Directory UMM :Data Elmu:jurnal:E:Environmental Management and Health:Vol09.Issue3.1998:
Managing environmental risks from genetically
modified organisms: the role of safety training
Norma Ford
De partme nt o f Enviro nme ntal Manage me nt, Unive rsity o f Salfo rd, Salfo rd, UK
Gai M urphy
De partme nt o f Enviro nme ntal Manage me nt, Unive rsity o f Salfo rd, Salfo rd, UK
Genetic modifi cation (GM) has
been called “ the new biotechnology” and has been hailed
as a leading enabling technology, facilitating major innovation in health care, as well as
in the chemical, agricultural
and food sectors. GM techniques facilitate the combination of DNA which would not
occur naturally and, although
there are no records of disease or accidents associated
with GM work, potential risks
do exist. Legislation designed
to ensure that workers are
adequately protected against
hazards also limits the risk of
environmental damage.
Human error plays an important role in accident causation, therefore appropriate
instruction, supervision and
training for personnel working
with GM/GMOs (genetically
modifi ed organisms) is essential. This article reviews the
regulatory controls for GM
work and discusses the fi ndings of a preliminary study
undertaken to identify the
level, content, format and
extent of biosafety training
currently provided at sites
undertaking GM work. While
high levels of biosafety training were reported, the content, organisation and management varied between the
establishments undertaking
GM work. Recommendations
are made regarding the management of biosafety training
including the need to establish competency levels for all
those working with, and
supervising and managing
work with, GMOs.
Enviro nme ntal Manage me nt
and He alth
9 / 3 [ 1998] 1 0 0 –1 0 5
© MCB Unive rsity Pre ss
[ ISSN 0956-6163]
[ 100 ]
Introduction
Th e a pplica tion of biotech n ology in in du str ies su ch a s ph a r m a ceu tica ls, fer m en ta tion
a n d a gr icu ltu r e h a s a lon g h istor y; for exa m ple, fa r m in g tech n iqu es h ave tr a dition a lly
u tilised m eth ods su ch a s n a tu r a l selection
a n d cr oss br eedin g to m a n ipu la te th e in h er ited ch a r a cter istics of pla n ts a n d a n im a ls.
However, cu r r en t in ter est a n d expa n sion in
th e field of biotech n ology lies pr im a r ily in
th e u se of gen etic m odifica tion (GM). Th e
Hou se of Lor ds Select Com m ittee on Scien ce
a n d Tech n ology (1992) descr ibed GM a s a k ey
en a blin g tech n ology fa cilita tin g m a jor in n ova tion in th e h ea lth ca r e, ch em ica l, a gr icu ltu r a l a n d food sector s lea din g to th e in ven tion of n ew dr u gs, a gr och em ica ls a n d br eedin g of pla n ts a n d a n im a ls. Th e tech n iqu es
m a k e it possible to ta ilor or ga n ism s to be
sa fer, m or e specific a n d m or e pr odu ctive in
wh a t th ey do th a n th eir u n m odified cou n ter pa r ts (HSE , 1995).
Risks from the new
biotechnology
GM is defin ed a s “th e a lter in g of th e gen etic
m a ter ia l in th a t or ga n ism by a w ay th a t does
n ot occu r n a tu r a lly by m a tin g or n a tu r a l
r ecom bin a tion or both ” (HSE , 1993). GM tech n iqu es ca n cir cu m ven t ba r r ier s th a t wou ld
n a tu r a lly r estr ict DNA exch a n ge between
u n r ela ted species (OE CD, 1986) a n d it is th is
fa ctor wh ich h a s r a ised pu blic con cer n s a n d
fu elled deba tes a bou t th e h u m a n a n d en vir on m en ta l r isk s a s well a s eth ica l issu es a r isin g
fr om th e a pplica tion of th e tech n ology (Miles
et a l., 1994).
Ma n y of th e poten tia l h a za r ds a r isin g fr om
th e u se of GM/ GMOs (gen etica lly m odifi ed
or ga n ism s) in r esea r ch la bor a tor ies a n d
in du str ia l settin gs a r e sim ila r to th ose fr om
th e u se of oth er biologica l a gen ts. Th ey
in clu de th e possibilities of:
• in fection of h u m a n s, a n im a ls or pla n ts fr om
th e h ost, r ecipien t or vector or ga n ism s;
• toxic or a ller gic effects a r isin g fr om th e
GMO, its com pon en ts or its m eta bolic pr odu cts;
• toxic or a ller gen ic effects a r isin g fr om th e
pr odu ct expr essed by th e GMO;
• en vir on m en ta l effects r esu ltin g fr om th e
a cciden ta l r elea se of GMOs (OE CD, 1986).
Mor e specific poten tia l h a za r ds a ssocia ted
w ith GM wor k h ave been r ecogn ised, sever a l
of wh ich h ave a n en vir on m en ta l im pa ct.
Th ese in clu de:
• Th e pr odu ction of m or e in fectiou s or dr u gr esista n t m icr o-or ga n ism s.
• Th e tr a n sfer of h a r m fu l gen etic m a ter ia l
(for exa m ple m a ter ia l a ssocia ted w ith ca n cer ) to h u m a n s via a GMO.
• Aggr essive gen etica lly m odified pla n ts
wh ich cou ld colon ise th e su r r ou n din g en vir on m en t, elim in a tin g pla n ts a lr ea dy livin g
th er e.
• Th e tr a n sfer of gen etic m a ter ia l fr om a
m odified pla n t wh ich m igh t be tr a n sfer r ed
to a r ela ted pla n t th a t is con sider ed a weed,
m a k in g it m or e com petitive, for exa m ple,
by en a blin g it to becom e r esista n t;
• In ter fer en ce of th e n a tu r a l r ecyclin g of
n u tr ien ts in th e en vir on m en t by m odifi ed
m icr o-or ga n ism s.
All la bor a tor y wor k in th e UK is r e gu la ted by
le gisla tion to en su r e th a t wor k er s a r e a dequ a tely pr otected a ga in st r isk s a r isin g fr om
th eir wor k . Mu ch of th e h ea lth a n d sa fety
le gisla tion is r ea ctive a n d w a s developed a s a
r esu lt of a cciden ts a n d/ or disea ses a r isin g in
th e wor k pla ce. In con tr a st, th e r e gu la tor y
con tr ols a pplyin g specifica lly to GM wor k
wer e developed a s a pr eca u tion a r y r espon se
to th e types of con jectu r a l r isk s ou tlin ed
a bove (sin ce n o disea ses/ a cciden ts a ttr ibu ta ble to GM tech n iqu es exist) a n d th er efor e
r epr esen t a “pr oa ctive” r e gu la tor y a ppr oa ch
ju stifi ed on th e ba sis of com plexity a n d
u n cer ta in ty. Th e issu e of com plexity pr im a r ily a pplies to th e r elea se of GMOs in to th e
en vir on m en t; ecologists a r gu e th a t it is
im possible to defin e u n a m bigu ou sly th e con sequ en ces of a r elea se or esca pe of GMOs
beca u se of th e im m en se com plexity of in ter a ction s w ith in livin g ecosystem s (F r om m er et
a l., 1989; Mellon , 1991). Un cer ta in ty, h owever,
a pplies to a ll wor k w ith GMOs, a n d is r ela ted
to its r ela tively r ecen t or igin s a n d in n ova tive
tech n iqu es (Ta it a n d Levidow, 1992).
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 bor a tor y wor k er s a r e pr otected by br oa dba sed occu pa tion a l h ea lth a n d sa fety le gisla tion wh ich in clu des Th e Hea lth a n d Sa fety a t
Wor k etc. Act (1974) (HSW); Th e Ma n a gem en t
of Hea lth a n d Sa fety a t Wor k Re gu la tion s
(1992) (MHSW) a n d Th e Con tr ol of Su bsta n ces
Ha za r dou s to Hea lth Re gu la tion s 1994
(COSHH). Th ose wor k in g w ith GM/ GMOs a r e
a lso r e gu la ted by m or e specific UK le gisla tion , th e Gen etica lly Modified Or ga n ism s
(Con ta in ed Use) Re gu la tion s (1992) a n d th e
Gen etica lly Modified Or ga n ism s (Deliber a te
Relea se) Re gu la tion s (1992), both of wh ich a r e
ba sed on E C Dir ectives. Th ese r e gu la tion s do
n ot a im dir ectly to con tr ol r isk sin ce th ey a r e
tech n iqu e r a th er th a n r isk -specific; bu t a im
to en su r e th a t a tten tion is pa id to th e possibility th a t th er e m ay be r isk s a ssocia ted w ith
GM/ GMO wor k (ACGM/ HSE / DOE , 1993).
