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CF34 1 94 Sug B es We iF aee e eaS S riae ’ ES moe ay : ul ia Ras, WA LC ET RERMON | DEPARTMENT OF THE ENVIRONMENT GOVERNMENT RESPONSE TO THE A) SEVENTH REPORT OF THE HOUSE OF LORDS SELECT COMMITTEE ON SCIENCE AND TECHNOLOGY, 1992-93 SESSION Regulation of the United Kingdom Biotechnology Industry 9 and Global Competitiveness Presented to Parliament by the Parliamentary Under Secretary of State for the Environment by Command of Her Majesty March 1994 LONDON : HMSO Cm 2528 £3.55 net hoe © saat pee1b Acs ES RR RAL ay LBIoBdR ARO YN L |General CCoolllleeccttiioonnss} 22502717824 Government Response to the House of Lords Select Committee on Science and Technology Report on Regulation of the United Kingdom Biotechnology Industry and Global Competitiveness Introduction 1. The Government welcomes this timely and detailed report from the Select Committee on how regulation of biotechnology affects the competitiveness of United Kingdom industry. The section of the enquiry dealing with the difficult issue of public understanding and acceptance of this fast moving technology is also welcomed. 2. The Government believes that modern biotechnology has far-reaching implications for the UK economy and will have a major impact on products and processes across a wide range of sectors. It is a key enabling technology which has the potential to enhance significantly the competitiveness of many sectors of British industry. The Government recognises the need to get both an appropriate regulatory framework and the right climate for investment to enable UK industry to remain competitive. Sensible regulation is crucial and, in line with Government policy, should be founded on the best scientific evidence available and be proportionate to any risk involved. Part I 3. The Government considers that the regulatory system now existing in the UK leaves industry well placed to compete in global markets but recognises that industry has not always shared this perception. However, rapid evolution has taken place in biotechnology regulation in the UK and elsewhere over the past few years, resulting in the introduction of fast track procedures for clearance of some deliberate releases of genetically modified organisms (GMOs) and simplification of notification procedures governing the contained use of GMOs. 4. Such evolution in regulation was foreseen as long ago as 1989 by the Royal Commission on Environmental Pollution (RCEP) in their thirteenth report, “The Release of Genetically Engineered Organisms to the Environment”, and was provided for in the tiered controls introduced in Part VI of the Environmental Protection Act 1990 (EPA). It has been and will remain an important aspect of Government policy. 5. Similarly, the evolution from process- to product-based regulation of GMOs, which the Committee supports, was foreseen during the drafting of the two relevant EC directives. The Government has been at the forefront of discussions in Brussels to ensure that GMO products are regulated together with equivalent products derived by conventional means. The safety criteria applied to these products should not be affected by the way they are subjected to regulation. The Government will continue to press in the European Community for the evolution from GMO regulation to a product-based approach where this is practicable. 6. The recent measures to reduce burdens on industry without compromising protection of human health and safety and the environment have only been possible as a result of the rapidly expanding body of objective scientific evidence pointing to the safety of many types of GMO operations. This could only come through experience with the technology. The Select Committee enquiry coincided with this period of transition not only of the regulatory regime but also while the relevant UK industry was becoming familiar with the new arrangements. 7. The Government agrees with the Committee that public acceptance is of pivotal importance in the marketplace. It is, of course, by no means certain that biotechnology products will ultimately gain public acceptance simply because they are desirable and reliable, they will also need to be perceived to be safe and to be successfully marketed. ' Cm 720, HMSO 243740 A2 po > b bee ceaell ro \ysdurrme” ner art “en rane ‘Yanlondsete im 105 yal> b e at Agen aD| i Ha a mo)" novgobousl a,\ ) vol i os recs Dadi adeb bans inc aaelt:W eg att ME Lene 2... 