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Genetically modified organisms (contained use) Regulations

Confidentiality and disclosure of notified data

Important changes: Disclosure of Notified Data for GMOs and the FOI Act

Contents:

BACKGROUND AND INVITATION TO COMMENT

1. The Genetically Modified Organisms (Contained Use) Regulations 2000 (from now on referred to as the Contained Use Regulations) are coming into force against a background of the Government's commitment to strengthening the public right of access to information. The Contained Use Regulations make the fundamental presumption that all information notified under the Regulations may be disclosed to the public unless the notifier can justify withholding items from disclosure on certain specified grounds and the Competent Authority1 for the Regulations agrees. Claims for confidentiality will be considered critically.

2. The various allowable grounds for claiming confidentiality are set out below as they appear in the legislation. Each claim must be justified and some justifications will be stronger than others. For all concerned, the Competent Authority (CA), the genetic modification community and members of the public, it is important that there is a common understanding of what claims would be acceptable, so that the allowable grounds are interpreted in a fair, consistent and transparent manner.

3. This document is designed to explain just what sorts of information may be justifiably claimed as confidential and hence accepted as such by the CA. Also, it attempts to further explain the categories of information that cannot be claimed as confidential.

4. We must emphasise that we cannot offer advice on the legal interpretation of the provisions in the Contained Use Regulations. The views expressed in the guidance as to those provisions are those of the CA. It is for the Courts alone to give a definitive view on the interpretation of the provisions in the Contained Use Regulations.

The opportunity to comment

5. Our aim is to build a system that balances openness and protection, and is broadly acceptable to as wide a range of stakeholders as possible. The criteria that the system must meet are that it:

6. This document is not set in stone. It will evolve over time. In particular as new questions are considered. We would welcome views from stakeholders about whether the thresholds it proposes are broadly acceptable. If you would like to comment please send them to :

ACGM Secretariat
Health Directorate, B2
Rose Court,
6th Floor, North Wing
2 Southwark Bridge
London SE1 9HS

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OVERVIEW OF THE GROUNDS FOR CLAIMING CONFIDENTIALITY

7. Confidentiality matters can be broadly divided into three groups:

An overview of each of these is given below.

Personal data

8. Subject to certain exceptions contained in the Data Protection Act 1998, personal data, including an individual's name, address and qualifications, cannot be disclosed without the written consent of the individual concerned. Claims for confidentiality for personal data do not have to be made.

9. Whilst protection will automatically be afforded to personal data, without claims for confidentiality being necessary, it will be helpful if notifications made under the Contained Use Regulations are structured in such a way that any personal information is easily identifiable and removable. The notification forms developed for use under the Regulations are specifically designed so that personal information is in a separate section which can be easily removed. (See below for detailed discussion of the individual sections of the forms.) If the forms (which are voluntary) are not used, people will have to consider how best they can achieve the same effect.

Gene therapy and other human clinical trials

10. Where a gene therapy trial involves the use of a genetically modified micro-organisms (GMM) as the therapeutic substance, and the activity constitutes contained use, the trial will be regulated under the Contained Use Regulations. Other human clinical trials, such as some trials involving genetically modified live vaccines, may also be contained use. Protection of personal data relating to the individuals taking part in such trials is an important consideration.

11. It would be expected that the names of individual patients would not be supplied in any notification under the Contained Use Regulations. However, in certain circumstances, and especially for very rare conditions, it might be possible to identify the patient by deduction, rather than direct disclosure of the individual's name. For instance, for a rare genetic condition where the person (or their family) is a member of a support group, revealing the location of the hospital or clinic together with the disease could by deduction lead to identification of the individual or the particular family. In such cases, and where this information is not already in the public domain, a claim for confidentiality of personal information could be made in relation to the precise identity of the disorder being treated. Note that it would not be possible to claim the location of the trial to be confidential because the Contained Use Regulations specifically exclude confidentiality claims in relation to location of activities involving GMMs, except for protection of IPR. (See Section 2 to the first table below for details.)

