EEB 180: Genetic Engineering in Developing Countries
The Cartagena Protocol and GM mosquitoes
- The Cartagena Protocol applies to transboundary movements of Living Modified Organisms (LMOs).
- Transgenic mosquitoes are LMOs and hence are covered by the Protocol.
- But the Protocol was drafted with GM crops for agriculture in mind.
- The final text of the protocol was a Protocol represented a balance between precaution and World Trade Organization (WTO) trade laws.
- Trade laws are less relevant to GM mosquitoes for disease control.
- At the same time, there are additional issues that face GM mosquitoes which do not face GM crops (e.g. the difficulty in containing GM mosquitoes within national borders).
- This leads us to question the applicability of the Cartagena Protocol to the use of GM mosquitoes for disease control.
- In acknowledging the shortcomings of the Cartagena Protocol, suggestions for improvement can be made.
GM mosquitoes are included within the scope of the Cartagena Protocol:
- According to Article 4, the Protocol applies to "the transboundary movement, transit, handling and use of all LMOs that may have aderse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health."
- "LMO" refers to "any living organism that possess a novel combination of genetic material obtained through the use of modern biotechnology" (Article 3).
- A "living organism" is "any biological entity capable of transferring or replicating genetic material" (Article 3).
- "Modern biotechnology" includes "the application of in vitro nucleic acid techniques, including recombinant DNA and direct injection of nucleic acid into cells or organelles... that overcome natural physiological reproductive or recombination barriers" (Article 3).
- "Transboundary movement" includes movement of LMOs between Parties and also between Parties and non-Parties (Article 3).
- GM mosquitoes satisfy the definition of an LMO.
- Therefore, the Cartagena Protocol applies to transboundary movement of GM mosquitoes between Parties to the Protocol, and also between Parties and non-Parties to the Protocol.
GM mosquitoes in transit are not covered by the Cartagena Protocol:
- The Cartagena Protocol does not apply to LMOs (and hence GM mosquitoes) in transit (Article 6, paragraph 1).
- In the case of an accidental release during transit, GM mosquitoes could be irreversibly introduced into the country of transit.
- Parties to the Protocol may regulate the transit of GM mosquitoes by their own initiative (Article 6, paragraph 1).
- However, without the Cartagena Protocol applying, it is unlikely that some a developing countries will be able to conduct sufficiently detailed risk assessment.
- Thus, in the case of GM mosquitoes, it would be advisable that the Cartagena Protocol and the AIA also cover LMOs in transit.
GM mosquitoes in contained field trials are not covered by the Advance Informed Agreement:
- The Advance Informed Agreement (AIA) procedure does not apply to LMOs (and hence GM mosquitoes) intended for contained use (Article 6, paragraph 2).
- This implies that the AIA does not apply to GM mosquitoes intended for use in outdoor cage trials.
- However, the importing country is entitled to conduct a risk assessment prior to their decision (Article 6, paragraph 2).
- The importing country is also entitled to determine the criteria for containment (Article 6, paragraph 2).
- One problem with the AIA not applying in this case is that contained field trials are necessary in the case of GM mosquitoes.
- However, some developing countries where GM mosquitoes could be tested do not have the capacity to conduct a sufficiently detailed risk assessment.
- They would therefore be in a weak position to impose minimum standards of containment on the exporting country.
- Thus, in the case of GM mosquitoes, it would be advisable that the AIA also covers LMOs destined for contained use.
The Advance Informed Agreement does cover the first intentional environmental release of GM mosquitoes:
- The AIA procedure applies prior to the first intentional transboundary movement of GM mosquitoes intended for environmental release in the receiving country (Article 7, paragraph 1).
- This means that a country of import can request that a country of export provide details of GM mosquitoes, including a risk assessment based on sound science, prior to their decision on whether to accept the GM mosquitoes or not.
- However, the AIA procedure does not apply to unintentional releases.
- Escape from field cage studies is likely (human error, lightening, sabotage, storm), and escape from transit vehicles is easily conceivable.
- This again stresses the importance of ensuring that the Cartagena Protocol be modified in the case of GM mosquitoes so that it also applies to GM mosquitoes in transit and in containment.
The environmental release of a GM mosquito is essentially a global release:
- It should be noted that mosquitoes, transgenic or not, do not respect national borders.
- The disease-endemic countries where GM mosquitoes would be released tend have little capacity to deal with the containment of GM mosquitoes within their borders.
- It is unlikely that even developed countries have the capacity to deal with containment of GM mosquitoes within their borders.
