Leaking From The Lab

Leaking From

The Lab?
The ‘Contained’ Use of Genetically Modified Micro-organisms

in the UK

The Mill House, Manchester Road, Tideswell, Buxton, Derbyshire, SK17 8LN, UK

Phone: + 44 (0)1298 871898 Fax: [phone]

E-mail: [e-mail] Website: http://www.genewatch.org

This research was funded by the ERR Research and Bursary Fund

Contents

1. SUMMARY 5

2. INTRODUCTION 9

3. RISKS OF GENETICALLY MODIFIED MICRO-ORGANISMS 10

4. THE REGULATORY FRAMEWORK 18

5. THE USE OF GENETICALLY MODIFIED MICRO-ORGANISMS IN THE UK 29

6. GMMS IN THE ENVIRONMENT 37

7. REVISION OF THE EU DIRECTIVE 90/219/EEC 42

8. CONCLUSIONS 46

9. RECOMMENDATIONS 49

APPENDIX 1: ADVISORY COMMITTEE MEMBERSHIP 51

APPENDIX 2: REGISTERED LARGE-SCALE GMM USERS 52

REFERENCES 54

Table of Figures

Table 1: Data requirements to predict the effect of the release of a GMM to the environment (adapted from Doyle et al (1995)) 10

Box 1: The History of the Regulation of the Laboratory Use of Genetically Modified Micro-organisms in the UK Error: Reference source not found,, 19

Table 2: Enforcement action taken by HSE on centres not complying with the Contained Use regulations 25

Table 3: Commercially Available Enzymes Made By Genetically Modified Micro-organisms For Use In Food Processing 34

Table 4: Medical products made using GMMs 36

Table 5: HSE Questionnaire Results (from Crook and Cottam (1996)) Error: Reference source not found 39

1. SUMMARY

While there has been much concern about the safety of genetically modified crops and foods, releases of genetically modified micro-organisms (GMMs) are taking place, unmonitored, on a daily basis from factories and laboratories around the UK. This form of pollution is escaping control measures and could increase dramatically in scale if proposed new regulations are agreed.

GMMs are being used widely in the UK both for research purposes and by industry to produce enzymes, food additives and drugs. This is called 'contained use' to distinguish it from the deliberate release of other GM organisms such as GM crops. Although GMMs used in these ways are presented as being restricted to the laboratory or factory, they are in fact being incidentally or accidentally released in the workplace and into the environment. GMMs are required to be ‘inactivated’ before waste is discharged, but in the majority of cases this does not mean that all organisms must be killed. This report details GeneWatch’s research into the use of GMMs, which has included reviewing the scientific literature; studying the public register of the use of GMMs in the UK; conducting a survey of large-scale users of GMMs; and making inquiries via officials and industry.
Bacteria, viruses, yeasts and fungi are all being genetically modified in the UK and there are 471 sites registered as using GMMs, mostly on a small scale for research purposes. However, this is an underestimate of the true figures because the Health and Safety Executive's (HSE’s) public register was only introduced in 1992 and many facilities started using GMMs before that time.
Thirty-four centres (probably a large underestimate of the real number) are registered as using GMMs on a large scale, mainly for industrial use. However, there is no information available about what products are being developed from GMMs in factories. Drugs (such as insulin and antibiotics), enzymes and food additives could be, and probably are, all being made from GMMs in the UK. The use of GMMs could be on a huge scale. Although most waste is treated to kill the majority of the organisms before it is disposed of, some living GMMs are still released. Fermenters (in which organisms are grown in factories) can range from 10 to 10,000 litres in capacity containing up to 10¹⁴ or 10¹⁶ organisms in the larger fermenters (10⁶ is one million organisms). Information on the public register shows that, after treatment to inactivate waste, companies still expect to be releasing waste containing hundreds, or even millions, of GMMs per litre. Extraordinarily, the Environment Agency, which is responsible for pollution control in the UK, has no information on where and how GMMs are being used in factories and therefore no knowledge of what GMMs are being released in waste streams or in aerial discharges by the companies involved. The HSE, which is responsible for implementing the regulations covering the use of GMMs, conducts no monitoring and no enforceable levels of allowed pollution are established.
GeneWatch has written to all the companies registered as using GMMs on a large scale. None of the companies using GMMs were prepared to supply details of what they were producing or releasing into the environment, their monitoring plans or data.
The main small-scale (less than ten litres) research uses of GMMs include the investigation of disease (especially cancer and infectious diseases) and the search for treatments in humans, animals and plants. Commercial research focuses on the use of GMMs to produce drugs and other products. The HSE estimates that there are around 5,500 new projects using GMMs on a small scale each year. There are no records of 90-95% of these because, once a laboratory is registered as using low-risk GMMs, there is no requirement to provide further information. The users conduct the risk assessments themselves and if they categorise a project as safe, no information is disclosed to the regulators. Only higher-risk GMMs which require tighter containment are scrutinised by the HSE.

Researchers at public institutes and universities appear to be the most irresponsible about the risks of GMMs even though they are often dealing with more dangerous organisms. The HSE has taken action against seven universities or institutes, including one (Edinburgh University) - twice, for failure to observe proper safety procedures:

November 1993:	National Institute of Medical Research - Improvement notices.
December 1993:	Birmingham University - Prohibition notice.
July 1994:	Kings College School of Medicine and Dentistry - Voluntary cessation of work. 3 improvement notices.
June 1995:	School of Hygiene and Tropical Medicine, London - Voluntary cessation of work. Improvement notice.
December 1996:	Institute for Animal Health, Pirbright - Improvement notice. Voluntary agreement that proposed work should not be undertaken until a full notification had been made.
July 1998:	University of Edinburgh - Improvement notice.
July 1998:	University College, London - Improvement notice.
February 1999:	University of Edinburgh - prosecuted and fined £3,500.

