UK and EU Regulation of the Laboratory and Factory Use of Genetically Modified Micro-Organisms, Plants and Animals - Contained Use

Contents:

Introduction

Genetically modified organisms which are still at the early 'laboratory' stages of development and those which are never intended to be released into the wider environment, come under the Contained Use regulations. In 2000, a new EU Directive became law in the UK. The following looks at how this law works and at the shortfalls which still exist.

The specific pieces of legislation are:

Scope of the EU Directive and UK Regulations

Critically the EU Directive is restricted to human health and environmental safety of genetically modified micro-organisms (GMMs) whereas the UK regulations also cover the human health aspects of contained use with GM plant and animals. The environmental aspects of contained use work with plants and animals is covered by the Environmental Protection Act 1990.
The UK regulations state that a micro-organism means 'a microbiological entity, cellular or non-cellular, capable or replication or of transferring genetic material, and includes a virus, a viroid and an animal or plant cell in culture'. This definition does not explicitly mention plasmids or isolated DNA which means they are probably excluded from the regulations. Effectively there is nowhere in UK law which recognises plasmids or isolated DNA as any kind of potential problem.

The Definition of 'Contained Use'

In the previous version of the EU Directive, the definition of contained use stipulated that ‘physical barriers, or a combination of physical together with chemical and or biological barriers' should be used to ‘limit their [GMMs] contact with the general population and the environment'.

The current Directive states "…any activity in which micro-organisms are genetically modified …and for which specific containment measures are used to limit their contact with the general population and the environment" (Article 2 (c)).

The current UK law states 'an activity in which organism are genetically modified…….and for which physical, chemical or biological barriers or any combination of barriers, are used to limit their contact with, and provide a high level of protection for, humans and the environment.'

By removing the requirement for physical barriers, with or without chemical and biological control measures, biological barriers alone (such as to reduce survival in the environment e.g. the inhibition of sporolation, and the use of disabled strains such as E.coli K12) are sufficient to satisfy the definition of ‘contained'. This change constitutes a weakening of the present system as it could allow the discharge of GMOs into the environment as waste which previously would have had some form of physical containment and inactivation before discharge.

Classification of GMOs

The EU Directive and the UK regulations classify GMOs into one of four classes. Class 1 is for organisms considered safest and class 4 for those which present the highest risks. Most GM plants are considered to be Class 1 because they are not usually modified to contain DNA sequences from human disease causing organisms. Class 4 is reserved for highly dangerous human or animal diseases such as small pox.

Notification of Premises and the Public register

When undertaking GM procedures for the first time, each centre must register with the HSE specifying their first activity. For those centres which will only undertake Class 1 activities at containment level 1 this may be the end of their contact with the HSE. Only activities of Class 2 and above need to notify the HSE of each new activity.

Under the old Directive there was a requirement to provide information to the public, which took the form of a public register held by the HSE in both Liverpool and London. The quality of the information varied enormously and in the main GeneWatch found it to be inadequate.

The current Directive continues to give provision for public access to notifications of both centres and activities. The HSE, which is the UK Competent Authority, had said it would be placing this public register online. The whole notification, except the risk assessment (available on request) and parts claimed as confidential, will be included on the web. The register was due to be placed online at the end of 2000 but is not yet available.

All personal information on individuals will remain confidential as a matter of course. This is in line with the Data Protection Act 1998. All other information is open to the public except where a specific claim is made. However, the regulations do not allow the following to be confidential; company/institute name and address of the notifier, location of the activity, general characteristics of the GMO, the class of the activity involving the genetic modification of the organism, the containment measures and the evaluation of foreseeable effects in particular any harmful effects on human health and the environment.
Since the September 11th attacks and subsequent anthrax letters information on certain organisms that may potentially be used as biological weapons, can be withheld from the register. Details about these provisions can be found in the HSE leaflet 'Contained Use of genetically modified organisms. - Excluding information from the public register.' This can be downloaded from: http://www.hse.gov.uk/pubns/indg357.pdf

Risk Assessment

The UK regulations outline, in schedules 3 and 4, the risk assessment procedure that should be followed to determine which containment level is necessary and which classification category the GMM and proposed activity fall into. The HSE Compendium of Guidance part 2 provides a more detailed description of the risk assessment and is produced in sections depending on the type of organism, cells and DNA being used. The following are examples of the approach to risk assessment.