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HON) lo se binhAtace att geiurwag sr 25 AD loved wait vd WR! ge oan aoul pa quires) aw nmelitean ai voltiiors doe” a |,,a o TET aT Frogger dipmerictt sift «1 (SFR) ental] Iapenineivall Gi edna jens.’ id eew fae ,Sewnnvuvns on) oF eominegsO’ bayeonignt YllmoFt ua Woumed | lstecharmy dead off Io PY pal ot beowhound) gigntnan betas oat) at Oh bobivwig \p Inoges Tendsoqut ne paler fiw bee cead na 5} (ATA) ORT DA aonostent spileg Inumanav0D aM 90 iebinativadie tierdl-souhang o! eon mort mnigedhoe ette lu? i, | nesvolen aw) ori: lo gnifsiboal gat wud aveeegw nahyoqtqu e solianan Y diesen8 i)a o suse to tnorlev? ad) Le mang earl samimevoD od F, onsen . smabery tatevivgs dw yadieae) besiege se emubond OMOD md fiiivweo utlehso cmhraevnOgD seaedfs T OF oboaitlsllyuygae n sois nbe xytteoiledzuoned eT e rengee=n er Ssep oe ac ig | OM) meni goltsiove oct rot einitmigD ceoqowd 2700 9 datdaoisoimg vel oe dasa boned yoivineneade iiodtw vtobal aoa habadd sokcben oF es) sa| Udinroy ed ylaoss vn Jencsetvonivensont) basy thwlee bie dttaad o ina ee nat shames sae nd gail ane omvineg bi vas entlT enqua: f ‘Nsw ss a (rhs sodden wendy: tant on iF IT vee ae bat wes 8. To address the need for regulatory scrutiny and public reassurance, the UK regulatory bodies, guided by the Advisory Committee on Genetic Modification (ACGM) and the Advisory Committee on Releases to the Environment (ACRE), have aimed at designing and maintaining legislative controls that balance the need for safety and public reassurance with the minimum of restraint on industry and researchers. Evolution of controls in a rapidly developing area of technology is an inevitable and desirable consequence of increasing knowledge and the advisory committees continue to provide Government with up to date advice on such matters. Drawing on such advice, the Government will continue to review the regulation of GMOs to ensure that not only are human health and safety and the environment fully protected but also that this is achieved with the minimum burden on industry and the research communities. The Select Committee inquiry too has been a valuable stimulus and contribution to this process. 9. Because the need for a flexible approach to regulation in this field was anticipated from the outset, the Government is able not only to endorse but also to implement the great majority of the recommendations in the report. The following detailed response follows the order of the Recommendations (Section 7) of the Select Committee’s Report. PART II Specific Recommendations The recommendations in italics refer to Chapter 7 of the Select Committee’s Seventh report in the 1992-93 session and are referred to by number. Where necessary, the recommendations have been grouped to make clearer the Government response. General 7.1 The benefits of biotechnology are already well proven; biotechnology and products of biotechnology are with us to stay; and these products are likely to yield enormous future benefits to mankind. 7.2 Biotechnology is a growth area and United Kingdom scientists and industry are good at it. 10. Agreed. Beyond the many benefits of biotechnology which are already well proven, the “new” biotechnology of genetic modification promises yet more benefits that make that aspect of the technology well worth pursuing: for example, in innovative health care, in new approaches to developing agriculture and in improved environmental management and sustainable use of natural resources. 11. In recognition of this potential, the Government announced in the May 1993 White Paper, “Realising Our Potential; A Strategy for Science, Engineering and Technology™’, its intention to create a new Biotechnology and Biological Sciences Research Council (BBSRC), which will come into being on 1 April 1994. The new Council will shortly receive its Royal Charter, which gives it a clear mission statement, placing special emphasis on meeting the needs of users of its research and training output. The creation of the new Council will serve to strengthen the already strong biotechnology science base which exists in the UK. The Government’s intention not only is to ensure that United Kingdom scientists and industry remain “good” at biotechnology, but to create a favourable climate for them to get even better at it. 7.3 Inall areas where biotechnology has applications people should be able to exploit its economic benefits subject only to such regulation as may be necessary to meet identifiable disbenefits, especially to preserve safety. 12. The Government is committed to creating the best climate for industry to develop the outputs of research, including that from the BBSRC. The Government agrees that the economic benefits of applications of biotechnology should be ' Cm 2250, HMSO exploitable where these meet appropriate safeguards. Potential disbenefits which need to be considered include those to human health and safety and the environment. Environmental impacts are not easily rectified after the event and environmental risks need to be evaluated in the context of potential benefits. 13. The present system of regulation also plays an important part in underpinning public confidence that biotechnology is controlled adequately. This need for public reassurance was clearly identified by the Royal Commission on Environmental Pollution (RCEP): in their thirteenth report, “The Release of Genetically Engineered Organisms to the Environment”. In line with the recommendations in this report however, regulation is, and must continue to be, based on objective criteria and scientific assessment of any risk involved. The market place should be left to decide the commercial success of individual applications. 