On ly th e Con ta in ed Use Re gu la tion s wh ich
a r e design ed to fa cilita te th e sa fe con ta in ed
u se a n d h a n dlin g of GMOs in th e wor k pla ce
a r e con sider ed in th is a r ticle. Th ey differ
fr om pr eviou s UK r e gu la tion s gover n in g GM,
in th a t r isk s to th e en vir on m en t fr om wor k
in volvin g gen etica lly m odifi ed m icr o-or ga n ism s (GMMs) a r e a ddr essed in a ddition to th e
r isk s to h u m a n h ea lth a n d sa fety. E n vir on m en ta l r isk s a r isin g fr om la r ger gen etica lly
m odified or ga n ism s, su ch a s pla n ts a n d a n im a ls, a r e dea lt w ith by th e E n vir on m en ta l
P r otection Act 1990.
“Con ta in ed u se” of GMOs is defi n ed a s a n
a ctivity in wh ich th er e a r e “ph ysica l ba r r ier s, possibly su pplem en ted by ch em ica l or
biologica l on es, lim itin g con ta ct between th e
or ga n ism a n d th e popu la tion a n d en vir on m en t” (HSE , 1993).
Th e Con ta in ed Use Regu 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 egu la tion s a r e su pplem en ted by
gu ida n ce pu blish ed by th e Advisor y Com m ittee on Gen etic Modifica 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 egu 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 specified
by th e ACGM con sist of a com bin a tion of sa fe
oper atin 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 ken .
Th e con ta in m en t r equ ir em en ts of th e Con ta in ed Use Re gu la tion s n ot on ly lim it th e
exposu r e of wor k er s a n d oth er per son s to th e
GMOs a n d to th eir pr odu cts, bu t pr even t th e
r elea se of poten tia lly h a za r dou s a gen ts in to
th e ou tside en vir on m en t (OE CD, 1986). Th ey
a r e a n in te gr a l pa r t of th e r e gu la tor y con tr ols
wh ich h ave been developed to con tr ol th e
r isk s to th e en vir on m en t a r isin g fr om th e
a cciden ta l r elea se of GMOs.
P h ysica l con ta in m en t is th e pr im a r y m ea n s
by wh ich or ga n ism s a r e con ta in ed du r in g
GM/ GMO wor k a n d in clu des th r ee elem en ts:
1 con ta in m en t equ ipm en t;
2 sa fe oper a tin g pr a ctices a n d tech n iqu es;
and
3 fa cility design .
Con ta in m en t ca n con sist of both pr im a r y a n d
secon da r y for m s, th e for m er design ed to
pr otect th e wor k er s a n d th e im m edia te vicin ity fr om r elea se a n d th e la tter to pr otect th e
w ider en vir on m en t a n d people ou tside of th e
la bor a tor y. Wh ile con ta in m en t equ ipm en t is
u sed to en su r e pr im a r y con ta in m en t a n d
su ita ble design of fa cilities en su r es
secon da r y con ta in m en t, sa fe oper a tin g pr ocedu r es a n d pr a ctices for th e per son n el
in volved a r e vita l to both (OE CD, 1986).
Other requirements within the
Contained Use Regulations
Th e r e gu la tion s a lso r equ ir e sites to u n der ta k e a h u m a n h ea lth a n d en vir on m en ta l r isk
a ssessm en t for a n y a ctivity in volvin g
GM/ GMOs a n d n otifica tion of th e a ctivity to
th e HSE (Kin der ler er, 1992). Th ese r isk
a ssessm en ts m u st be r ecor ded a n d k ept for a t
lea st ten yea r s a fter th e a ctivity h a s cea sed
a n d m u st be su bm itted to th e HSE a s pa r t of
th e n otifi ca tion pr ocedu r e for cer ta in types of
wor k . N otifica tion pr ocedu r es va r y a ccor din g
to th e h a za r ds of th e or ga n ism s u sed a n d th e
sca le a n d pu r pose of th e wor k , a n d a r e su m m a r ised in Ta ble I.
Biosafety training
Tr a in in g a n d in str u ction of per son n el in
biosa fety is im por ta n t in or der to im pa r t in for m a tion on sa fe oper atin g pr ocedu r es, pa r ticu la r ly beca u se of th e r ela tive pr edom in a n ce of
h u m a n er r or in a cciden t ca u sa tion . Isr a eli
(1986) fou n d th a t 80 per cen t of la bor a tor y
a cqu ir ed in fection s ca u sed by a n iden tifia ble
a cciden t occu r r ed a s a r esu lt of h u m a n er r or
a n d on ly 20 per cen t wer e du e to equ ipm en t
er r or. Sim ila r ly, stu dies of sa fety in h igh tech n ology in du str ies (su ch a s th e n u clea r in du str y) h ave con clu ded th a t th e m a in sou r ce of
a cciden ts lies in th e poten tia l for h u m a n er r or,
sin ce en gin eer in g devices h ave r ea ch ed a h igh
level of soph istica tion (ACSNI, 1990). Sin ce
h u m a n er r or plays a n im por ta n t r ole in a cci-
[ 101 ]
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 al., 1990).
Th e 1986 OECD 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 za r ds a n d m u st be tr a in ed a n d pr oficien 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 isin g th e im por ta n t r ole th a t biosa fety
tr a in in g plays in th e a tta in m en t of
“con ta in ed” u se a n d th u s th e avoida n ce of
a cciden ta l r elea se a n d con sequ en t en vir on m en ta l da m a ge, th e Hea lth a n d Sa fety E xecu tive (HSE ) com m ission ed a pr elim in a r y stu dy
to iden tify th e level, con ten t, for m a t a n d
exten t of biosa fety tr a in in g cu r r en tly pr ovided a t sites u n der ta k in g GM/ GMO oper a tion s (For d et a l., 1995). Da ta for th e r esea r ch
wer e collected by m ea n s of a posta l qu estion n a ir e a dm in ister ed to a ll sites cu r r en tly n otified to ca r r y ou t GM/ GMO a ctivities, plu s 20
in -depth ca se stu dies of selected sites. A
r espon se r a te of 41.2 per cen t w a s obta in ed
fr om th e posta l su r vey a n d th e ch a r a cter istics of r espon den ts cor r ela ted closely w ith th e
ch a r a cter istics of th e tota l popu la tion of sites
su r veyed in ter m s of or ga n isa tion a l type. Th e
r a tio of pu blic to pr iva te sector sites u n der ta k in g GM wor k w a s a lm ost 3:1, w ith u n iver sities con stitu tin g th e la r gest gr ou p of
r espon den ts followed by pu blic sector
r esea r ch in stitu tes a n d in du str ia l sites (F igu r es 1 a n d 2).
Of a ll pr ojects u n der ta k en a t th e r espon den t sites, 85 per cen t wer e cla ssified a s con ta in m en t level 1, wh ich r epr esen ts th e lowest
level of r isk , a n d a lm ost h a lf of th e r espon den ts u n der took wor k on ly a t th is level. On ly
9 per cen t of pr ojects u n der ta k en by r espon den ts u sed Gr ou p II (pa th ogen ic) or ga n ism s
a n d on ly 3 per cen t of pr ojects wer e cla ssified
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
to environment; small-sc ale
Non-pathogenic (Group I); poses no risk
to environment; large-sc ale
Pathogenic (Group II); small-sc ale
Annual retrospec tive c ount
Pathogenic (Group II); large-sc ale
[ 102 ]
Prior notific ation and summaries of risk
assessments submitted to the HSE
Prior notific ation and summaries of risk
assessments submitted to the HSE
Full risk assessment submitted and c onsent of
the HSE required before work c ommenc es
Figure 1
Establishme nt type s in to tal po pulatio n o f
no tifie d site s
Othe r
Industrial
Public
He alth/
Diagnostic
Unive rsity
Re se arc h
Institute
Figure 2
Establishme nt type s in re spo nde nt sample
Othe r
Industrial
Unive rsity
Public
He alth/
Diagnostic
Re se arc h
Institute
a s Type B (la r ge-sca le) (see Appen dix for
defin ition s of Types A a n d B). Cu r r en tly th e
h igh est r isk pr ojects u n der ta k en a t r espon den t sites wer e a t con ta in m en t level 3, w ith
on ly 2 per cen t of a ll pr ojects bein g u n der ta k en a t th is con ta in m en t.
