Working to reduce the use of animals in scientific research
Delivery Report
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Acknowledgements
© Crown copyright 2015
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated.
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This Delivery Report describes the progress made on actions set out in the Delivery Plan published on 7 February
2014. The Report has been prepared by the Home Office (HO), the Department for Business, Innovation and Skills
(BIS) and the Department of Health (DH). It includes substantial contributions from other government departments
including the Department for Environment, Food and Rural Affairs (Defra), the Foreign & Commonwealth Office
(FCO) and the Food Standards Agency (FSA), and from government agencies including Public Health England
(PHE), the Medicines and Healthcare Products Regulatory Agency (MHRA), the Veterinary Medicines Directorate
(VMD), the Animal & Plant Health Agency (APHA), the Food and Environment Research Agency (Fera), the Centre
for Environment, Fisheries and Aquaculture Science (Cefas) and the Health and Safety Executive (HSE). The
Research Councils have also contributed significantly to this work.
We recognise in particular the major contribution made to the implementation of the Delivery Plan by the National
Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs).
ISBN: 978-1-78246-731-1
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
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Foreword
In February 2014, the Government published its Delivery Plan ‘Working to reduce the use of animals in scientific research’1. In this Delivery Report we summarise progress since that publication.The Delivery Plan brought together new and existing initiatives, through a science-led approach, for promoting the widespread adoption of scientific and technological advances which present significant opportunities to replace animal use, to reduce the number of animals used and to refine the procedures involved so as to find additional ways to minimise suffering of animals used in scientific research – the 3Rs. The Plan also proposed ways in which the UK would increase openness and transparency.Since the Plan was published, a wealth of significant new research and knowledge dissemination on the 3Rs has been completed. It includes the launch of the first products from the NC3Rs open innovation programme CRACK IT, a £4m competition run by Innovate UK and the NC3Rs to fund the commercialisation of non-animal technologies, and the publication of important new studies on veterinary and human vaccine testing by Defra and Public Health England which have identified scope to reduce the numbers of animals used in developing vaccines. New joint working by the RSPCA and the Home Office has additionally produced refined testing models to reduce animal suffering.We have taken major steps to encourage greater international adoption of 3Rs techniques, including a ground-breaking programme of knowledge-sharing with regulators and life science associations in China led by the Animals in Science Regulation Unit. In addition, we have published collaborative research across the global life sciences sector led by the NC3Rs and the
UK’s Medicines and Healthcare Products Regulatory Agency to minimise the use of recovery animals in pharmaceutical development.The use of animals in scientific research rightly attracts considerable attention and scrutiny. The public is entitled to know why such research is carried out, how animal welfare needs are addressed and what steps are being taken to reduce dependence on animal-based research. We are therefore delivering on our commitments to increase openness in the use of animals for research in the UK. In particular, we have consulted on options to reform section 24 of the Animals (Scientific Procedures) Act 1986 to allow greater access to animal research information. Greater openness brings increased opportunities to explain why the carefully regulated use of animals in scientific research remains of vital importance in improving our understanding of human and animal disease, and in ensuring the safety of new medicines.The UK is a global leader in the 3Rs and the concerted efforts underpinning the Delivery Plan have provided a new platform and new tools to accelerate the domestic and international uptake of scientifically valid alternatives in research and safety testing. Ongoing scientific and technological advances will provide many further opportunities to reduce our dependence on animal-based testing. We will build on the momentum generated and cross-sector relationships developed through this Plan’s implementation to ensure that the UK stays at the forefront of global efforts to find and use alternatives to animal testing, while continuing to make clear the important benefits that animal research brings to society.
1 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/277942/bis-14-589-working-to-reduce-the-use-of_animals-in-research.pdf
The Rt Hon Lynne Featherstone MP
Minister for Crime Prevention
Home Office
George Freeman MP
Minister for Life Sciences
Dept for Business, Innovation & Skills,
& Dept of Health
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
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Contents
Acknowledgements ....................................................................................................................2
Foreword ....................................................................................................................................3
Contents .....................................................................................................................................5
Introduction .................................................................................................................................7
Progress on the three strategic objectives .................................................................................8
Strategic Priority 1 .....................................................................................................................8
Strategic Priority 2 ...................................................................................................................10
Strategic priority 3 ....................................................................................................................12
Tables .......................................................................................................................................15
Glossary ...................................................................................................................................34
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
7
The Government is clear that science has a major role
to play in developing new technologies and approaches
that wherever possible replace, reduce and refine
the use of animals in scientific research (the ‘3Rs’).
Breakthroughs in areas such as tissue engineering,
stem cells and computer modelling have opened up
significant opportunities to reduce our reliance on
animal research models. Government departments,
agencies and other publicly funded bodies with a role
in life sciences research have an important part to play
in helping find and seize these new opportunities, and
to share knowledge in this area both in the UK and
internationally.
The Government is also committed to increasing
openness and transparency in animal research,
by giving the public new tools and opportunities to
understand how and why such research is carried out,
and to scrutinise the steps being taken to minimise
suffering and find alternatives.