7.4 Early fears about GMOs in contained use turned out to be unfounded. As a general principle, except where pathogens are involved, existing laboratory (GMP) and industrial (GILSP) practice provide sufficient safeguards under the purview of institutional biosafety committees. Except where pathogens are involved separate regulation of GMOs in contained use is unnecessary. 14. Based on the most up to date scientific advice of the relevant advisory committees, the Government agrees with the Select Committee that the risks associated with the use of GMOs in contained use, particularly to human health, are now seen to be much smaller than may once have been anticipated. 15. There are two main reasons for this: the events that would have to take place at molecular level for a modified organism to acquire unintended novel harmful properties have been shown to be unlikely; and where GMOs are known to be hazardous there is growing confidence that these are controllable in contained facilities, and, indeed, that organisms can be selected so that they are unable to survive except in the special environment of the experiment or process. 16. Less is known about the risks to the environment than about risks to human health, partly because of the complexity of the environment and partly because there is less experience. Environmental protection is an important consideration in evaluating the safety of GMOs in contained use because of the possibility of escape. Nevertheless, as for human health, as more has become known about GMOs, many of the risks posed to the environment have come to be seen to be smaller than first thought and it now appears clear that much of the work with GMOs in containment poses little or no risk to the environment. 17. Consequently, the Government agrees with the Select Committee that good laboratory or industrial practice provides sufficient physical safeguards for the contained use of GMOs which are not pathogenic (ie are not harmful to humans or the environment). In fact as regards physical safeguards the regulations do not require more than that. What separate regulation there is for non-pathogens is chiefly concerned with the advance notification of industrial processes. In line with the Select Committee’s recommendation the case for relaxation of this is already being pursued by the UK Government in the Committee of Competent Authorities set up under EC Council directive 90/219/EEC'. 7.5 _ With a few exceptions involving bacterial or virus vectors, live vaccines, or modification of the genome of animals (which should continue to be monitored by ACRE), deliberate release of GMOs is not inherently dangerous. 18. The Government broadly agrees. Experience with GMOs in the United Kingdom and elsewhere has proved that, in many cases, the deliberate release of GMOs is not inherently dangerous and this view is reflected in recent moves to reduce the regulatory burden on certain types of GMO release. Such moves were anticipated by the RCEP in their thirteenth report and in subsequent Government policy statements. 19. Following advice from the Advisory Committee on Releases to the Environment (ACRE), the Government agreed in October 1993 a new scheme for ! EC Council Directive 90/219/EEC on the Contained Use of Genetically Modified Microorganisms 243740 B* Rahn e WF tiie te “iy Bray 6FB waan dga re 7 we ah e), } aan) een GEN -s in WL RAALME er“ i?! 7 7 ‘ iy ti bola dh ou-tP iet oinnasies » Aaa Ly a : Ni10 A pe AN acorn Web eat io blh)a l ae Sei thye T ey ee beitinrobl ==one 0 se . ny bergon ’ : : i ret voshaun $07 ‘howf oveento keyy h on a7 0 webu 7 ae a eV | ; shemcwbnga 0 UA balitivitja 96)O t aanU anirni state abatnns:w lC OD “ontmt i Regrettor aiiienep eco needs oy liga tae code wlan alates veloheei peirt o n heer ; j sreveava sia thg es honing oe iho ccniieiet Sole elle \roeivbs mevelon ast %o salve oflitasioa seh oF qu teonr ad? mp Bonet et te fi waast it teed soplinminy ‘alee ord iw esnge joernemvot ot zai | , A Miltod cape of yliilusirw peu baniniggousi COMO Yo sey 2 om Aoteycaitie pasd snd cond Yom onal valfeese down od Of io south soled eced bho fork) tyes lt ails rol spouse ninet ow ou snd sa Oe rig mp nae phere epee perl ipeirythe me ) Many eee oo} gyond ous COMD omdw ban -yiadilay sd of nwonadse)e eva dt! 0b3a nsiinosois oants sYlodra?l tobatri!a)e on e obea tsoxoodl)n eot ood mdi ses oancotbetiilaaaoyst o gJneitwte t.yb ooab eis ihaa e: ssitilion’ : ; sso 20 Ieerulrequy eli to tnowtamivns teooqa oe stiS ess aire ua neu OF ein Wwods mers taomncrivncsul t oba dele ort tudbe edi voy Baet - ie nueod YiTtEG bre teomacuves set to yabestpenes oct to spond Of aotmehiReds lennqeni pn 2 eOateny wennmpriee oqn eo Yo yiiliviexoe: cdiY o sania aesh eotasmeatgeOabe 2 7 d vast 2OMD toda mond pr atp asha gh he 2 ee 1{ 7 Jeu) GA ealbionioyned1 t) pn meyers veer a phoniay te