Grounds for claiming confidentiality (excluding IPR)

12. Apart from protection of intellectual property rights, the other grounds on which confidentiality may be claimed are listed below.

Commercial or industrial confidential information - general discussion

13. Commercially (or industrially) confidential information includes:

Trade secrets include (but are not limited to):

Commercial confidences

14. This is a wider category than trade secrets. It includes information which might not have intrinsic commercial value but where disclosure might unreasonably disadvantage the person to whom it relates in the conduct of their business, commercial, financial or professional affairs. This category might include (non exhaustive list):

15. In determining whether the information should be considered commercially confidential two key factors will be considered:

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Information for which confidentiality may never be claimed

16. In relation to the grounds for confidentiality claims set out above (but not to claims in respect of IPR protection) the Contained Use Regulations set out certain information which may not be kept confidential. In no case can the name and address of the notifier be kept confidential. The name of the notifier will normally be the name of the organisation, such as a university or company. However, there may be instances where the notifier is an individual. In such cases the name and address - even though it is personal information - will not be kept confidential.

17. Also, in the case of notifications relating to activities involving GMMs, the following information shall not be kept confidential:

18. The activity and premises notification forms developed for use under the Contained Use Regulations specify the sections in which this information should be entered. There may be closely related information, eg specific characteristics of the GMM, which must be notified to the CA where it is required for scrutiny of the risk assessment, but which, in certain circumstances, could be claimed as confidential. Later sections of this document will set out how this distinction should be made and its implications for the way in which information is presented.

Confidentiality Claims Based on Intellectual Property Rights (IPR)

19. A distinction is made in regulation 22 of the Contained Use Regulations between claims for confidentiality based on IPR and claims on other grounds. Typically, a claim for protection of IPR would have to demonstrate that disclosure of information would compromise the notifier's scope to seek a related patent. Regulation 22(8) recognises that the disclosure of any item of notified information could, in certain circumstances, compromise intellectual property rights. In contrast to the other grounds for claiming confidentiality set out above, the items listed at paragraph 17 could be subject to a claim for confidentiality in respect of protection for IPR.

20. It must be emphasised that any claim for confidentiality based on IPR protection would have to be fully justified; the notifier would have to demonstrate a causal link between disclosure of the particular item of information and the compromise of IPR. Notifiers may wish to seek the opinion of a patent agent and this opinion could be part of the evidence submitted to support a claim.

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THRESHOLDS, JUSTIFICATION AND NOTIFICATION

21. The above sections set out the legal position in respect of the grounds upon which confidentiality claims may be made. However, they leave a great number of interpretative questions unanswered and give little indication of the type and level of information for which the CA would be likely to accept confidentiality claims and the sort of justification that would be needed. The other aspect which has only just been touched on so far is advice on how to structure notified information so that confidential information is clearly identifiable.

22. The following sections take you through the notification forms2 and discuss the likely acceptability of confidentiality claims for the various types of information to be notified.

Structure of the Notification Forms

23. The forms for notification of premises (CU1 2000) and of individual activities (CU2 2000) are provided as an aid to notifiers who may be wondering how to structure their notifications. They have been designed so that all information which may not be kept confidential (except in respect of IPR) is entered into the first part of the form, which also constitutes the public register entry.

24. The second part of the form is for personal information, which will be subject to the provisions of the Data Protection Act 1998, and information relevant to the first part of the form, but for which the notifier wishes to claim confidentiality. Information subject to confidentiality claims should be entered onto the form giving:

25. Notifiers must bear in mind that all relevant information must be submitted in the notification. The fact that certain information may be claimed to be kept confidential does not mean that it can be withheld from the CA, which will need it to evaluate the risk assessment.

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The risk assessment

26. In addition to the information required on the form, notifiers must also submit a copy of the risk assessment. It is possible that some of the information in the risk assessment is subject to a claim for confidentiality. As with the information required on the form, care must be taken to clearly identify any information for which confidentiality is claimed in the risk assessment and to provide clear justification for each claim made. Some examples of ways in which this can be achieved follow.

