brian crook igem talk
TRANSCRIPT
ww
w.h
sl.g
ov.u
kA
n A
gency
of
the H
ealth a
nd S
afe
ty E
xecutive
ww
w.h
sl.g
ov.u
kA
n A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Synth
etic B
iolo
gy -
bio
safe
ty
regula
tions a
nd a
ssessin
g r
isk
(or…
……
)B
ria
n C
roo
k, M
icro
bio
logy T
eam
Lea
der
He
alth a
nd
Safe
ty L
abora
tory
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Either:
•H
ow
syn
theti
c b
iolo
gy w
ill save
man
kin
d
OR
•W
icked
Fra
nken
ste
in s
cie
nti
sts
p
layin
g g
od
…ag
ain
.
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Health &
Safe
ty L
abora
tory
(H
SL –
who
we a
re, w
hat w
e d
o w
ww
.hsl.gov.u
k)
�L
oca
ted
ne
ar
Bu
xto
n, U
K�
Bri
tain
's le
ad
ing
in
dustr
ial h
ea
lth
an
d s
afe
ty
facili
ty -
an
ag
ency o
f H
SE
�
45
0 p
eo
ple
co
ve
rin
g a
ll m
ain
scie
nce
are
as,
e.g
.m
icro
bio
log
y, im
mu
no
log
y, ch
em
istr
y,
en
gin
eeri
ng
, ve
ntila
tio
n, p
sych
olo
gy,
me
tallu
rgy &
ma
teri
als
, m
ine
rals
& fib
res,
erg
on
om
ics, co
mp
uta
tio
nal m
od
elli
ng
, fire
an
d
exp
losiv
es, in
cid
en
t p
ho
togra
ph
y�
Our
serv
ices to
pub
lic a
nd
pri
va
te s
ecto
rs:
–R
esearc
h a
nd d
evelo
pm
ent
–In
cid
ent
investigation f
or
HS
E
–E
nvironm
enta
l and b
iolo
gic
al m
onitori
ng
–R
isk A
ssessm
ent
and c
ontr
ol evalu
ation
–T
rain
ing
–S
pecia
list
advic
e a
nd c
onsultancy
–D
raft
ing o
f guid
ance a
nd leg
isla
tion
–V
alid
ation a
nd c
ert
ific
ation
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
HS
L : W
here
we s
it
Ce
ntr
al G
overn
ment
HS
LH
ealth a
nd
Safe
tyLab
ora
tory
HS
E
He
alth a
nd
Safe
ty E
xe
cutive
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Health a
nd S
afe
ty L
egis
lation r
ele
vant
to b
iolo
gic
al safe
ty
Du
ty u
nd
er
the
law
to
ass
es
s a
nd
man
ag
e t
he
ris
ks
ass
oc
iate
d
wit
h b
iolo
gic
al a
ge
nts
, c
urr
en
tly…
RE
PO
RT
ING
OF
INJU
RIE
S D
ISE
AS
ES
AN
D D
AN
GE
RO
US
OC
CU
RR
EN
CE
S
RE
GU
LA
TIO
NS
1995
CA
RR
IAG
E O
F
DA
NG
ER
OU
S
GO
OD
S…
RE
GU
LA
TIO
NS
2004
GE
NE
TIC
ALLY
MO
DIF
IED
OR
GA
NIS
MS
(CO
NT
AIN
ED
US
E)
RE
GU
LA
TIO
NS
2000
MA
NA
GE
ME
NT
OF
HE
ALT
H
AN
D S
AF
ET
Y A
T W
OR
K
RE
GU
LA
TIO
NS
1999
CO
NT
RO
L O
F S
UB
ST
AN
CE
S
HA
ZA
RD
OU
S T
O H
EA
LT
H
RE
GU
LA
TIO
NS
2002
HE
ALT
H A
ND
SA
FE
TY
AT
WO
RK
AC
T 1
974
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
CO
NT
RO
L M
EA
SU
RE
S
•C
OS
HH
co
ve
rs b
oth
ch
em
ica
l a
nd
bio
log
ica
l h
aza
rds
Every
em
plo
ye
r shall
ensure
that
the e
xposu
re o
f his
em
plo
yees t
o
substa
nces h
aza
rdous t
o h
ea
lth is e
ither
pre
vente
d o
r, w
here
this
is
not
reason
ably
pra
cticable
, ad
equate
ly c
ontr
olle
d
•H
iera
rch
y o
f p
rin
cip
les
fo
r c
on
tro
llin
g e
xp
os
ure
:
1.