Training provision
Th e m a in fi n din gs of th e su r vey wer e th a t
over a ll, h igh levels of tr a in in g wer e sa id to be
pr ovided for GM per son n el a t n otified sites,
h owever, exten sive va r ia tion s existed in th e
con ten t, for m a t a n d per ceived qu a lity of th e
tr a in in g for differ en t sta ff gr ou ps a n d differ en t sites.
Va r ia tion s fir st a r ose in th e a r ea s cover ed
in th e tr a in in g r eceived by differ en t sta ff.
Tr a in in g in pr a ctica l sk ills su ch a s good
m icr obiologica l pr a ctice w a s con cen tr a ted
a m on g ben ch sta ff a n d pr odu ction wor k er s,
wh er ea s m a n a ger s a n d biologica l sa fety officer s (BSOs) r eceived h igh levels of tr a in in g in
th e le gisla tion cover in g GM wor k a n d in r isk
a ssessm en t pr ocedu r es (see Ta ble II). Th is
va r ia tion su ggests th e topics bein g a ddr essed
did r efl ect th e r oles a n d r espon sibilities of
th ose bein g tr a in ed.
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
Th e fr equ en cy of tr a in in g pr ovided to per son n el w a s a lso fou n d to va r y a cr oss sta ff
gr ou pin gs (see Ta ble III). Wh ile r esea r ch a n d
tech n ica l sta ff wer e gen er a lly tr a in ed on
r ecr u itm en t, wh en th ey beca m e exposed to
n ew r isk s a n d con tin u a lly on th e job, m a n a gem en t r a r ely r eceived GM sa fety tr a in in g on
r ecr u itm en t a n d wer e m ost likely to r eceive it
on ly wh en lega l r equ ir em en ts/ du ties wer e
in tr odu ced. Refr esh er tr a in in g w a s r a r ely
offer ed to a n y of th e GM wor k er gr ou ps.
Meth ods of deliver in g tr a in in g iden tified in
th e qu estion n a ir e in clu ded off-th e-job tr a in in g, on -th e-job tr a in in g a n d th e pr ovision of
w r itten in for m a tion . Th e u se of th ese differ en t m eth ods a t th e r espon den t sites w a s fou n d
to va r y depen din g on th e r oles a n d r espon sibilities of differ en t per son n el. Wh ile m a n a ger ia l sta ff r elied h eavily on r eceivin g w r itten
in for m a tion r ega r din g sa fety r a th er th a n
en ga gin g in m or e pa r ticipa tive for m s of tr a in in g, on -th e-job tr a in in g com bin ed w ith w r itten in for m a tion w a s th e m ost com m on m ea n s
of deliver in g tr a in in g a n d in str u ction to both
ben ch sta ff a n d to pr odu ction wor k er s.
The management of training
Th e su r vey r evea led eviden ce of poor m a n a gem en t of sa fety tr a in in g for GM/ GMO
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 safe ty (pe r c e nt)
Recipients
BSO
Senior manager
Laboratory technician
Production worker
Notes:
L + LR:
RA:
GMP:
GMO:
L + LR
RA
GM P
GM O
91
80
72
78
93
78
71
71
86
69
91
92
88
72
82
78
Legislation and legal responsibilities
Risk assessment
Good mic robiologic al prac tic e
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 staff
wo rking in GM (pe r c e nt)
Recipients
Recr
N/ C risk
M anagers
25
27
Technical staff
69
58
Notes:
Rec r:
On being rec ruited
N/ C risk: On exposure to new or c hanged risk
Refr:
Refresher/ annual training c ourse
C leg:
On c hanged legal requirement
o-t-j
On-the-job i.e. c ontinually
Refr
C leg
o-t-j
13
9
47
39
19
64
wor k . On ly 40 per cen t of sites r epor ted
h avin g system s for m on itor in g th e pr ovision
of tr a in in g a n d m a n y of th ese h a d in for m a l
a r r a n gem en ts, su ch a s on -th e-job m on itor in g
by su per visor s.
Va r ia tion s a r ose between pu blic a n d pr iva te sector sites in th e system s u sed to
m a n a ge GM sa fety tr a in in g. For in sta n ce,
wh ile 71 per cen t of pr iva te sector sites
r epor ted th a t w r itten tr a in in g r ecor ds wer e
k ept, on ly 21 per cen t of pu blic sector sites
sta ted th a t th ey k ept su ch r ecor ds. Th e w r itten r ecor ds a t pr iva te sector sites con sisted of
a for m a l tr a in in g system , specifyin g a ppr opr ia te ou tcom es for ea ch level of tr a in in g,
en su r in g com peten cy w a s a ch ieved in ea ch
a r ea . Sa fety tr a in in g a t m a n y pu blic sector
sites w a s m a n a ged depa r tm en ta lly a n d sin ce
m a n y depa r tm en ts wer e sm a ll, th e u se of
in for m a l tr a in in g w ith ou t a n y cen tr a lised
pla n n in g w a s fr equ en tly a dopted. Wh ile th is
in for m a lity m ay be a ppr opr ia te in cer ta in
situ a tion s (e.g. wh er e low r isk wor k is u n der ta k en a n d sta ff h ave a lr ea dy r eceived tr a in in g
in GMP ), pr oblem s wer e r epor ted in th ose
ca ses wh er e sta ff r espon sible for th e pr ovision of tr a in in g felt in a dequ a tely equ ipped;
wh er e th ey h a d in su fficien t tim e a n d
r esou r ces ava ila ble to deliver th e tr a in in g; or
wh er e th eir n e ga tive a ttitu des tow a r ds sa fety
h in der ed tr a in in g pr ovision .
P r esen t gu ida n ce a bou t sa fety tr a in in g for
th e ACGM is m in im a l a n d descr ibes in br oa d
ter m s th e tr a in in g in pu ts r equ ir ed for ea ch
con ta in m en t level; for exa m ple, for GM wor k
a t con ta in m en t level 3, it is su ggested th a t:
“la bor a tor y per son n el m u st h ave h a d tr a in in g in h a n dlin g level 3 m icr o-or ga n ism s”
(ACGM/ HSE / DOE , 1988). N o gu ida n ce is
given on th e pa r ticu la r a r ea s in wh ich sta ff
sh ou ld be com peten t. Ou r r esu lts su ggest th a t
it m ay be m or e u sefu l to specify a ppr opr ia te
tr a in in g ou tcom es (in a sim ila r m a n n er to th e
COSHH Re gu la tion s a n d th e a ccom pa n yin g
Appr oved Code of P r a ctice). It wou ld be pa r ticu la r ly h elpfu l if th e a ppr opr ia te tr a in in g
a ction s for ea ch con ta in m en t level wer e
defin ed.
Organisational arrangements for
biosafety
A com pa r ison of th e or ga n isa tion a l a r r a n gem en ts for GM sa fety a t pu blic a n d pr iva te
sector sites r evea led th a t pu blic sector sites,
th e m a jor ity of wh ich wer e u n iver sities,
ten ded to h ave decen tr a lised a r r a n gem en ts,
w ith r espon sibilities for biosa fety devolved
to in dividu a l depa r tm en ts; wh er ea s
pr iva te sector sites h a d m or e cen tr a lised
[ 103 ]
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 ts, a llow in g sta n da r disa tion
a cr oss th e wh ole site.
