Genetically modified organisms (contained use) Regulations

1. Name and address of organisation

IPR

Claims are legally possibly only in respect of IPR protection. However, the CA considers it unlikely that there will be circumstances in which this could be justified.

The address given may be that of administrative offices, headquarters, or the actual premises where the activity will take place. A PO Box would be unlikely to be acceptable. The key thing is that it should clearly identify the organisation making the notification.

2. Address(es) of premises where activities will actually be conducted (ie location of the activities)

For GMMs: IPR.

For GM animals and plants: IPR & EIR

This section need not be completed if the address at section 1 already fully identifies the location of the activities.

If the activities at the premises are to involve GMMs the address of the location of the activities must be given unless disclosure would compromise IPR. However, the CA considers it unlikely that there will be circumstances in which this could be justified.

The location address (or addresses) must be given in a form that reflects the totality of the geographic location of facilities used for genetic modification activities. For instance, if a university department has a set of buildings on one street, but an annex on another street, two separate addresses would have to be given to reflect the two separate geographic locations. Similar comments apply where there are split campuses or geographically separate industrial sites. It would not be necessary, however, to detail each individual laboratory or other facility within each co-located site.

If the proposed activities at the premises are to involve GM animals or plants (but not GMMs) confidentiality for the location address ( as opposed to the address of the organisation in section 1) may be claimed on any grounds. However, the most likely ground the CA foresees as admissible is harm to public security and then usually in relation to work with vertebrates where the work might be likely to attract the attention of animal rights activists. Even then, notifiers should consider whether the location address could be given in such a way that does not precisely reveal the animal facility. This might be the case where the animal facility is on a campus or otherwise within a complex of buildings. It is, however, accepted that there will be some times when the only address possible for the location (as opposed to the organisation - section 1) will precisely locate the actual facility. In such cases the CA is likely to accept claims for confidentiality in relation to the location.

Note that the address of the organisation in section 1 cannot be claimed as confidential on any grounds except in relation to IPR. Therefore, if the address of the organisation (section 1) and the address of the location (section 2) is the same it will necessarily be disclosable.

It is unlikely that claims on grounds of public security related to GM plants would be accepted at the present time.

Note that if in the future you want to add a further geographic location to the premises already notified you must inform the CA. This is because it will be a significant change to the premises notification. No fee is charged and you may use a simple letter giving the address of the new facility. The same confidentiality considerations will apply.

3. Details of genetic modification safety committee (GMSC)

IPR & EIR

Claims could legally be made on any grounds, but the CA considers it unlikely that there will be circumstances in which any would be justified. Note that no details of individual people are required in this section. The CA needs to know only the number of members, their areas of expertise and the interests they represent, as well as the GMSC's operating procedures.

4. Nature of premises where activities are to be carried out

(For containment measures)

For GMMs: IPR

For GM animals and plants: IPR & EIR

For GMMs the only justification allowed in respect of containment measures (which form a major part of the description of the nature of the premises) is for protection of IPR. However, the CA considers it unlikely that there will be circumstances in which this could be justified. Containment measures are normally described in terms of the standard containment level to be applied (ie level 1, level 2 etc). The additional factor involved in whether the containment is a laboratory, large scale facility, animal house etc. Although other grounds for claiming confidentiality are available for this aspect, the CA can only foresee one circumstance in which it might usually be accepted. That is where a claim is made in respect of public security for activities involving GMMs and animals (eg a veterinary vaccine trial) and where the animal house is closely defined by the location address given in section 2. In such cases the CA is likely to accept that the notifier can claim as confidential the fact of the facility being an animal house, but the level of containment must be given. (That is, the notifier would tick the level 2 laboratory box but not the level 2 animal house box.) Note that the strength of such a claim will depend on how closely the address of the animal house is defined. If the animal house is in a complex of buildings, such as a campus, it is unlikely that a claim would be accepted.

For premises to be used for work with GM animals and plants, any of the grounds for confidentiality may be claimed. Although unlikely, it is possible that commercial or industrial confidentiality could be justified if the premises cannot be characterised as a laboratory, animal unit, growthroom, glasshouse or large scale activity and the requirement to specify the nature of the premises might reveal design innovations to competitors. Similarly IPR protection may be relevant if those innovations are to be patented. The CA would be likely to accept such claims.