  • The Assessment must be done in parallel to a COSHH assessment which looks at the health and safety aspects of the organism regardless of their genetic modification.
  • The initial containment level is set by assigning the host organism to a 'Biological Agents Hazard Group' The effects of genetic modification are then added into this assessment and a series of adjustments are made.
  • The Assessment process deals first with human health and then 'adds on' environmental considerations.

The whole risk assessment process however is dependant on the genetic modification safety committee at the registered centre and, particularly in the case of assessments which designate and activity to class 1, the HSE has limited opportunity to check on the quality of these assessments. It is only when HSE inspectors visit a centre that any checks will be carried out. The number of centres is large and the staff time of the HSE inspectors limited.

When the regulations were revised, GeneWatch raised concerns about the removal of the requirement for annual returns to be made. These returns, though limited, told the HSE of the number of risk assessments carried out by different centres and therefore gave a guide to how many different projects where taking place in centres where only low level risk work (Class 1) was undertaken. GeneWatch believes there should be some mechanism for formal monitoring of centres undertaking only class 1 work to check that their GM safety committees are making adequate risk assessments.

Containment Levels and then Inactivation of Waste

The EU Directive allows Class 1 micro-organisms to be released in to the environment via waste streams without a requirement for inactivation. The UK regulations do require this inactivation. However, there will still be some release of GMMs into the environment via hand washing silks and showers and also from air vents, all of which require no filters or inactivation. Furthermore inactivation may not necessarily kill all micro-organisms.

No Specific Monitoring Requirement

Whilst the HSE has mentioned monitoring within the notification forms, and requires centres to explain how they will monitor their processes, it is likely that this will mainly be focused on monitoring inactivation procedures. Centres will argue that if inactivation procedures are working correctly, there is no need to monitor externally. Even when inactivation procedures only have a 95% kill rate, centres will argue the initial risk assessment showed this to be safe and so there is still no necessity monitor externally.

Whilst improvements have been made to the regulations, requiring centres to state how they will inactivate the GM organisms and undertake monitoring GeneWatch still believes that because microbial ecology is little understood external monitoring should be undertaken. The obvious body to do this would be the Environment Agency which could maintain record of which GMOs are being released in waste streams.

Contained Use of GM Plants and Animals

The health risks from using GM plants and animals in laboratories or factories are covered by the Contained Use Regulations (both current and old versions), but the environmental risks are still not. Although the users of GM plants and animals in contained facilities have to register ‘first use', they do not have to inform the HSE of any subsequent changes to the types of GM animals and plants they produce if they consider that these do not pose an additional health risk. This is even if they pose increased environmental risks. This is even if they pose increased environmental risks.

The environmental risks of the contained use of GM animals and plants are covered by Part VI of the Environment Protection Act 1990 but the only requirement is that the users conduct their own risk assessments and keep appropriate records. Therefore, although the environmental risk may increase, no statutory body has to be informed and so no scrutiny of such work takes place. Environmentally dangerous experiments with genetically modified plants and animals could be taking place in laboratories in the UK without the knowledge of any statutory agency. Greenhouses do not prevent the movement of pollen and cannot prevent the entry and exit of all insects. Similarly, GM fish and insects could escape and effect ecosystems.

Contacts for Further Information:

For more information from the Health and Safety Executive, or if you want to consult the public register which is located in London and Bootle, contact:

Biotechnology Policy Section, Health and Safety Executive, Rose Court, 2 Southwark Bridge, London SE1 9HS
Tel: 020 7717 6348
Fax: 020 7717 6199

OR

Dr Paul Logan, Health and Safety Executive, Technology Division 6, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ
Tel: 0151 951 4767
Fax: 0151 951 3474
Email: paul.logan@hse.gov.uk

Website: http://www.hse.gov.uk/biosafety/gmo/index.htm

Contents:

Introduction

Genetically modified organisms which are still at the early 'laboratory' stages of development and those which are never intended to be released into the wider environment, come under the Contained Use regulations. In 2000, a new EU Directive became law in the UK. The following looks at how this law works and at the shortfalls which still exist.

