Elements of the Precautionary Principle

Romeo F. Quijano, M.D.
Department of Pharmacology and Toxicology
College of Medicine, University of the Philippines Manila
547 Pedro Gil St., Ermita, Manila 1000, Philippines

The main objective of a scientific exercise to determine the potential threats of harm from chemicals is to protect health and the environment. Yet this fundamental objective is often forgotten or ignored in the appraisal of risks inherent in the production, distribution, and use of potentially harmful chemical products. Dominant forces in the scientific community and regulatory agencies impose an evaluation system that relies heavily on numerical data and on the “smoking gun” type of evidence of harm that presumes the chemical to be innocuous until proven otherwise. This supposedly “science-based” risk assessment methodology has proven to be more effective in protecting vested interests rather than protecting health and the environment. In fact, “science-based” risk assessment is not the decisive factor in determining the regulatory status of a toxic chemical. The reality is that corporate interests and political expediency are the dominant considerations influencing regulatory decisions pertaining to toxic chemicals, especially in Southern countries where financial, technical, human and other resources are sorely lacking and where socio-political circumstances are conducive for powerful chemical companies to exert influence and manipulate public policy. In a country (the Philippines, for example) where thousands of toxic chemical products are imported under a liberalized economic regime and where the income of a foreign chemical company from just one chemical product exceeds many times over the entire budget of the regulatory authority, it is not surprising that health and environmental protection is at the mercy of the market economy. This situation is aggravated by the fact that only a handful of medical toxicologists, most of whom have to contend with numerous other responsibilities as faculty, researcher, clinician, resource person, etc., are available to provide technical expertise to the government which, for some reason, is even reluctant to tap that expertise.

The unequal power relations between the strong and the weak, between the rich and the poor, and between the First world and the Third world is very much in the decision-making processes of government. Decisions that tend to protect health and environment are allowed only in so far as these do not threaten significantly the dominant economic interests or only when strong public pressure is exerted on government. It is not unusual, for example, that bureacrats ignore the recommendations of a government appointed toxicology committee or even abolish the committee itself rather than ban or restrict the toxic chemicals that the committee has deemed to be too dangerous to be allowed into the market. It is also not unusual that a technical expert in that committee who criticizes government inaction and corporate bad practices is marginalized, harassed, threatened and sued in court for being outspoken and for exposing to the public the dangers that the toxic chemicals bring to human health and the environment.

Even intergovernmental bodies are not immune to corporate influence as technical committees are packed with corporate scientists or scientists under their influence. The chemical peddlers, regulatory authorities and other decision makers often rely on the “risk assessments” done by these supposedly objective “scientific” bodies as the basis for concluding a certain toxic chemical is “proven” to be safe. To them, this is “sound science”. True science, however, is about truth and means the search for new knowledge in a systematic and logical manner so that people may benefit from it. True science involves astute observation of objects and events, careful formulation of hypotheses, unbiased experimentation and analysis, and logical conclusions. On the other hand, corporate pseudo-science (disguised as “sound science”) is characterized by manipulation of objects and events, vested interest-driven and obscured formulation of hypotheses, biased experimentation and analysis, and market-directed, predetermined conclusions. In this distorted kind of science, data are collected, generated, or even fabricated to support corporate objectives and achieve marketing targets. Arguments are based not on human logic but are made to protect corporate interests. Information is not something that may be true or false but something that is created and packaged to sell a product. Thus, “science” and scientists, too often, have become effective tools of corporate interests at the expense of public health and the environment. The case histories of endosulfan, methylene chloride and asbestos illustrate just a few examples of such an unfortunate development.

The obfuscation of science is in no small measure due to the inherent reductionist character of most scientists. By the very nature of their training and work, scientists often become tubular in their thinking. Too much pre-occupation on their specialty work and dependence on corporate funded research tend to make them blind to social realities. As a consequence, they often lose their common sense.