The Delivery Plan, published on 7 February 2014, set
out three strategic priorities in meeting the Coalition
Government’s commitment to work to reduce the use of
animals in scientific research:
● advance the use of the 3Rs within the UK;
● use international leadership to influence the uptake
and adoption of 3Rs approaches globally; and
● promote an understanding and awareness of
animals where no alternatives exist.
In Sections 1, 2 and 3 of this report, we describe the
progress that has been achieved in pursuing these
three core objectives, including new initiatives that have
been launched since the original Plan was published. In
the tables at the end of the report we provide updates
on each specific action.
The Plan has been implemented through a partnership
comprising:
● relevant central government departments and non-
ministerial departments including the Home Office,
BIS, Defra, the Department of Health, the Foreign
Office and the Food Standards Agency;
● the National Centre for the 3Rs (NC3Rs); and its
main funders, the Medical Research Council (MRC)
and the Biotechnology and Biological Sciences
Research Council (BBSRC); and
● agencies, including Public Health England (PHE),
the Medicines and Healthcare Products Regulation
Agency (MHRA), the Health and Safety Executive
(HSE), the Food and Environment Research Agency
(Fera), the Animal & Plant Health Association
(APHA), the Centre for Environment, Fisheries
and Aquaculture Science (Cefas), the Veterinary
Medicines Directorate (VMD) and Innovate UK
(formerly the Technology Strategy Board).
The partnership has brought together expertise,
knowledge and data-sharing around a common set
of priorities and provides a strong platform to identify
further opportunities
to implement the
3Rs in the UK and
overseas. It has
also helped drive a
more proactive and
consistent approach
in communicating
with the public
about the use of
animals in scientific
research.
Introduction
Working to reduce the use of animals in scientific research
ASRU Delivery Plan final artwork.indd 1 04/12/2013 17:53
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PROGRESS ON THE THREE STRATEGIC OBJECTIVES
Strategic Priority 1 Advancing the use of the 3Rs in the UK
Overview and summary progress on actions (for a detailed breakdown see Tables, Strategic Priority 1)
The UK has strength and depth to support the delivery
of 3Rs approaches through the NC3Rs, other funders
and the regulatory framework but also strongly
supported by researchers and organisations in the life
sciences sector.
The NC3Rs’ mission is to replace, refine and reduce the
use of animals in research. Building on their ten-year
history, they not only lead the UK science community
in developing and sharing 3Rs techniques and practice
here but show strong international leadership in the
field. The various programmes and initiatives funded
by the NC3Rs have both identified problems and found
innovative solutions to shape changes in policy, practice
and regulations through science-led approaches. The
recent publication of the NC3Rs’ vision for the next ten
years is a holistic approach focusing on five inter-related
areas: Practice, Procedures,
People, Places and Policy2.
It is not only the 3Rs that are
important. The Government
recognises that innovative
approaches to research can
open up new fields of study in
areas where animal methods
have limits, and in doing
so find improved methods
for answering scientific
questions that could lead to
a real reduction in the use of
animals in the longer term.
Such innovation is being
backed by Innovate UK, working with the NC3Rs and
the Research Councils, through the funding (£3m
committed) last year of business-led feasibility studies
into Non-Animal Technologies (NATs). Innovate UK
has now announced a new £6m funding competition
in this area which opens on 23 March3 and is working
in parallel with partners, including the NC3Rs and
Research Councils, to produce a NATs Roadmap for the
UK. The Roadmap will provide a focus for supporting
and increasing the scale and impact of NATs activities in
the UK research and industry base, and develop routes
to commercialisation and adoption of the NATs products
and services generated.
The Home Office Animals in Science Regulation Unit
(ASRU – the regulator) has delivered new Guidance
and a Code of Practice with increased emphasis on the
3Rs during 2014. ASRU continues to engage across the
spectrum of stakeholders, through proactive stakeholder
2 http://www.nc3rs.org.uk/our-vision3 https://interact.innovateuk.org/-/developing-non-animal-technologies
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
meetings, consultation and presentations
at a range of national fora, to disseminate
the 3Rs and promote leading practice to
improve animal welfare within the regulatory
framework.
Case study examples from the Delivery Plan
Action 1.1 (1) Publication of the review of the NC3Rs’ pharmaceutical industry collaborations
The NC3Rs published its ten-year review of
working with more than 40 pharmaceutical
and biotechnology companies and
regulatory agencies from the UK, elsewhere
in Europe and the USA, fostering a
cross-company approach to the 3Rs.
The NC3Rs is a trusted partner for data-
sharing with companies providing extensive
non-clinical and clinical data-sets from
historic compounds and those currently
in development. The NC3Rs works with
companies to interrogate and analyse data
and rationalise the requirement for in vivo
studies to deliver 3Rs impacts. Through
its collaborations the NC3Rs has sought
to build evidence bases that could not be
achieved by any one company alone.
Action 1.8 Updated requirements for applications which include animal research
The Medical Research Council and the Biotechnology
and Biological Sciences Research Council (MRC
and BBSRC) have produced updated guidance on
their expectations for applicants and reviewers in
relation to the use of animals in bioscience research.
The emphasis is on improving the information on
experimental design and the 3Rs. As part of the process
of implementing this, a workshop was held jointly with
NC3Rs in September 2014 to promote the importance
of improved scrutiny of experimental design in the
peer review process, including representatives from
charitable funders.