- If gene drive systems are to work, then transgene spread will inevitably be worldwide.
- The case of the P element in Drosophila melanogaster serves as a good case study - this element, which was naturally transferred from one species of fruit fly to another, spread through the worldwide population of D. melanogaster within a span of decades.
- Hence, releasing a GM mosquito must be considered as a worldwide release.
What does the Cartagena Protocol have to say about transboundary movements?
- Under the Advance Informed Agreement, which applies to the environmental release of GM mosquitoes, the importing country may request that the exporting country performs a risk assessment (Article 15, paragraph 2).
- The importing country may require that the exporting country bear the cost of the risk assessment (Article 15, paragraph 3).
- This will assist in the decision of the importing country on whether to accept the GM mosquito or not (Article 12, paragraph 4).
- This risk assessment should determine the likelihood of an unintentional transboundary movement of GM mosquitoes if they are to be released in the importing country (Article 16, paragraph 3).
- Furthermore, "each Party shall take appropriate measures to prevent unintentional transboundary movements of LMOs" (Article 16, paragraph 3).
- This suggests that the importing country should require the exporting country to assess the likelihood that GMs will cross borders unintentionally.
- If such a border crossing is likely, then the release is not allowed.
What does the Protocol say if an unintentional transboundary movement does occur?
- In the event of an unintentional transboundary movement of GM mosquitoes, the Protocol says that the country where the environmental release occured "shall immediately consult the affected or potentially affected States to enable them to determine appropriate responses and initiate necessary action, including emergency measures" (Article 17, paragraph 4).
- This is the case whether the transboundary movement has occured, or whether it may occur.
- Thus, as soon as the country of release knows of the possibility of GM mosquitoes crossing into other countries, they must provide information about this possibility to the susceptible States (Article 17, paragraph 1).
- This information should include:
- the date of release;
- the characteristics of the GM mosquitoes;
- possible adverse affects to human health and the environment; and
- possible risk management strategies (Article 17, paragraph 3).
- In the case of GM mosquitoes, presumably neighboring countries and countries connected by aeroplane flights should be notified by the country of release as soon as the release occurs, or maybe even before a release occurs.
- If a transboundary movement occurs and is not intentional, then it is an "illegal transboundary movement" (Article 25, paragraph 1).
- All Parties to the Protocol are required to prevent GM mosquitoes crossing boundaries illegally (Article 25, paragraph 1); however this is impossible, as previously discussed.
- All Parties to the Protocol are responsible for penalizing illegal movements of GM mosquitoes into their borders (Article 25, paragraph 1); however this is unlikely to occur in developing countries.
- Furthermore, it is uncertain how such penalizing would occur given the lack of a concrete policy of liability and redress (Article 27).
- One measure cited in the Protocol is that the country into whose borders the GM mosquitoes travelled may request the country where the release occurred to "dispose, at its own expense," the GM mosquitoes "by repatriation or destruction, as appropriate." (Article 25, paragraph 3).
- This is quite a week demand given that it is only a "request."
- Furthermore, both repatriation and destruction are unlikely to be achieveable for GM mosquitoes.
- Thus, it seems that the means for dealing with illegal transboundary movements of GM mosquitoes are either not in place (liability) or are essentially impossible (repatriation and destruction).
Could regional arrangements provide a solution?
- The only way to escape the problem of illegal transboundary movements is to label these movements as intentional and to have their approval in all cases.
- The Cartagena Protocol does have a provision for bilateral, regional or multilateral agreements regarding transboundary movements of LMOs. The two criteria of these agreements are that they are "consistent with the objective of this Protocol" and "do not result in a lower level of protection than that provided for by the Protocol" (Article 14, paragraph 1).
- This is encouraging, however a release of GM mosquitoes, if it works, will potentially effect every country on the planet.
- Thus, in order to be "consistent with the Protocol" and to "not result in a lower level of protection than that provided for by the Protocol," the multilateral agreement for GM mosquitoes would require every country in the world to sign onto it.
- This requirement of consent also applies to non-Parties, because the Protocol also demands that "transboundary movements of LMOs between Parties and non-Parties be consistent with the objective of this Protocol." The Protocol also states that "Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements" (Article 24, paragraph 2).
- Thus, for a release of GM mosquitoes, the Cartagena Protocol would logically require that every country in the world sign on to the Protocol.
- Such a demand is essentially impossible to meet. The European disdain for GM food and the rejection of milled GM food aid in Zambia are two good indicators of the difficulty of a unanimous worldwide decision.
