Gene Drive and International Governance

THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE

Dear Friends and Colleagues

Gene Drive and International Governance

Gene drive is a genetic engineering technology that, in theory, can drive certain genetic traits through populations rapidly, leapfrogging natural laws of inheritance. Significantly, the technology allows genetic engineers to reach beyond domesticated species and into wild species, while conferring the ability to rapidly eliminate or reengineer entire species, which could rapidly alter ecosystems in irreversible and damaging ways.Applications envisaged include those in the public health, conservation and agricultural spheres.

Any release of an organism containing gene drive will very likely have transboundary implications as a gene drive is designed to spread. A decision by one nation, or one group, to make a release might therefore eventually affect every country where the species exists. While it is uncertain when a gene drive organism might be ready for field trial or release into the environment, it is imperative that international governance arrangements be considered now.

A new report by the Sustainability Council of New Zealand explores these issues in depth. It identifiesprinciples and essential elements for a governance framework, including: collective consent, precaution, governance of all stages of development, comparison against alternatives, availability of appropriate risk assessment tools, monitoring, and liability.

The report reviews existing international agreements for their suitability as a platform for building comprehensive gene drive governance and concludes that these are inadequate to deal with the technique because it is not a mere extension of genetic engineering in its ambitions or capacity.The Convention on Biodiversity (CBD) and its Protocols could however be adapted and offer the best structure currently in place on which to build gene drive governance. The report examines the Cartagena Protocol on Biosafety in greater detail, and assesses the gaps in relation to gene drives.

The key recommendations of the report are that:

1. A constraint period is established as soon as possible by the international community, such that no gene drive release or field trial takes place until international governance that is fit-for-purpose is in place.
2. The international governance regime:
3. Provide for “collective consent”, requiring the approval of each country whose territory could be impacted by a gene drive release in another jurisdiction
4. Be founded on the precautionary principle and recognise the CBD principle that countries shall not cause damage to the environment of other countries
5. Make field trials and releases of gene drive organisms subject to collective consent
6. Set laboratory containment standards for research to address gene drive’s specific environmental hazards
7. Require gene drive proposals to be compared against alternative ways of meeting the same objective with less risk
8. Require monitoring to be undertaken to track the movement of gene drive organisms and the potential spread of introduced traits
9. Set a strict liability standard for any harm resulting from a gene drive release, as a condition of approval

We reproduce below the Summary of the report. The full report is available at http://www.sustainabilitynz.org/gene-drive-gmos-would-need-nzs-neighbours-to-agree/

With best wishes,

Published July 2018
Sustainability Council of New Zealand
www.sustainabilitynz.org

Summary

‘Gene drive’ offers the power to deliver “extinction to order” or the permanent reengineering of wild species. Since this new genetic engineering technique was first mooted in 2014, calls to place the technology under global governance have quickly followed.

The recognition that gene drive is no ordinary technology – one that “knows no political boundaries” – has bolstered that call.

Yet existing international agreements are inadequate to deal with the technique because it is not a mere extension of genetic engineering in its ambitions or capacity.

Gene drive technology has the potential to rapidly alter ecosystems in irreversible and damaging ways, where the removal of a species or population could trigger unintended cascades through the environment.

Fundamental Governance Requirements

A critical building block for international governance over gene drive is “collective consent” whereby countries in which a gene drive release is proposed would need to gain the consent of other countries whose territory might be affected by that release. This reflects the potential for a gene drive release in one jurisdiction to have far-reaching impacts on another and that unilateral decision-making is quite inappropriate for this technology.

Other fundamental requirements for the international governance of gene drives include:

• Precaution: The precautionary principle lies at the heart of the international governance of GMOs under the Cartagena Protocol, and the additional risks posed by gene drive GMOs make precaution even more central for this technology.

• Coverage: Governance of all activities involving gene drive organisms is required. Field trials should be considered a form of full release as the escape of even one individual carries the potential for severe consequences.

• Containment Standards: Biological security standards for research need to be specified for gene drive activities as current standards are not designed to meet the technology’s specific environmental hazards.

• Assessment Against Alternatives: An alternative approach that carries less risk and can achieve the same outcomes should be preferred by the regulator, other things being equal.

• Risk Analysis:Existing risk assessment models for GMOs are too narrow for evaluating gene drives and new models will need to address wide societal perspectives in addition to standard environmental and health issues.

• Monitoring:Monitoring systems would be required to track the movement of gene drive organisms and the potential spread of introduced traits, through populations and across borders, and identify unintended harmful impacts.

• Liability: Operators should be strictly liable for any harm resulting from a gene drive release, as a condition of approval.

The Governance Challenge

However, responding to the gene drive challenge will require more than regulatory action. In its ambition and potential for far reaching effects, gene drive technology triggers what has been called “a constitutional moment” – one that is both civilisational and ecological.