Further actions supplementing the Delivery Plan
Frozen Embryo and Sperm Archive
There has been a steady increase in usage of the
Frozen Embryo and Sperm Archive (FESA) at MRC
Harwell, part of the European Mutant Mouse Archive,
both for archiving stocks and in requests for distribution.
Improved techniques have led to a shift from freezing
embryos towards freezing sperm, which reduces the
numbers of mice necessary per strain for archiving and
recovery.
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Strategic Priority 2 Influencing the uptake and adoption of 3Rs approaches globally
Overview and summary progress on actions (for a detailed breakdown see Tables, Strategic Priority 2)
The UK’s commitment and development of 3Rs
approaches places it in a strong position to spread
best practice and influence overseas. Our vision for
the continued development of non-animal technologies
provides a bright future for predictive test systems that
supports both the drive for animal welfare and a thriving
life sciences community that uses animals only where
there are no validated alternatives. Furthermore, the
UK seeks to give companies with high ethical standards
greater opportunities to trade in growing markets that
currently require the use of questionable animal tests in
order to market their products. The UK also continues to
support the UK life sciences industry through working to
harmonise international regulatory testing requirements.
Through the Delivery Plan we have made significant
progress against our objectives, in particular by:
● supporting the NC3Rs’ international initiatives;
● engaging with other countries to promote
harmonisation of global regulatory standards which
use alternatives wherever possible;
● providing an evidence base for where changes
would be beneficial to international regulations
which require animal use; and
● working to end unnecessary animal testing for
cosmetics globally.
Case study examples from the Delivery Plan
Actions under 2.1 Joint international leadership by the NC3Rs and MHRA
In addition to engagement with specific countries on
the 3Rs, the UK has helped lead discussions in OECD
and other international fora to secure agreement to
new validated alternatives to animal testing. The tables
with this report describe joint international leadership
by the NC3Rs and the MHRA to identify opportunities
to reduce the use of animals in safety pharmacology
studies and to minimise the use of recovery animals
in pharmaceutical studies. The UK also played a key
part in discussions that led to the OECD publishing two
new Test Guidelines on human health hazard endpoint
skin sensitisation that are expected to replace gradually
animal tests required in this area.
The Government and its partner agencies have taken
new action to promote the 3Rs within Europe. For
example, the NC3Rs carried out a detailed programme
of knowledge-sharing with the Italian Ministry of Health
and the Lombardy Regional Government. This is
helping lead to the creation of a panel of scientists that
can advocate the use of the 3Rs in Italy.
Action 2.4 Cosmetics alternatives and Action 2.5 Developing Delivery Plan priorities into an effective international communication and influencing strategy
The UK and EU have banned animal testing of
cosmetics. However, 80% of other countries have not.
There is therefore significant scope to reduce global
testing on animals through the UK showing global
leadership and influence. This will, in turn, deliver
economic benefits for the UK by opening up foreign
cosmetics markets to ethically produced UK cosmetic
products.
This priority has a particular focus on China where
animal testing is mandated for cosmetics imported
from the EU and elsewhere. Through this work we
support a drive to further incorporate 3Rs techniques
into frameworks, thus encouraging the move towards
greater acceptance of non-animal data and the opening
up of markets to trade.
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
China has relaxed the requirements for animal data
on domestically produced cosmetics so that there
is no longer a mandate to provide such data as
long as an adequate risk assessment can be made
based on other data. However, there is still work to
be done both to apply this to cosmetics produced
outside China (e.g. in the UK) and to up-skill Chinese
regulators and cosmetics producers to be able to
perform such risk assessments. We are supporting
China in this endeavour alongside our partners in the
EU Commission and the European trade association,
Cosmetics Europe.
The Home Office Animals in Science Regulation Unit,
and BIS have hosted a visit to the UK by a senior
delegation of officials from the China Food & Drug
Administration (CFDA) to discuss ways
in which human safety of cosmetics and
medicines can be assured through rigorous
risk assessments which do not include
unnecessary animal data. Their programme
included visits to: the NC3Rs; Huntingdon
Life Sciences; the Association of the British
Pharmaceutical Industry (ABPI); Unilever;
Walgreens Boots Alliance; and meetings
with the EU Commission and Cosmetics
Europe as well as UK government teams.
The visits demonstrated best practice in
cosmetic and pharmaceutical safety testing
and showcased UK expertise in the 3Rs
with a particular focus on non-animal testing
methods.
UK government officials, in partnership with
the Chinese Association for Laboratory
Animal Sciences (CALAS), held a scene-
setting seminar in Beijing to explore
opportunities for UK–China cooperation
in the development of standards for the
welfare of research animals and their
ethical use in China. This is important to
create an ethical framework within which
UK scientists can collaborate with partners
in China on a compatible basis. A further
UK–China Seminar is planned for 2015 to support the
further development of current voluntary standards
for research animal care, welfare and ethical use to
become mandatory national standards in China.
We have also engaged with other countries that
mandate testing for cosmetics, including Brazil, where
we are encouraging a new domestic political initiative
to legislate against the unnecessary use of animals in
testing cosmetics and also the acceptance of safety
data which has been produced overseas, such as in
the UK. As the third largest consumer of cosmetics in
the world, Brazil has the potential to deliver the great
reductions in animal testing.