Socially responsible scientists need to get out of this trap. The first step, perhaps, is to think like an ordinary human being and recognize that man-made chemicals are inherently hazardous and must be presumed harmful unless proven otherwise. This is the precautionary approach. It recognizes the fact that, historically, most hazardous chemicals have been shown to cause serious and irreversible damage to human health and the environment. It accepts the reality that the long-term impacts of toxic chemicals are difficult to predict and often impossible to prove. It is not dependent, as the risk assessment methodology is, on a system of decision making that demands generation of extensive scientific data and requires exhaustive and quantitative analysis of risks as pre-conditions to policy formulation and action. This is particularly relevant to third world countries where the resources needed to characterize the risks are not readily available.

The precautionary principle has several essential elements:

1. Preventive – This is the first essential element of the precautionary principle.
Prevention is the major activity, not mitigation. Avoidance of exposure is the major concern, not defining the limits of exposure as in the risk assessment approach. The question asked is not how much exposure is allowable but whether the exposure is necessary in the first place. Very often, it is claimed that the precautionary approach is already applied in risk assessment and the use of “safety factors” to allow for uncertainties in limits of exposure is cited as an example. This is not correct. This is not precautionary but a “reactionary” measure. True precaution does not only expand the dragnet to capture an escaped convict but takes immediate preventive measures so that the convict does not escape in the first place and addresses, on the long term, the socio-political factors that tend to create the criminal.

2. Reverse onus – This means putting the burden of proof of safety on the
polluters and not putting the burden of proof of harm on the potential victims. Too often, toxic chemicals cannot be banned because current laws and international agreements, like the GATT-WTO, mandate liberalized entry and persistence of toxic chemicals in the environment unless proven harmful beyond reasonable doubt. Efforts to regulate, restrict or prohibit the production, sale and distribution of toxic chemicals to protect health and the environment are often considered “trade restrictions” and are challenged by the chemical companies or by countries where these companies are based. This situation is obviously biased in favor of business interests highly disadvantageous to people’s health and the environment. The precautionary approach attempts to change this unjust situation.

3. Elimination – The ultimate goal under the precautionary principle is the elimination of
toxic chemicals, not just the management of risks. Especially for persistent organic pollutants (POPs), elimination is the only long term option because risks are considered unmanageable. The recent discovery that very low levels of POPs can cause significant reproductive, developmental, neurological, immunological and other disorders directly or indirectly due to endocrine disruptive effects reveal that previous assumptions about tolerable levels based on risk assessments are incorrect. Increasingly, toxic chemicals characterized as persistent, bioaccumulative and transported over long distances are now beginning to be allocated a zero level of tolerance, which means that for such chemicals, there is no safe level at all.

4. Community-oriented – The health of communities is a primary concern of the
precautionary principle. The people’s basic right to health and to a healthful environment take precedence over corporate and proprietary rights. The right to engage in a profit making venture (like selling a chemical) is a derogable, conditional right, while the right to health is a non-derogable, fundamental human right. Corporate “rights” are ascribed rights and non-human, while community right to health is a basic human and social right. Any potential threat of harm from chemicals must be dealt with in a precautionary manner that protects basic human rights using the best available knowledge and should not wait for rigorous scientific studies to provide evidence of harm. Evidence of harm in pre-clinical studies must be presumed to be evidence of harm to humans. Community monitoring data and people’s testimonies of harm must be given due importance and should be sufficient to form the basis of a precautionary action.

5. Alternatives assessment – Assessing the alternatives to address the needs that the toxic
chemicals are supposed to fill is another important element of the precautionary principle. This is not even considered under the risk assessment paradigm. More often than not, the need that chemicals are supposed to address can be addressed more effectively and safely over the long term by non-chemical alternatives. For example, the use of higly toxic pesticides is often justified in terms of increasing crop yields. However, a closer study of factors that contribute to sustainable crop yields would reveal that pesticides are not really necessary and that an integrated, ecological approach to plant, soil and pest management would be the better option for a sustainable crop production that would not endanger health and the environment.