Public security can be claimed as a ground for confidentiality if people are working with vertebrates likely to attract the attention of animal rights activists. However, if the address(es) given at section 1 and 2 do not reveal the precise location of the animal facilities, the CA is likely to question whether the claim is justified. Note also that leaving the table completely blank is itself revealing. Claims in relation to work with GM plants and public security are unlikely to be accepted.

5. Nature of work to be undertaken

IPR & EIR

Although any ground is legally possible, the CA is only likely to accept claims in relation to public security if notifiers are working with vertebrates likely to attract the attention of animal rights activists. As with section 4 it is also relevant to consider whether, if the location of the animal facilities is not specified precisely, it is still reasonable to claim confidentiality. The likelihood of the animal facility itself being identified is therefore a relevant consideration and only where the facility is closely defined by the address can strong claims be made. Claims in relation to GM plants are unlikely to be accepted.

6. Waste management measures for Class 1 activities involving GMMs

IPR & EIR

Although any ground is legally possible, the CA is only likely to accept commercial or industrial confidentiality or protection of IPR. That said, the nature of the information claimed as confidential will be critically assessed with a presumption that unless a very good case can be made for confidentiality the maximum amount of detail needs to be entered into the box.

Where standard methods of waste treatment are used, such as off the shelf disinfectants, standard heat treatment and incineration, it is unlikely that details of the waste treatment measures would be allowed as confidential.

However, it is possible that if a novel method of waste management has been developed that gives a competitive advantage and / or is going to be patented, commercial / industrial confidentiality, or claims for protection of IPR, are likely to be allowed.

For industrial production, or scale up work, the CA are likely to allow details about precise volume throughput to be claimed as commercially confidential where it can be shown that the data could give competitors knowledge of production capacity and profit margins. However, it would be expected that broad "ball park" figures should be available for disclosure, possibly by stating volumes in ranges, or as "more than" or "less than" terms.

7. Indication whether Class 1 risk assessment is attached to CU 1

[For GMMs: IPR For GM animals and plants: IPR & EIR]

Although possible, it is unlikely that a claim would be accepted.

8. Comments of GMSC² on the risk assessment

IPR & EIR

Confidentiality may legally be claimed on any of the grounds. The fact that the GMSC has commented on a particular aspect of the assessment should not itself need to be kept confidential. However, it is possible that the comments themselves may reveal information about a matter in the risk assessment for which a claim for confidentiality is being made. Any claim for confidentiality would need to be linked to a claim in the risk assessment, or possibly, section 6 in relation to waste management.

Summary risk assessment

IPR & EIR

(See advice below under the "Risk Assessment" section in relation to the activity notification form. CU2 2000.)

1. Name and address of organisation

IPR

Claims are legally possible only in respect of IPR protection. However, the CA considers it unlikely that there will be circumstances in which this could be justified.

The address given may be that of administrative offices, headquarters, or the actual premises where the activity will take place. A PO Box would be unlikely to be acceptable. The key thing is that the address should clearly identify the organisation making the notification. It would be expected that the details would be the same as for the premises notification (CU1 2000) so that there is no confusion about the link between premises and activities.

Note that if the address of the location of the proposed activity is different to the organisation address and was not included in the original premises notification (see section 2 of the previous table) you must inform the CA of this significant change. For GMMs this address cannot be claimed as confidential, although for GM vertebrates claims in respect of the location of the animal facility are likely to be accepted if the address will necessarily reveal the precise location and it is not the organisation address.

2. Date of premises notification

[IPR & EIR]

In theory any grounds for a claim would be legally valid, but it is unlikely that any claim would be accepted. (This information would already be in the public domain.)

3. Indication of a connected programme

[IPR & EIR]

In theory any grounds for a claim would be legally valid, but it is unlikely that any claim would be accepted.

4. Class(es) of activity

For GMMs: IPR

For GM animals and plants: IPR & EIR

For activities involving GMMs claims in relation to IPR are allowable. However, it is unlikely that such a claim would be accepted by the CA.