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Strategic priority 3 Promoting an understanding and awareness about the use of animals where no alternatives exist
Overview and summary progress on actions (for a detailed breakdown see Tables, Strategic Priority 3)
The Government is committed to promoting a culture of
openness and transparency around the use of animals
in scientific research. Openness is crucial to help people
understand, and challenge if they wish, the reasons for
animal research where no validated alternatives exist,
and to demonstrate more widely the many safeguards in
place to minimise suffering. Public trust in the regulatory
system depends in large part on people feeling that they
have the ability to get answers to their questions and
to explore any concerns. Being able and willing to talk
openly about the use of animals also helps signal to
global industry and academia that the UK remains one
of the best places for high quality life sciences research.
To understand public opinion in this area and gauge
the success of new approaches on openness, the
Government continues to commission an independent
opinion poll on public attitudes to animal research.
Results from the latest poll in March 2014 indicate that
around two-thirds of the public continue to accept the
use of animals in medical research where there are no
alternatives. At the same time, the poll suggested that
more could be done to increase public understanding
around animal research. For example, only three in
ten respondents said that they felt “well informed”
about the use of animals in research, while a similar
proportion still believed that animal testing is allowed
for cosmetics, despite this having been banned in the
UK for over a decade. The poll clearly indicates the
need for openness and transparency to place public
understanding on a firm footing to inform well-evidenced
public debate on the issues. Since that poll was carried
out, a number of new initiatives on openness and
transparency have been launched, as summarised
below.
Action 3.3 Concordat on openness and transparency
In May 2014, the life sciences sector launched a
landmark ‘Concordat on openness and transparency in
UK animal research’4. The Concordat has been signed
by 86 organisations working across the UK life sciences
sector, including major pharmaceutical companies
and contract research organisations, UK universities
engaged in animal research and the UK’s medical
research charities. It commits each organisation to the
following four pledges.
● To be clear about when, how and why they use
animals in research.
● To enhance their communications with the media
and the public about their research using animals.
● To be proactive in providing opportunities for the
public to find out about research using animals.
● To report on progress annually.
4 http://www.understandinganimalresearch.org.uk/policy/concordat-openness-animal-research/
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
5 http://www.ucl.ac.uk/animal-research http://www.cam.ac.uk/research/research-at-cambridge/animal-research http://www.cardiff.ac.uk/research/our-research-environment/integrity-and-ethics/animal-research http://www.bristol.ac.uk/university/governance/policies/animal-policy.html
6 https://www.gov.uk/government/publications/compliance-investigations-by-the-animals-in-science-regulation-unit
The Concordat puts the UK life sciences sector at
the head of global efforts to increase openness and
transparency in animal research. Every signatory
organisation has given a clear commitment both to
facilitate greater scrutiny of their animal research and
to be visibly accountable by reporting annually on their
progress towards implementing the Concordat.
Its publication has already led directly to a number of
new initiatives on public engagement, including the
development of new websites5 and outreach activities
by, among others, University College London, the
University of Cambridge, the University of Bristol and
Cardiff University. Signatories are also taking steps to
engage directly with the public and the media, to explain
why they use animals in research and the measures
in place to ensure animal care and welfare. This more
accountable approach to the use of research animals
is intended to give members of the public a clearer idea
of the work carried out in animal research facilities, as
well as stimulate discussion and challenge. A progress
report on implementation of the Concordat is due to
be published in June 2015, and will include measures
taken to promote greater public dialogue about the
use of animals in research, as well as to invite greater
accountability.
Action 3.4: Review of section 24 of the Animals (Scientific Procedures) Act 1986
As we committed to in the Delivery
Plan, the Government has held
a full public consultation on
options to reform section 24 of the
Animals (Scientific Procedures)
Act 1986 (ASPA). Section 24
currently places a blanket ban on
the disclosure of any information
provided to the regulator or
those involved in animal research in confidence. The
Government recognises that this is out of step with
wider policy on openness and transparency. Last year’s
consultation document set out a preferred government
option of moving to more open disclosure of information
while retaining statutory prohibitions on the disclosure
of sensitive information, including that which could
prejudice intellectual property rights or compromise
personal safety.
Further actions supplementing the Delivery Plan objectives on openness
Publication of investigation reports
Further to the Delivery Plan, the Home Office has, in
2014, started publishing anonymised summaries of
reports where there has been a substantial investigation
by the regulator6. The Home Office has routinely
reported high-level summaries of all cases of non-
compliance in the ASRU Annual Report for several
years. However, these reports are in addition to the
usual reporting to help ensure that all stakeholders
can learn from the outcomes of these investigations
as early as possible and enable them to address any
potential weaknesses. In addition, the reports provide
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
the public with an insight into this work. In determining
which investigation reports to publish, the Home Office
have applied a public interest test. In the interests of
transparency, we expect that a decision to not publish
an investigation report to be the exception.
