Health and Safety Executive Board / HSE/ YY /
Meeting Date: / 24 April 2013 / FOI Status: / Open
Type of Paper: / Above the Line / Exemptions: / N/A
TRIM Reference: / 2013/105025
Keywords: / Genetically Modified Organisms, Callaghan review; Animal Pathogens

An update on HSE's work to consolidate legislation on human pathogens, animal pathogens and genetically modified organisms following the Callaghan and Löfstedt Reviews

Board1 (01.10)

Page 1 of 11

Purpose of the paper

  1. To ask the Board to provide a steer on:

(a)  Our revised plan to provide a single regulatory framework for human pathogens, animal pathogens and genetically modified organisms (GMOs), of which (b) is one of three strands of work; and

(b)  An initial proposal for the consolidation of the Genetically Modified Organisms (Contained Use) Regulations to deliver the Löfstedt review recommendation by the end of 2014.

Background

  1. The Löfstedt review included GMO as one of the five ‘sector’ consolidations, which the government has committed to completing by the end of 2014. The relevant legislation is the Genetically Modified Organisms (Contained Use) Regulations 2000 and its three amending Regulations made in 2002, 2005 and 2009 - consolidating 4 into 1. In summary, the Regulations provide for a high level of protection of human health and for the environment by limiting contact between GMOs and humans and/or the environment, using physical, chemical or biological barriers (containment measures). The choice of appropriate containment measures is in proportion to the risk. These Regulations are not concerned with the supply of food, medicines or other products containing GMOs or of the deliberate release of GMOs (eg GM crops).
  2. The GMO contained use ‘sector’, also referred to as the biotechnology sector, is not a discrete sector as such. It is a technology that cuts across academic and commercial research, health, chemicals and agriculture. GMO contained use work is predominantly carried out in laboratories, plus some larger scale research and development and production facilities (mostly pharmaceutical). Analysis done by the Department for Business, Innovation and Skills has identified that the biotechnology sector is one in which the UK already excels and has significant growth potential, including in areas such as synthetic biology; (multi-discipline work that seeks to apply engineering design principles to biological ‘building blocks’). Research Councils are targeting investment in synthetic biology; for example in November 2012 the Biological and Bioscience Research Council announced £20million of investment in six research projects[1].
  3. The BIS stakeholder consultation looking at the potential for this sector to grow, found a consensus among the scientific institutions that the current contained use regulations are broadly adequate[2]. However, Professor Lofstedt considered that the GMO Contained Use Regulations should be consolidated to produce a single set of up-to-date, straightforward Regulations . Annex A provides more detail on the sector and HSE Biological Agents Unit’s intervention plan.
  4. Those who work with GMOs involving human or animal pathogens are also required to comply with two other sets of regulations covering containment requirements :

  a) the Control of Substances Hazardous to Health Regulations 2002, relating to work related risks from human pathogens (biological agents) and/or

  b) the relevant Specified Animal Pathogens Order (SAPO) (In Scotland, England or Wales) relating to risks to animal health from certain listed animal pathogens.

  In 2007, an outbreak of Foot and Mouth Disease (FMD) was linked to biosafety failures associated with the use of live FMD virus at a contained use site at Pirbright, Surrey. A subsequent review by Sir Callaghan brought together the findings from several previous reports and extensive consultation with those working in the sector and concluded that the then regulatory system for work with animal pathogens was inadequate. He found there was confusion caused by the different approaches to containment under the three sets of legislation covering GMOs, human pathogens and animal pathogens. Consequently, his report recommended that Defra work with HSE, Department of Health and others to bring the legislation within a single regulatory framework.

  1. With Defra and the devolved governments, HSE tried to establish a single regulatory framework (SRF) using a Legislative Reform Order (LRO) with a single set of health and safety Regulations (last before the Board in January 2011). However, we were unable to complete this work due to legal difficulties that, at the final stage, proved insurmountable. We could not make the necessary changes to primary legislation using alternative routes in any reasonable timescale (see Annex B).
  2. However, operationally, HSE, Defra and the devolved administrations have taken significant steps to improve the regulation of contained work with animal pathogens. For example, HSE now inspects and and enforces SAPO on behalf of Defra and the devolved governments.

