[ 1 0 0]
De partme nt o f Enviro nme ntal Manage me nt, Unive rs ity o f Salfo rd, Salfo rd, UK
Gai M urphy
De partme nt o f Enviro nme ntal Manage me nt, Unive rs ity o f Salfo rd, Salfo rd, UK
[ 1 0 1] No rma Fo rd and
Gai Murphy
Managing e nviro nme ntal risks fro m ge ne tic ally mo difie d o rganisms: the ro le o f safe ty training
Enviro nme ntal Manage me nt and He alth
9 / 3 [1 9 9 8 ] 1 0 0 –1 0 5
Regulatory controls applying
to work with GMOs
La b or a t or y wor k er s a r e p r ot ect ed by b r oa d b a sed occu p a t ion a l h ea lt h a n d s a fet y le gisla -t ion w h ich in clu d es T h e H ea l-t h a n d Sa fe-t y a -t Wor k et c. Act (1974) (H SW); T h e Ma n a gem en t of H ea lt h a n d Sa fet y a t Wor k Re gu la t ion s (1992) (M H SW) a n d T h e Con t r ol of Su b st a n ces H a za r d ou s t o H ea lt h Re gu la t ion s 1994 (COSH H ). T h ose wor k in g w it h GM / GMOs a r e a lso r e gu la t ed by m or e s p ecifi c UK le gisla -t ion , -t h e Gen e-t ica lly M od ifi ed Or ga n ism s (Con t a in ed Use) Re gu la t ion s (1992) a n d t h e Gen et ica lly M od ifi ed Or ga n ism s (Delib er a t e Relea s e) Re gu la t ion s (1992), b ot h of w h ich a r e b a sed on E C Dir ect ives. T h ese r e gu la t ion s d o n ot a im d ir ect ly t o con t r ol r is k sin ce t h ey a r e t ech n iq u e r a t h er t h a n r is k -s p ecifi c; bu t a im t o en s u r e t h a t a t t en t ion is p a id t o t h e p os sib il-it y t h a t t h er e m ay b e r is k s a s s ocia t ed w il-it h GM / GM O wor k (ACGM / H SE / DOE , 1993).
On ly t h e Con t a in ed Us e Re gu la t ion s w h ich a r e d es ign ed t o fa cilit a t e t h e sa fe con t a in ed u s e a n d h a n d lin g of GM Os in t h e wor k p la ce a r e con s id er ed in t h is a r t icle. T h ey d iffer fr om p r ev iou s UK r e gu la t ion s gover n in g GM, in t h a t r is k s t o t h e en v ir on m en t fr om wor k in volv in g gen et ica lly m od ifi ed m icr oor ga n -is m s (GM M s) a r e a d d r es s ed in a d d it ion t o t h e r isk s t o h u m a n h ea lt h a n d sa fet y. E n v ir on -m en t a l r is k s a r is in g fr o-m la r ger gen et ica lly m od ifi ed or ga n ism s, s u ch a s p la n t s a n d a n i-m a ls, a r e d ea lt w it h by t h e E n v ir on i-m en t a l P r ot ect ion Act 1990.
“Con t a in ed u s e” of GM Os is d efi n ed a s a n a ct iv it y in w h ich t h er e a r e “p h y sica l b a r r i-er s, p os s ibly su p p lem en t ed by ch em ica l or b iologica l on es, lim it in g con t a ct b et w een t h e or ga n ism a n d t h e p op u la t ion a n d en v ir on -m en t ” (H SE , 1993).
Th e Con ta in ed Use Re gu la tion s a r e design ed to en su r e th a t th e u se a n d h a n dlin g of GMOs is ca r r ied ou t sa fely u n der con dition s of con ta in -m en t. Th ese r e gu la tion s a r e su pple-m en ted by gu ida n ce pu blish ed by th e Advisor y Com m it-tee on Gen etic Modifi ca tion (ACGM). Th is body con sists of r epr esen ta tives of em ployer s, em ployees, scien tists a n d m edica l specia lists wh o a dvise on th e r e gu la tion s a n d pr ovide a n a ppr oved fr a m ewor k for ca r r yin g ou t r isk a ssessm en ts (Cr ipps, 1992; Kin der ler er, 1992). Con ta in m en t m ea su r es for GM wor k specifi ed by th e ACGM con sist of a com bin a tion of sa fe oper a tin g pr a ctices, con ta in m en t equ ipm en t a n d fa cilities design ta ilor ed to th e level of r isk of th e wor k u n der ta k en .