Th e MHSW Re gu la tion s r equ ir e em ployer s
to a ppoin t com peten t per son (s) to a ssist th em
in com plyin g w ith h ea lth a n d sa fety le gisla tion ; ACGM a dvise th a t a t GM sites, a BSO
sh ou ld be a ppoin ted to fu lfil th is r ole. Va r ia tion s between pu blic a n d pr iva te sector
sites wer e a ppa r en t in th e n a tu r e of th e BSO’s
r ole. In th e pr iva te sector, a sin gle BSO
w ith a fu ll tim e a dvisor y r ole w a s gen er a lly
a ppoin ted for th e wh ole esta blish m en t. Th e
decen tr a lised a r r a n gem en ts w ith in u n iver sities, h owever, n ecessita ted th e a ppoin tm en t of
BSOs a t depa r tm en t level. Som e u n iver sities
a ppoin ted a n a ddition a l BSO to th e cen tr a l
sa fety office (a u n iver sity BSO (UBSO)) a n d
th eir r ole w a s to lia ise w ith th e depa r tm en ta l
BSO.
Th is lia ison va r ied w idely a t differ en t sites
a n d often r efl ected th e cu ltu r a l eth os of th a t
u n iver sity. BSOs w ith in u n iver sities a n d
r esea r ch in stitu tes wer e u su a lly a ppoin ted
fr om a m on g existin g r esea r ch or a ca dem ic
sta ff a n d u n der took th is r ole in a ddition to
th eir oth er r espon sibilities, cr ea tin g th e
poten tia l for con flictin g pr ior ities. Ca se stu dies of su ch esta blish m en ts su ggested th a t th e
su ppor t r eceived by depa r tm en ta l BSOs a n d
th eir ow n per ceived levels of com peten ce
va r ied m a r k edly, a ccor din g to th e tim e th ey
h a d ava ila ble to spen d on th e r ole, th e tr a in in g th ey h a d r eceived a n d th e exten t a n d
qu a lity of com m u n ica tion s w ith th e cen tr a l
sa fety office. Som e of th e depa r tm en ta l BSOs
a t u n iver sity sites wer e clea r ly u n su r e a s to
wh er e th eir le ga l r espon sibilities lay.
Conclusions
Alth ou gh th e r esu lts of th e r esea r ch r evea led
w idespr ea d pr ovision of in for m a tion ,
in str u ction a n d tr a in in g to per son n el wor k in g w ith or m a n a gin g GM oper a tion s, th e
n a tu r e a n d qu a lity of th e tr a in in g pr ovided
did va r y. Differ en ces in th e n a tu r e of tr a in in g
deliver y a ccor din g to per son n el type gen er a lly r eflected differ en ces in th e types of ta sk s
ca r r ied ou t, e.g. h igh er levels of on -th e-job
tr a in in g for per son n el ca r r yin g ou t pr edom in a n tly pr a ctica l or sk ill-ba sed ta sk s, su ch a s
r esea r ch a ssista n ts, tech n icia n s or pr odu ction wor k er s. It is, h owever, of som e con cer n
th a t m u ch of th e tr a in in g in GM sa fety for
m a n a ger s con sisted pr im a r ily of th e pr ovision of w r itten in for m a tion r a th er th a n
en ga gem en t in m or e pa r ticipa tive for m s of
tr a in in g. Th e r esea r ch su ggests th a t
r esou r ces wer e devoted to biosa fety tr a in in g,
bu t in som e or ga n isa tion s pa r ticu la r ly th ose
[ 104 ]
in th e pu blic sector, th e eva lu a tion of sa fety
tr a in in g w a s n ot bein g a ddr essed.
Con fu sion over th e con ten t of tr a in in g
a ppr opr ia te for GM sa fety w a s a ppa r en t
a m on g per son n el wor k in g a t n otified sites.
Som e for m of in str u ction a n d tr a in in g is
n ecessa r y for wor k a t a ll levels of con ta in m en t a n d th e specifica tion of com peten cy
levels wou ld en a ble th ose wh o felt th a t th ey
wer e n ot a dequ a tely tr a in ed to m ea su r e th eir
existin g com peten cies a ga in st a ppr oved sta n da r ds. Th ese sta n da r ds wou ld a lso fa cilita te
m or e effective pla n n in g a n d m a n a gem en t of
tr a in in g a t a loca l level by fa cilita tin g th e
iden tifi ca tion of th e tr a in in g n eeds of sta ff.
Wh ile th e specifica tion of com peten cy levels
for sa fe GM wor k wou ld a ssist in th e m a n a gem en t of tr a in in g pr ovision , th e r esu lts a lso
im plied th a t sites r equ ir e fu r th er gu ida n ce
on a ppr opr ia te m ea n s by wh ich sa fety tr a in in g cou ld be m on itor ed a n d eva lu a ted.
Mor e deta iled gu ida n ce is a lso r equ ir ed on
th e r oles, r espon sibilities a n d com peten cies
of BSOs, sin ce a t pr esen t th er e is w ide va r ia tion in th eir per ceived com peten ce a n d effectiven ess. Th is in for m a tion wou ld fa cilita te
th e iden tifica tion of in dividu a ls su ita ble for
th e position of BSO, en h a n ce th e a ssessm en t
of th eir tr a in in g n eeds, cla r ify th eir r ole for
em ployer s/ m a n a ger s a n d pr ovide a focu s
a r ou n d wh ich m a n a gem en t a n d BSOs in ea ch
esta blish m en t or depa r tm en t cou ld n e gotia te
a n a ch ieva ble wor k loa d to su it loca l con dition s a n d r esou r ces.
Hu m a n er r or plays a n im por ta n t r ole in
a cciden t ca u sa tion a n d if th e a cciden ta l
r elea se of poten tia lly h a r m fu l GMMs is to be
avoided em ployees m u st be aw a r e of a n y
poten tia l h a za r ds a n d tr a in ed to be pr oficien t
in th e pr a ctices a n d tech n iqu es n ecessa r y for
sa fe h a n dlin g.
References
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ACGM/ HSE / DOE (1993), Gu id a n ce N ote 7: Gu id elin es for th e R isk A ssessm en t of Opera tion s
In volvin g th e Con ta in ed Use of Gen etica lly
M od ifi ed M icro-orga n ism s (GM M s),
ACGM/ HSE / DOE .
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Gr ou p (1990), First R epor t on T ra in in g a n d
R ela ted M a tters, HSE Book s.
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“Biosa fety con sider a tion s in in du str ies w ith
pr odu ction m eth ods ba sed on th e u se of
r ecom bin a n t deoxyr ibon u cleic a cid”, S ca n d in a via n J ou r n a l of Work pla ce En viron m en ta l
Hea lth , Vol. 16, pp. 85-9.
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 ipps, Y. (1992), “‘E viden ce fr om Dr Yvon n e
Cr ipps, Dir ector of Stu dies in Law, E m m a n u el
Colle ge, Ca m br idge’ in Hou se of Lor ds Select
Com m ittee 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 petitiv en ess, HMSO, Lon don .
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Prelim in a r y Eva lu a tion of th e A d equ a cy of
Cu r ren t B iosa fety T ra in in g Provision for
T h ose W h o A re Work in g w ith , S u per visin g or
M a n a gin g Gen etic M od ifi ca tion , HSE .
F r om m er, W., Ager, B., Ar ch er, L. et a l. (1989),
“Sa fe biotech n ology III. Sa fety pr eca u tion s
for h a n dlin g m icr o-or ga n ism s of differ en t
r isk cla sses”, A pplied M icrob iolog y a n d
B iotech n olog y, Vol. 30, pp. 541-52.
Hea lth a n d Sa fety E xecu tive (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, HMSO, Lon don .
HSE (1995), Gen etic M od ifi ca tion – R isk s a n d S a fegu a rd s, HSE Book s.
Isr a eli, E . (1986), “Biosa fety in biotech n ologica l
pr ocesses”, in Liss, A.R. (E d.), A dva n ces in
B iotech n ologica l Processes, p. 6.
Kin der ler er, J . (1992), “‘E viden ce fr om Dr J u lia n
Kin der ler er, Depa r tm en t of Molecu la r Biology a n d Biotech n ology, th e Un iver sity of
Sh effield’ in Hou se of Lor ds Select Com m ittee
on Scien ce a n d Tech n ology”, in R egu la tion of
th e UK B iotech n ology In d u str y a n d Glob a l
Com petitiv en ess, HMSO, Lon don .
Mellon , M. (1991), “An en vir on m en ta list’s per spective”, in Davis, B. (E d.), T h e Gen etic R evolu tion , J oh n s Hopk in s Un iver sity P r ess.