ee ae 7 aN Foeccenias ace of 8 MER) yLikwe bere nett“ ted oen tale 718 wont2 : . at dosaporvsafDt o F Fei on x . boda tedd sagen tgs ont driv 16f romnseriavOD oi} ‘ od} 10) abides loteyly Jastoifue | sutloery, bei arenncertt or ficeror! tos sueo F)a limegontiieSeoyu ni OND Yo 2 Jon Ob wneiinleegsr ost ebrati yale leoieglg “i compudieg-tton 19) oi ope) Ootieigget olnragae thw peril et) ecensocney Ladetuirheri 1 aaelibeaninaetans Hb side pec #1t i. Yo ee ! Mocks MuaeqereDt os ettiramea.d i ab jose . Cs) iWyvgot nuts i9d ost w nkimose hagaa, Anlbi n) adrsonieaws wa tteewe i ooa a Sata es) sai nat hosint! aghheti> sahn e Seer 7a di ng ha: sab if 1 ah FeenAtta ebvuodce naedryiteoF® )U RMR d ,E S “fast-track” procedures for low-hazard and low-risk GMO crop plants. The first tranche of releases qualifying for this scheme were announced in January this year. ACRE has a statutory duty to advise on all releases, but the Government is keen to ensure that ACRE is able to focus its attention on unfamiliar or higher risk releases. The low risk releases of GMOs dealt with under fast track procedures are those for which ACRE has already given generic advice. ACRE, together with the Department of the Environment, will regularly monitor the GMO releases included in the fast track. In this way, additional release categories may be incorporated into the scheme, or if necessary removed from it, in the light of developing experience. 7.6 In framing the Directives on which the United Kingdom regulations are based the European Commission took an excessively precautionary line which, in terms of scientific knowledge, was already out of date when they were being prepared in the late 1980s. Advice to that effect appears to have been ignored. 20. Biotechnology is a fast-moving technology and it is therefore appropriate that legislative and administrative controls regulating the use of GMOs are in a state of continuing evolution. As scientific experience accumulates, regulations will be reviewed and tightened or loosened as is appropriate to risk. It is therefore no surprise that the Select Committee views some of the detailed provisions of the two EC directives governing the use of GMOs now to be dated and the Government agrees with this view. However, notable progress has been made in revising aspects of each directive in recent months, and the Government is committed to continuing to pursue the development of European legislation in line with the best scientific advice available. 21. The Government will consult widely on future proposed amendments to regulations controlling biotechnology products, as it has in the past. 7.7 It is vital for the future development of biotechnology regulation that Commission policy be coherent and the work of the Biotechnology Co-ordinating Committee is essential to that process. 22. The Government considers that it remains important for European policies on biotechnology to be co-ordinated effectively. The role of the European Commission is, of course, central to this task and the Government is confident that the Commission will note the view expressed by the Select Committee on the work of their Biotechnology Co-ordinating Committee. Contained use 7.8 The classification of pathogenicity of organisms and scale of activities as the basis of risk assessment in the contained use Directive is fundamentally unscientific. The Government should press for amendment of the EC Directive to substitute a risk assessment system in place of the present classification. 23. The Government agrees that a scientifically based risk assessment system is key to the regulation of contained use of GMOs but does not share the view that the classification system used in the contained use regulations is fundamentally at odds with this maxim. The present criteria for the classification of organisms and, with the few exceptions identified at paragraph 27 below, the activity classification criteria, are derived from risk assessment principles. They are an attempt to identify the elements of a GM activity that contribute to the risk, and express them as criteria which will be determinant enough to act as triggers for notification procedures. They are not themselves the “basis of risk assessment”. 24. Taking a standard risk assessment approach, the criteria for classification of organisms and activities distinguish between the hazard (the potential for harm - here mainly associated with the properties of the modified organism) and the likelihood that harm will actually result (mainly to do with the activity in which the organism is used). 25. There is no “risk assessment system” that is different in principle from this, or that would not analyze into the same elements. Some commentators have had in mind the risk assessment method developed by the Advisory Committee on Genetic “porn — nit r | omalbiend lid ale bagi g dial 1 iba lle nacea ap, sc bea°k _ Ta fi Mecawlor sah yan) Saha ee % od Bho wu on paw vi tt dais. 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