T h e con t a in m en t r eq u ir em en t s of t h e Con -t a in ed Us e Re gu la -t ion s n o-t on ly lim i-t -t h e exp os u r e of wor k er s a n d ot h er p er son s t o t h e GM Os a n d t o t h eir p r od u ct s, bu t p r even t t h e
r elea se of p ot en t ia lly h a za r d ou s a gen t s in t o t h e ou t sid e en v ir on m en t (OE CD, 1986). T h ey a r e a n in t e gr a l p a r t of t h e r e gu la t or y con t r ols w h ich h ave b een d evelop ed t o con t r ol t h e r is k s t o t h e en v ir on m en t a r isin g fr om t h e a ccid en t a l r elea se of GMOs.
P h y sica l con t a in m en t is t h e p r im a r y m ea n s by w h ich or ga n is m s a r e con t a in ed d u r in g GM/ GMO wor k a n d in clu d es t h r ee elem en t s: 1 con t a in m en t eq u ip m en t ;
2 s a fe op er a t in g p r a ct ices a n d t ech n iq u es; a n d
3 fa cilit y d esign .
Con t a in m en t ca n con sist of b ot h p r im a r y a n d secon d a r y for m s, t h e for m er d esign ed t o p r ot ect t h e wor k er s a n d t h e im m ed ia t e v icin -it y fr om r elea se a n d t h e la t t er t o p r ot ect t h e w id er en v ir on m en t a n d p eop le ou t sid e of t h e la b or a t or y. Wh ile con t a in m en t eq u ip m en t is u sed t o en su r e p r im a r y con t a in m en t a n d su it a ble d esign of fa cilit ies en s u r es
secon d a r y con t a in m en t , sa fe op er a t in g p r oce-d u r es a n oce-d p r a ct ices for t h e p er s on n el
in volved a r e v it a l t o b ot h (OE CD, 1986).
Other requirements within the
Contained Use Regulations
T h e r e gu la t ion s a lso r eq u ir e sit es t o u n d er -t a k e a h u m a n h ea l-t h a n d en v ir on m en -t a l r isk a ssessm en t for a n y a ct iv it y in volv in g GM/ GMOs a n d n ot ifi ca t ion of t h e a ct iv it y t o t h e H SE (Kin d er ler er, 1992). T h ese r isk a ssessm en t s m u st b e r ecor d ed a n d k e p t for a t lea st t en yea r s a ft er t h e a ct iv it y h a s cea sed a n d m u st b e su b m it t ed t o t h e H SE a s p a r t of t h e n ot ifi ca t ion p r oced u r e for cer t a in t y p es of wor k . N ot ifi ca t ion p r oced u r es va r y a ccor d in g t o t h e h a za r d s of t h e or ga n ism s u sed a n d t h e sca le a n d p u r p ose of t h e wor k , a n d a r e su m -m a r is ed in Ta ble I.
Biosafety training
cci-No rma Fo rd and Gai Murphy
Managing e nviro nme ntal risks fro m ge ne tic ally mo difie d o rganisms: the ro le o f safe ty training
Enviro nme ntal Manage me nt and He alth
9 / 3 [1 9 9 8 ] 1 0 0 –1 0 5
den t ca u sa tion , a ppr opr ia te in str u ction a n d tr a in in g for per son n el wor k in g w ith GM/ GMOs is essen tia l (An dr u p et a l., 1990). Th e 1986 OE CD gu idelin es on sa fety con sider a -tion s for a pplica -tion s of r ecom bin a n t DNA stipu la te th a t per son n el wor k in g w ith poten -tia lly in fectiou s a gen ts or a ller gen ic/ toxic m a ter ia ls m u st be aw a r e of a n y poten tia l h a z-a r ds z-a n d m u st be tr z-a in ed z-a n d pr ofi cien t in th e pr a ctices a n d tech n iqu es n ecessa r y for th e sa fe h a n dlin g of su ch m a ter ia ls.