Miles, C.M., Win sta n ley, M.A., Gu n n in g, J .G. a n d
Du r a n t, J . (1994), “Tow a r ds a pu blic con sen su s
on biotech n ology”, S cien ce in Pa rlia m en t,
Vol. 51, pp. 14-16.
OE CD Repor t (1986), R ecom b in a n t DN A S a fety
Con sid era tion s, Or ga n isa tion for E con om ic
Co-oper a tion a n d Developm en t, P a r is.
Ta it, J . a n d Levidow, L. (1992), “P r oa ctive a n d
r ea ctive a ppr oa ch es to r isk r e gu la tion . Th e
ca se for biotech n ology”, Fu tu res, Vol. 24 N o. 3,
pp. 219-31.
Appendix. Defi nitions of Types A and B
activities
Type A o pe ratio n
An y a ctivity in volvin g gen etica lly m odified
m icr o-or ga n ism s for th e pu r poses of tea ch in g, r esea r ch , developm en t, or for n on -in du str ia l or n on -com m er cia l pu r poses on a sca le
a t wh ich th e pr a ctices a n d con dition s of th e
oper a tion s r ela tive to th e cu ltu r e, volu m e a n d
n u m ber of or ga n ism s in volved is su ch th a t:
• th e system u sed to k eep th e or ga n ism s
u n der con ta in m en t r eflects good m icr obiologica l pr a ctice a n d good occu pa tion a l
sa fety a n d h ygien e: a n d
• It is possible to r en der th e or ga n ism s in a ctive by sta n da r d la bor a tor y decon ta m in a tion tech n iqu es.
Type B o pe ratio n
An y a ctivity in volvin g gen etic m odifica tion
of m icr o-or ga n ism s oth er th a n a Type A oper a tion .
[ 105 ]
modified organisms: the role of safety training
Norma Ford
De partme nt o f Enviro nme ntal Manage me nt, Unive rsity o f Salfo rd, Salfo rd, UK
Gai M urphy
De partme nt o f Enviro nme ntal Manage me nt, Unive rsity o f Salfo rd, Salfo rd, UK
Genetic modifi cation (GM) has
been called “ the new biotechnology” and has been hailed
as a leading enabling technology, facilitating major innovation in health care, as well as
in the chemical, agricultural
and food sectors. GM techniques facilitate the combination of DNA which would not
occur naturally and, although
there are no records of disease or accidents associated
with GM work, potential risks
do exist. Legislation designed
to ensure that workers are
adequately protected against
hazards also limits the risk of
environmental damage.
Human error plays an important role in accident causation, therefore appropriate
instruction, supervision and
training for personnel working
with GM/GMOs (genetically
modifi ed organisms) is essential. This article reviews the
regulatory controls for GM
work and discusses the fi ndings of a preliminary study
undertaken to identify the
level, content, format and
extent of biosafety training
currently provided at sites
undertaking GM work. While
high levels of biosafety training were reported, the content, organisation and management varied between the
establishments undertaking
GM work. Recommendations
are made regarding the management of biosafety training
including the need to establish competency levels for all
those working with, and
supervising and managing
work with, GMOs.
Enviro nme ntal Manage me nt
and He alth
9 / 3 [ 1998] 1 0 0 –1 0 5
© MCB Unive rsity Pre ss
[ ISSN 0956-6163]
[ 100 ]
Introduction
Th e a pplica tion of biotech n ology in in du str ies su ch a s ph a r m a ceu tica ls, fer m en ta tion
a n d a gr icu ltu r e h a s a lon g h istor y; for exa m ple, fa r m in g tech n iqu es h ave tr a dition a lly
u tilised m eth ods su ch a s n a tu r a l selection
a n d cr oss br eedin g to m a n ipu la te th e in h er ited ch a r a cter istics of pla n ts a n d a n im a ls.
However, cu r r en t in ter est a n d expa n sion in
th e field of biotech n ology lies pr im a r ily in
th e u se of gen etic m odifica tion (GM). Th e
Hou se of Lor ds Select Com m ittee on Scien ce
a n d Tech n ology (1992) descr ibed GM a s a k ey
en a blin g tech n ology fa cilita tin g m a jor in n ova tion in th e h ea lth ca r e, ch em ica l, a gr icu ltu r a l a n d food sector s lea din g to th e in ven tion of n ew dr u gs, a gr och em ica ls a n d br eedin g of pla n ts a n d a n im a ls. Th e tech n iqu es
m a k e it possible to ta ilor or ga n ism s to be
sa fer, m or e specific a n d m or e pr odu ctive in
wh a t th ey do th a n th eir u n m odified cou n ter pa r ts (HSE , 1995).
Risks from the new
biotechnology
GM is defin ed a s “th e a lter in g of th e gen etic
m a ter ia l in th a t or ga n ism by a w ay th a t does
n ot occu r n a tu r a lly by m a tin g or n a tu r a l
r ecom bin a tion or both ” (HSE , 1993). GM tech n iqu es ca n cir cu m ven t ba r r ier s th a t wou ld
n a tu r a lly r estr ict DNA exch a n ge between
u n r ela ted species (OE CD, 1986) a n d it is th is
fa ctor wh ich h a s r a ised pu blic con cer n s a n d
fu elled deba tes a bou t th e h u m a n a n d en vir on m en ta l r isk s a s well a s eth ica l issu es a r isin g
fr om th e a pplica tion of th e tech n ology (Miles
et a l., 1994).
Ma n y of th e poten tia l h a za r ds a r isin g fr om
th e u se of GM/ GMOs (gen etica lly m odifi ed
or ga n ism s) in r esea r ch la bor a tor ies a n d
in du str ia l settin gs a r e sim ila r to th ose fr om
th e u se of oth er biologica l a gen ts. Th ey
in clu de th e possibilities of:
• in fection of h u m a n s, a n im a ls or pla n ts fr om
th e h ost, r ecipien t or vector or ga n ism s;
• toxic or a ller gic effects a r isin g fr om th e
GMO, its com pon en ts or its m eta bolic pr odu cts;
• toxic or a ller gen ic effects a r isin g fr om th e
pr odu ct expr essed by th e GMO;
• en vir on m en ta l effects r esu ltin g fr om th e
a cciden ta l r elea se of GMOs (OE CD, 1986).
Mor e specific poten tia l h a za r ds a ssocia ted
w ith GM wor k h ave been r ecogn ised, sever a l
of wh ich h ave a n en vir on m en ta l im pa ct.
Th ese in clu de:
• Th e pr odu ction of m or e in fectiou s or dr u gr esista n t m icr o-or ga n ism s.
• Th e tr a n sfer of h a r m fu l gen etic m a ter ia l
(for exa m ple m a ter ia l a ssocia ted w ith ca n cer ) to h u m a n s via a GMO.
• Aggr essive gen etica lly m odified pla n ts
wh ich cou ld colon ise th e su r r ou n din g en vir on m en t, elim in a tin g pla n ts a lr ea dy livin g
th er e.
• Th e tr a n sfer of gen etic m a ter ia l fr om a
m odified pla n t wh ich m igh t be tr a n sfer r ed
to a r ela ted pla n t th a t is con sider ed a weed,
m a k in g it m or e com petitive, for exa m ple,
by en a blin g it to becom e r esista n t;
• In ter fer en ce of th e n a tu r a l r ecyclin g of
n u tr ien ts in th e en vir on m en t by m odifi ed
m icr o-or ga n ism s.
