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categories: ["society", "foundations"]categories: ["society", "foundations"]tags: ["governance", "risk", "regulation", "biotechnology", "law", "uncertainty"]tags: ["governance", "risk", "regulation", "biotechnology", "law", "uncertainty"]summary: "The regulatory doctrine that scientific uncertainty about a serious or irreversible harm is not by itself a reason to permit the activity that might cause it."summary: "The regulatory doctrine that scientific uncertainty about a serious or irreversible harm is not by itself a reason to permit the activity that might cause it."updated: "2026-07-27"updated: "2026-08-23"issues: ["The WTO 2006 panel, 2018 CJEU ruling and 2024 Philippine decision carry no citations."]------ ```infobox```infoboxlines 58–64 → 57–6343 unchanged lines not shown
**Where precaution has been vindicated.** The 1975 [[asilomar-conference]] is the field's founding case: researchers imposed a moratorium on recombinant DNA work under acknowledged uncertainty, developed containment levels, and resumed. The moratorium lasted under a year and produced a containment framework that is still the template for self-governance in the field. The requirement that drug sponsors demonstrate safety and efficacy before marketing — a burden-shifting rule of exactly the strong-form type — is uncontroversial and followed a series of harms including thalidomide.**Where precaution has been vindicated.** The 1975 [[asilomar-conference]] is the field's founding case: researchers imposed a moratorium on recombinant DNA work under acknowledged uncertainty, developed containment levels, and resumed. The moratorium lasted under a year and produced a containment framework that is still the template for self-governance in the field. The requirement that drug sponsors demonstrate safety and efficacy before marketing — a burden-shifting rule of exactly the strong-form type — is uncontroversial and followed a series of harms including thalidomide. **Where precaution has been costly.** The European Union's de facto moratorium on approvals of genetically modified crops from 1999 was found by a World Trade Organization panel in 2006 to have caused undue delay. A 2018 Court of Justice ruling brought organisms produced by genome editing within the EU's GMO directive, subjecting edits indistinguishable from natural mutations to the full approval regime; the Commission subsequently proposed a separate regime for new genomic techniques. In 2024 a Philippine appellate court revoked biosafety permits for Golden Rice and Bt eggplant on precautionary grounds, a decision that was appealed. In each case, the costs of delay fell on people who would have benefited and are not counted in the risk assessment.**Where precaution has been costly.** The European Union's de facto moratorium on approvals of genetically modified crops from 1999 was found by a World Trade Organization panel in 2006 to have caused undue delay.[^wto2006] A 2018 Court of Justice ruling brought organisms produced by genome editing within the EU's GMO directive, subjecting edits indistinguishable from natural mutations to the full approval regime; the Commission subsequently proposed a separate regime for new genomic techniques.[^cjeu2018] In 2024 a Philippine appellate court revoked biosafety permits for Golden Rice and Bt eggplant on precautionary grounds, a decision that was appealed.[^ca2024] In each case, the costs of delay fell on people who would have benefited and are not counted in the risk assessment. **Where the argument is live.** [[gene-drive]] releases are the clearest current test, because a self-propagating edit cannot be recalled and field trials are the only way to obtain the missing information. Proposals for [[germline-editing]] are governed by an explicitly precautionary international consensus, discussed in [[governance-of-genome-editing]], which the [[he-jiankui-affair]] hardened rather than created. The 2024 call by a large group of scientists to halt work toward [[mirror-life]] is a precautionary argument in its purest modern form: the authors argue that chirally inverted organisms could evade immune recognition across many species, that no adequate defence is known, and that the research should stop before the capability exists.[^adamala2024]**Where the argument is live.** [[gene-drive]] releases are the clearest current test, because a self-propagating edit cannot be recalled and field trials are the only way to obtain the missing information. Proposals for [[germline-editing]] are governed by an explicitly precautionary international consensus, discussed in [[governance-of-genome-editing]], which the [[he-jiankui-affair]] hardened rather than created. The 2024 call by a large group of scientists to halt work toward [[mirror-life]] is a precautionary argument in its purest modern form: the authors argue that chirally inverted organisms could evade immune recognition across many species, that no adequate defence is known, and that the research should stop before the capability exists.[^adamala2024] lines 75–80 → 74–8910 unchanged lines not shown
A fourth is that it is applied asymmetrically to novel technologies. Existing practices with well-characterised large harms are grandfathered, while novel practices with speculative small harms face the burden — a pattern visible in the regulatory treatment of [[xenotransplantation]] relative to the ongoing mortality documented in [[organ-shortage]].A fourth is that it is applied asymmetrically to novel technologies. Existing practices with well-characterised large harms are grandfathered, while novel practices with speculative small harms face the burden — a pattern visible in the regulatory treatment of [[xenotransplantation]] relative to the ongoing mortality documented in [[organ-shortage]]. > [!debate] Is the incoherence fatal?