Research findings
Recogn is in g t h e im p or t a n t r ole t h a t b iosa fet y t r a in in g p lay s in t h e a t t a in m en t of
“con t a in ed ” u s e a n d t h u s t h e avoid a n ce of a ccid en t a l r elea s e a n d con seq u en t en v ir on m en t a l d a m a ge, t h e H ea lt h a n d Sa fet y E xecu -t ive (H SE ) com m is sion ed a p r elim in a r y s-t u dy t o id en t ify t h e level, con t en t , for m a t a n d ext en t of b iosa fet y t r a in in g cu r r en t ly p r ov id ed a t s it es u n d er t a k in g GM / GM O op er a -t ion s (For d e-t a l., 1995). Da -t a for -t h e r es ea r ch w er e collect ed by m ea n s of a p ost a l q u es t ion -n a ir e a d m n ist er ed t o a ll s it es cu r r e-n t ly -n ot i-fi ed t o ca r r y ou t GM/ GM O a ct iv it ies, p lu s 20 in -d e p t h ca s e st u d ies of select ed s it es. A r esp on s e r a t e of 41.2 p er cen t w a s ob t a in ed fr om t h e p ost a l s u r vey a n d t h e ch a r a ct er is -t ics of r es p on d en -t s cor r ela -t ed clos ely w i-t h -t h e ch a r a ct er is t ics of t h e t ot a l p op u la t ion of s it es s u r veyed in t er m s of or ga n isa t ion a l t y p e. T h e r a t io of p u blic t o p r iva t e s ect or s it es u n d er t a k in g GM wor k w a s a lm os t 3:1, w it h u n iver -s it ie-s con -s t it u t in g t h e la r ge-s t gr ou p of r esp on d en t s follow ed by p u blic s ect or r esea r ch in st it u t es a n d in d u s t r ia l s it es (F ig-u r es 1 a n d 2).
Of a ll p r oject s u n d er t a k en a t t h e r es p on d en t s it es, 85 p er cen t w er e cla s s ifi ed a s con -t a in m en -t level 1, w h ich r e p r es en -t s -t h e low es -t level of r is k , a n d a lm ost h a lf of t h e r es p on -d en t s u n -d er t ook wor k on ly a t t h is level. On ly 9 p er cen t of p r oject s u n d er t a k en by r es p on -d en t s u s e-d Gr ou p II (p a t h ogen ic) or ga n ism s a n d on ly 3 p er cen t of p r oject s w er e cla s s ifi ed
a s Ty p e B (la r ge-sca le) (see Ap p en d ix for d efi n it ion s of Ty p es A a n d B). Cu r r en t ly t h e h igh es t r isk p r oject s u n d er t a k en a t r esp on -d en t s it es w er e a t con t a in m en t level 3, w it h on ly 2 p er cen t of a ll p r oject s b ein g u n d er -t a k en a -t -t h is con -t a in m en -t .
Training provision
T h e m a in fi n d in gs of t h e su r vey w er e t h a t over a ll, h igh levels of t r a in in g w er e sa id t o b e p r ov id ed for GM p er son n el a t n ot ifi ed sit es, h ow ever, ext en sive va r ia t ion s exis t ed in t h e con t en t , for m a t a n d p er ceived q u a lit y of t h e t r a in in g for d iffer en t st a ff gr ou p s a n d d iffer -en t sit es.
Va r ia t ion s fi r st a r ose in t h e a r ea s cover ed in t h e t r a in in g r eceived by d iffer en t st a ff. T r a in in g in p r a ct ica l sk ills su ch a s good m icr ob iologica l p r a ct ice w a s con cen t r a t ed a m on g b en ch st a ff a n d p r od u ct ion wor k er s, w h er ea s m a n a ger s a n d b iologica l s a fet y offi-cer s (BSOs) r eceived h igh levels of t r a in in g in t h e le gisla t ion cover in g GM wor k a n d in r isk a ssessm en t p r oced u r es (see Ta ble II). T h is va r ia t ion su gges t s t h e t op ics b ein g a d d r essed d id r efl ect t h e r oles a n d r esp on sib ilit ies of t h ose b ein g t r a in ed .