All la bor a tor y wor k in th e UK is r e gu la ted by
le gisla tion to en su r e th a t wor k er s a r e a dequ a tely pr otected a ga in st r isk s a r isin g fr om
th eir wor k . Mu ch of th e h ea lth a n d sa fety
le gisla tion is r ea ctive a n d w a s developed a s a
r esu lt of a cciden ts a n d/ or disea ses a r isin g in
th e wor k pla ce. In con tr a st, th e r e gu la tor y
con tr ols a pplyin g specifica lly to GM wor k
wer e developed a s a pr eca u tion a r y r espon se
to th e types of con jectu r a l r isk s ou tlin ed
a bove (sin ce n o disea ses/ a cciden ts a ttr ibu ta ble to GM tech n iqu es exist) a n d th er efor e
r epr esen t a “pr oa ctive” r e gu la tor y a ppr oa ch
ju stifi ed on th e ba sis of com plexity a n d
u n cer ta in ty. Th e issu e of com plexity pr im a r ily a pplies to th e r elea se of GMOs in to th e
en vir on m en t; ecologists a r gu e th a t it is
im possible to defin e u n a m bigu ou sly th e con sequ en ces of a r elea se or esca pe of GMOs
beca u se of th e im m en se com plexity of in ter a ction s w ith in livin g ecosystem s (F r om m er et
a l., 1989; Mellon , 1991). Un cer ta in ty, h owever,
a pplies to a ll wor k w ith GMOs, a n d is r ela ted
to its r ela tively r ecen t or igin s a n d in n ova tive
tech n iqu es (Ta it a n d Levidow, 1992).
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 bor a tor y wor k er s a r e pr otected by br oa dba sed occu pa tion a l h ea lth a n d sa fety le gisla tion wh ich in clu des Th e Hea lth a n d Sa fety a t
Wor k etc. Act (1974) (HSW); Th e Ma n a gem en t
of Hea lth a n d Sa fety a t Wor k Re gu la tion s
(1992) (MHSW) a n d Th e Con tr ol of Su bsta n ces
Ha za r dou s to Hea lth Re gu la tion s 1994
(COSHH). Th ose wor k in g w ith GM/ GMOs a r e
a lso r e gu la ted by m or e specific UK le gisla tion , th e Gen etica lly Modified Or ga n ism s
(Con ta in ed Use) Re gu la tion s (1992) a n d th e
Gen etica lly Modified Or ga n ism s (Deliber a te
Relea se) Re gu la tion s (1992), both of wh ich a r e
ba sed on E C Dir ectives. Th ese r e gu la tion s do
n ot a im dir ectly to con tr ol r isk sin ce th ey a r e
tech n iqu e r a th er th a n r isk -specific; bu t a im
to en su r e th a t a tten tion is pa id to th e possibility th a t th er e m ay be r isk s a ssocia ted w ith
GM/ GMO wor k (ACGM/ HSE / DOE , 1993).
On ly th e Con ta in ed Use Re gu la tion s wh ich
a r e design ed to fa cilita te th e sa fe con ta in ed
u se a n d h a n dlin g of GMOs in th e wor k pla ce
a r e con sider ed in th is a r ticle. Th ey differ
fr om pr eviou s UK r e gu la tion s gover n in g GM,
in th a t r isk s to th e en vir on m en t fr om wor k
in volvin g gen etica lly m odifi ed m icr o-or ga n ism s (GMMs) a r e a ddr essed in a ddition to th e
r isk s to h u m a n h ea lth a n d sa fety. E n vir on m en ta l r isk s a r isin g fr om la r ger gen etica lly
m odified or ga n ism s, su ch a s pla n ts a n d a n im a ls, a r e dea lt w ith by th e E n vir on m en ta l
P r otection Act 1990.
“Con ta in ed u se” of GMOs is defi n ed a s a n
a ctivity in wh ich th er e a r e “ph ysica l ba r r ier s, possibly su pplem en ted by ch em ica l or
biologica l on es, lim itin g con ta ct between th e
or ga n ism a n d th e popu la tion a n d en vir on m en t” (HSE , 1993).
Th e Con ta in ed Use Regu 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 egu la tion s a r e su pplem en ted by
gu ida n ce pu blish ed by th e Advisor y Com m ittee on Gen etic Modifica 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 egu 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 specified
by th e ACGM con sist of a com bin a tion of sa fe
oper atin 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 ken .
Th e con ta in m en t r equ ir em en ts of th e Con ta in ed Use Re gu la tion s n ot on ly lim it th e
exposu r e of wor k er s a n d oth er per son s to th e
GMOs a n d to th eir pr odu cts, bu t pr even t th e
r elea se of poten tia lly h a za r dou s a gen ts in to
th e ou tside en vir on m en t (OE CD, 1986). Th ey
a r e a n in te gr a l pa r t of th e r e gu la tor y con tr ols
wh ich h ave been developed to con tr ol th e
r isk s to th e en vir on m en t a r isin g fr om th e
a cciden ta l r elea se of GMOs.
P h ysica l con ta in m en t is th e pr im a r y m ea n s
by wh ich or ga n ism s a r e con ta in ed du r in g
GM/ GMO wor k a n d in clu des th r ee elem en ts:
1 con ta in m en t equ ipm en t;
2 sa fe oper a tin g pr a ctices a n d tech n iqu es;
and
3 fa cility design .
Con ta in m en t ca n con sist of both pr im a r y a n d
secon da r y for m s, th e for m er design ed to
pr otect th e wor k er s a n d th e im m edia te vicin ity fr om r elea se a n d th e la tter to pr otect th e
w ider en vir on m en t a n d people ou tside of th e
la bor a tor y. Wh ile con ta in m en t equ ipm en t is
u sed to en su r e pr im a r y con ta in m en t a n d
su ita ble design of fa cilities en su r es
secon da r y con ta in m en t, sa fe oper a tin g pr ocedu r es a n d pr a ctices for th e per son n el
in volved a r e vita l to both (OE CD, 1986).
Other requirements within the
Contained Use Regulations
Th e r e gu la tion s a lso r equ ir e sites to u n der ta k e a h u m a n h ea lth a n d en vir on m en ta l r isk
a ssessm en t for a n y a ctivity in volvin g
GM/ GMOs a n d n otifica tion of th e a ctivity to
th e HSE (Kin der ler er, 1992). Th ese r isk
a ssessm en ts m u st be r ecor ded a n d k ept for a t
lea st ten yea r s a fter th e a ctivity h a s cea sed
a n d m u st be su bm itted to th e HSE a s pa r t of
th e n otifi ca tion pr ocedu r e for cer ta in types of
wor k . N otifica tion pr ocedu r es va r y a ccor din g
to th e h a za r ds of th e or ga n ism s u sed a n d th e
sca le a n d pu r pose of th e wor k , a n d a r e su m m a r ised in Ta ble I.
Biosafety training
Tr a in in g a n d in str u ction of per son n el in
biosa fety is im por ta n t in or der to im pa r t in for m a tion on sa fe oper atin g pr ocedu r es, pa r ticu la r ly beca u se of th e r ela tive pr edom in a n ce of
h u m a n er r or in a cciden t ca u sa tion . Isr a eli
(1986) fou n d th a t 80 per cen t of la bor a tor y
a cqu ir ed in fection s ca u sed by a n iden tifia ble
a cciden t occu r r ed a s a r esu lt of h u m a n er r or
a n d on ly 20 per cen t wer e du e to equ ipm en t
er r or. Sim ila r ly, stu dies of sa fety in h igh tech n ology in du str ies (su ch a s th e n u clea r in du str y) h ave con clu ded th a t th e m a in sou r ce of
a cciden ts lies in th e poten tia l for h u m a n er r or,
sin ce en gin eer in g devices h ave r ea ch ed a h igh
level of soph istica tion (ACSNI, 1990). Sin ce
h u m a n er r or plays a n im por ta n t r ole in a cci-
[ 101 ]
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 al., 1990).
Th e 1986 OECD 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 za r ds a n d m u st be tr a in ed a n d pr oficien 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 isin g th e im por ta n t r ole th a t biosa fety
tr a in in g plays in th e a tta in m en t of
“con ta in ed” u se a n d th u s th e avoida n ce of
a cciden ta l r elea se a n d con sequ en t en vir on m en ta l da m a ge, th e Hea lth a n d Sa fety E xecu tive (HSE ) com m ission ed a pr elim in a r y stu dy
to iden tify th e level, con ten t, for m a t a n d
exten t of biosa fety tr a in in g cu r r en tly pr ovided a t sites u n der ta k in g GM/ GMO oper a tion s (For d et a l., 1995). Da ta for th e r esea r ch
wer e collected by m ea n s of a posta l qu estion n a ir e a dm in ister ed to a ll sites cu r r en tly n otified to ca r r y ou t GM/ GMO a ctivities, plu s 20
in -depth ca se stu dies of selected sites. A
r espon se r a te of 41.2 per cen t w a s obta in ed
fr om th e posta l su r vey a n d th e ch a r a cter istics of r espon den ts cor r ela ted closely w ith th e
ch a r a cter istics of th e tota l popu la tion of sites
su r veyed in ter m s of or ga n isa tion a l type. Th e
r a tio of pu blic to pr iva te sector sites u n der ta k in g GM wor k w a s a lm ost 3:1, w ith u n iver sities con stitu tin g th e la r gest gr ou p of
r espon den ts followed by pu blic sector
r esea r ch in stitu tes a n d in du str ia l sites (F igu r es 1 a n d 2).