27. One final point. Remember not to include personal information, such as individual's names, in the risk assessment. It should usually not be necessary to do so as the CA will not normally need to know the names of the individual staff working on the projects. (The names of people responsible for safety etc will already have been entered onto the notification form.)

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NOTIFICATION FORMS AND CONFIDENTIALITY CLAIMS

28. The following tables follow the structure of the premises and activity notification forms respectively. For each section of the form there is an indication of both what is legally possible to claim as confidential and the permissible grounds for such claims. An indication of the likelihood of the CA accepting claims for different types of information, and on different grounds, is also given. The tables do not include mention of where disclosure might harm international relations or national defence. This is because these grounds are only likely to affect a small number of centres. However, where confidentiality can properly be claimed on this ground, such a claim is likely to be successful.

CU 1 2000 - PREMISES NOTIFICATION

Section Legally possible claims1 Claims that are likely to be accepted

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 The possible claims are for IPR protection or for one of the other grounds as set out in the Environmental Information Regulations (EIR) - see paragraph 10 for detail. Claims do not have to be made in respect of personal information - this will be automatically withheld from disclosure.

2 GMSC = Genetic Modification Safety Committee. All notifiers must set up a GMSC to advise them on risk assessments.


CU2 2000 - ACTIVITY NOTIFICATION

Section Legally possible claims1 Claims that are likely to be accepted

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.

1 The possible claims are for IPR protection or for one of the other grounds as set out in the Environmental Information Regulations (EIR) - see paragraph 12 for detail. Claims do not have to be made in respect of personal information - this will be automatically withheld from disclosure.

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ACTIVITIES INVOLVING GMMS AND ANIMALS (OR PLANTS)

29. The Contained Use Regulations allow confidentiality claims in respect of GM animals or plants to be made on the basis of any of the EIR grounds or for protection of IPR. The one exception to this is the organisation address which can only be claimed as confidential on the basis of IPR protection - see section 1 of the first table. The likelihood of the CA accepting the claim will vary depending on the nature of the information concerned. But the CA is likely to accept claims in relation to GM vertebrates on public security grounds where the precise animal facility address is involved. Similarly, claims in respect of characteristics of the GM animal may also be accepted on public security grounds if the details would necessarily reveal the location. (See the discussion in the tables for details.)

30. It is unlikely, at the present time, that claims in relation to public security would be accepted for GM plants.

31. As explained at paragraphs 16 - 18 there is certain information in relation to activities involving GMMs where the information cannot be claimed as confidential, except for protection of IPR. This includes the location of the activity involving GMMs.

32. Some activities with GMMs may also involve animals. Sometimes the animals will themselves be genetically modified. Sometimes not. Although the location address for GM vertebrate animals may be claimed as confidential on one or more of the grounds set out in EIR, including for reasons of public security (except if it is also the organisation address), the location of activities involving GMMs may not. This necessarily means that there will be cases where, because GMMs are involved, the location address for animal facilities may be disclosable. This could obviously be a source of concern to people. The following advice outlines approaches people can take to minimise difficulties.

Location

33. The first thing to consider is whether the location address would necessarily reveal precise details of the animal facility. As discussed at Section 2 of the table dealing with the premises notification form the location address must be given in a form that reflects the totality of the geographic location of facilities used for genetic modification activities. For relatively large premises, with several facilities within a defined geographic location (which might include a large building or set of buildings on a campus or particular street), this would not have the effect of identifying the precise location of the animal facility. However, there may be cases where the animal facility is geographically separate from other parts of the notified premises and the requirement to reveal the geographic location would necessarily reveal precisely where the animal facility is. This would be especially so if the animal facility is on a geographically distinct site and consists of a single building used solely for activities involving animals.

