The Precautionary Principle

Participation also includes the right to information and participation in controlling the risks involved in particular scientific processes and its applications. In this context, the precautionary principle plays an important role. This principle demands that, in the absence of full scientific certainty, when an action or policy may lead to unacceptable harm to the public or the environment, actions will be taken to avoid or diminish that harm.

That placement is the single most examinable thing about the paragraph. On this syllabus precaution is not an idea borrowed from environmental law and attached to science. It is a limb of the right to science itself: if you have a right to take part in scientific progress, you have a right to a say in the risks that progress creates. The Committee's own footnote attributes the formulation to the World Commission on the Ethics of Scientific Knowledge and Technology, "The precautionary principle" (Paris, UNESCO, 2005).

Broken down

The principle has four elements, and an answer that states all four is worth far more than one that states the slogan.

1. A threat of harm that can be identified in advance. Somebody must be able to say what the feared harm is and by what route it would occur. A vague unease is not a threat.
2. Absence of full scientific certainty. This is the trigger, and it cuts both ways. There must be enough science to raise the concern and not enough to settle it. Where the harm is proved, the principle is not needed; where nothing but imagination supports the fear, the principle does not apply.
3. The harm must be unacceptable. General Comment 25 gives four categories, and any one of them is enough: harm threatening to human life or health; harm that is serious and effectively irreversible; harm inequitable to present or future generations; and harm imposed without adequate consideration of the human rights of those affected. The fourth category is the one students miss, and it is the most useful, because it makes the manner of imposition a ground of objection by itself.
4. Action to avoid or diminish the harm. The Committee says that actions "will be taken", not that the activity will be forbidden. The response is graduated.

The same paragraph names the working tools: "Technological and human rights impact assessments are tools that help to identify potential risks early in the process and the use of scientific applications." An impact assessment is a structured study, done before a project proceeds, of what it is likely to do to a defined interest.

What the principle does to the burden of proof

The burden of proof is the answer to the question "if nobody can tell, who loses?" Ordinarily it lies on the person complaining: a claimant who cannot show that the factory caused the illness fails, however sympathetic the claim.

Precaution moves it. Once a credible threat of unacceptable harm is shown, the proponent of the activity is required to show that it can proceed safely, or on what conditions. The doubt no longer works in favour of the person creating the risk. That single shift is what the principle is for, and it is what its critics dislike about it.

Notice what it does not do. It does not reverse the burden in a criminal prosecution, where the accused is presumed innocent, and it does not make a regulator's opinion unchallengeable. It allocates the consequence of scientific uncertainty in a regulatory decision, and nothing more.

A worked example

Kaveri Agro Ltd applies to the licensing authority for permission to market a new seed coating in Maharashtra. Two published studies suggest that the compound persists in groundwater; a third finds no effect. Nobody has studied its effect on the children of the farming households that will handle it. Villagers in Warud object.

Element one, the threat. The objection is specific: persistence in groundwater, with a route of exposure through drinking water. That is a stated threat, not an unease.

Element two, the uncertainty. Two studies against one is exactly the state of knowledge the principle addresses. If the science were settled either way, the authority would simply apply it.

Element three, unacceptability. Harm through drinking water is threatening to health, which is the first category. Persistence makes it capable of being effectively irreversible, which is the second. And because nobody has studied the children who will handle the product, the harm would be imposed without adequate consideration of the human rights of those affected, which is the fourth.

Element four, the response, and it is graduated. The authority is not obliged to choose between a licence and a ban. It may require a human rights and technological impact assessment before deciding. It may licence on conditions: restricted quantities, mandatory protective equipment, monitoring of the village wells, and a reporting obligation. It may licence for a fixed period and review. It may suspend a decision until one study is repeated. Prohibition is the last of a series, not the first.

What the ordinary law would have done. A negligence claim would begin after the wells were contaminated, would require the villagers to prove that this compound caused their illness, and would probably fail on causation. The precautionary principle exists because that sequence arrives too late to be of use to anyone.

Where the principle already operates in Indian law

India has no single enactment that states the principle in general terms, but the shape of it is visible in statutes a student on this paper is already reading, and quoting one of them is worth more than an assertion that Indian law accepts precaution.

Section 26A of the Drugs and Cosmetics Act, 1940. The Central Government may act if it "is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human beings or animals", and may then "regulate, restrict or prohibit" its manufacture, sale or distribution. The trigger is likelihood of risk, not proof of injury, and the response is expressly graduated in the same three words the principle uses. The chapter on drugs control in Module II works the section in full.

Section 2(1) of the Epidemic Diseases Act, 1897. The State Government may take special measures when it is satisfied that the State or any part of it "is visited by, or threatened with, an outbreak of any dangerous epidemic disease". A threat is put on the same footing as a visitation. Module II examines the public health powers that follow.

The Constitution. Article 51A(g) makes it the duty of every citizen "to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures", and article 48A places the corresponding endeavour on the State. The chapter on the environment in the Constitution takes article 48A; what matters here is that the constitutional text supplies a footing for anticipatory protection rather than only for compensation after the event.

Distinctions

What it does NOT mean

It does not demand zero risk. Nothing human is riskless, and a principle requiring proof of complete safety would forbid everything, including the technologies that save lives. The test is unacceptable harm, and the word doing the work is unacceptable.