Publication of actual severity data pilot7
The recently transposed EU Directive (2010/63/EU)
requires the collection of data on the actual severity
of procedures. Each animal that undergoes scientific
procedures must be allocated a severity classification
indicating the level of harm actually suffered due to
those procedures. As an aid to ensuring a smooth
implementation of the new requirement for reporting
actual severity, a pilot study was carried out over a
two-month period in August and September 2013. The
data collected were a sample and not intended to be
entirely representative of the distribution of procedures
performed in the UK; however, it provided a preliminary
snapshot of the distribution of actual severity.
A prospective classification that predicts the likely
harms is assessed by inspectors and is used as part
of the harm–benefit analysis of a proposed project.
The intention behind introducing recording actual
rather than just prospective harm is primarily to
increase transparency on the real harms of animal use.
Collecting these data will also have the potential to aid
in the targeting of refinement initiatives by identifying
areas of high severity.
The results showed that 5% of the 35,409 procedures
reported were determined to be sub-threshold, 81.5%
were reported as mild, 11% were reported as moderate
and only 2% were reported as severe. Just over 1%
were non-recovery procedures. The severe procedures
involved mainly mice, rats and fish. Severe outcomes
were reported for both basic and applied research
procedures, and also for routine production, but not for
regulatory testing.
This information is now formally collected in the UK,
and in the rest of the EU for the first time for procedures
completed from January 2014 onwards. It will be
published for the first time later in 2015.
7 https://www.gov.uk/government/publications/animals-in-science-regulation-unit-annual-report-2013
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
15
In this section we describe each of the actions set out
in the Delivery Plan and provide a detailed report on
progress.
In the Delivery Plan we described a wide range of
measures to promote the 3Rs, both within the UK and
internationally. The Plan also provided opportunities
for researchers and industry to address the 3Rs in
their work. The actions included existing programmes
and also sought to foster new, specifically targeted,
programmes.
As in the Delivery Plan, the Delivery Report tables in
this section consider progress on delivery against each
of our three strategic priorities:
Strategic Priority 1 – a domestic programme which
focuses on advancing the use of the 3Rs within the UK;
Strategic Priority 2 – an international programme
aimed at influencing the uptake and adoption of 3Rs
approaches globally; and
Strategic Priority 3 – a programme aimed at promoting
an understanding and awareness about the use of
animals where no alternatives exist.
Tables
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Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Stra
tegi
c Pr
iorit
y 1:
Adv
anci
ng th
e us
e of
the
3Rs
dom
estic
ally
by
putti
ng th
em a
t the
hea
rt o
f sci
ence
-led
prog
ram
mes
.
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
1.1
Nat
iona
l Cen
tre
for t
he R
epla
cem
ent,
Ref
inem
ent a
nd
Red
uctio
n of
Ani
mal
s in
R
esea
rch
prog
ram
mes
(NC
3Rs)
1) P
ublic
atio
n of
the
seco
nd re
view
of t
he N
C3R
s re
sear
ch p
ortfo
lio b
y N
ovem
ber 2
013.
- Rec
eive
d po
sitiv
ely
by s
take
hold
ers
and
sect
or.
- Enh
ance
d un
ders
tand
ing
by s
take
hold
ers
and
publ
ic o
f hig
h-qu
ality
rese
arch
fund
ed
by th
e N
C3R
s an
d th
e an
imal
wel
fare
, sc
ient
ific
and
soci
etal
ben
efits
of t
his.
Com
plet
ed.
2) L
aunc
h of
the
NC
3Rs
Exp
erim
enta
l Des
ign
Ass
ista
nt o
nlin
e re
sour
ce.
Ear
ly u
ptak
e an
d us
e by
rese
arch
co
mm
unity
and
impr
oved
und
erst
andi
ng
of th
e 3R
s be
nefit
s to
goo
d ex
perim
enta
l de
sign
.
The
beta
test
ing
is n
ow c
ompl
ete
and
the
syst
em
is b
eing
am
ende
d fro
m s
take
hold
er fe
edba
ck. T
he
Exp
erim
enta
l Des
ign
Ass
ista
nt w
ill b
e la
unch
ed in
20
15.
3) C
RA
CK
IT: T
he 2
013
CR
AC
K IT
Cha
lleng
es
com
petit
ion
cons
ists
of f
ive
Cha
lleng
es id
entif
ied
join
tly b
y th
e N
C3R
s an
d in
dust
ry s
pons
ors
who
pr
ovid
e in
-kin
d co
ntrib
utio
ns in
clud
ing
data
, ac
cess
to c
ompo
unds
, val
idat
ion
stud
ies,
etc
. C
RA
CK
IT C
halle
nges
is a
mile
ston
e-dr
iven
fu
ndin
g co
mpe
titio
n fro
m th
e N
C3R
s w
hich
is
desi
gned
to (i
) min
imis
e th
e us
e of
ani
mal
s in
re
sear
ch; a
nd (i
i) su
ppor
t the
dev
elop
men
t of
mar
keta
ble
prod
ucts
and
/or i
mpr
oved
bus
ines
s pr
oces
ses.
The
tota
l bud
get f
or th
e 20
13 ro
und
of C
RA
CK
IT C
halle
nges
is a
ppro
xim
atel
y £7
m.
Con
tract
s aw
arde
d to
add
ress
the
chal
leng
es.
