conducted by manufacturers as a part of EPA mandated registration process. There is still room – indeed, there is an important need – to have a third party conduct the toxicological risk assessments. That is one reason why studies conducted by the EPA’s Health Effects Research Lab and the National Toxicology Program’s cancer bioassay testing programs are so important as hazard assessment programs.

Opponents to the Precautionary Principle have argued that many US federal agencies already use a precautionary approach (see Kriebel et al., The precautionary principle in environmental science, Environmental Health Perspectives, vol. 109, pp 871-875, 2001). We have had a past history of environmental legislation with a precautionary approach. There are important elements that have been introduced into environmental legislation, including adding extra safety factors, when setting limits on certain chemicals. For instance, an extra 10-fold safety factor can be used when setting maximum levels of pesticide residues, called tolerances, on food.

Much of chemical regulatory policy in the United States is based on a more traditional risk assessment procedure where harm must be proven before a chemical is removed from the manufacturing stream, and steps are then taken to mitigate the risk by limiting exposures. This approach can result in a very lengthy risk assessment procedure that can delay policy decisions. It also does have the advantage of providing a wealth of scientific data upon which to make decisions. Again, the cost is often time and continued exposure of the chemical to at risk populations while risk assessment data is being collected. For instance, special review and re-registration assessment of certain pesticides by the EPA make take as long as five to ten years.

The second criticism is that a precautionary approach will invoke a "monsters under the bed" syndrome. As a scientist, I would agree that this is a potential problem. It is important to realize that the precautionary approach does not eliminate the need for assessing harmful effects of chemicals. The definitions of the precautionary principle outlined in earlier in this article do have the common element that precautionary action should be taken when there is credible, scientific evidence of harm. Action should not be taken because of a perceived risk. But, under this principle, action can be taken when there is still scientific uncertainty in order to protect public health.

The third argument is that the precautionary principle is not science-based (Ref: Starr, The precautionary principle versus risk analysis, Risk Analysis, vol. 23, pp. 1-3, 2003). In response, many scientists and policy makers emphasize that the best science must to be brought to the table when using the precautionary principle to make policy decisions. The decisions cannot be made in a vacuum. They cannot be made without scientific evidence of potential harm. We know very little about their risk of many chemicals. The absence of data does not mean there is an absence of harm, but rather that data must be gathered to provide a basis for decision-making. The Precautionary Principle as invoked in the EU REACH program, and in a policy framework recently enacted by the Canadian government (see side bar article), does not require less science. On the contrary, because of the absence of data on so many chemicals, a precautionary approach will require more extensive risk assessments to evaluate if actions are necessary. The question still remains, however, what level of scientific evidence is needed to trigger policy actions based on a precautionary approach. According to John Carins, at Virginia Polytechnic Institute, "… the precautionary principle requires scientists to develop and improve methods and procedures for studying complex natural systems" (Ref: Carins, Interrelationships between the precautionary principle, prediction strategies, and sustainable use of the planet, Environmental Health Perspectives, vol. 111, pp. 877-880, 2003). The best elements of a precautionary approach do not demand less science; rather it is a challenge to the scientific community to improve methods used for risk assessment.

The fourth criticism is that the use of the precautionary principle will stifle industry and competitiveness. Yes, and no. It may cause some industries to no longer operate if a chemical is regulated, but at the same time such action may create entirely new industries. The green industry to produce environmentally friendly products is a viable, market-based industry. For instance, the phasing out of mercury thermometers resulted in an entire digital industry for measuring temperatures in the ears of feverish children. The auto industry survived phasing lead out of gasoline. So did the paint industry. New alternatives for medical tubing without phthalates are now available. This means premature babies and dialysis patients no longer have to be exposed to harmful phthalates that can leach out of plastic tubing. New markets for new products were created that are safer for people and the environment. Seeking alternatives may open up competitiveness for multiple manufacturing streams to replace a single, environmentally toxic product. A summary of the International Summit on Science and the Precautionary Principle held in Lowell Massachusetts in 2001 stated: "Applying the precautionary principle can foster innovation in materials, products and production processes. The goal of precaution is to prevent harm — not progress — and support a sustainable future" (Ref. Sanderson, Conference Report on the International Summit on Science and the Precautionary Principle, Environmental. Science & Research, vol. 9, pp. 155-156, 2002). Our inventiveness can be the best measure of our competitiveness in a global market that will no longer tolerate products that harm human health or the ecology of the earth.

Acknowledgements: The content of these articles are based on the literature and references cited. Funding for the preparation of this article was made possible by the New York State Department of Health and the Department of Environmental Conservation. Any opinions, findings, conclusions or recommendations expressed in this article are those of the author and do not necessarily reflect the view of the New York State Department of Health and the Department of Environmental Conservation.

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What is the Precautionary Principle? How is it Taking Shape Nationally and Globally? The Ribbon

What is the Precautionary Principle? How is it Taking Shape Nationally and Globally?
The Ribbon