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The potential for misuse of DNA sequences (oligonucleotides) and the implications for regulation

  1. In August 2006, representatives from across Government attended a meeting to consider the feasibility and potential risks of viruses being created by joining together oligonucleotides (sequences of DNA).  
  2. The meeting concluded that -

  1. current legislation is adequate to address the current risk. Additional regulation would be inappropriate at the present time, although the situation will be kept under review; and

  2. any risk should be considered within the wider agenda to prevent the misuse or dual use of biotechnologies.

This note explains the background to those conclusions.

Background

  1. Oligonucleotides are single strands of DNA, comprising a maximum of 70 nucleotides. Three nucleotides are needed to form a DNA sequence that can code for the production of a single amino acid when the sequence is combined into a helix with a second strand of appropriate nucleotides.
  2. Oligonucleotides can be joined naturally if there are matching sequences or by synthetic stitching if there are not. A large number of oligonucleotides would be needed to make the genome of a virus.  Bacterial genomes are generally larger than viruses and even more difficult to create.
  3. Manufactured oligonucleotides could be used to produce viruses in two ways –

  1. chemical synthesis. This is very difficult and requires sophisticated equipment. At present only relatively small numbers of oligonucleotides can be joined in this way; and  

  2. recreation of DNA from large remnants of DNA extracted from an organism. The role of the oligonucleotides is to fill in gaps in the DNA. To do this requires access to the natural nucleotide template (ie from the organism) and knowledge of the sequences. Scientists with this kind of expertise and access to materials and facilities will be working within the biological community and subject to the various safeguards that apply to legitimate work (see paragraph 11 below). 
  1. When the genome of a virus is made, virus production cannot occur until the naked genomic material is transfected (introduced) into an appropriate cell line. Moreover, the cell line must contain all the other components necessary to reproduce the virus. This kind of work would demand sophisticated expertise and equipment, and containment facilities to ensure that the laboratory staff were not infected.

Uses of oligonucleotides

  1. Manufactured oligonucleotides are considered standard laboratory reagents and as such underpin most modern biotechnology (for example, in polymerase chain reaction (PCR) techniques). They offer the ability to amplify genes and detect specificity. They are used in a vast range of applications, including DNA fingerprinting, screening for inherited diseases, diagnostic tests, analytical research tools and the development of vaccines and drugs. As such, they are essential to the identification and treatment of health problems. They are widely used in laboratories, universities and schools, often in kits provided by the manufacturers. 

Risks

  1. In themselves, oligonucleotides pose little or no risk to health, safety or the environment. 
  2. Any risk would only come if a large number of oligonucleotides were deliberately combined to form a pathogen or material that could create a pathogen if incorporated into a suitable organism.  (A pathogen is an infectious agent that causes disease or illness.)
  3. Chemical synthesis of this sort requires expensive, complicated equipment and is sufficiently difficult that it is unlikely that it would be done other than in a legitimately controlled laboratory. 

Legislative controls

  1. Because they are not viable organisms (but are artificial cellular material) and are extremely unlikely to be hazardous in themselves, there is no legislation specifically governing oligonucleotides.  However, were they to be used to create hazardous/pathogenic organisms or biological agents, one or more of the following national measures would apply –
  1. There is also UK legislation (made under the Export Control Act 2002) which implements controls as set out in Council Regulation (EC) No. 1334/2000, on the export to non-EU countries of dual use items and technologies. The Regulation controls items and their associated technologies required to produce chemical and biological weapons by requiring exports of such items and technologies to be licensed by EU competent authorities, which in the UK is the DTI. Although the Regulation does not specifically identify oligonucleotides, it does cover genetically modified micro-organisms or genetic elements that contain nucleic acid sequences associated with pathogenicity in a number of listed human, animal and plant micro-organisms.   

Other controls

  1. Although not specifically focussing on oligonucleotides, the Government has been working, and will continue to work, to raise awareness of the Biological and Toxins Weapons Convention (BTWC)  among the scientific community and industries involved in life sciences, including engaging with scientists to develop their own specific codes of conduct to address the potential for misuse of legitimate products and processes or dual use of pathogens and their delivery. 
  2. In addition, suitable controls already exist in companies and research laboratories through standard operating practices that cover legal, health and safety obligations. These controls and similar ethical systems can be used to respond quickly to changes in technology. 

Next steps

  1. Although there is a theoretical risk, the likelihood of misuse of this kind at the moment, and in the foreseeable future, is very low. It is conceivable that technologies will advance such that pathogenic organisms could be constructed or (more likely) be modified more easily. The Government will therefore keep the issue under review, and has asked key organisations to alert Government if they become aware of any significant advances which might lead to major technological changes and thus to increases in risk. 

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