Argument

  1. Our proposed approach is to simplify and streamline in the short term, whilst exploring longer-term possibilities, including changes to European legislation, to introduce a version of the single regulatory framework. There are three strands to this work, of which the GMO consolidation is one:

a) GMO consolidation

  1. The Government response to Löfstedt has committed us to consolidating the four sets of GMO (Contained Use) Regulations into one, by 2014. The aim is to ensure that we have a single set of up-to-date, straightforward regulations. This is essentially a small-scale, legal and technical tidy up. We are clear that the consolidation must not remove any necessary safety protections. As the Regulations currently closely follow the 2009/41/EC Contained Use of Genetically Modified Micro-organisms Directive, we do not expect to make significant changes. However, the need to consolidate provides an opportunity for us to remove any unnecessary burdens from those carrying out work in this area; while recognising these are not likely to represent large savings. Our next step will be to work up details of the proposed changes (see Annex C).
  2. We will carry out the early informal consultation in stages. We will be looking for views from those who work in the sector on the practical implications of the proposals. In particular, we need to identify if the consequence of any proposed changes would be to lower the protection provided to human health or the environment. We also need to understand the costs that might be saved by the proposed changes or any unintended additional costs that we might introduce. We will use the opportunity of existing stakeholder meetings and groups to discuss the initial proposals for change. We will also be setting up an online community to allow stakeholders to discuss specific proposals. We are aiming for a formal consultation on final proposals during September to December 2013.
  3. The timetable for the consolidation is at Annex D. We are aiming to have new consolidated GMO (Contained Use) Regulations coming into force on the common commencement date of October 2014.

b) Negotiating to streamline European legislation

  1. In the meantime, the Commission is proposing to:

(a)  Review the 2000/54/EC Biological Agents at Work Directive as part of its review of all the health and safety ‘daughter’ directives in 2013-15 (with possible consequential amendments to COSHH); and

(b)  Include in a proposal for consolidating EU Animal Health law, a new Article requiring that animal pathogens are not released from laboratory research and similar facilities (with possible consequential changes to SAPO). The existing EU legislation relates only to Foot and Mouth disease virus. This proposal is at the early stages of European legislative development, unlikely to be finalised before 2015.

  1. Therefore, we have an opportunity, over the next couple of years, to argue that the relevant European source legislation should be better aligned. If we are successful, this will allow us, in due course, to bring the implementing legislation in the UK closer to the single regulatory framework we want to achieve.

c) Review of arrangements for licensing under the Specified Animal Pathogens Orders

  1. HSE inspects and takes enforcement action at sites holding a SAPO license. While Defra and HSE feel that the arrangements in place since 2008 are ensuring that work with the highest risk pathogens is effectively controlled, there is room for improving the system for both the licence holders and the regulators. We considered whether we could leave the arrangements as they are until any changes required by the EU animal health law need to be implemented. However, as changes in Europe could take at least five years, and the potential improvements can be made relatively quickly; we feel that making the changes now is justified.
  2. We have therefore begun scoping the options for a significant overhaul of our operational arrangements to deliver an improved SAPO licensing scheme. For example, one option would be to transfer the licensing function to HSE under an agency agreement. The review will include consideration of:

(a)  Streamlining licensing processes

(b)  Better reflecting risk assessment and management principles – ensuring controls required are proportionate to the real risks

(c)  Alignment where possible with other containment regimes

(d)  Revised guidance for duty holders

(e)  Clarification of how the enforcement approach for SAPO sits within HSE’s existing Enforcement policy and associated procedures (if required)

(f)  HSE inspector resources and training – including whether we have the right balance of appropriate specialist expertise (including access to Defra veterinary experts).

Application of fee for intervention

  1. In addition to the work on the core legislation, we will look again at the current exemption applied to fee for intervention (FFI) to contained use work with human pathogens and contained use of GMOs where there is a human health risk (which we estimate is 90% of BAU’s current work). This exemption was applied on the basis that we had expected to move to a full single regulatory framework in a short timescale and that it would be appropriate to introduce charging at the same time. We will now look to remove this exemption should an appropriate opportunity arise.
  2. HSE currently charges a flat fee for notifications under the GMO Regulations, for which we receive around £130k per year. In light of HSE’s wider approach to cost recovery for permissioning work, we will review the arrangements for charging a fee for such notifications.
  3. HSE will continue to charge Defra and the devolved administrations for HSE time on the inspection and enforcement of SAPO (approx £130k) and from other work for Defra (around £30k). We will need to establish procedures to ensure that inspectors can appropriately allocate their time when they deal with material breaches of legislation subject to FFI and those that are not.

Summary

  1. For the next few years we have three parallel and overlapping work streams that will ultimately contribute to a revised single regulatory framework:

(a)  HSE consolidation of GMO (Contained Use) Regulations 2000 with its three amending sets of legislation (4 to 1) to meet the Löfstedt commitment by the end of 2014. This is essentially a legal/technical tidy up, but there is also an opportunity to simplify some areas of the Regulations (see paragraph 9-11).