However, the failures identified so far are likely to be the tip of the iceberg since the HSE only has the equivalent of one person (in terms of hours allocated) dedicated to the inspection of the 500 sites using GMMs.

Although the use of GM techniques in research which is intended to bring human health benefits will probably be viewed much more sympathetically than the use of GM in crop and food production, risks to workers, the public or the environment should be avoided. The power of the HSE is restricted to determining the level of containment - not whether the GMMs should be produced at all. Experiments which may be considered irresponsible can be carried out and potential examples include the transfer of genes between two morbilliviruses - canine distemper virus and rinderpest virus. Morbilliviruses can cross species boundaries and, with very small changes, could cause dramatic alterations in their ability to cause disease.
Although many of the organisms involved in large-scale and research use are mainly classified as 'low risk', there is evidence that:

even low-risk GMMs can survive for days or weeks in the environment;

a GMM’s foreign DNA can be passed to other organisms, and vice versa, with the potential to create new organisms which could alter ecosystems;

so-called 'naked' DNA (DNA released from cells which have died and broken down) can be taken up by some bacteria;

GMMs frequently contain antibiotic resistance genes, possibly increasing the likelihood of drug resistance appearing in disease-causing organisms;

minor changes in genes can dramatically alter how dangerous an organism is;

the vectors used to facilitate gene transfer in the laboratory may make gene transfer in the environment more likely.

The regulations covering the contained use of GMMs are about to be revised following the introduction of a revised Contained Use Directive in Europe. However, the new Directive weakens existing safeguards by removing the requirement to prevent the release of GMMs categorised as low-risk and by allowing for some GMMs to be exempt from any control. Because the revised Directive only sets minimum standards, the UK Government is free to impose stricter regulations to protect human health and the environment, but this opportunity has not been taken.
Instead, the Government proposes to remove the requirement to prevent the release of those GMMs categorised as low risk without any provision for independent monitoring, enforceable standards for containment, or a system to record all uses of GMMs. The user would be responsible for deciding whether a GMM was of low risk. Furthermore, the UK proposes introducing a mechanism to allow live GMMs to be released to the environment on a large scale without any treatment at all. In another proposal, 400-500 projects annually could be exempted from scrutiny. Disturbingly, rather than taking the opportunity to collect information, test scientific assumptions rigorously and learn more about GMMs, a naive faith has been placed in the ability of risk assessments to decide the likelihood and level of harm and, in the majority of cases, this decision is left to the GMM users themselves.
In the light of the research findings in this report, GeneWatch believes that the regulation of the contained use of GMMs must be brought into line with other pollution controls in the UK. To achieve this, and to improve the system more generally, GeneWatch recommends that:
More information must be obtained:

The HSE must backdate the public register to pre-1992 to include all centres registered as using GMMs. Information on the commercial use of GMMs must be collected and include data on the products manufactured from them. The proposed interim arrangements should be extended to include this.

Annual returns must be continued and extended to include lists of all risk assessments undertaken to enable scrutiny of the evaluations conducted by users of GMMs.

The public register must be made available via the Internet, should include a search engine and be comprehensive. Information must include details of the organisms involved, how they are modified, why the modification is being undertaken, how the risk assessment has been arrived at, the dates use started and finished, what precautions are being taken to prevent release, and what monitoring takes place.

Risk evaluations must be improved:

In taking decisions about GMMs - and given the uncertainties involved and the potential for serious irreversible harm - a precautionary approach must be adopted.

Plasmids and naked DNA should be brought within the scope of the regulations.

Users must be required to present a worst case scenario when notifying the use of a GMM to reveal the full extent of the uncertainties.

The requirement for physical barriers to the release of GMMs should remain, together with the presumption (for all classes of GMMs) that there should be no releases of living GMMs into the environment. No discharges should be allowed unless reliable monitoring is available, a detailed risk assessment is presented which takes into account the local environment and the use of other GMMs, and a full justification for the need to discharge live GMMs or intact DNA is given.

Provisions for liability for any environmental harm arising from the use of GMMs should be included in the new regulations.

Pollution from GMMs must be monitored, policed and appropriate controls enforced:

The development of effective monitoring techniques must be a priority.

A legal system specifying the levels of GMM pollution that can be released in waste should be established. This would be consistent with other approaches to pollution control (e.g. chemicals), allow for prosecutions if breaches arise and drive a proper monitoring system.

The Environment Agency should be made responsible for independent monitoring of environmental releases of GMMs via waste streams and air and for the policing of discharges.

In addition, users of GMMs must be required to monitor to verify containment procedures and to implement systems for the detection of sudden leaks.

There must be increased investment in policing and enforcement.

Openness and transparency of the regulatory system must be established:

Refusal to disclose information about releases of GMMs to the environment on the grounds of commercial confidentiality must not be allowed under any circumstances. Users must supply details of any GMMs (including the species and how and why they have been genetically modified), the levels of release to the environment in waste and the monitoring systems in place.

Representation of public interest groups should be increased on the advisory committees, meetings should take place in public, and annual reports summarising each year’s activities should be produced.

There should be greater public involvement in decision-making about the use of GMMs.