For activities involving GM animals or plants any of the grounds for a claim would be legally valid. However, the ground that might have most relevance is that of public security where notifiers are working with vertebrates likely to attract the attention of animal rights activists. Such a claim would have to be fully justified. However, it may be difficult to make a strong case if the precise location of the activity is not to be revealed and given that section 4 asks for no details.

5. Descriptive title of activity

IPR & EIR

Confidentiality could be claimed on any of the grounds. However, it should be possible to formulate a meaningful title that, whilst it allows people to understand the nature of the activity, does not prejudice any confidentiality. The notifier would have to give a very good reason why it is not possible to formulate the title in a way that would not prejudice confidentiality. It is unlikely that a claim would be accepted.

Claims in respect of IPR protection are the ones that the CA envisages are likely to be successful and then only if there was robust justification.

6. Purpose of the contained use

IPR & EIR

Confidentiality may be claimed on any of the grounds. However, the CA believes that in most cases it should be possible to describe the purpose in terms that would not prejudice confidentiality. That said, it is possible that claims in respect of IPR, or commercial or industrial confidentiality, would be allowed if it can be clearly demonstrated that disclosure of the purpose of the work, even in general terms, could affect competitive position or the ability to obtain a patent. Also possible might be claims in relation to public security where work is with vertebrates. However, the likely success of such a claim will depend on whether the precise location is disclosable and the notifier would have to show that no suitable wording can be found that does not give rise to potential public security problems.

Claims in respect of international relations and national defence might also be admitted, but are unlikely to succeed unless a very good reason can be given for the impossibility of finding suitable wording.

7. Characteristics of the GMOs including the evaluation of foreseeable effects.

For GMMs: IPR (&EIR for some aspects)

For GM plants and animals: IPR & EIR

For GMMs the Regulations do not allow any of the EIR grounds to be claimed in respect of general characteristics or evaluation of foreseeable effects (ie potential harmful effects on human health or the environment). "General characteristics" are defined by exception. They do not include: genus, species, genotype, serotype and strain of the GMO. It is possible to make a claim on any of the grounds in respect of these specific characteristics, but only claims in respect of IPR will be considered in relation to general characteristics.

For GM animals and plants claims are legally possible on any of the grounds in respect of any of the characteristics and the evaluation of foreseeable effects.

The section on the form is broken down into four boxes, each is detailed below with an indication of possible claims.

Recipient or parental organism

For GMMs, unless IPR protection is claimed, the GMMs must be described in at least general terms. Notifiers are required to supply details of those specific characteristics that are necessary for the CA to evaluate the risk assessment. However, notifiers may claim that the specific characteristics are confidential. For GMMs claims in respect of commercial or industrial confidentiality could be made for specific characteristics and must demonstrate that disclosure would harm competitive position. The CA can foresee that successful claims could be made.

Claims in respect of IPR, for either specific or general characteristics would have to demonstrate that disclosure would compromise patentability. It is likely that claims for specific characteristics will be accepted. Claims may also be acceptable for general characteristics.

For GM animals claims in respect of public security are likely to be made where GM vertebrates are involved and in such cases both general and specific characteristics may be claimed as confidential. However, the likelihood of the claim being accepted will depend on how easy it would be for activists to identify the relevant animal facility. Claims in respect of specific characteristics are more likely to be accepted than claims for confidentiality of general characteristics.

For GM animals and plants claims can be made in relation to commercial or industrial confidentiality or for IPR protection for both specific and general characteristics. It is likely that a claim for specific characteristics to be confidential will be accepted. A claim in respect of general characteristics is less likely to be accepted, although IPR based claims in particular may still be justified.

Claims in relation to international relations and national security are possible for GM animals and plants. Only claims in relation to specific characteristics would be likely to be accepted.

Host / vector system

This forms part of the characteristics of the GMO and so the comments in respect of the recipient or parental organism above apply. Note that for GMMs the specific characteristics in relation to the vector will be the genotype of the vector as it remains in the final GMM. It is possible to claim that this genotype is confidential - but the discussion above will apply as to the likely success of any claim. It is unlikely that a claim for confidentiality in respect of a commercially available, off the shelf, vector would be accepted, unless it was being used in a highly novel way.