The
2014
Pha
se 1
aw
ards
for p
roof
-of-c
once
pt s
tudi
es
have
bee
n m
ade
for t
he th
ree
CR
AC
K IT
Cha
lleng
es
– th
ese
focu
s on
toxi
city
end
-poi
nts
and
we
have
sp
onso
rs (w
ho p
rovi
de in
-kin
d co
ntrib
utio
ns) f
rom
the
phar
mac
eutic
al a
nd c
hem
ical
sec
tors
. The
Pha
se 2
w
inne
rs w
ill b
e de
cide
d in
Jul
y 20
15.
4) S
trate
gic
awar
d: Im
agin
g te
chno
logy
de
velo
pmen
t for
the
3Rs
– th
e N
C3R
s ha
ve
rece
ntly
ann
ounc
ed a
stra
tegi
c fu
ndin
g ca
ll to
sup
port
high
-qua
lity
rese
arch
pro
posa
ls
to a
ddre
ss g
enui
ne te
chno
logi
cal c
halle
nges
in
pre
clin
ical
imag
ing
whi
ch, i
f sol
ved,
wou
ld
adva
nce
scie
nce
and
the
3Rs.
The
tota
l bud
get
for t
his
stra
tegi
c ca
ll is
£1m
.
Awar
ds m
ade.
Th
e su
m o
f £1.
5 m
illio
n ha
s be
en in
vest
ed in
five
im
agin
g pr
ojec
ts w
ith c
o-fu
ndin
g fro
m th
e E
ngin
eerin
g an
d P
hysi
cal S
cien
ces
Res
earc
h C
ounc
il (E
PS
RC
).
5) D
isea
se m
odel
s –
the
NC
3Rs
are
deve
lopi
ng
a pr
ogra
mm
e of
wor
k, b
ased
on
prev
ious
ex
perie
nce,
focu
sing
on
dise
ase
mod
els
and
effic
acy
test
ing.
Thi
s in
clud
es d
isea
se a
reas
su
ch a
s as
thm
a, e
pile
psy
and
pain
, and
they
are
w
orki
ng w
ith th
e A
BP
I to
secu
re fu
ndin
g to
lead
on
this
. An
initi
al p
riorit
y is
can
cer m
odel
s.
Eng
agin
g an
d bu
ildin
g re
latio
nshi
ps w
ith
the
canc
er re
sear
ch c
omm
unity
in a
pply
ing
the
3Rs
to th
eir r
esea
rch.
A w
orks
hop
was
hel
d in
Feb
ruar
y 20
15 c
over
ing
prec
linic
al o
ncol
ogy
rese
arch
mod
els.
The
out
put o
f w
orks
hop
will
info
rm N
C3R
s’ fu
ture
pla
ns in
onc
olog
y su
ch a
s re
sear
ch in
vest
men
t.
17
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
1.2
Impr
oved
reso
urce
sh
arin
g in
clud
ing
outc
omes
of r
esea
rch,
re
sour
ces,
ani
mal
s an
d da
ta
(NC
3Rs
with
MR
C a
nd
BB
SRC
)
Exa
mpl
es o
f ong
oing
wor
k in
clud
e:- R
ecen
tly la
unch
ed N
C3R
s In
frast
ruct
ure
for
Impa
ct (I
fL) s
chem
e.- S
hare
d A
gein
g R
esea
rch
Mod
els
(ShA
RM
–
Bio
repo
sito
ry o
f age
d m
ouse
tiss
ues)
.- A
vaila
bilit
y of
Non
Hum
an P
rimat
e tis
sue
from
C
entre
for M
acaq
ues
(CFM
).- E
nhan
ced
arch
ivin
g of
ani
mal
mod
els
in
acad
emia
.- C
oord
inat
ed m
ouse
phe
noty
ping
of g
enet
ical
ly
alte
red
anim
als
(IMP
C).
- The
NC
3Rs
and
fund
ers
are
cons
ider
ing
way
s to
enh
ance
dat
a-sh
arin
g an
d pu
blic
atio
n of
ne
gativ
e re
sults
.
Four
Infra
stru
ctur
e fo
r Im
pact
pro
ject
s aw
arde
d to
talli
ng £
1.3m
.Th
ere
has
been
a s
tead
y in
crea
se in
usa
ge o
f th
e Fr
ozen
Em
bryo
and
Spe
rm A
rchi
ve (F
ES
A) a
t M
RC
Har
wel
l, pa
rt of
the
Eur
opea
n M
utan
t Mou
se
Arc
hive
, bot
h fo
r arc
hivi
ng s
tock
s an
d in
requ
ests
fo
r dis
tribu
tion.
Impr
oved
tech
niqu
es h
ave
led
to a
sh
ift fr
om fr
eezi
ng e
mbr
yos
tow
ards
free
zing
spe
rm,
whi
ch re
duce
s th
e nu
mbe
rs o
f mic
e ne
cess
ary
per
stra
in fo
r arc
hivi
ng a
nd re
cove
ry. A
wor
ksho
p w
as
held
in F
ebru
ary
2015
that
bro
ught
toge
ther
fund
ers,
pu
blis
hers
and
sci
entis
ts to
dis
cuss
the
impa
ct o
f pu
blic
atio
n bi
as o
n an
imal
rese
arch
1.3
Post
grad
uate
3R
s tr
aini
ng
(NC
3Rs)
PhD
stu
dent
ship
sch
eme
as p
art o
f the
NC
3Rs
stra
tegy
to e
mbe
d th
e 3R
s in
the
train
ing
and
deve
lopm
ent o
f sci
entis
ts fr
om th
e st
art o
f the
ir ca
reer
s. T
o da
te 3
7 aw
ards
in to
tal h
ave
been
m
ade.
