Oxitec export notifications

Exports of genetically modified (GM) mosquito eggs for open release require notification to the UK and EC by the exporter, including risk assessments and emergency plans.

Oxford University's spin-out company Oxitec has made exports of GM mosquito eggs to:

  • the Cayman Islands for open release experiments which took place in late 2009 and in 2010;
  • Malaysia, where contained use experiments were made, followed by the development of a new strain, which was used in an open release experiment in December 2010/January 2011;
  • Brazil, where an open release experiment took place in February 2011.

GeneWatch has obtained documents which show that Oxitec did not meet the necessary legal requirements for its exports of GM mosquito eggs to Cayman and Brazil.

Regulatory requirements

The Cartagena Protocol to the UN Convention on Biological Diversity regulates transboundary movements of living modified organisms (LMOs) from one country to another. It establishes an advance informed agreement (AIA) procedure for LMOs that are exported for intentional introduction to the environment. LMOs are known as GMOs (genetically modified organisms) in UK and EU legislation.

The Protocol is implemented in the EU by Regulation (EC) 1946/2003 on transboundary movement of genetically modified organisms. Article 4 requires the company exporting a GMO for deliberate release into the environment to ensure notification, in writing, to the importing country prior to the first intentional transboundary movement. The notification must contain the information specified in Annex I, which includes a previous and existing risk assessment report consistent with EU standards (which are specified in Annex II of Directive 2001/18/EC). Article 6 requires these documents to be supplied to the government of the exporting country and to the European Commission. The Commission is supposed to make these documents available to the public in accordance with the Community rules on access to environmental information. Article 12 specifies the documents that accompany exports of GMOs for contained use or for deliberate release. Article 13 requires the exporter to notify the export to governments that have taken the decision to regulate transit of GMOs through their territory.

EC Regulation 1946/2003 has been implemented in England and Wales by The Genetically Modified Organisms (Transboundary Movements) (England) Regulations 2004. These regulations make the Secretary of State for Environment, Food and Rural Affairs responsible for enforcing the legal requirements.

Cayman notification documents

On 3rd February 2011, GeneWatch UK received an email response from the EC (DG Sanco) containing the information provided by Oxitec under Annex I of Regulation (EC) 1946/2003 for the notification of an export by Oxitec of GM mosquito eggs to the Cayman Islands. GeneWatch had originally contacted DG Sanco on 30th November 2010 but we were initially told this issue was DG Environment's responsibility. The email states that this is the only notification concerning a transboundary movement for release into the environment by Oxitec, "as it seems that their other exports have been for the purpose of contained use".

The main document lists the information provided by Oxitec.

The annexes to the list of Oxitec's responses contain:

  1. Appendix 1: document 1: An unsigned invoice to Angela Harris at the Cayman Islands' Mosquito Control and Research Unit (MRCU) for approximately 50,000 eggs, with a shipment date of 4th November 2009.
  2. Appendix 1: document 2: A letter to Colin Wakelin, Veterinary Officer 1, Department of Agriculture, Cayman Islands and Angela Harris (MRCU), signed by Camila Beech (Oxitec's head of regulatory affairs) and dated 11th August 2009, giving a brief (2 paragraph) description of the mosquitoes to be imported.
  3. Appendix 2: A risk assessment which states it was prepared in October 2009. This is the same one released to the UK Parliament in January 2011.
  4. Appendix 3: document 1: A draft agreement with MRCU, prepared by Luke Alphey of Oxitec, dated 18th March 2009. This is an outline only and does not include terms of use which it states are to be negotiated. It sets out a draft timetable for the trials, including identifying stakeholders and implementing a communications/engagement plan.
  5. Appendix 3: document 2: Protocols for the experiments, prepared by Luke Alphey (undated)
  6. Appendix 4: Technical background in four documents (Mosquito rearing protocol; Lab cage mating effectiveness; Eliminating tetracycline contaminants; Aedes aegypti and Aedes Albopictus: life cycles, biology and distribution).
  7. Appendix 5 (at the end of the main document): An unsigned import permit for 350,000 eggs dated 28 August 2009 on Cayman Islands Ministry of Agriculture headed paper. Consignee: Angela Harris at MRCU.

Correspondence with the UK Department of Environment, Food and Rural Affairs (DEFRA) and the European Commission

After receiving Oxitec's Cayman notification documents from the Commission, GeneWatch wrote to Secretary of State Caroline Spelman at DEFRA and to Commissioner Dalli at DG Sanco expressing concerns that Oxitec had not met the transboundary notification requirements for its shipment of GM mosquito eggs to the Cayman Islands.

We told DEFRA and DG Sanco that Oxitec's failure to provide the risk assessment to the Cayman Islands prior to the grant of the import permit and the failure to notify the UK and Commission prior to transboundary movement, rendered the process meaningless in relation to its intended purpose, namely, organising the supervision and control of transboundary movements of GMOs "in order to contribute to ensuring the conservation and sustainable use of biological diversity, taking also into account risks to human health, and so as to enable citizens to make a free and informed choice in regard to GMOs" (Regulation (EC) 1946/2003, paragraph 4) and "to make sure third countries have the necessary data to make an informed decision taking due consideration of potential adverse effects to health and the environment". GeneWatch called on the Secretary of State to take enforcement action, and on the Commission to create a public register for notifications and ensure they are provided in a timely manner. We also called on Commissioner Dalli to correct his statement to the European Parliament in which he stated that Oxitec's risk assessment report was consistent with Annex II of Directive 2001/18/EC, and to instigate an independent process by which this could be assessed.

We received a reply from DEFRA (page 1 and page 2) on 9th April, stating that the Government did not believe it was appropriate to take enforcement action against Oxitec. DEFRA also informed us in this letter that Oxitec had now made a notification for a shipment of GM mosquito eggs to Brazil, following a request from the Brazilian Government to provide further mosquito eggs for the trial in Brazil.

Our initial reply from DG Sanco on 7th March again told us that we raised issues that are DG Environment's responsibility. However, on 13th April we received a further letter in which DG Sanco stated that it was the exporter's responsibility to declare that its own risk assessment is factually correct and scientifically sound. DG Sanco also stated that it has no plans to create a public register or set time limits on when notification documents should be provided to it.

Brazil notification documents

On 20th April 2011 GeneWatch requested a copy of the Brazil notification documents from the EC and from DEFRA. On 10th May 2011 GeneWatch received a copy of the main notification document by email from the EC listing the information supplied to it by Oxitec. Most of the information, including the risk assessment, is listed as included in the dossier to the Brazilian government. This dossier (Appendix 2) is witheld as confidential. Appendix 3 (Protocols) is also witheld as confidential.

Appendix 1 is a shipping invoice dated 9th February 2011, for 5,000 GM mosquito eggs sent to Margareth Capurro at the University of Sao Paulo, signed by Andrew McKemey of Oxitec.

Appendix 4 contains the import and field release permits from the Brazilian government.


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