Summary report

Responses to HSE’s targeted consultation on the revised guidance for the control and containment of specified animal pathogens

2 – 27 February 2015

Summary

  • HSE received seven written responses to the targeted consultation – two from Universities, four from Government facilities and one from a research institute
  • Verbal feedback was also received from four stakeholder events during February 2015 including regional biosafety officer (BSO) meetings of the Institute for Safety in Technology & Research (ISTR) and a meeting of the Advisory Committee for Dangerous Pathogens (ACDP)
  • Overall, the revised licence conditions and guidance have been positively received by those who responded to the consultation and at the stakeholder meetings
  • Stakeholders expressed some concern over the transition from the existing to the new licensing regime
  • One response sought greater clarity on the interaction between SAPO and the Genetically Modified Organisms (Contained Use) Regulations
  • The guidance has been amended to reflect responses to the consultation
  • A further review of the guidance is planned in 2016 after stakeholders have had direct experience of the new arrangements

Introduction

  1. In June 2014, agreement was reached across Government(HSE, Defra, Scottish and Welsh Ministers) to the proposal to revise the licensing, inspection and enforcement arrangements for activities involving specified animal pathogens. The revised arrangements involve non-legislative changes to deliver the main principles set out in the Callaghan Review (following the outbreak of foot & mouth disease in 2007) including:

a)transfer of licensing responsibilities to HSE;

b)devising goal setting and more risk based licence conditions;

c)providing a single contact point and on-line portal for contained use of specified animal pathogens, human pathogens and genetically modified microorganisms (GMM).

  1. The new arrangements are intended to come into force from 1 April 2015. The revised licence conditions and associated guidance form a pivotal part of these new arrangements and have been developed with assistance of a core stakeholder group consisting of individuals from organisations in academia, industry, Government and research institutes; and are geographically spread across England, Scotland and Wales. Wider feedback on the guidance was sought via a targeted consultation involving all current SAPO licence holders and wider biological agents’ community.
  1. The targeted consultation took place from 2 February 2015for four weeks.Stakeholders were asked to provide feedback on the guidance and the related Business Engagement Assessment (BEA), which estimates the impact of the proposed changes on licence holders. The consultation closed on 27 February 2015. In order to bring the consultation to the attention of relevant stakeholders, the revised SAPO licence conditions, guidance and BEA werepublicised by:

a)direct email to all SAPO licence holders(68) alerting them to the consultation and enclosing the guidance and BEA;

b)posting the guidance and BEA on the HSE Microbiological Hazards Web Community (104 members); and

c)including an item in the January edition of HSE’s Biological Agents eBulletin (~ 18000 subscribers).

  1. HSE also attendedseveralstakeholder meetings to explain the proposed changes to the SAPO arrangements and to obtain feedback from participants. These meetings were:

a)the ISTRNorthern Region BSOmeeting(for the North of England and Scotland; ~20 BSO attendees);

b)the ISTR Midlands Region BSO meeting(for Midlands, South West & Wales ~12 attendees);

c)the meeting of the Advisory Committee on Dangerous Pathogens (ACDP); scientific experts); and

d)astakeholder presentation at a Government research facility (~20 attendees including scientists and safety officers).

  1. Further stakeholder events are planned in March, including the ISTR Southern Region BSO meeting on 20 March, and the Scientific Advisory Committee on Genetic Modification (Contained Use) meeting on 24 March.
  1. This targeted consultation did not require responses to specific questions (as seen in other public consultations) but requested a more holistic response by canvassing views or opinions on any aspect of the revised guidance and the BEA.HSE received seven email responses to the targeted consultation, all of which were from SAPO licence holders (two from Universities; four from Government laboratories and one research institute).
  1. These responses along with the feedback received at the stakeholder meetingshave been summarised and captured in this report.

Summary of Responses

a) Feedback on the revised approach to the regulation of specified animal pathogens

  1. Most of the responses (either written or verbal) were supportive of the revised arrangements for the regulation of specified animal pathogens. Respondents described the changes as:

a)sensible and pragmatic;

b)more closelyaligned with the risk-based approach in the Genetically Modified Organisms (Contained Use) 2014 Regulations(GMO(CU) and the Control of Substances Hazardous to Health 2002 Regulations (COSHH);

c)improved clarity and synergy between SAPO and the other containment regimes;

d)proportionate control and containment approach for the differentSAPO containment levels; and

e)containment tables are helpful.