Impr
oved
trai
ning
on
proj
ect d
esig
n fo
r P
hD s
tude
nts.
In D
ecem
ber 2
014
an
awar
d w
as g
iven
to a
furth
er
coho
rt of
ten
PhD
stu
dent
ship
s to
talli
ng £
900,
000.
Tw
o of
the
awar
ds a
re fo
r pro
ject
s to
refin
e ro
dent
mod
els
of s
troke
.
Stra
tegi
c P
riorit
y 1
18
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
1.4
Incr
ease
the
impa
ct o
f H
ome
Offi
ce in
spec
tors
an
d ot
her r
egul
ator
s in
th
e di
ssem
inat
ion
of 3
Rs
adva
nces
and
adv
ise
abou
t im
plem
enta
tion
(HO
and
MH
RA
)
Enh
ance
d di
ssem
inat
ion
of th
e 3R
s th
roug
h co
ntin
ued
deve
lopm
ent o
f exp
ert k
now
ledg
e ne
twor
ks (i
nter
nal H
O In
spec
tora
te a
ctiv
ities
w
orki
ng w
ith o
ther
s e.
g. N
C3R
s) a
nd e
xter
nally
w
ith li
cens
ees
thro
ugh:
- pub
licat
ion
of G
uida
nce
on th
e op
erat
ion
of th
e A
ct w
ith in
crea
sed
emph
asis
on
3Rs
and
harm
–be
nefit
ass
essm
ent;
- out
reac
h ac
tiviti
es a
ttend
ing
and
spea
king
at
mee
tings
and
con
fere
nces
; and
- reg
ular
dis
cuss
ions
with
new
and
exi
stin
g lic
ense
es.
i) G
uida
nce
to n
ew re
gula
tions
pub
lishe
d in
clud
ing
sign
ifica
nt m
ater
ial o
n 3R
s an
d ha
rm–b
enef
it as
sess
men
t.ii)
Insp
ecto
rate
hav
e fo
rmal
ised
a
stra
tegy
for i
nter
nal k
now
ledg
e tra
nsfe
r.
iii) I
nspe
ctor
ate
have
form
alis
ed a
stra
tegy
fo
r dis
sem
inat
ion
of 3
Rs
info
rmat
ion
and
impl
emen
tatio
n w
ith li
cens
ees.
iv) C
ontin
uatio
n of
Con
tinuo
us P
rofe
ssio
nal
Dev
elop
men
t act
iviti
es a
nd n
etw
orki
ng w
ith
rele
vant
sta
keho
lder
s.
i) G
uida
nce
com
plet
ed.
ii) Im
prov
ed k
now
ledg
e tra
nsfe
r and
dis
sem
inat
ion
of 3
Rs
info
rmat
ion
bein
g de
velo
ped
as p
art o
f a
tech
nolo
gy re
set p
rogr
amm
e to
be
deliv
ered
late
201
5.iii
) A re
view
of t
he in
spec
tion
proc
ess
has
emer
ging
fin
ding
s to
adv
ance
them
atic
insp
ectio
n to
dev
elop
w
ider
eng
agem
ent w
ith s
peci
alis
t gro
ups,
NC
3Rs
and
licen
sees
to p
rom
ote
cons
iste
nt le
adin
g pr
actic
e.iv
) Ong
oing
incl
udin
g at
tend
ance
at N
C3R
s w
orks
hops
, ext
erna
l sta
keho
lder
mee
tings
(LA
SA
, LA
VA, I
nter
natio
nal N
euro
logy
and
Imm
unol
ogy
Con
fere
nces
) and
EU
Com
mis
sion
wor
ksho
ps.
Incr
ease
d re
quire
men
t to
appl
ican
ts fo
r new
M
arke
ting
Aut
horis
atio
ns to
dem
onst
rate
ab
senc
e of
a s
uita
ble
non-
anim
al te
st b
efor
e an
aut
horis
atio
n ba
sed
on a
n an
imal
test
will
be
appr
oved
. Wor
king
with
the
Hom
e O
ffice
, MH
RA
to
pur
sue
man
ufac
ture
rs w
ith e
xist
ing
Mar
ketin
g A
utho
risat
ions
to v
alid
ate
non-
anim
al te
sts
for
thei
r pro
duct
, par
ticul
arly
whe
re th
e an
imal
test
is
sev
ere,
or w
here
ano
ther
man
ufac
ture
r of a
si
mila
r pro
duct
has
val
idat
ed a
non
-ani
mal
test
.
i) N
ew M
arke
ting
Aut
horis
atio
ns b
ased
on
non-
anim
al te
sts
bein
g ap
prov
ed.
ii) W
aivi
ng o
f app
licat
ion
fee
by c
lass
ifyin
g su
ch a
cha
nge
as a
Typ
e 1
varia
tion
to th
e M
arke
ting
Aut
horis
atio
n.iii
) Non
-ani
mal
test
s fo
r exi
stin
g M
arke
ting
Aut
horis
atio
ns b
eing
sub
mitt
ed.