The specific pieces of legislation are:

  • EU Directive: 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
  • UK Regulations: Genetically modified organisms (contained use) regulations 2000 (S.I. 2000/2831)

Scope of the EU Directive and UK Regulations

Critically the EU Directive is restricted to human health and environmental safety of genetically modified micro-organisms (GMMs) whereas the UK regulations also cover the human health aspects of contained use with GM plant and animals. The environmental aspects of contained use work with plants and animals is covered by the Environmental Protection Act 1990.
The UK regulations state that a micro-organism means 'a microbiological entity, cellular or non-cellular, capable or replication or of transferring genetic material, and includes a virus, a viroid and an animal or plant cell in culture'. This definition does not explicitly mention plasmids or isolated DNA which means they are probably excluded from the regulations. Effectively there is nowhere in UK law which recognises plasmids or isolated DNA as any kind of potential problem.

The Definition of 'Contained Use'

In the previous version of the EU Directive, the definition of contained use stipulated that ‘physical barriers, or a combination of physical together with chemical and or biological barriers' should be used to ‘limit their [GMMs] contact with the general population and the environment'.

The current Directive states "…any activity in which micro-organisms are genetically modified …and for which specific containment measures are used to limit their contact with the general population and the environment" (Article 2 (c)).

The current UK law states 'an activity in which organism are genetically modified…….and for which physical, chemical or biological barriers or any combination of barriers, are used to limit their contact with, and provide a high level of protection for, humans and the environment.'

By removing the requirement for physical barriers, with or without chemical and biological control measures, biological barriers alone (such as to reduce survival in the environment e.g. the inhibition of sporolation, and the use of disabled strains such as E.coli K12) are sufficient to satisfy the definition of ‘contained'. This change constitutes a weakening of the present system as it could allow the discharge of GMOs into the environment as waste which previously would have had some form of physical containment and inactivation before discharge.

Classification of GMOs

The EU Directive and the UK regulations classify GMOs into one of four classes. Class 1 is for organisms considered safest and class 4 for those which present the highest risks. Most GM plants are considered to be Class 1 because they are not usually modified to contain DNA sequences from human disease causing organisms. Class 4 is reserved for highly dangerous human or animal diseases such as small pox.

Notification of Premises and the Public register

When undertaking GM procedures for the first time, each centre must register with the HSE specifying their first activity. For those centres which will only undertake Class 1 activities at containment level 1 this may be the end of their contact with the HSE. Only activities of Class 2 and above need to notify the HSE of each new activity.

Under the old Directive there was a requirement to provide information to the public, which took the form of a public register held by the HSE in both Liverpool and London. The quality of the information varied enormously and in the main GeneWatch found it to be inadequate.

The current Directive continues to give provision for public access to notifications of both centres and activities. The HSE, which is the UK Competent Authority, had said it would be placing this public register online. The whole notification, except the risk assessment (available on request) and parts claimed as confidential, will be included on the web. The register was due to be placed online at the end of 2000 but is not yet available.

All personal information on individuals will remain confidential as a matter of course. This is in line with the Data Protection Act 1998. All other information is open to the public except where a specific claim is made. However, the regulations do not allow the following to be confidential; company/institute name and address of the notifier, location of the activity, general characteristics of the GMO, the class of the activity involving the genetic modification of the organism, the containment measures and the evaluation of foreseeable effects in particular any harmful effects on human health and the environment.
Since the September 11th attacks and subsequent anthrax letters information on certain organisms that may potentially be used as biological weapons, can be withheld from the register. Details about these provisions can be found in the HSE leaflet 'Contained Use of genetically modified organisms. - Excluding information from the public register.' This can be downloaded from: http://www.hse.gov.uk/pubns/indg357.pdf

Risk Assessment

The UK regulations outline, in schedules 3 and 4, the risk assessment procedure that should be followed to determine which containment level is necessary and which classification category the GMM and proposed activity fall into. The HSE Compendium of Guidance part 2 provides a more detailed description of the risk assessment and is produced in sections depending on the type of organism, cells and DNA being used. The following are examples of the approach to risk assessment.