Of a ll pr ojects u n der ta k en a t th e r espon den t sites, 85 per cen t wer e cla ssified a s con ta in m en t level 1, wh ich r epr esen ts th e lowest
level of r isk , a n d a lm ost h a lf of th e r espon den ts u n der took wor k on ly a t th is level. On ly
9 per cen t of pr ojects u n der ta k en by r espon den ts u sed Gr ou p II (pa th ogen ic) or ga n ism s
a n d on ly 3 per cen t of pr ojects wer e cla ssified
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
to environment; small-sc ale
Non-pathogenic (Group I); poses no risk
to environment; large-sc ale
Pathogenic (Group II); small-sc ale
Annual retrospec tive c ount
Pathogenic (Group II); large-sc ale
[ 102 ]
Prior notific ation and summaries of risk
assessments submitted to the HSE
Prior notific ation and summaries of risk
assessments submitted to the HSE
Full risk assessment submitted and c onsent of
the HSE required before work c ommenc es
Figure 1
Establishme nt type s in to tal po pulatio n o f
no tifie d site s
Othe r
Industrial
Public
He alth/
Diagnostic
Unive rsity
Re se arc h
Institute
Figure 2
Establishme nt type s in re spo nde nt sample
Othe r
Industrial
Unive rsity
Public
He alth/
Diagnostic
Re se arc h
Institute
a s Type B (la r ge-sca le) (see Appen dix for
defin ition s of Types A a n d B). Cu r r en tly th e
h igh est r isk pr ojects u n der ta k en a t r espon den t sites wer e a t con ta in m en t level 3, w ith
on ly 2 per cen t of a ll pr ojects bein g u n der ta k en a t th is con ta in m en t.
Training provision
Th e m a in fi n din gs of th e su r vey wer e th a t
over a ll, h igh levels of tr a in in g wer e sa id to be
pr ovided for GM per son n el a t n otified sites,
h owever, exten sive va r ia tion s existed in th e
con ten t, for m a t a n d per ceived qu a lity of th e
tr a in in g for differ en t sta ff gr ou ps a n d differ en t sites.
Va r ia tion s fir st a r ose in th e a r ea s cover ed
in th e tr a in in g r eceived by differ en t sta ff.
Tr a in in g in pr a ctica l sk ills su ch a s good
m icr obiologica l pr a ctice w a s con cen tr a ted
a m on g ben ch sta ff a n d pr odu ction wor k er s,
wh er ea s m a n a ger s a n d biologica l sa fety officer s (BSOs) r eceived h igh levels of tr a in in g in
th e le gisla tion cover in g GM wor k a n d in r isk
a ssessm en t pr ocedu r es (see Ta ble II). Th is
va r ia tion su ggests th e topics bein g a ddr essed
did r efl ect th e r oles a n d r espon sibilities of
th ose bein g tr a in ed.
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
Th e fr equ en cy of tr a in in g pr ovided to per son n el w a s a lso fou n d to va r y a cr oss sta ff
gr ou pin gs (see Ta ble III). Wh ile r esea r ch a n d
tech n ica l sta ff wer e gen er a lly tr a in ed on
r ecr u itm en t, wh en th ey beca m e exposed to
n ew r isk s a n d con tin u a lly on th e job, m a n a gem en t r a r ely r eceived GM sa fety tr a in in g on
r ecr u itm en t a n d wer e m ost likely to r eceive it
on ly wh en lega l r equ ir em en ts/ du ties wer e
in tr odu ced. Refr esh er tr a in in g w a s r a r ely
offer ed to a n y of th e GM wor k er gr ou ps.
Meth ods of deliver in g tr a in in g iden tified in
th e qu estion n a ir e in clu ded off-th e-job tr a in in g, on -th e-job tr a in in g a n d th e pr ovision of
w r itten in for m a tion . Th e u se of th ese differ en t m eth ods a t th e r espon den t sites w a s fou n d
to va r y depen din g on th e r oles a n d r espon sibilities of differ en t per son n el. Wh ile m a n a ger ia l sta ff r elied h eavily on r eceivin g w r itten
in for m a tion r ega r din g sa fety r a th er th a n
en ga gin g in m or e pa r ticipa tive for m s of tr a in in g, on -th e-job tr a in in g com bin ed w ith w r itten in for m a tion w a s th e m ost com m on m ea n s
of deliver in g tr a in in g a n d in str u ction to both
ben ch sta ff a n d to pr odu ction wor k er s.
The management of training
Th e su r vey r evea led eviden ce of poor m a n a gem en t of sa fety tr a in in g for GM/ GMO
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 safe ty (pe r c e nt)
Recipients
BSO
Senior manager
Laboratory technician
Production worker
Notes:
L + LR:
RA:
GMP:
GMO:
L + LR
RA
GM P
GM O
91
80
72
78
93
78
71
71
86
69
91
92
88
72
82
78
Legislation and legal responsibilities
Risk assessment
Good mic robiologic al prac tic e
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 staff
wo rking in GM (pe r c e nt)
Recipients
Recr
N/ C risk
M anagers
25
27
Technical staff
69
58
Notes:
Rec r:
On being rec ruited
N/ C risk: On exposure to new or c hanged risk
Refr:
Refresher/ annual training c ourse
C leg:
On c hanged legal requirement
o-t-j
On-the-job i.e. c ontinually
Refr
C leg
o-t-j
13
9
47
39
19
64
wor k . On ly 40 per cen t of sites r epor ted
h avin g system s for m on itor in g th e pr ovision
of tr a in in g a n d m a n y of th ese h a d in for m a l
a r r a n gem en ts, su ch a s on -th e-job m on itor in g
by su per visor s.
Va r ia tion s a r ose between pu blic a n d pr iva te sector sites in th e system s u sed to
m a n a ge GM sa fety tr a in in g. For in sta n ce,
wh ile 71 per cen t of pr iva te sector sites
r epor ted th a t w r itten tr a in in g r ecor ds wer e
k ept, on ly 21 per cen t of pu blic sector sites
sta ted th a t th ey k ept su ch r ecor ds. Th e w r itten r ecor ds a t pr iva te sector sites con sisted of
a for m a l tr a in in g system , specifyin g a ppr opr ia te ou tcom es for ea ch level of tr a in in g,
en su r in g com peten cy w a s a ch ieved in ea ch
a r ea . Sa fety tr a in in g a t m a n y pu blic sector
sites w a s m a n a ged depa r tm en ta lly a n d sin ce
m a n y depa r tm en ts wer e sm a ll, th e u se of
in for m a l tr a in in g w ith ou t a n y cen tr a lised
pla n n in g w a s fr equ en tly a dopted. Wh ile th is
in for m a lity m ay be a ppr opr ia te in cer ta in
situ a tion s (e.g. wh er e low r isk wor k is u n der ta k en a n d sta ff h ave a lr ea dy r eceived tr a in in g
in GMP ), pr oblem s wer e r epor ted in th ose
ca ses wh er e sta ff r espon sible for th e pr ovision of tr a in in g felt in a dequ a tely equ ipped;
wh er e th ey h a d in su fficien t tim e a n d
r esou r ces ava ila ble to deliver th e tr a in in g; or
wh er e th eir n e ga tive a ttitu des tow a r ds sa fety
h in der ed tr a in in g pr ovision .