  1. None of the responses raised concerns in relation to the revised arrangements.

b) Feedback on the revised guidance

  1. Respondents were supportive of the revised guidance, the approach in which ismore aligned with that forGMO(CU), COSHH and the Management of Health & Safety at Work Regulations. The guidance provides a better understanding of the requirements for the dutyholder.
  1. Some respondents felt the guidance was overly detailed in certain sections. A number of specific amendmentswere requested (ie typographical errors, points of clarification), which will be addressed in the final version of the guidance.

i) Transfer licences for moving a specified animal pathogen to a different site within the UK

  1. Dutyholders have welcomed the removal of the requirement to obtain a licence to transfer a specified animal pathogen between sites or organisations. They said this will improve collaborative working between research sites and significantly reduce the time and paperwork required to obtain a transfer licence.
  1. One respondent (from stakeholder meeting) requested for the guidance to clarifyto what extent confirmation of a SAPO licence is required before transferring material between sites (egthe type ofdocumentation).
  1. A further respondent (from presentation to Government lab) asked about transfer of SAPO agents after the 1 April but before a new licence has been issued. It is important to note that the change to transfer licences will only take effect after the licence holder has moved to a new SAPO licence. For those with existing licences, transfer licence will still be required before SAPO agents can be transferred between licence holders.After 1 April, these requests should be directed to HSE.

ii) The categorised list of specified animal pathogens

  1. Several respondents made points in relation to the categorised list of specified animal pathogens. These comments included:

a)Where the animal pathogen is zoonotic, theACDP hazard group classificationshould be provided;

b)Who has responsibility for updating the categorised list of specified animal pathogens; and

c)Could attenuated strains be added to the list?

  1. The categorised list of specified animal pathogens will be amended toindicate where an animal pathogen is also classified under COSHH (ACDP classification). Licence holders will have to refer to the Approved list of biological agents for the current ACDP classification. This mirrors the approach taken in the Approved list of biological agents.
  1. Although the licensing, inspection and enforcement responsibilities of SAPO transfer to HSE on 1 April 2015, Defraand the Devolved Governments will retain the policy lead for SAPO and responsibility for the list of specified animal pathogens. There is no intention to review the current classification in the short term. If a new and emerging pathogen required categorisation, Defra would seek advice from ACDP.
  1. While ACDP hasthe appropriate expertise within the Committee, there is scope to appoint appropriate veterinary advice on an ad hoc basis or to form a sub-group where more detailed analysis is required.

iii) Transitional arrangements for transferring from the existing SAPO regime to the new SAPO regime

  1. Respondents asked for further information regarding the transitional arrangements for transferring from the existing SAPO regime to the new regime. Some concern was expressed in relation to the timescale for moving to the new licence.
  1. HSE will circulate further information to SAPO licence holders on the transitional arrangement (in the form of a question and answerbriefing) and publish the information on the HSE website. In addition, HSE will write to licence holders to confirm details of the new licence and agree a date by which the licence holder will be compliant with the conditions of their new licence. This will be tailored to individual sites based on the complexity and quantity of SAPO activities.

iv) Application for a new SAPO licence or amendment to an existing licence

  1. Respondents asked about the new online application process for SAPO licences. Several respondents highlighted the limitations of existingHSE online forms and the requirement to complete an application in one sitting.
  1. HSE website hosts online forms for notifying statutory requirements. For SAPO, the HSE website will host a single online portal through which, users can meet their notification requirements forall containment regimes (COSHH, GMO(CU) & SAPO). This will be a combined online form but with separate elements for each of the different containment regimes.
  1. Although a combined form,separate parts will need to be completed for each regime that applies. For example, for the first notification ofgenetic modification of a specified animal pathogen, both the SAPO and GMO parts of the form would need to be submitted. This is because the different regimes have separate requirements(egfees payable for GMO but not SAPO).
  1. In addition to the online forms,HSE also provides word versions of these forms. For those who are unable to complete the online formsin one sitting, due to the complexity of the notification or application, the word version can be downloaded and submitted to HSE via email or post. This will be the same for the application form for a SAPO licence.
  1. The application form will have guidance associated with it, to explain what is required in each section of the form. An accident or dangerous occurrence notification form will also be available.

v) Overlap between SAPO and GMO(CU)

  1. Several respondents raised questions over how genetically modified versions of the specified animal pathogens will be incorporated into SAPO licences. This extended to questions about disabled/attenuated versions and disabled vectors.
  1. The definition of a specified animal pathogen is set out in SAPO and includes intact pathogens, attenuated/genetically modified versions and nucleic acid, which when introduced into a biological system is capable of producing the pathogen. This definition has not been changed and therefore the same approach as currently applied will continue. This means disabled strains or vectors are not encompassed by SAPO unless they produce the pathogen.However, attenuated strains would be covered. Separate SAPO licences are not required for non-modified and genetically modified versions of the same specified animal pathogen.

Conclusions

  1. HSE has completed a targeted consultation on the revised guidance to the licence conditions required for SAPO licences. Given the involvement of the core stakeholder group in preparing these documents, coupled with the wider stakeholder meetings, HSE is content that sufficient stakeholder input has been obtained to ensure the revised arrangements are practical and proportionate.
  1. The responses to the targeted consultation both written and verbal are supportive of the revised arrangements and supporting guidance. HSE will make the necessary changes or provide clarification where highlighted by respondents. In addition, the intention is to review the guidance in September 2016, once all licence holders have experience of using the guidance.
  1. HSE is grateful to all licence holders who read the guidance and those who have provided responses either verbally or in writing. HSE is particularly grateful to the members of the core stakeholder group, who have provided their time and expertise on a voluntary basis. This has been very much appreciated.

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