Any ground for a claim is allowed for GM animals and plants. But unless there is an unusual situation it is unlikely that claims will succeed where commercially available vectors are used. Public security claims are unlikely to succeed unless the vector would necessarily reveal other matters that are being claimed as confidential (eg the vector details might reveal the species of the animal and hence the precise location if highly specialised facilities are needed that would be easily identified).

Origins and intended functions of the genetic material involved

As above, for GMMs it is possible to claim that the specific origin of the inserted genetic material is confidential on any of the grounds. It would also be possible to claim that the specific gene is also confidential. However, except in relation to claims in respect of IPR, for GMMs it is not possible to claim that the origin and intended function, given in general terms, is confidential. Claims for commercial or industrial confidentiality in respect of specific characteristics (eg species and gene) are likely to be successful.

For GM animals and plants claims may be based on any of the grounds. In relation to commercial or industrial confidentiality claims made in respect of specific characteristics are likely to be accepted. Claims in respect of general characteristics are less likely to be accepted.

It is likely that for both GMMs and GM animals and plants claims in respect of IPR for even general characteristics would be successful.

Claims in respect of public security for vertebrate GM animals are perhaps less likely to be accepted, especially if there has been a claim for the recipient animal to be confidential and the precise location of the animal facility is not be to disclosed.

Evaluation of foreseeable effects

This involves identifying any actual or potential hazards which could lead to harm to humans or the environment. (Only human health matters in relation to GM animals and plants.)

For GMMs this cannot be claimed as confidential except if it is to protect IPR. It is likely that claims made in respect of IPR, where the identification of potential hazards would necessarily reveal other confidential information, would be accepted.

As just mentioned above, for GMMs claims in respect of EIR grounds are not allowable. However, it should be possible to set out the potential hazards without revealing details of any specific characteristics that have been claimed as confidential.

For GM animals and plants claims in respect of any of the grounds are legally possible. However, it is unlikely that a strong case for confidentiality could be made, except in relation to protection of IPR. As for GMMs it should normally be possible to set out the potential hazards without revealing other confidential matters.

8. Containment and control measures for GMOs that are not micro-organisms (ie GM animals and plants)

IPR & EIR

Claims are legally possible on any of the grounds. However, IPR, commercial or industrial confidentiality, or confidentiality in relation to public security are the grounds most likely to be claimed.

For work with GM vertebrate animals it is possible that a claim in respect of public security would be accepted if the description of the containment measures would necessarily reveal the identity of the animal and a claim for confidentiality of the identity of the animal had also been made. The strength of the claim would also depend on whether the actual animal facility could be identified from either the description given here or the premises notification. Claims under public security grounds in relation to GM plants are unlikely to be accepted.

Claims in respect of commercial or industrial confidentiality are only likely to be accepted if the description would reveal a novel containment method that gives a competitive advantage. The use of standard containment facilities is unlikely to constitute a strong case.

IPR claims may be more likely to succeed either where the novel containment is patentable or if the nature of the containment would reveal other details, such as the nature of the GM animals or plants, that would affect patentability.

9. Maximum culture volumes for GMMs

IPR & EIR

Claims for culture volumes to remain confidential may be made under any of the grounds. The most likely to be justified are claims in respect of IPR and commercial or industrial confidentiality. Where supporting justification shows that culture volumes would reveal production capacity and pricing regimes, the CA is likely to accept a claim. But, unless there are compelling reasons, the CA would expect an indication of volume to be given - possibly as a range, or in terms such as "less than" or "more than".

10. Containment level for GMMs

IPR

Claims in respect of IPR only are legally possible. However, the CA considers it unlikely that a claim will be accepted given the very general nature of the information and the fact that the containment levels are well known standards.

11. Application for derogation from full containment for GMMs.

IPR for measures, IPR and EIR for justification

Stating the containment measures for which a notifier is applying for a derogation can only be claimed as confidential on the basis of protecting IPR. The CA can envisage that if the containment measure would reveal a patentable design innovation or a novel feature of the GMM a claim for confidentiality would be accepted. (Although it is unlikely that such situations will arise.)