P r esen t gu ida n ce a bou t sa fety tr a in in g for
th e ACGM is m in im a l a n d descr ibes in br oa d
ter m s th e tr a in in g in pu ts r equ ir ed for ea ch
con ta in m en t level; for exa m ple, for GM wor k
a t con ta in m en t level 3, it is su ggested th a t:
“la bor a tor y per son n el m u st h ave h a d tr a in in g in h a n dlin g level 3 m icr o-or ga n ism s”
(ACGM/ HSE / DOE , 1988). N o gu ida n ce is
given on th e pa r ticu la r a r ea s in wh ich sta ff
sh ou ld be com peten t. Ou r r esu lts su ggest th a t
it m ay be m or e u sefu l to specify a ppr opr ia te
tr a in in g ou tcom es (in a sim ila r m a n n er to th e
COSHH Re gu la tion s a n d th e a ccom pa n yin g
Appr oved Code of P r a ctice). It wou ld be pa r ticu la r ly h elpfu l if th e a ppr opr ia te tr a in in g
a ction s for ea ch con ta in m en t level wer e
defin ed.
Organisational arrangements for
biosafety
A com pa r ison of th e or ga n isa tion a l a r r a n gem en ts for GM sa fety a t pu blic a n d pr iva te
sector sites r evea led th a t pu blic sector sites,
th e m a jor ity of wh ich wer e u n iver sities,
ten ded to h ave decen tr a lised a r r a n gem en ts,
w ith r espon sibilities for biosa fety devolved
to in dividu a l depa r tm en ts; wh er ea s
pr iva te sector sites h a d m or e cen tr a lised
[ 103 ]
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 ts, a llow in g sta n da r disa tion
a cr oss th e wh ole site.
Th e MHSW Re gu la tion s r equ ir e em ployer s
to a ppoin t com peten t per son (s) to a ssist th em
in com plyin g w ith h ea lth a n d sa fety le gisla tion ; ACGM a dvise th a t a t GM sites, a BSO
sh ou ld be a ppoin ted to fu lfil th is r ole. Va r ia tion s between pu blic a n d pr iva te sector
sites wer e a ppa r en t in th e n a tu r e of th e BSO’s
r ole. In th e pr iva te sector, a sin gle BSO
w ith a fu ll tim e a dvisor y r ole w a s gen er a lly
a ppoin ted for th e wh ole esta blish m en t. Th e
decen tr a lised a r r a n gem en ts w ith in u n iver sities, h owever, n ecessita ted th e a ppoin tm en t of
BSOs a t depa r tm en t level. Som e u n iver sities
a ppoin ted a n a ddition a l BSO to th e cen tr a l
sa fety office (a u n iver sity BSO (UBSO)) a n d
th eir r ole w a s to lia ise w ith th e depa r tm en ta l
BSO.
Th is lia ison va r ied w idely a t differ en t sites
a n d often r efl ected th e cu ltu r a l eth os of th a t
u n iver sity. BSOs w ith in u n iver sities a n d
r esea r ch in stitu tes wer e u su a lly a ppoin ted
fr om a m on g existin g r esea r ch or a ca dem ic
sta ff a n d u n der took th is r ole in a ddition to
th eir oth er r espon sibilities, cr ea tin g th e
poten tia l for con flictin g pr ior ities. Ca se stu dies of su ch esta blish m en ts su ggested th a t th e
su ppor t r eceived by depa r tm en ta l BSOs a n d
th eir ow n per ceived levels of com peten ce
va r ied m a r k edly, a ccor din g to th e tim e th ey
h a d ava ila ble to spen d on th e r ole, th e tr a in in g th ey h a d r eceived a n d th e exten t a n d
qu a lity of com m u n ica tion s w ith th e cen tr a l
sa fety office. Som e of th e depa r tm en ta l BSOs
a t u n iver sity sites wer e clea r ly u n su r e a s to
wh er e th eir le ga l r espon sibilities lay.
Conclusions
Alth ou gh th e r esu lts of th e r esea r ch r evea led
w idespr ea d pr ovision of in for m a tion ,
in str u ction a n d tr a in in g to per son n el wor k in g w ith or m a n a gin g GM oper a tion s, th e
n a tu r e a n d qu a lity of th e tr a in in g pr ovided
did va r y. Differ en ces in th e n a tu r e of tr a in in g
deliver y a ccor din g to per son n el type gen er a lly r eflected differ en ces in th e types of ta sk s
ca r r ied ou t, e.g. h igh er levels of on -th e-job
tr a in in g for per son n el ca r r yin g ou t pr edom in a n tly pr a ctica l or sk ill-ba sed ta sk s, su ch a s
r esea r ch a ssista n ts, tech n icia n s or pr odu ction wor k er s. It is, h owever, of som e con cer n
th a t m u ch of th e tr a in in g in GM sa fety for
m a n a ger s con sisted pr im a r ily of th e pr ovision of w r itten in for m a tion r a th er th a n
en ga gem en t in m or e pa r ticipa tive for m s of
tr a in in g. Th e r esea r ch su ggests th a t
r esou r ces wer e devoted to biosa fety tr a in in g,
bu t in som e or ga n isa tion s pa r ticu la r ly th ose
[ 104 ]
in th e pu blic sector, th e eva lu a tion of sa fety
tr a in in g w a s n ot bein g a ddr essed.
Con fu sion over th e con ten t of tr a in in g
a ppr opr ia te for GM sa fety w a s a ppa r en t
a m on g per son n el wor k in g a t n otified sites.
Som e for m of in str u ction a n d tr a in in g is
n ecessa r y for wor k a t a ll levels of con ta in m en t a n d th e specifica tion of com peten cy
levels wou ld en a ble th ose wh o felt th a t th ey
wer e n ot a dequ a tely tr a in ed to m ea su r e th eir
existin g com peten cies a ga in st a ppr oved sta n da r ds. Th ese sta n da r ds wou ld a lso fa cilita te
m or e effective pla n n in g a n d m a n a gem en t of
tr a in in g a t a loca l level by fa cilita tin g th e
iden tifi ca tion of th e tr a in in g n eeds of sta ff.
Wh ile th e specifica tion of com peten cy levels
for sa fe GM wor k wou ld a ssist in th e m a n a gem en t of tr a in in g pr ovision , th e r esu lts a lso
im plied th a t sites r equ ir e fu r th er gu ida n ce
on a ppr opr ia te m ea n s by wh ich sa fety tr a in in g cou ld be m on itor ed a n d eva lu a ted.
Mor e deta iled gu ida n ce is a lso r equ ir ed on
th e r oles, r espon sibilities a n d com peten cies
of BSOs, sin ce a t pr esen t th er e is w ide va r ia tion in th eir per ceived com peten ce a n d effectiven ess. Th is in for m a tion wou ld fa cilita te
th e iden tifica tion of in dividu a ls su ita ble for
th e position of BSO, en h a n ce th e a ssessm en t
of th eir tr a in in g n eeds, cla r ify th eir r ole for
em ployer s/ m a n a ger s a n d pr ovide a focu s
a r ou n d wh ich m a n a gem en t a n d BSOs in ea ch
esta blish m en t or depa r tm en t cou ld n e gotia te
a n a ch ieva ble wor k loa d to su it loca l con dition s a n d r esou r ces.
Hu m a n er r or plays a n im por ta n t r ole in
a cciden t ca u sa tion a n d if th e a cciden ta l
r elea se of poten tia lly h a r m fu l GMMs is to be
avoided em ployees m u st be aw a r e of a n y
poten tia l h a za r ds a n d tr a in ed to be pr oficien t
in th e pr a ctices a n d tech n iqu es n ecessa r y for
sa fe h a n dlin g.
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Appendix. Defi nitions of Types A and B
activities
Type A o pe ratio n
An y a ctivity in volvin g gen etica lly m odified
m icr o-or ga n ism s for th e pu r poses of tea ch in g, r esea r ch , developm en t, or for n on -in du str ia l or n on -com m er cia l pu r poses on a sca le
a t wh ich th e pr a ctices a n d con dition s of th e
oper a tion s r ela tive to th e cu ltu r e, volu m e a n d
n u m ber of or ga n ism s in volved is su ch th a t:
• th e system u sed to k eep th e or ga n ism s
u n der con ta in m en t r eflects good m icr obiologica l pr a ctice a n d good occu pa tion a l
sa fety a n d h ygien e: a n d
• It is possible to r en der th e or ga n ism s in a ctive by sta n da r d la bor a tor y decon ta m in a tion tech n iqu es.
Type B o pe ratio n
An y a ctivity in volvin g gen etic m odifica tion
of m icr o-or ga n ism s oth er th a n a Type A oper a tion .
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