(b)  HSE negotiating in Europe (as part of the EU review of Biological Agents Directive); and supporting Defra’s negotiation in Europe (on the EU animal health law proposal) to achieve better alignment of the relevant legislation at European level. Followed by a fresh look at how best to transpose the relevant Directives, subject to the EU timetable (see paragraph 12 and 13).

(c)  HSE working with Defra and the devolved governments to overhaul our operational arrangements to deliver the SAPO licensing scheme. We are aiming to have firm proposals by January 2014 (see paragraph 14 and 15).

Action

  1. The Board is asked to:

(a)  Note and provide comment on the ongoing work to improve the regulatory framework for work with human pathogens, animal pathogens and GMOs in contained use facilities; and

(b)  approve the scope, direction and timetable for the proposal to consolidate the Genetically Modified Organisms (Contained Use) Regulations 2000 with its three amending Regulations by October 2014.

Paper clearance

Peter Brown, Head of Major Hazard Policy Unit, HID and at the SMT meeting of 3 April 2013.

Contact

Anna Bliss, Biological Agents Policy, Major Hazards Policy, HID, Bootle.
Tel: 0151 951 3581
Annex A – The biotechnology sector and HID’s intervention strategy

The sector

1.  The GMO ‘sector’ actually cuts across other sectors: research (higher education, government, medical), healthcare (clinical diagnostic microbiology), chemicals (pharmaceutical, biotechnology) and agriculture (veterinary, plants). The basic genetic modification techniques and technology are now well-established tools for the various scientific disciplines working in this ‘biotechnology sector’. However, not all duty holders in biotechnology will carry out activities using GMOs that fall within scope of the Genetically Modified Organisms (Contained Use) Regulations 2000 (the GMO Regulations).

2.  The UK's medical/veterinary biotechnology sector continues to grow in response to the threat from new and emerging infectious diseases but also in response to new technologies that have enabled the development of advanced therapies/treatments for previously untreatable diseases (e.g. in gene therapy the UK is second globally only to the US). Other applications of GMOs being developed include their use of biosensors (eg to detect environmental contamination) or to more efficiently convert biomass to fuel. In 2011, we estimated that the sector encompasses approximately 790 duty holders in the UK employing in the region of 65,000 staff. A number of key stakeholders are taking forward significant new build projects, funded largely by public money (eg Pirbright Institute and Medical Research Council).

3.  Contained use work is categorised in the following ways:

Legislation / Categorisation / Criteria / Examples /
COSHH / Hazard Groups 1 to 4 where 4 is highest hazard / The severity of the disease, how it might spread and whether a vaccine or treatment is available.
HG1 is where there is no disease or unlikely to be any disease, so examples are not listed. / HG 2: Influenza and Herpes viruses
HG3: HIV Hepatitis B virus, and the causative agent of Tuberculosis
HG4: Ebola and Lassa Fever viruses (which cause fatal hemorrhagic diseases)
SAPO / Hazard Groups 1 to 4 where 4 is highest hazard,
Rabies, foot and mouth disease and arthropods (insects that carry pathogens) have additional specific requirements / The categorisation is primarily the ability of the pathogen to spread in a relevant host species,
Whether or not an animal pathogen is specified at all is decided by factors such as:
- whether the UK needs to maintain a disease-free status in an exotic disease,
- the severity of the disease,
- the ability of an animal host species to act as a reservoir for a human disease, and/or
- impact on the economic viability of the host species. / HG 4:
- Foot and Mouth Disease (HG1 for COSHH)
- Hanta and Nipah viruses which are carried by rodents and bats respectively and cause fatal hemorrhagic diseases (HG4 for COSHH also).
GMO / Containment level 1 is no or negligible risk and Containment Level 4 is the highest risk / Categorised by an individual risk assessment that takes into account any hazardous properties of the parent and donor organisms and, if relevant, the vector. Is based on the containment measures required for the work being done. / The vast majority (over 90%) of GMO work is carried out at Containment Level 1 and 2, often using well-established ‘laboratory’ organisms, such as Escherichia Coli K12 that has been modified so that it does not thrive in the intestine and therefore is very unlikely to cause disease.
CL4 GMO work will usually involve work on a COSHH or SAPO HG4 organism, for example seeking to identify or produce a vaccine for that agent.

4.  While the containment measures required for work at any given level are now broadly similar, there were significant differences for SAPO 4 and COSHH/GMO 4 at the time of the Callaghan review.