34. Where it is the case that the location address will identify precisely the animal facility there are still things that can be done to minimise risks to public security. The first is to ensure that the building / facility name does not automatically indicate that it is used solely for activities involving animals. Similarly, although details of the GMM, class of activity, containment measures and evaluation of foreseeable effects do have to be given, it should be possible to draft the information without explicit mention of the involvement of animals. For instance, notifiers could discuss the pathogenic potential for a GMM for animals without mentioning that the activity involves actually infecting animals. Similarly it would be possible to discuss waste management in terms of appropriate treatments for bulk, contaminated, solid waste, without mentioning that the waste is animal bedding. (Of course the CA will require this detail, but it will be possible to claim it as confidential on the grounds of public security.) For the requirement to state the containment measures it would be possible to state that, say, full containment level 2 will be used as set out in the schedule to the Regulations, without stating that the facility is an animal house.

35. Note that although this same approach could be taken for activities where the location address does not precisely indicate the animal facility, the justification for claiming confidentiality for other aspects would be much less strong and may not be accepted by the CA unless there are very unusual circumstances.

36. For GM animal facilities where the location address is the same as the organisation address, and so is disclosable, there is greater scope for confidentiality claims than for activities involving GMMs. (See the tables for details.) However, note that the fact that information is withheld may itself be revealing. The best advice in such situations is for users to try to avoid the location and the organisation address being the same where it could closely identify the location of a vertebrate animal facility.

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DUTY TO INFORM THE COMPETENT AUTHORITY IF THE CLAIM FOR CONFIDENTIALITY IS NO LONGER VALID

37. When a claim is accepted by the CA, confidential information will remain non-disclosable whilst the justification for the claim remains valid. However, as soon as a claim is no longer valid the notifier is obliged by regulation 22(9) of the Contained Use Regulations 2000 to inform the CA. This can be done in the form of a letter and does not attract a fee. Notifiers should make sure that they are careful to precisely identify the material which is no longer confidential, especially if the notification contains several claims, some of which will continue to be valid.

38. Claims will be no longer valid for various reasons. These may include:

39. One final point related to confidentiality claims and location addresses. A premises notification may have included a claim for a location address to be confidential on the grounds of public security because it was being used solely for work with GM vertebrates. The claim had been accepted by the CA. However, the notifier subsequently wishes to use the same location for work with GMMs, whether or not connected with the activities involving GM animals. The location address would therefore become disclosable in relation to activities involving GMMs. Where this is the case notifiers must inform the CA. This would be done as a significant change to an existing notification and would involve notifying the CA by letter of the change in confidentiality status of the location. No fee would be charged.

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APPEALS AGAINST COMPETENT AUTHORITY DECISIONS

40. The Contained Use Regulations allow notifiers to appeal against decisions made by the CA on confidentiality claims. Claims are made to the Secretary of State (in England and Wales) or jointly to the Secretary of State and Scottish Ministers (for Scotland). Whilst appeals are being heard and decided, by an independent person appointed by the Secretary of State (or jointly with the Scottish Ministers), the information claimed as confidential shall not be disclosed except to the extent necessary to evaluate the notification and to the European Commission. The European Commission or people receiving the information for reasons of evaluation - mainly advisory committee members - would be bound by confidentiality agreements.

GLOSSARY

CA
Competent Authority (for the Regulations)
Contained Use Regulations
Genetically Modified Organisms (Contained Use) Regulations 2000
EIR
Environmental Information Regulations
GM
Genetically Modified
GMM(s)
Genetically Modified Micro-Organism(s)
GMSC
Genetic Modification Safety Committee
HSE
Health and Safety Executive
IPR
Intellectual Property Rights

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Annex A

SOURCES OF INFORMATION

Public register

Health and Safety Executive
Health Directorate, B2
Rose Court
2 Southwark Bridge
London
SE1 9HS

Registers containing those entries relevant to the locality are held in main HSE offices. (Addresses may be found in the telephone book.)


Footnotes:
1 The Competent Authority for England and Wales is the Health and Safety Executive (HSE), the Secretary of State and the Minister for Agriculture, Fisheries and Food. For Scotland the Competent Authority is HSE and the Scottish Ministers.

2 People do not have to use the forms, but the guidance should read across to whatever approach is taken to supplying the information required in a notification.

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Updated 2014-11-18