Table I
No tific atio n re quire me nts fo r wo rk with GMOs
Nature of work Notification requirements
Non-pathogenic (Group I); poses no risk Annual retrospec tive c ount to environment; small-sc ale
Non-pathogenic (Group I); poses no risk Prior notific ation and summaries of risk
to environment; large-sc ale assessments submitted to the HSE
Pathogenic (Group II); small-sc ale Prior notific ation and summaries of risk assessments submitted to the HSE
Pathogenic (Group II); large-sc ale Full risk assessment submitted and c onsent of the HSE required before work c ommenc es
Unive rs ity Othe r
Public He alth/ Diagnostic Re s e arc h Ins titute Indus trial
Figure 1
Es tablis hme nt type s in to tal po pulatio n o f no tifie d s ite s
Unive rs ity Othe r
Public He alth/ Diagnostic Re s e arc h Ins titute Indus trial
Figure 2
[ 1 0 3] No rma Fo rd and
Gai Murphy
Managing e nviro nme ntal risks fro m ge ne tic ally mo difie d o rganisms: the ro le o f safe ty training
Enviro nme ntal Manage me nt and He alth
9 / 3 [1 9 9 8 ] 1 0 0 –1 0 5
T h e fr eq u en cy of t r a in in g p r ov id ed t o p er -son n el w a s a lso fou n d t o va r y a cr oss st a ff gr ou p in gs (see Ta ble III). Wh ile r esea r ch a n d t ech n ica l st a ff wer e gen er a lly t r a in ed on r ecr u it m en t , wh en t h ey b eca m e exp osed t o n ew r isk s a n d con t in u a lly on t h e job, m a n a ge-m en t r a r ely r eceived GM sa fet y t r a in in g on r ecr u it m en t a n d wer e m ost lik ely t o r eceive it on ly wh en le ga l r eq u ir em en t s/ d u t ies wer e in t r od u ced . Refr esh er t r a in in g w a s r a r ely offer ed t o a n y of t h e GM wor k er gr ou p s.
Met h od s of d eliver in g t r a in in g id en t ifi ed in t h e q u est ion n a ir e in clu d ed offt h ejob t r a in -in g, on -t h e-job t r a -in -in g a n d t h e p r ov ision of w r it t en in for m a t ion . Th e u se of t h ese d iffer -en t m et h od s a t t h e r esp on d -en t sit es w a s fou n d t o va r y d ep en d in g on t h e r oles a n d r esp on sib ilit ies of d iffer en t p er son n el. Wh ile m a n a ger -ia l st a ff r elied h eav ily on r eceiv in g w r it t en in for m a t ion r e ga r d in g sa fet y r a t h er t h a n en ga gin g in m or e p a r t icip a t ive for m s of t r a in -in g, on -t h e-job t r a -in -in g com b -in ed w it h w r it-t en in for m a it-t ion w a s it-t h e m osit-t com m on m ea n s of d eliver in g t r a in in g a n d in st r u ct ion t o b ot h b en ch st a ff a n d t o p r od u ct ion wor k er s.
The management of training
T h e su r vey r evea led ev id en ce of p oor m a n -a gem en t of s-a fet y t r -a in in g for GM/ GM O
wor k . On ly 40 p er cen t of sit es r e p or t ed h av in g sy st em s for m on it or in g t h e p r ov ision of t r a in in g a n d m a n y of t h ese h a d in for m a l a r r a n gem en t s, su ch a s on -t h e-job m on it or in g by su p er v isor s.