  • The Assessment must be done in parallel to a COSHH assessment which looks at the health and safety aspects of the organism regardless of their genetic modification.
  • The initial containment level is set by assigning the host organism to a 'Biological Agents Hazard Group' The effects of genetic modification are then added into this assessment and a series of adjustments are made.
  • The Assessment process deals first with human health and then 'adds on' environmental considerations.

The whole risk assessment process however is dependant on the genetic modification safety committee at the registered centre and, particularly in the case of assessments which designate and activity to class 1, the HSE has limited opportunity to check on the quality of these assessments. It is only when HSE inspectors visit a centre that any checks will be carried out. The number of centres is large and the staff time of the HSE inspectors limited.

When the regulations were revised, GeneWatch raised concerns about the removal of the requirement for annual returns to be made. These returns, though limited, told the HSE of the number of risk assessments carried out by different centres and therefore gave a guide to how many different projects where taking place in centres where only low level risk work (Class 1) was undertaken. GeneWatch believes there should be some mechanism for formal monitoring of centres undertaking only class 1 work to check that their GM safety committees are making adequate risk assessments.

Containment Levels and then Inactivation of Waste

The EU Directive allows Class 1 micro-organisms to be released in to the environment via waste streams without a requirement for inactivation. The UK regulations do require this inactivation. However, there will still be some release of GMMs into the environment via hand washing silks and showers and also from air vents, all of which require no filters or inactivation. Furthermore inactivation may not necessarily kill all micro-organisms.

No Specific Monitoring Requirement

Whilst the HSE has mentioned monitoring within the notification forms, and requires centres to explain how they will monitor their processes, it is likely that this will mainly be focused on monitoring inactivation procedures. Centres will argue that if inactivation procedures are working correctly, there is no need to monitor externally. Even when inactivation procedures only have a 95% kill rate, centres will argue the initial risk assessment showed this to be safe and so there is still no necessity monitor externally.

Whilst improvements have been made to the regulations, requiring centres to state how they will inactivate the GM organisms and undertake monitoring GeneWatch still believes that because microbial ecology is little understood external monitoring should be undertaken. The obvious body to do this would be the Environment Agency which could maintain record of which GMOs are being released in waste streams.

Contained Use of GM Plants and Animals

The health risks from using GM plants and animals in laboratories or factories are covered by the Contained Use Regulations (both current and old versions), but the environmental risks are still not. Although the users of GM plants and animals in contained facilities have to register ‘first use', they do not have to inform the HSE of any subsequent changes to the types of GM animals and plants they produce if they consider that these do not pose an additional health risk. This is even if they pose increased environmental risks. This is even if they pose increased environmental risks.

The environmental risks of the contained use of GM animals and plants are covered by Part VI of the Environment Protection Act 1990 but the only requirement is that the users conduct their own risk assessments and keep appropriate records. Therefore, although the environmental risk may increase, no statutory body has to be informed and so no scrutiny of such work takes place. Environmentally dangerous experiments with genetically modified plants and animals could be taking place in laboratories in the UK without the knowledge of any statutory agency. Greenhouses do not prevent the movement of pollen and cannot prevent the entry and exit of all insects. Similarly, GM fish and insects could escape and effect ecosystems.

Contacts for Further Information:

For more information from the Health and Safety Executive, or if you want to consult the public register which is located in London and Bootle, contact:

Biotechnology Policy Section, Health and Safety Executive, Rose Court, 2 Southwark Bridge, London SE1 9HS
Tel: 020 7717 6348
Fax: 020 7717 6199

OR

Dr Paul Logan, Health and Safety Executive, Technology Division 6, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ
Tel: 0151 951 4767
Fax: 0151 951 3474
Email: paul.logan@hse.gov.uk

Website: http://www.hse.gov.uk/biosafety/gmo/index.htm

Contents:

Introduction

Genetically modified organisms which are still at the early 'laboratory' stages of development and those which are never intended to be released into the wider environment, come under the Contained Use regulations. In 2000, a new EU Directive became law in the UK. The following looks at how this law works and at the shortfalls which still exist.