The justification for the derogation will be based on the risk assessment and, possibly, specific properties of the GMM. It is possible that the justification could reveal commercially or industrially sensitive information and a strong claim could therefore be made. Similarly, for protection of IPR.

Note that the case for making the claim in respect of the justification would be likely to be the same as the related claim in the risk assessment or section 7 of the CU2 2000 form.

12. Waste management measures

IPR & EIR

Although any ground is legally possible, the CA is only likely to accept commercial or industrial confidentiality, or protection for IPR. That said, the nature of the information claimed as confidential will be critically assessed, with a presumption that unless a very good case can be made for confidentiality the maximum amount of detail needs to be entered into the box.

Where standard methods of waste treatment are used, such as off the shelf disinfectants, standard heat treatment and incineration, it is unlikely that details of the waste treatment measures would be allowed as confidential. However, it is possible that if a novel method of waste management has been developed that gives a competitive advantage, and / or is patentable, commercial or industrial confidentiality or claims for protection of IPR are likely to be allowed. Even when the detail is claimed as confidential it would be expected that more general information will be available for disclosure.

For industrial production (which for Class 2 - 4 currently involves only small volumes) the CA will usually allow details of precise volume throughput to be claimed as commercially confidential where it can be shown that the data could give competitors knowledge of production capacity and pricing structures. However, it would be expected that broad, "ball park" figures should be available for disclosure, possibly by stating volumes in ranges or in terms such as "more than" or "less than".

13. Indication of emergency plan is required

[IPR & EIR]

In theory any ground for a claim could be allowed, but it is unlikely that any claim would be accepted. Note that the notifier is responsible for making the plan and any revisions publicly available, so the emergency plan is necessarily not a confidential document.

14. Indication of inclusion of a risk assessment and whether any sections of the risk assessment are confidential

[IPR & EIR]

In theory any ground for a claim could be allowed, but it is unlikely that any claim would be accepted.

15. Comments of GMSC on the risk assessment

IPR & EIR

Confidentiality may legally be claimed on any of the grounds. The fact that the GMSC has commented on a particular aspect of the assessment should not in itself need to be kept confidential. However, it is possible that the comments themselves may reveal information about a matter in the risk assessment for which a claim for confidentiality is being made. Any claim for confidentiality would need to be linked to a claim in the risk assessment, or, possibly, section 6 in relation to waste management.

Risk assessment (or for CU1 2000 the risk assessment summary)

Varies

Typically risk assessments will include (as appropriate):

• a descriptive title;
• an overview of the activity;
• hazard identification (as appropriate from the recipient, insert, vector, donor and the final GMO);
• characteristics of the activity (eg operations undertaken, scale);
• severity of the potential harm;
• likelihood of the potentially harmful effects occurring;
• containment and control measures, and justification for them;
• standard operating procedures;
• waste management measures;
• class of the activity;
• copies of published papers.

Some notifiers in the past have also included the names of individual staff in the risk assessment . This constitutes personal data and would be removed before disclosure. In fact, we would encourage notifiers not to include individual's names in the risk assessment as this is normally not necessary.

The grounds on which confidentiality may be claimed will vary depending on the nature of the information. Each type of information is discussed below.

Descriptive title

The comments at section 5 above apply.

An overview of the activity

This may in part include details about the purpose of the contained use. For the parts of the overview relevant to purpose the comments at section 6 above apply.

For other types of information included in the overview IPR and EIR claims are possible. However, normally it would be expected to be possible to give the information in general terms so that confidentiality is not a problem.

Hazard identification

As for any other information claimed as confidential, the precise characteristics of the GMO and its component parts will have to be given to the CA. It is possible that claims in respect of IPR and EIR grounds could be justified. However, note that for activities involving GMMs, claims in respect of general characteristics can be made in relation to IPR only. For activities involving GM animals and plants it is possible to claim confidentiality under IPR or any of the EIR grounds for any of the information. However, it is unlikely that a claim for confidentiality would be successful except in connection with work with vertebrates and where the location of the animal facility is also to be revealed. It would be expected that the some indication of the hazards would be possible. (See discussion at section 7 above for more detail.)