Va r ia t ion s a r ose b et w een p u blic a n d p r i-va t e s ect or sit es in t h e sy st em s u sed t o m a n a ge GM sa fet y t r a in in g. For in st a n ce, w h ile 71 p er cen t of p r iva t e sect or sit es r e p or t ed t h a t w r it t en t r a in in g r ecor d s w er e k e p t , on ly 21 p er cen t of p u blic s ect or sit es st a t ed t h a t t h ey k e p t su ch r ecor d s. T h e w r it -t en r ecor d s a -t p r iva -t e sec-t or si-t es con sis-t ed of a for m a l t r a in in g sy st em , s p ecify in g a p p r o-p r ia t e ou t com es for ea ch level of t r a in in g, en su r in g com p et en cy w a s a ch ieved in ea ch a r ea . Sa fet y t r a in in g a t m a n y p u blic sect or sit es w a s m a n a ged d e p a r t m en t a lly a n d sin ce m a n y d e p a r t m en t s w er e sm a ll, t h e u se of in for m a l t r a in in g w it h ou t a n y cen t r a lised p la n n in g w a s fr eq u en t ly a d op t ed . Wh ile t h is in for m a lit y m ay b e a p p r op r ia t e in cer t a in sit u a t ion s (e.g. w h er e low r isk wor k is u n d er -t a k en a n d s-t a ff h ave a lr ea dy r eceived -t r a in in g in GM P ), p r oblem s w er e r e p or t ed in t h ose ca ses w h er e st a ff r esp on sible for t h e p r ov i-sion of t r a in in g felt in a d eq u a t ely eq u ip p ed ; w h er e t h ey h a d in s u fficien t t im e a n d r esou r ces ava ila ble t o d eliver t h e t r a in in g; or w h er e t h eir n e ga t ive a t t it u d es t ow a r d s sa fet y h in d er ed t r a in in g p r ov ision .
P r esen t gu id a n ce a b ou t s a fet y t r a in in g for t h e ACGM is m in im a l a n d d escr ib es in b r oa d t er m s t h e t r a in in g in p u t s r eq u ir ed for ea ch con t a in m en t level; for exa m p le, for GM wor k a t con t a in m en t level 3, it is su ggest ed t h a t : “la b or a t or y p er son n el m u st h ave h a d t r a in -in g -in h a n d l-in g level 3 m icr o-or ga n is m s” (ACGM / H SE / DOE , 1988). N o gu id a n ce is given on t h e p a r t icu la r a r ea s in w h ich st a ff sh ou ld b e com p et en t . Ou r r esu lt s su ggest t h a t it m ay b e m or e u sefu l t o sp ecify a p p r op r ia t e t r a in in g ou t com es (in a sim ila r m a n n er t o t h e COSH H Re gu la t ion s a n d t h e a ccom p a n y in g Ap p r oved Cod e of P r a ct ice). It wou ld b e p a r -t icu la r ly h elp fu l if -t h e a p p r op r ia -t e -t r a in in g a ct ion s for ea ch con t a in m en t level w er e d efi n ed .
Organisational arrangements for
biosafety
A com p a r ison of t h e or ga n isa t ion a l a r r a n ge-m en t s for GM sa fet y a t p u blic a n d p r iva t e sect or sit es r evea led t h a t p u blic sect or sit es, t h e m a jor it y of w h ich w er e u n iver sit ies, t en d ed t o h ave d ecen t r a lis ed a r r a n gem en t s, w it h r esp on sib ilit ies for b iosa fet y d evolved t o in d iv id u a l d e p a r t m en t s; w h er ea s p r iva t e s ect or sit es h a d m or e cen t r a lised Table II
Le ve ls o f training re c e ive d by e mplo ye e gro ups in fo ur are as re late d to GM/ GMO s afe ty (pe r c e nt)
Recipients L + LR RA GM P GM O
BSO 9 1 9 3 8 6 8 8
Senior manager 8 0 7 8 6 9 7 2
Laboratory technician 7 2 7 1 9 1 8 2
Production worker 7 8 7 1 9 2 7 8
Notes:
L + LR: Legislation and legal responsibilities
RA: Risk assessment
GMP: Good mic robiologic al prac tic e
GMO: Genetic ally modified organisms – their hazards and c ontrol
Table III
Po ints at whic h training was pro vide d to manage rs and te c hnic al s taff wo rking in GM (pe r c e nt)
Recipients Recr N/ C risk Refr C leg o-t-j
M anagers 2 5 2 7 1 3 4 7 1 9
Technical staff 6 9 5 8 9 3 9 6 4
Notes:
Rec r: On being rec ruited
[ 1 0 4] No rma Fo rd and Gai Murphy
Managing e nviro nme ntal risks fro m ge ne tic ally mo difie d o rganisms: the ro le o f safe ty training
Enviro nme ntal Manage me nt and He alth
9 / 3 [1 9 9 8 ] 1 0 0 –1 0 5
a r r a n gem en t s, a llow in g s t a n d a r d isa t ion a cr os s t h e w h ole s it e.