6 . Uncertainty is a threat – Unlike in risk assessment where uncertainty is given the
benefit of the doubt, the precautionary principle considers uncertainty as a potential threat. While those fixated with the risk assessment paradigm often considers absence of evidence as evidence of absence (of harm), precautionary principle advocates would consider absence of evidence as no evidence of absence (of harm). Infinitesimal uncertainty factors often preclude demonstration of cause and effect relationships and probabilistic characterization of risks. To be meaningfully protective, therefore, an assessment process looking into the potential environmental and health impacts of a chemical should consider uncertainties as a warning signal. Addressing the knowledge gaps pertaining to that chemical should be made an obligatory matter for the chemical manufacturer to the people’s satisfaction before any chemical is allowed to be released into the environment.

7. Technically/scientifically sound – Contrary to what the critics often say, the
precautionary principle is scientifically and technically sound. The evaluation process using a precautionary approach is not just an arbitrary procedure based on mere speculations and unfounded fears. It is based on the best available scientific evidence and guided by technically sound analytical procedures. For example, the potential toxicity and kinetic disposition of many chemicals on human population and the environment can be assessed by analyzing structure-activity relationships, physico-chemical characteristics, molecular mechanisms of action, animal toxicologic and ecotoxicologic data, and other types of information relevant to the chemicals in question in much the same way as in the risk assessment methodology. There is a wide array of available scientific data that could provide sufficient basis to make a sound judgement as to the potential risks that a chemical poses to human health. However, for existing chemicals in commerce where scientific data is lacking or is inappropriate or impractical to generate (such as direct experimentation on humans), precautionary action protective of human health and environment should be taken even if there are doubts that the chemical in question poses unacceptable risks, making use of the best available knowledge and taking into account not only scientific but also socio-cultural factors.

8. Information unrestricted – A key element in the practice of the precautionary principle
is access to information. While the risk assessment paradigm accepts confidentiality of information to protect corporate proprietary rights, the application of the precautionary principle would require full disclosure and accessibility of information relevant to the appraisal of potential threats that a chemical brings to human health and the environment. Since the protection of health and the environment is the paramount objective, all relevant information should be made available and accessible, otherwise, the appraisal process would be made subordinate to corporate interests. This would be tantamount to the violation of the people’s fundamental right to health and to a healthful environment. The right to information is an extension of the right to health and any abridgement or restriction of the right to information would violate the non-derogable nature of the right to health.

9. Open – A risk appraisal system based on the precautionary principle is an open,
democratic and participatory process. It is not the exclusive domain of elite scientists. It is not just a matter between the chemical industry and the regulatory authorities. The main object of the exercise is people. Therefore, people have the right to look into and scrutinize what steps are being done to protect them from hazardous chemicals. It is the people’s right to participate in the decision making processes relevant to the protection of their health and their environment. The right to participate in decision making is an extension of the people’s right to self determination. The people have the right to determine for themselves what chemicals they need and what they don’t need; what risks are acceptable and what are not acceptable. This right is also an extension of the right to health, since without it, the right to health is unattainable.

10. Need based - Most of the chemicals that were introduced into the market after the
second world war were not the outcome of mission-oriented researches directed towards fulfilling particular human needs. They were by-products of the oil industry and the war machinery of the industrialized countries. To maintain profitability after the war, the corporations that created them began searching for “needs” and began creating demands that would be filled by these chemicals. Thus, the synthetic dye industry, the solvent based manufacturing process, the pesticide dependent agriculture, the chemical preservative dependent food products, and many more chemical dependent activities were created. The demand for synthetic chemicals became phenomenal and today, hardly anyone can pass the day without consuming or using a synthetic chemical dependent product. The need for synthetic chemicals have thus been automatically presumed in the current regulatory system under the risk assessment paradigm. This system, however, has led to disastrous consequences and have now put the living organisms in this planet, including humans, in extreme danger. Clearly, our “need” for synthetic chemicals, especially pesticides and other intrinsically hazardous chemicals, must be re-assessed. This is precisely what the precautionary approach does, assess the need for the chemical as part of a comprehensive and integrative approach to risk appraisal before it is allowed to be released into the market. The benefits that the chemical brings to people must be reasonably clear and more important that the potential threats of harm.

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©heal toxics, 2003
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