Elim
inate
the r
isks
2.
Contr
ol risks a
t sourc
e
3.
Min
imis
e t
he r
isks b
y d
esig
nin
g s
uitab
le s
yste
ms o
f w
ork
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
CO
SH
H H
IER
AR
CH
Y
•E
lim
ina
tio
n
•S
ub
sti
tuti
on
•E
ng
ine
eri
ng
co
ntr
ols
•S
afe
ty p
roc
ed
ure
s
•P
PE
an
d R
PE
•V
ac
cin
ati
on
…if t
he o
bje
ctives o
f th
e w
ork
can b
e m
et
without
usin
g a
bio
log
ical a
gent
…w
ith a
less h
aza
rdo
us b
iolo
gic
al a
gent
…e.g
. conta
inm
ent
labora
tory
, safe
ty c
abin
ets
, m
echa
nic
al ventila
tion
…e.g
. hand h
ygie
ne p
olic
y,
waste
dis
posal a
nd d
eco
nta
min
ation
…la
b c
oats
, glo
ves,
gogg
les,
respirato
rs
…is
the v
ery
la
st
line o
f defe
nce.
if t
here
is r
elia
nce o
n t
he p
rote
ction
aff
ord
ed b
y a
vaccin
e t
he
n o
ther
contr
ols
are
inad
equ
ate
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Cu
rren
t U
K R
eg
ula
tory
Po
sit
ion
fo
r b
iolo
gic
al ag
en
ts
Co
ntr
ol
of
Su
bsta
nces H
azard
ou
s
to H
ealt
h R
eg
ula
tio
ns
Sp
ecif
ied
An
imal
Path
og
en
s O
rders
En
gla
nd
; S
co
tlan
d;
Wale
s;
NI
(SA
PO
)
Gen
eti
call
y M
od
ifie
d O
rgan
ism
s
(Co
nta
ined
Use)
Reg
ula
tio
ns
Imp
lem
en
ts 2
00
0/5
4/E
C (
Bio
logic
al A
ge
nts
Dir
ective
)
Imp
lem
en
ts 2
00
9/4
1/E
C (
GM
Co
nta
ine
d U
se
Dir
ective
)
No
tifica
tio
n;
Ris
k A
sse
ssm
en
t; I
nsp
ectio
n;
En
forc
em
en
t
Ris
k A
ssessm
en
t; N
otifica
tio
n;
Pe
rmis
sio
nin
g;
Insp
ectio
n;
En
forc
em
en
t
Insp
ectio
n -
Lic
en
se
; In
sp
ectio
n -
Re
-lic
en
se
Lic
ence
im
ple
men
ts 2
00
3/8
5/E
C (
FM
D D
ire
ctive
)
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Ho
w t
he R
eg
ula
tio
ns f
it t
og
eth
er
Ge
ne
tic
all
y M
od
ifie
d
Org
an
ism
s (
Co
nta
ine
d
Us
e)
Re
gu
lati
on
sS
pe
cif
ied
An
ima
l P
ath
og
en
s O
rde
r
Co
ntr
ol
of
Su
bs
tan
ce
s
Ha
za
rdo
us
to
He
alt
h
Re
gu
lati
on
s
Zo
on
os
es
GM
Zo
on
os
es
GM
An
ima
l
Pa
tho
ge
ns
GM
Hu
ma
n
Pa
tho
ge
ns
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Th
e f
utu
re –
wo
rkin
g t
ow
ard
s a
S
ing
le R
eg
ula
tory
Fra
mew
ork
GM
O (
Co
nta
ined
Use)
Reg
ula
tio
ns
Sp
ecif
ied
An
imal
Path
og
en
s O
rders
CO
SH
H
Sch
ed
ule
3
Bio
log
ical
Ag
en
ts a
nd
Gen
eti
call
y
Mo
dif
ied
Org
an
ism
s (
Co
nta
ined
U
se)
Reg
ula
tio
ns 2
011
Imp
lem
en
ts 2
00
0/5
4/E
C (
Bio
logic
al A
ge
nts
Dir
ective