T h e M H SW Re gu la t ion s r eq u ir e em p loyer s t o a p p oin t com p et en t p er son (s ) t o a ss ist t h em in com p ly in g w it h h ea lt h a n d s a fet y le gisla -t ion ; ACGM a dv ise -t h a -t a -t GM s i-t es, a BSO sh ou ld b e a p p oin t ed t o fu lfi l t h is r ole. Va r ia -t ion s b e-t w een p u blic a n d p r iva -t e s ec-t or sit es w er e a p p a r en t in t h e n a t u r e of t h e BSO’s r ole. In t h e p r iva t e s ect or, a s in gle BSO w it h a fu ll t im e a dv isor y r ole w a s gen er a lly a p p oin t ed for t h e w h ole es t a blis h m en t . T h e d ecen t r a lis ed a r r a n gem en t s w it h in u n iver s i-t ies, h ow ever, n eces sii-t a i-t ed i-t h e a p p oin i-t m en i-t of BSOs a t d e p a r t m en t level. Som e u n iver s it ies a p p oin t ed a n a d d it ion a l BSO t o t h e cen t r a l sa fet y office (a u n iver s it y BSO (UBSO)) a n d t h eir r ole w a s t o lia ise w it h t h e d e p a r t m en t a l BSO.
T h is lia is on va r ied w id ely a t d iffer en t sit es a n d oft en r efl ect ed t h e cu lt u r a l et h os of t h a t u n iver s it y. BSOs w it h in u n iver s it ies a n d r esea r ch in s t it u t es w er e u s u a lly a p p oin t ed fr om a m on g exis t in g r es ea r ch or a ca d em ic st a ff a n d u n d er t ook t h is r ole in a d d it ion t o t h eir ot h er r es p on sib ilit ies, cr ea t in g t h e p ot en t ia l for con fl ict in g p r ior it ies. Ca s e st u d -ies of s u ch est a blish m en t s su gges t ed t h a t t h e su p p or t r eceived by d e p a r t m en t a l BSOs a n d t h eir ow n p er ceived levels of com p et en ce va r ied m a r k ed ly, a ccor d in g t o t h e t im e t h ey h a d ava ila ble t o s p en d on t h e r ole, t h e t r a in -in g t h ey h a d r eceived a n d t h e ext en t a n d q u a lit y of com m u n ica t ion s w it h t h e cen t r a l sa fet y office. Som e of t h e d e p a r t m en t a l BSOs a t u n iver s it y s it es w er e clea r ly u n su r e a s t o w h er e t h eir le ga l r es p on s ib ilit ies lay.
Conclusions
Alt h ou gh t h e r esu lt s of t h e r es ea r ch r evea led w id es p r ea d p r ov ision of in for m a t ion , in st r u ct ion a n d t r a in in g t o p er s on n el wor k -in g w it h or m a n a g-in g GM op er a t ion s, t h e n a t u r e a n d q u a lit y of t h e t r a in in g p r ov id ed d id va r y. Differ en ces in t h e n a t u r e of t r a in in g d eliver y a ccor d in g t o p er son n el t y p e gen er -a lly r efl ect ed d iffer en ces in t h e t y p es of t -a s k s ca r r ied ou t , e.g. h igh er levels of on -t h e-job t r a in in g for p er s on n el ca r r y in g ou t p r ed om i-n a i-n t ly p r a ct ica l or sk ill-b a sed t a s k s, s u ch a s r esea r ch a s sist a n t s, t ech n icia n s or p r od u c-t ion wor k er s. Ic-t is, h ow ever, of s om e con cer n t h a t m u ch of t h e t r a in in g in GM s a fet y for m a n a ger s con s is t ed p r im a r ily of t h e p r ov i-sion of w r it t en in for m a t ion r a t h er t h a n en ga gem en t in m or e p a r t icip a t ive for m s of t r a in in g. T h e r es ea r ch su gges t s t h a t
r es ou r ces w er e d evot ed t o b iosa fet y t r a in in g, bu t in s om e or ga n isa t ion s p a r t icu la r ly t h os e
in t h e p u blic sect or, t h e eva lu a t ion of sa fet y t r a in in g w a s n ot b ein g a d d r essed .