It does not licence a State to shut down research. General Comment 25 says in terms that the principle "should not hinder and prevent scientific progress, which is beneficial for humanity", and that limitations on the freedom of scientific research are compatible with the Covenant only within article 4 of the ICESCR, which permits limitations determined by law, solely for the purpose of promoting the general welfare in a democratic society, and compatible with the nature of the right. Paragraph 22 adds that any limitation on the content of scientific research "implies a strict burden of justification by States". Precaution bites hardest on the use and application of scientific results and least on the asking of questions.

It is not a substitute for evidence. It applies where there is a scientific basis for concern. Invoked against a fear with no scientific basis at all, it becomes a licence for whoever shouts loudest.

It is not a rule of criminal law. It governs what a regulator may do in advance. It does not lower the standard of proof for punishing anybody.

Limits and criticism

There is no single agreed formulation. Stated weakly, it says that uncertainty is not a reason to postpone cost effective measures against serious harm. Stated strongly, it says that no activity may proceed until its proponent proves it safe. The strong version is close to impossible to satisfy, because safety cannot be proved, only failed to be disproved, and a student who states only the strong version invites the obvious objection.

Inaction has victims too. Refusing or delaying a technology is itself a decision with a cost, measured in the harm the technology would have prevented. A delayed vaccine, a withheld diagnostic and an unapproved treatment all injure real people, and those people have the right to enjoy the benefits of scientific progress. The principle is a rule for deciding under uncertainty, not a presumption against novelty.

It can be captured. A rule that lets a State restrict a product without proving harm can be used for disguised protection of domestic industry, or by an established producer against a new competitor. The safeguard is procedural: reasons, evidence and review.

Somebody has to decide what is unacceptable, and that is a value judgment, not a scientific one. General Comment 25 accepts the difficulty and answers it with process. Because the application of the principle "is sometimes controversial", it says, participation and transparency become crucial: the risks and the potential of a technical advance should be made public so that society can decide, through informed, transparent and participatory public deliberation, whether the risks are acceptable. On this syllabus that is the answer to give. Precaution is legitimate when the people who will carry the risk have been told about it and heard.

Quick revision

• Precautionary principle: in the absence of full scientific certainty, where an action or policy may lead to unacceptable harm to the public or the environment, action is taken to avoid or diminish that harm.
• Stated for this paper in General Comment No. 25 (2020), E/C.12/GC/25, paragraph 56, under the heading "Participation and the precautionary principle". Precaution is a limb of the right to science, not an import.
• Four categories of unacceptable harm: threatening to life or health; serious and effectively irreversible; inequitable to present or future generations; imposed without adequate consideration of the human rights of those affected.
• Four elements: identified threat, scientific uncertainty, unacceptable harm, proportionate action. Tools: technological and human rights impact assessments.
• Its real effect is on the burden of proof: the proponent must justify the activity, not the exposed person prove the injury.
• Indian shape: section 26A of the Drugs and Cosmetics Act 1940 ("likely to involve any risk"), section 2(1) of the Epidemic Diseases Act 1897 ("visited by, or threatened with"), articles 48A and 51A(g) of the Constitution.
• Limits: it must not hinder scientific progress; restrictions on research need strict justification under ICESCR article 4; inaction has victims; acceptability is decided by participation and transparency.

Test yourself

1. State the precautionary principle and identify its four elements. In the absence of full scientific certainty, where an action or policy may lead to unacceptable harm to the public or the environment, measures must be taken to avoid or diminish that harm. Its elements are a threat of harm identified in advance; genuine scientific uncertainty, meaning enough evidence to raise the concern and not enough to settle it; harm that is unacceptable, which General Comment 25 defines as threatening to life or health, serious and effectively irreversible, inequitable across generations, or imposed without adequate consideration of the human rights of those affected; and a response proportionate to the threat.

2. Why does it matter that General Comment 25 places the principle under participation? Because it makes precaution part of the right to science rather than a borrowing from environmental law. If everyone has a right to participate in scientific progress, that participation includes a say in the risks the progress creates. It also supplies the answer to the principle's hardest question, which is who decides that a risk is unacceptable: the Committee's answer is informed, transparent and participatory public deliberation, not the unexplained opinion of a regulator.

3. A State bans all research on a new gene editing method because the public is anxious about it. Is that an application of the principle? Not as it stands. Precaution operates chiefly on the use and application of scientific results, and General Comment 25 says the principle should not hinder and prevent scientific progress. A limitation on the content of research must satisfy article 4 of the ICESCR, being determined by law, compatible with the nature of the right, and solely for the general welfare in a democratic society, and it carries a strict burden of justification. Public anxiety with no stated threat and no scientific basis does not discharge that burden.

4. How does the principle change the burden of proof, and why is that its most important feature? Ordinarily the person alleging harm must prove it, so that scientific doubt defeats the claim and benefits whoever created the risk. Under the principle, once a credible threat of unacceptable harm is shown, the proponent of the activity must justify proceeding and on what conditions. It matters because the evidence about a new technology usually matures only after a population has been exposed, so leaving the burden where it ordinarily lies means the harm must occur before the law can respond.

5. Give two Indian statutory provisions that are precautionary in structure, and say what makes them so. Section 26A of the Drugs and Cosmetics Act 1940 lets the Central Government regulate, restrict or prohibit a drug or cosmetic where it is satisfied that its use "is likely to involve any risk" to human beings or animals: the trigger is likelihood, not proof, and the three verbs are a graduated response. Section 2(1) of the Epidemic Diseases Act 1897 lets a State Government take special measures where the State is "visited by, or threatened with" an outbreak, placing a threat on the same footing as an actual outbreak.