The specific pieces of legislation are:

  • EU Directive: 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms
  • UK Regulations: Genetically modified organisms (contained use) regulations 2000 (S.I. 2000/2831)

Scope of the EU Directive and UK Regulations

Critically the EU Directive is restricted to human health and environmental safety of genetically modified micro-organisms (GMMs) whereas the UK regulations also cover the human health aspects of contained use with GM plant and animals. The environmental aspects of contained use work with plants and animals is covered by the Environmental Protection Act 1990.
The UK regulations state that a micro-organism means 'a microbiological entity, cellular or non-cellular, capable or replication or of transferring genetic material, and includes a virus, a viroid and an animal or plant cell in culture'. This definition does not explicitly mention plasmids or isolated DNA which means they are probably excluded from the regulations. Effectively there is nowhere in UK law which recognises plasmids or isolated DNA as any kind of potential problem.

The Definition of 'Contained Use'

In the previous version of the EU Directive, the definition of contained use stipulated that ‘physical barriers, or a combination of physical together with chemical and or biological barriers' should be used to ‘limit their [GMMs] contact with the general population and the environment'.

The current Directive states "…any activity in which micro-organisms are genetically modified …and for which specific containment measures are used to limit their contact with the general population and the environment" (Article 2 (c)).

The current UK law states 'an activity in which organism are genetically modified…….and for which physical, chemical or biological barriers or any combination of barriers, are used to limit their contact with, and provide a high level of protection for, humans and the environment.'

By removing the requirement for physical barriers, with or without chemical and biological control measures, biological barriers alone (such as to reduce survival in the environment e.g. the inhibition of sporolation, and the use of disabled strains such as E.coli K12) are sufficient to satisfy the definition of ‘contained'. This change constitutes a weakening of the present system as it could allow the discharge of GMOs into the environment as waste which previously would have had some form of physical containment and inactivation before discharge.

Classification of GMOs

The EU Directive and the UK regulations classify GMOs into one of four classes. Class 1 is for organisms considered safest and class 4 for those which present the highest risks. Most GM plants are considered to be Class 1 because they are not usually modified to contain DNA sequences from human disease causing organisms. Class 4 is reserved for highly dangerous human or animal diseases such as small pox.

Notification of Premises and the Public register

When undertaking GM procedures for the first time, each centre must register with the HSE specifying their first activity. For those centres which will only undertake Class 1 activities at containment level 1 this may be the end of their contact with the HSE. Only activities of Class 2 and above need to notify the HSE of each new activity.

Under the old Directive there was a requirement to provide information to the public, which took the form of a public register held by the HSE in both Liverpool and London. The quality of the information varied enormously and in the main GeneWatch found it to be inadequate.

The current Directive continues to give provision for public access to notifications of both centres and activities. The HSE, which is the UK Competent Authority, had said it would be placing this public register online. The whole notification, except the risk assessment (available on request) and parts claimed as confidential, will be included on the web. The register was due to be placed online at the end of 2000 but is not yet available.

All personal information on individuals will remain confidential as a matter of course. This is in line with the Data Protection Act 1998. All other information is open to the public except where a specific claim is made. However, the regulations do not allow the following to be confidential; company/institute name and address of the notifier, location of the activity, general characteristics of the GMO, the class of the activity involving the genetic modification of the organism, the containment measures and the evaluation of foreseeable effects in particular any harmful effects on human health and the environment.
Since the September 11th attacks and subsequent anthrax letters information on certain organisms that may potentially be used as biological weapons, can be withheld from the register. Details about these provisions can be found in the HSE leaflet 'Contained Use of genetically modified organisms. - Excluding information from the public register.' This can be downloaded from: http://www.hse.gov.uk/pubns/indg357.pdf

Risk Assessment

The UK regulations outline, in schedules 3 and 4, the risk assessment procedure that should be followed to determine which containment level is necessary and which classification category the GMM and proposed activity fall into. The HSE Compendium of Guidance part 2 provides a more detailed description of the risk assessment and is produced in sections depending on the type of organism, cells and DNA being used. The following are examples of the approach to risk assessment.