The fundamental ethical question it presents is under what circumstances, if ever, is it acceptable to wipe a species off the face of the earth.

Gene drive development also raises significant distributive justices issues. Most development and sponsorship is centred in the Global North, but many of the applications are intended for the Global South. Beyond ensuring that these distributive justice issues are squarely dealt with regionally and internationally, lie significant questions of who determines technology pathways.

Meeting the challenges that gene drive technology presents will require open-ended “constitutional conversations” within and across communities to deliberate common values and goals, and to explore the range of pathways before significant political and economic commitments are made to any gene drive applications.

Existing International Agreements

A number of treaties could potentially cover aspects of gene drive use and releases, but would not provide a clear and coherent base for regulation. The Convention on Biodiversity (CBD) and its protocols could however be adapted to this and offer the best structure currently in place on which to build gene drive governance.

The Cartagena Protocol to the CBD is a potential natural home for gene drive governance as its purpose is protecting biodiversity and human health from impacts arising through the transboundary movement of living GMOs, such as gene drives.

Central to the protocol is the concept of a receiving country having the right to decide in advance whether to accept any shipment of a living GMO. Yet the Cartagena Protocol has serious gaps, including:

• Membership: Although 171 countries have ratified the Cartagena Protocol, a key challenge to it providing effective governance is that the US, Canada, Argentina and Australia (all GM food exporting nations) and Russia are not party to the protocol.

• Unintended Migration: Although the protocol specifies prior informed consent for intended shipments, no such consent is required (only notification) if a release by one country risks unintended spread to another.

• Enforcement and Monitoring:The protocol lacks enforcement provisions and is weak on accountability generally.

• Physical containment: No special standards for containing a gene drive or similar organism have been specified in the protocol.

• Assessment of Alternatives:The protocol does not require the consideration of alternative ways of achieving the same outcomes.

• Liability:A supplementary protocol provides for nations to develop civil liability rules in their own legislation but does not require that this be a strict liability standard that would avoid the socialisation of risk.

Pathways to an International Governance Regime

Credible international governance could be established through a number of different arrangements including: an amendment to the Cartagena Protocol, a new annex under that protocol, or a new protocol. Issues influencing the choice include: the treaty structures, the need to ensure GMO exporting nations participate, and the time and resources required to deliver gene drive governance.

Key operational issues requiring specification under any instrument are:

• Collective consent of affected parties: The most obvious grounds for a country to have standing in the process are if it is habitat to the same or related species that is the target of a gene drive release in another jurisdiction, or if that country could experience ecological, public health or other negative consequences as a result of the gene drive organism. It would be reasonable to expect countries to provide evidence that qualifies them to take part in such decisions.

•Coordination: While the parties given standing would hold authority to support or oppose a release proposal, delegating certain functions to a coordinating body would be efficient. It would provide facilitation and oversight for Information distribution and monitoring any release.

Until fit-for-purpose governance arrangements are adopted and operational, a globally-agreed restraint period prohibiting the outdoor use of gene drives is necessary.

Governance of Gene Drive in New Zealand

To date, New Zealand government officials have been reluctant to concede that the existing international governance of genetic modification is inadequate to regulate gene drives.

Yet a country that is otherwise vigilant to biosecurity risks should be alive to the ways in which gene drive releases in other countries could prove a significant biosecurity threat. New Zealand needs to fundamentally reappraise gene drive’s risk and benefit profile and reset policy in line with this.

While aspects of the law governing GMOs – the Hazardous Substances and New Organisms Act (HSNO) – could effectively regulate gene drive organisms, there are three important deficiencies: the exercise of precaution is optional rather than  required, there are significant gaps in the liability arrangements, and it is unclear to what extent effects beyond New Zealand are to be counted in an assessment.

It will be preferable for the new international governance rules to be known before considering changes to HSNO. In the meantime, New Zealand should set a constraint period during which no releases, field trials and outdoor GM development activities that involve gene drive organisms may be undertaken.

As gene drives contemplated for New Zealand – wasps, possums, stoats and rats – are generally agreed to be years away, the constraint period would not materially affect any local research and development.

The greater effect of taking this position would be to set an example globally and lay the foundations for the commitment needed to develop a global governance regime.

No Case for Regulatory Discounts

Ultimately, gene drive is just one technology option for meeting societal objectives. A process of collective consent is a baseline requirement for gene drive governance. If there is not sufficient political will to establish such governance processes, that is not grounds for a regulatory discount: it is a signal to gene drive developers that the technology is at least not sufficiently mature.

Diluting regulatory requirements that would properly protect against risk does not advantage society as the risks are simply shifted from developers and users on to the environment and third parties.

There is real urgency to meet this governance challenge. A commitment by all countries not to allow gene drives until proper governance is in place is a first critical step and would be a signal that the international community recognises the enormous challenge this technology presents.