)
Imp
lem
en
ts 2
00
9/4
1/E
C (
GM
Co
nta
ine
d U
se
Dir
ective
)
Imp
lem
en
ts “
Min
imu
m S
tan
da
rds”
in 2
00
3/8
5/E
C (
FM
D D
ire
ctive
)
Ris
k A
ssessm
en
t; I
nte
gra
ted
No
tifica
tio
ns;
Pe
rmis
sio
nin
g(C
lass 3
an
d 4
); I
nsp
ectio
n;
En
forc
em
en
t
Co
mb
ine
d c
on
tain
me
nt
tab
les (
Co
nta
inm
en
t le
ve
ls 1
-4 w
ith
de
rog
atio
n*)
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
No
tify
HS
E (
cla
ss
2-4
)
Ap
ply
fo
r D
ero
ga
tio
n†
†d
ero
ga
tio
ns
c
an
b
e
req
ues
ted
fo
r w
ork
w
ith
a
ny
GM
Ms
an
d
sp
ec
ifie
d
an
ima
l p
ath
og
en
s
bu
t o
nly
c
ert
ain
w
ild
-typ
e
hu
ma
n
pa
tho
ge
ns
Ide
nti
fy a
ny u
nn
ec
es
sa
ry c
on
tro
l m
ea
su
res
Ho
w t
his
will aff
ect
the A
pp
roach
to
Ris
k A
ssessm
en
t
As
sig
n r
isk
cla
ss
ific
ati
on
(c
las
s 1
-4)
us
ing
co
mb
ine
d c
on
tain
me
nt
tab
les
Ca
rry o
ut
a r
isk
as
se
ss
me
nt
De
term
ine
ha
za
rd g
rou
p o
f w
ild
-typ
e B
A(u
sin
g A
pp
rove
d L
ist
or
as
sig
ne
d b
y u
se
r)
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Wh
at
do
es a
ll t
his
mean
to
syn
theti
c b
iolo
gy?
•B
iolo
gic
al m
ate
ria
ls a
re “
su
bsta
nce
s h
aza
rdo
us
to h
ea
lth
”;
•A
t p
rese
nt,
syn
the
tic b
iolo
gic
al a
ge
nts
will
be
asse
sse
d u
nd
er
GM
O r
eg
ula
tio
ns;
•In
fu
ture
, lik
ely
to
be
asse
sse
d u
nd
er
‘CU
20
11
’
reg
ula
tio
ns (
sim
ilar
in p
rin
cip
le t
o G
M r
eg
s.)
;
•E
ith
er
wa
y, th
ere
is a
ne
ed
to
asse
ss r
isk,
cla
ssify, a
nd
assig
n p
rop
ort
ion
ate
co
ntr
ols
.
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Assess, cla
ssif
y, assig
n –
tell m
e m
ore
Th
is is h
ow
it
wo
rks w
ith
GM
M (
se
e S
AC
GM
C
om
pe
nd
ium
of
Gu
ida
nce
http
://w
ww
.hse
.go
v.u
k/b
iosa
fety
/gm
o/a
cg
m/a
cgm
co
mp
/part
2.p
df):
•K
no
wle
dg
e o
f risk a
ssocia
ted w
ith p
are
nt
org
an
ism
s
(recip
ient, insert
, vecto
r) -
takin
g into
accou
nt
dis
ab
lem
ent
or
attenuation;
•P
ote
ntia
l fo
r m
odific
ation t
o a
lter
host
org
an
ism
path
og
en
icity, virule
nce,
infe
ctivity, tr
opis
m, host
range,
susceptib
ility
to p
rophyla
xis
;
•D
ete
rmin
e n
ecessary
contr
ols
(hum
an h
ealth a
nd
environm
ent)
•F
inal cla
ssific
ation s
ub
mitte
d to H
SE
for
appro
va
l.
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Cra
ig V
en
ter’
s late
st
-‘s
yn
theti
c
bacte
riu
m’o
r T
roja
n H
ors
e?