Con fu sion over t h e con t en t of t r a in in g a p p r op r ia t e for GM sa fet y w a s a p p a r en t a m on g p er son n el wor k in g a t n ot ifi ed sit es. Som e for m of in s t r u ct ion a n d t r a in in g is n ecessa r y for wor k a t a ll levels of con t a in -m en t a n d t h e sp ecifi ca t ion of co-m p et en cy levels wou ld en a ble t h ose w h o felt t h a t t h ey w er e n ot a d eq u a t ely t r a in ed t o m ea s u r e t h eir exist in g com p et en cies a ga in s t a p p r oved st a n -d a r -d s. T h es e s t a n -d a r -d s wou l-d a lso fa cilit a t e m or e effect ive p la n n in g a n d m a n a gem en t of t r a in in g a t a loca l level by fa cilit a t in g t h e id en t ifi ca t ion of t h e t r a in in g n eed s of st a ff. Wh ile t h e sp ecifi ca t ion of com p et en cy levels for sa fe GM wor k wou ld a ssis t in t h e m a n a ge-m en t of t r a in in g p r ov ision , t h e r es u lt s a lso im p lied t h a t s it es r eq u ir e fu r t h er gu id a n ce on a p p r op r ia t e m ea n s by w h ich sa fet y t r a in -in g cou ld b e m on it or ed a n d eva lu a t ed .
Mor e d et a iled gu id a n ce is a lso r eq u ir ed on t h e r oles, r esp on sib ilit ies a n d com p et en cies of BSOs, sin ce a t p r esen t t h er e is w id e va r ia -t ion in -t h eir p er ceived com p e-t en ce a n d effec-t iven es s. T h is in for m a effec-t ion wou ld fa cilieffec-t a effec-t e t h e id en t ifi ca t ion of in d iv id u a ls su it a ble for t h e p osit ion of BSO, en h a n ce t h e a ss essm en t of t h eir t r a in in g n eed s, cla r ify t h eir r ole for em p loyer s/ m a n a ger s a n d p r ov id e a focu s a r ou n d w h ich m a n a gem en t a n d BSOs in ea ch est a blish m en t or d e p a r t m en t cou ld n e got ia t e a n a ch ieva ble wor k loa d t o su it loca l con d i-t ion s a n d r esou r ces.
H u m a n er r or p lay s a n im p or t a n t r ole in a ccid en t ca u sa t ion a n d if t h e a ccid en t a l r elea s e of p ot en t ia lly h a r m fu l GMMs is t o b e avoid ed em p loyees m u st b e aw a r e of a n y p ot en t ia l h a za r d s a n d t r a in ed t o b e p r ofi cien t in t h e p r a ct ices a n d t ech n iq u es n ecessa r y for sa fe h a n d lin g.
References
ACGM / H SE / DOE (1988), Gu id a n ce N ote 8: L ab ora
tor y Con ta in m en t Fa cilities for Gen etic M a n ip -u la tion , ACGM / H SE / DOE .
ACGM / H SE / DOE (1993), Gu id a n ce N ote 7: Gu id
e-lin es for th e R isk A ssessm en t of Op era tion s In v olv in g th e Con ta in ed Use of Gen etica lly M od ifi ed M icr o-orga n ism s (GM M s),
ACGM / H SE / DOE .
Adv is or y Com m it t ee on t h e Sa fet y of N u clea r In s t a lla t ion s (ACSN I) H u m a n F a ct or s St u dy Gr ou p (1990), First R ep or t on T ra in in g a n d
R ela ted M a tters, H SE Book s.
An d r u p, L., N iels en , B.H . a n d Kolv r a a , S. (1990), “Bios a fet y con sid er a t ion s in in d u st r ies w it h p r od u ct ion m et h od s b a sed on t h e u s e of r ecom b in a n t d eoxy r ib on u cleic a cid ”, S ca n d
[ 1 0 5] No rma Fo rd and
Gai Murphy
Managing e nviro nme ntal risks fro m ge ne tic ally mo difie d o rganisms: the ro le o f safe ty training
Enviro nme ntal Manage me nt and He alth
9 / 3 [1 9 9 8 ] 1 0 0 –1 0 5
Cr ip p s, Y. (1992), “‘E v id en ce fr om Dr Yvon n e Cr ip p s, Dir ect or of St u d ies in Law, E m m a n u el Colle ge, Ca m b r id ge’ in H ou se of Lor d s Select Com m it t ee on Scien ce a n d Tech n ology ”, in
R egu la tion of th e UK B iotech n olog y In d u str y a n d Glob a l Com p etitiv en ess, H M SO, Lon d on .