Characteristics of the activity

Claims in respect of IPR and any of the EIR grounds are possible. Commercial or industrial confidentiality is the most likely basis for a claim, particularly if a novel method is being used that gives competitive advantage or if details of volume may reveal production capacity or pricing structures etc. Claims in respect of IPR are likely to be accepted if disclosure could compromise patentability. For activities involving GM vertebrates claims in relation to public security may be accepted, especially if other details in the notification would reveal the precise location of the animal facility.

Severity of the potential harm

As the severity of any potential harm forms part of the "evaluation of foreseeable effects", claims are only allowed for GMM activities in respect of IPR. Even then, it is unlikely that a claim would be accepted given that information on the severity of any hazard is unlikely to reveal detailed characteristics of the GMM or process involved. However, the CA is more likely to accept as confidential the justification for the level of severity identified as it would probably have to reveal other confidential details. It would be possible to make a claim in relation to GM animals and plants for IPR protection or on any of the EIR grounds. However, as for GMMs, it is unlikely that a claim for confidentiality would be accepted except in relation to the justification for the level of severity identified. (See also section 7 above.)

Likelihood of the potential harmful effects

Although it is possible to claim IPR or any of the EIR grounds as the basis for confidentiality the CA would be unlikely to accept a claim unless it can be demonstrated that the information would necessarily reveal other matters such as specific characteristics of the GMMs or novel activity characteristics that are also claimed as confidential. It would normally be expected that the likelihood of a harmful effect occurring would never be confidential, but that the justification for the identified level of likelihood may be. For GM vertebrate animals claims might be justified in relation to details that would reveal the specific type of animal being used, but a strong case could probably only be made if the location was also given in precise terms.

Containment and control measures and justification

In relation to GMMs the measures themselves (ie level 1, level 2 etc) cannot be claimed as confidential for any reason other than protection of IPR. However, given that the measures are likely to be standard it is unlikely that such a claim would be accepted. The justification for the particular measures, or more likely justification for any derogations, may reveal other information that would be claimed as confidential (such as the specific details of the GMM). It is therefore possible to claim the justification (but not the measures themselves) to be confidential under IPR or EIR grounds. The most likely grounds for successful claims will be for commercial or industrial confidentiality or IPR.

For GM animals and plants it is possible to claim confidentiality on any of the EIR grounds or for IPR protection. The most likely claims might be in respect of GM vertebrates for public security if the description of the facility will reveal matters (such as the type of animal or location) that were being claimed as confidential. Claims for industrial or commercial confidentiality and IPR protection for GM animal and plant containment might also be allowed if novel containment methods are being used which either give a competitive advantage or are patentable.

Standard operating procedures

It is quite common for notifiers to include these with their risk assessment. It is permissible to claim them as confidential under IPR or EIR grounds so long as the main body of the risk assessment indicates the control measure to be used. For example, the measure may be the use of a microbiological safety cabinet. This cannot be kept confidential (except for IPR reasons). However, standard operating procedures for the use of the cabinet could be claimed as confidential. That said, it is unlikely that a claim for confidentiality would be accepted by the CA.

Waste management measures

The comments at section 12 above apply.

Class of the activity

This only applies to activities involving GMMs. It cannot be claimed as confidential except in relation to IPR. However, it is unlikely that a claim for confidentiality on IPR grounds would be accepted by the CA.

Copies of published papers

It is fairly common for people to include copies of published papers with the risk assessment. This is encouraged by the CA, especially where the paper contains information relevant to the justification of statements made in the risk assessment. Given that these papers are already in the public domain the CA would never accept a claim for confidentiality for these. However, some notifiers have argued that if competitors know what papers they are interested in this could in itself reveal commercially confidential information about the proposed activity, which could undermine competitive advantage. This is a reasonable argument. But if this was the case the best advice would be to not include the paper. It would be rare for there only to be a single paper which provides any justification for statements in a risk assessment. Statements about the purpose of an activity would not need to be justified and this would be the more likely area where papers could reveal commercially sensitive information.