- Thus, it would seem that the Cartagena Protocol effectively prevents the environmental release of GM mosquitoes.
Could GM mosquitoes be exempt from the Cartagena Protocol because they are seen as pharmaceuticals?
- Macer (2003) notes the exclusion of LMOs which are pharmaceuticals for humans from the Cartagena Protocol, and implies that perhaps GM mosquitoes could be considered in this way.
- Specifically, the Protocol states that "this Protocol shall not apply to the transboundary movement of LMOs which are pharmaceuticals for humans that are addressed by other relevant international agreements or organizations" (Article 5).
- The term "pharmaceutical" is not defined in the Protocol; however this interpretation seems like a bit of a stretch. The term is unlikely to apply to GM foods such as vaccine-containing bananas, and GM mosquitoes seem like a weaker case, particular when typical transgenes are designed to protect mosquitoes from a disease rather than humans. Humans are instead indirectly protected, however the text of the Protocol refers specifically to "pharmaceuticals for humans" (Article 5).
Institutions in the US are very involved in the creation of transgenic mosquitoes for disease control:
- A transgene for dengue resistance in Aedes aegypti mosquitoes was engineered by Ken Olson's laboratory at Colorado State University, Colorado.
- A transgene for resistance to rodent malaria in Anopheles stephensi mosquitoes was engineered by Marcelo Jacobs-Lorena's laboratory at Johns Hopkins University, Madison.
- The most promising gene drive system, Medea, has been engineered and demonstrated to work in Drosophila melanogaster by Bruce Hay's laboratory at Caltech, California.
- The Gates Foundation, which funds a lot of this work, is based in Seattle, Washington.
- The US National Institutes of Health (NIH) also fund a lot of the work.
- There are also scientists throughout the world working towards the creation of transgenic mosquitoes, both in developed and developing nations.
- For example, another promising gene drive system, the homing endonuclease gene, was invented by Austin Burt's laboratory at Imperial College, England.
- A GM version of the sterile insect technique (SIT) to reduce mosquito population sizes has been invented and commercialized by Luke Alphey of Oxitec, England.
- However, even with this in mind, the US are likely to be very involved in the creation and possible future release of transgenic mosquitotes for disease control in developing nations.
But the US are not a signatory to the Cartagena Protocol:
- As one of the world's few GM crop producers, the US did not want some of the more precautionary elements of the Cartagena Protocol to apply interfere with WTO trade laws.
- Their refusal to sign the Protocol is based on trade in GM crops and is independent of issues relating to GM mosquitoes.
- Covering GM crops and GM mosquitoes in the same Protocol has therefore led to US rejection of a Protocol concerning GM mosquitoes - an issue where trade laws are irrelevant.
- If the US is to export GM mosquitoes to a country that is Party to the Protocol, the receiving country is required to ensure that the transboundary movement is consistent with the objective of the Protocol (Article 24, paragraph 1).
- Of course, if the importing Party is a developing country, it is highly unlikely that they will be able to enforce this requirement.
- On the other hand, a problem could arise if the US were to export GM mosquitoes to a country that is not a Party to the Protocol. In this case, neither country is bound by the terms or demands of the Protocol, and hence the movement of GM mosquitoes between their borders would not contradict the Protocol, even if there could be subsequent unintentional transboundary movements.
- Several countries that are affected by mosquito-borne diseases are not Parties to the Cartagena Protocol. For example, the following countries in Africa are not Parties to the Protocol: Cote d'Ivoire, Equatorial Guinea, Guinea-Bissau, Malawi, Sierra Leone, Sao Tome and Principe, and Somalia.
- The environmental release of GM mosquitoes by the US into these countries is not governed by the Cartagena Protocol.
What can be done?
- This suggests the importance of not linking GM crops and GM mosquitoes within the same Protocol.
- It would be worthwhile having a new protocol for GM mosquitoes that addresses their unique concerns and is not complicated by the balance between precaution and trade rules.
- Cosbey, A., and S. Burgiel, 2000 The Cartagena Protocol on Biosafety: An analysis of results. International Institute for Sustainable Development, Winnipeg, Manitoba, Canada.
- Macer, D., 2003 Ethical, legal and social issues of genetically modified disease vectors in public health. WHO, Geneva.
- Marshall, J. M., and C. E. Taylor, 2009 Transgenic mosquitoes for malaria control. PLoS Medicine 6: e1000020.
- Secretariat of the Convention on Biological Diversity, 2000 Cartagena Protocol on Biosafety to the Convention on Biological Diversity. World Trade Center, Montreal, Quebec, Canada.