For d , N.J ., Mu r p h y, R.G. a n d Ray, K. (1995), A
Prelim in a r y E v a lu a tion of th e A d equ a cy of Cu r ren t B iosa fety T ra in in g Pr ov ision for T h ose W h o A re Work in g w ith , S u p er v isin g or M a n a gin g Gen etic M od ifi ca tion , H SE .
F r om m er, W., Ager, B., Ar ch er, L. et a l. (1989), “Sa fe b iot ech n ology III. Sa fet y p r eca u t ion s for h a n d lin g m icr o-or ga n is m s of d iffer en t r isk cla sses”, A p p lied M icr ob iolog y a n d
B iotech n olog y, Vol. 30, p p. 541-52.
H ea lt h a n d Sa fet y E xecu t ive (1993), A Gu id e to th e
Gen etica lly M od ifi ed Orga n ism s (Con ta in ed Use) R egu la tion s 1992, H M SO, Lon d on .
H SE (1995), Gen etic M od ifi ca tion – R isk s a n d S a
fe-gu a rd s, H SE Book s.
Isr a eli, E . (1986), “Biosa fet y in b iot ech n ologica l p r ocesses”, in Liss, A.R. (E d .), A d v a n ces in
B iotech n ologica l Pr ocesses, p. 6.
Kin d er ler er, J . (1992), “‘E v id en ce fr om Dr J u lia n Kin d er ler er, De p a r t m en t of M olecu la r Biol-ogy a n d Biot ech n olBiol-ogy, t h e Un iver s it y of Sh effield ’ in H ou se of Lor d s Select Com m it t ee on Scien ce a n d Tech n ology ”, in R egu la tion of
th e UK B iotech n olog y In d u str y a n d Glob a l Com p etitiv en ess, H MSO, Lon d on .
Mellon , M . (1991), “An en v ir on m en t a lis t ’s p er s p ect ive”, in Dav is, B. (E d .), T h e Gen eectic R ev olu
-tion , J oh n s H op k in s Un iver s it y P r es s.
M iles, C.M ., Win s t a n ley, M.A., Gu n n in g, J .G. a n d Du r a n t , J . (1994), “Tow a r d s a p u blic con s en su s on b iot ech n ology ”, S cien ce in Pa rlia m en t, Vol. 51, p p. 14-16.
OE CD Re p or t (1986), R ecom b in a n t DN A S a fety
Con sid era tion s, Or ga n is a t ion for E con om ic
Co-op er a t ion a n d Develop m en t , P a r is. Ta it , J . a n d Lev id ow, L. (1992), “P r oa ct ive a n d
r ea ct ive a p p r oa ch es t o r isk r e gu la t ion . T h e ca se for b iot ech n ology ”, Fu tu res, Vol. 24 N o. 3, p p. 219-31.
Appendix. Defi nitions of Types A and B
activities
Type A o pe ratio n
An y a ct iv it y in volv in g gen et ica lly m od ifi ed m icr oor ga n is m s for t h e p u r p oses of t ea ch -in g, r esea r ch , d evelop m en t , or for n on --in d u s-t r ia l or n on -com m er cia l p u r p oses on a sca le a t w h ich t h e p r a ct ices a n d con d it ion s of t h e op er a t ion s r ela t ive t o t h e cu lt u r e, volu m e a n d n u m b er of or ga n is m s in volved is su ch t h a t : • t h e sy st em u sed t o k ee p t h e or ga n ism s
u n d er con t a in m en t r efl ect s good m icr ob io-logica l p r a ct ice a n d good occu p a t ion a l s a fet y a n d h ygien e: a n d
• It is p ossible t o r en d er t h e or ga n ism s in a ct ive by sct a n d a r d la b or a ct or y d econ ct a m in a -t ion -t ech n iq u es.
Type B o pe ratio n