  • The Assessment must be done in parallel to a COSHH assessment which looks at the health and safety aspects of the organism regardless of their genetic modification.
  • The initial containment level is set by assigning the host organism to a 'Biological Agents Hazard Group' The effects of genetic modification are then added into this assessment and a series of adjustments are made.
  • The Assessment process deals first with human health and then 'adds on' environmental considerations.

The whole risk assessment process however is dependant on the genetic modification safety committee at the registered centre and, particularly in the case of assessments which designate and activity to class 1, the HSE has limited opportunity to check on the quality of these assessments. It is only when HSE inspectors visit a centre that any checks will be carried out. The number of centres is large and the staff time of the HSE inspectors limited.

When the regulations were revised, GeneWatch raised concerns about the removal of the requirement for annual returns to be made. These returns, though limited, told the HSE of the number of risk assessments carried out by different centres and therefore gave a guide to how many different projects where taking place in centres where only low level risk work (Class 1) was undertaken. GeneWatch believes there should be some mechanism for formal monitoring of centres undertaking only class 1 work to check that their GM safety committees are making adequate risk assessments.

Containment Levels and then Inactivation of Waste

The EU Directive allows Class 1 micro-organisms to be released in to the environment via waste streams without a requirement for inactivation. The UK regulations do require this inactivation. However, there will still be some release of GMMs into the environment via hand washing silks and showers and also from air vents, all of which require no filters or inactivation. Furthermore inactivation may not necessarily kill all micro-organisms.

No Specific Monitoring Requirement

Whilst the HSE has mentioned monitoring within the notification forms, and requires centres to explain how they will monitor their processes, it is likely that this will mainly be focused on monitoring inactivation procedures. Centres will argue that if inactivation procedures are working correctly, there is no need to monitor externally. Even when inactivation procedures only have a 95% kill rate, centres will argue the initial risk assessment showed this to be safe and so there is still no necessity monitor externally.

Whilst improvements have been made to the regulations, requiring centres to state how they will inactivate the GM organisms and undertake monitoring GeneWatch still believes that because microbial ecology is little understood external monitoring should be undertaken. The obvious body to do this would be the Environment Agency which could maintain record of which GMOs are being released in waste streams.

Contained Use of GM Plants and Animals

The health risks from using GM plants and animals in laboratories or factories are covered by the Contained Use Regulations (both current and old versions), but the environmental risks are still not. Although the users of GM plants and animals in contained facilities have to register ‘first use', they do not have to inform the HSE of any subsequent changes to the types of GM animals and plants they produce if they consider that these do not pose an additional health risk. This is even if they pose increased environmental risks. This is even if they pose increased environmental risks.

The environmental risks of the contained use of GM animals and plants are covered by Part VI of the Environment Protection Act 1990 but the only requirement is that the users conduct their own risk assessments and keep appropriate records. Therefore, although the environmental risk may increase, no statutory body has to be informed and so no scrutiny of such work takes place. Environmentally dangerous experiments with genetically modified plants and animals could be taking place in laboratories in the UK without the knowledge of any statutory agency. Greenhouses do not prevent the movement of pollen and cannot prevent the entry and exit of all insects. Similarly, GM fish and insects could escape and effect ecosystems.

Contacts for Further Information:

For more information from the Health and Safety Executive, or if you want to consult the public register which is located in London and Bootle, contact:

Biotechnology Policy Section, Health and Safety Executive, Rose Court, 2 Southwark Bridge, London SE1 9HS
Tel: 020 7717 6348
Fax: 020 7717 6199

OR

Dr Paul Logan, Health and Safety Executive, Technology Division 6, Magdalen House, Stanley Precinct, Bootle, Merseyside L20 3QZ
Tel: 0151 951 4767
Fax: 0151 951 3474
Email: paul.logan@hse.gov.uk

Website: http://www.hse.gov.uk/biosafety/gmo/index.htm

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