•S
ynth
esis
of
Mycopla
sm
a
myco
ides
in a
M.caprico
lum
cell
–uses w
ell
defin
ed
org
an
ism
s a
nd p
ropert
ies;
•R
isk c
an b
e a
ssessed
fro
m
kno
wn p
ropert
ies o
f th
e
age
nts
involv
ed;
•P
rovid
es p
roof
of princip
le,
but
clo
ser
to G
M (
‘top d
ow
n’)
than s
ynth
etic b
iolo
gy
(‘bott
om
up’)?
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Assessin
g t
he r
isk p
rop
ert
ies o
f a
realsyn
theti
c o
rgan
ism
Th
e s
imp
listi
c v
iew
:
•T
he s
ynth
etic a
gent
will
com
prise a
num
ber
(n)
of
synth
etic g
enom
es a
ssem
ble
d t
ogeth
er
to c
reate
a s
elf
replic
atin
g o
rgan
ism
;
•E
ach ind
ivid
ua
l synth
etic g
enom
e p
resents
zero
ris
k t
o
hum
an h
ea
lth a
nd t
he e
nvironm
ent;
•T
here
fore
–n x
zero
= z
ero
.
Ho
wever:
•In
realit
y t
he s
um
is g
reate
r th
an the in
div
idu
al part
s;
•T
here
fore
ho
w d
o y
ou a
ssess t
he r
isk?
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Reg
ula
tin
g n
ew
tech
no
log
y –
str
ikin
g t
he r
igh
t b
ala
nce
•In
public
co
nsu
ltation,
eff
ective r
egula
tion
and c
ontr
ol co
nsid
ere
d o
ne o
f th
e m
ost
import
ant
issu
es;
•S
cie
ntists
“sho
uld
not
be a
llow
ed t
o
regula
te t
hem
selv
es”;
•In
the U
K,
it w
as c
onsid
ere
d t
hat
safe
guard
s in p
lace w
ould
be
eff
ective in
contr
olli
ng c
urr
ent
researc
h,
but
that
“regula
tions n
eed t
o k
eep a
pa
ce w
ith
scie
ntific d
evelo
pm
ents
to r
em
ain
adeq
uate
”.
•W
hile
th
e n
eed
to
co
ntr
ol w
as
imp
ort
an
t, r
eg
ula
tio
n s
ho
uld
a
lso
“n
ot stifle
de
ve
lopm
en
t a
nd
pro
gre
ss o
f syn
the
tic
bio
log
y”.
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Ho
w H
SE
pla
ns t
o r
eg
ula
te
syn
theti
c b
iolo
gy
•G
ath
er
know
led
ge o
n c
urr
ent
and futu
re a
ctivitie
s in t
he
UK
an
d g
loba
lly;
•E
ng
ag
e w
ith r
esearc
hers
to u
nde
rsta
nd t
heir c
urr
ent
and f
utu
re w
ork
;
•U
se c
urr
en
t G
MO
legis
lative f
ram
ew
ork
as b
asis
for
regu
lation;
•P
ossib
le c
han
ges t
o r
egu
latio
ns w
ill f
ollo
w G
MO
ris
k
assessm
en
t princip
les;
•C
ontin
ue d
ialo
gue w
ith
UK
researc
hers
to d
evelo
p a
pra
gm
atic leg
isla
tive f
ram
ew
ork
with p
ractical guid
ance.
An A
gency o
f th
e H
ealth a
nd S
afe
ty E
xecutive
Tim
efr
am
e a
nd
fu
ture
acti
on
s
•H
SL,
on H
SE
’s b
eha
lf, are
curr
ently u
ndert
akin
g
kno
wle
dge g
ath
eri
ng a
nd m
akin
g c
onta
cts
with s
ynth
etic
bio
logy r
esearc
h n
etw
ork
s;
•F
inal re
port
back t
o H
SE
by e
nd o
f 2010;
•H
SE
to u
se info
rmation t
o d
evelo
p f
utu
re g
uid
ance
(inte
rna
l gu
idelin
es o
n a
ssessin
g a
pp
lication
s; exte
rna
l
gu
idance to r
esearc
hers
);
•Y
OU
R I
NP
UT
TO
TH
IS I
S V
ITA
L–
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