> Whether Sunstein's paralysis argument refutes the principle or only a caricature of it is itself> disputed. Daniel Steel's book-length defence recasts the weak principle as a meta-rule — scientific> uncertainty must not by itself justify inaction — and binds stronger versions to consistency and> efficiency constraints under which a precaution cannot be both recommended and forbidden by the> same rule.[^steel2015] Reviewers of that repair answer that permitting different versions in> different contexts revives the incoherence objection one level up. What divides the camps is> whether the principle is a decision rule at all or a constraint on other rules, and no regulatory> outcome can settle that, because each side classifies the same outcome differently. ## The proactionary reply## The proactionary reply [[max-more]] proposed the *proactionary principle* in 2004 as an explicit counterweight, articulating a presumption in favour of proceeding: freedom to innovate is valuable, restriction has costs that must be counted symmetrically, and evaluation should use the best available evidence rather than worst cases, weighting probability rather than mere possibility.[^more2013] The formulation has roots in [[extropianism]] and has been developed at book length by Steve Fuller and Veronika Lipinska.[[max-more]] proposed the *proactionary principle* in 2004 as an explicit counterweight, articulating a presumption in favour of proceeding: freedom to innovate is valuable, restriction has costs that must be counted symmetrically, and evaluation should use the best available evidence rather than worst cases, weighting probability rather than mere possibility.[^more2013] The formulation has roots in [[extropianism]] and has been developed at book length by Steve Fuller and Veronika Lipinska.lines 106–112 → 115–12525 unchanged lines not shown
[^ec2000]: `report` European Commission. *Communication from the Commission on the Precautionary Principle*, COM(2000) 1. Brussels, 2000. {A Commission communication is guidance on how the principle should be applied, not a binding instrument in itself.}[^ec2000]: `report` European Commission. *Communication from the Commission on the Precautionary Principle*, COM(2000) 1. Brussels, 2000. {A Commission communication is guidance on how the principle should be applied, not a binding instrument in itself.}[^adamala2024]: `paper` Adamala, K. P. et al. "Confronting risks of mirror life." *Science*, 2024. {A policy argument signed by a large group of researchers, not an experimental result; no mirror organism exists to have been studied.}[^adamala2024]: `paper` Adamala, K. P. et al. "Confronting risks of mirror life." *Science*, 2024. {A policy argument signed by a large group of researchers, not an experimental result; no mirror organism exists to have been studied.}[^wto2006]: `law` World Trade Organization. *European Communities — Measures Affecting the Approval and Marketing of Biotech Products*, Panel Reports WT/DS291/R, WT/DS292/R, WT/DS293/R, 2006. {The panel found undue delay in the completion of approval procedures for 24 of 27 products under the SPS Agreement — a procedural finding, not an assessment of the products themselves.}[^cjeu2018]: `law` *Confédération paysanne and Others v Premier ministre*, Case C-528/16, Court of Justice of the European Union, Grand Chamber, 25 July 2018.[^ca2024]: `law` Court of Appeals of the Philippines, decision of 17 April 2024 granting a writ of kalikasan against the commercial propagation of Golden Rice and Bt eggplant. {The court cited conflicting scientific views and uncertainty about risks and halted propagation until agencies submit proof of safety and legal compliance.}[^sunstein2005]: `book` Sunstein, C. R. *Laws of Fear: Beyond the Precautionary Principle*. Cambridge University Press, 2005.[^sunstein2005]: `book` Sunstein, C. R. *Laws of Fear: Beyond the Precautionary Principle*. Cambridge University Press, 2005.[^steel2015]: `book` Steel, D. *Philosophy and the Precautionary Principle: Science, Evidence, and Environmental Policy*. Cambridge University Press, 2015.[^more2013]: `book` More, M. "The Proactionary Principle: Optimizing Technological Outcomes." In More, M. and Vita-More, N. (eds), *The Transhumanist Reader*. Wiley-Blackwell, 2013.[^more2013]: `book` More, M. "The Proactionary Principle: Optimizing Technological Outcomes." In More, M. and Vita-More, N. (eds), *The Transhumanist Reader*. Wiley-Blackwell, 2013.[^taleb2014]: `preprint` Taleb, N. N., Read, R., Douady, R., Norman, J. and Bar-Yam, Y. "The Precautionary Principle (with Application to the Genetic Modification of Organisms)." Extreme Risk Initiative working paper, NYU School of Engineering, 2014. {A working paper rather than a reviewed article; its argument is about payoff structure, and it takes genetically modified crops as the worked example.}[^taleb2014]: `preprint` Taleb, N. N., Read, R., Douady, R., Norman, J. and Bar-Yam, Y. "The Precautionary Principle (with Application to the Genetic Modification of Organisms)." Extreme Risk Initiative working paper, NYU School of Engineering, 2014. {A working paper rather than a reviewed article; its argument is about payoff structure, and it takes genetically modified crops as the worked example.} removed, struck through added, underlinedLine numbers count the serialised markdown of each revision, frontmatter included.
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