The
Med
icin
es a
nd H
ealth
care
Pro
duct
s R
egul
ator
y A
genc
y (M
HR
A) h
as c
ontin
ued
to w
ork
with
com
pani
es
to d
evel
op a
nim
al a
ltern
ativ
es a
nd h
ighl
ight
s an
y su
ch
poss
ibili
ties
whe
n as
sess
ing
doss
iers
.Stra
tegi
c P
riorit
y 1
19
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
1 ht
tp://
jour
nals
.lww
.com
/sho
ckjo
urna
l/Abs
tract
/pub
lisha
head
/Ref
inem
ent_
of_A
nim
al_M
odel
s_of
_Sep
sis_
and_
Sep
tic.9
8571
.asp
x2
http
://w
ww
.fram
e.or
g.uk
/wp-
cont
ent/u
ploa
ds/2
014/
09/R
SP
CA
-Roa
d-M
ap.p
df
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
1.5
Ref
inem
ent o
f mod
els
(RSP
CA
with
HO
)
(Cef
as w
ith N
C3R
s)
Wor
k to
refin
e th
e m
ost s
ever
e m
odel
s to
av
oid
or re
duce
ani
mal
suf
ferin
g. M
odel
s to
be
cons
ider
ed in
clud
e:
- Exp
erim
enta
l Aut
oim
mun
e E
ncep
halo
mye
litis
(E
AE
);- S
eizu
res;
- Rhe
umat
oid
arth
ritis
; and
- Sep
sis.
- Rep
orts
on
each
of t
he s
elec
ted
topi
cs
prep
ared
and
pub
lishe
d.
- Rec
omm
enda
tions
pro
mul
gate
d.
Rhe
umat
oid
arth
ritis
repo
rt co
mpl
eted
and
sub
mitt
ed to
A
rthrit
is R
esea
rch
& T
hera
py, c
urre
ntly
with
revi
ewer
s.
Rep
ort p
rom
oted
via
pos
ter a
t RU
S-L
AS
A-IC
LAS
by
HO
I co-
auth
or, f
urth
er p
rom
otio
n by
Roy
al S
ocie
ty fo
r th
e P
reve
ntio
n of
Cru
elty
to A
nim
als
(RS
PC
A) p
lann
ed
whe
n re
port
is in
pre
ss1 .
The
RS
PC
A al
so d
evel
oped
an
d pu
blis
hed
a ‘R
oad
Map
’ tow
ards
end
ing
seve
re
suffe
ring
in 2
0142 :
This
pro
vide
s ge
neric
gui
danc
e in
the
form
of a
se
ries
of p
ract
ical
ste
ps th
at e
stab
lishm
ents
can
ta
ke to
iden
tify
and
impl
emen
t app
roac
hes
to e
nabl
e th
em to
wor
k to
war
ds e
ndin
g th
e us
e of
mod
els
and
proc
edur
es th
at c
an c
ause
sev
ere
suffe
ring.
RS
PC
A pl
ans
for w
ork
on s
ever
e su
fferin
g fo
r 201
5:• T
wo
furth
er E
WG
s w
ill b
e es
tabl
ishe
d in
201
5 w
ith th
e ai
m to
com
plet
e gu
idan
ce fo
r pub
licat
ion
in e
arly
201
6.• T
he ‘R
oad
Map
’ app
roac
h w
ill b
e de
velo
ped
furth
er,
incl
udin
g th
e pr
oduc
tion
of a
reso
urce
pac
k th
at c
an b
e im
plem
ente
d at
est
ablis
hmen
ts.
• An
onlin
e re
sour
ce to
pro
vide
pra
ctic
al g
uida
nce
on
refin
ing
and
avoi
ding
pro
cedu
res
that
cou
ld c
ause
se
vere
suf
ferin
g is
cur
rent
ly a
t the
pla
nnin
g st
age.
Stra
tegi
c P
riorit
y 1
20
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
i) M
easu
res
take
n to
elim
inat
e de
ath
as a
n en
d-po
int i
n fis
h di
seas
e st
udie
s to
redu
ce s
uffe
ring.
Th
is re
pres
ents
bet
wee
n 76
% a
nd 9
4% o
f the
fis
h w
ork
of th
e N
atio
nal R
efer
ence
Lab
orat
ory.
ii) R
efin
emen
t of t
he F
ish
Sex
ual D
evel
opm
ent
Test
(FS
DT)
for d
etec
ting
early
life
-sta
ge e
ffect
s an
d po
tent
ial a
dver
se c
onse
quen
ces
of p
utat
ive
endo
crin
e di
srup
ting
com
poun
ds o
n se
xual
de
velo
pmen
t (C
efas
– fu
ndin
g fro
m N
C3R
s).
The
deve
lopm
ent o
f mol
ecul
ar m
arke
rs fo
r st
ickl
ebac
k en
docr
ine
func
tion
and
prot
ocol
s fo
r st
udyi
ng b
ehav
iour
of t
he a
nim
als
to fa
cilit
ate
a de
crea
se in
use
of s
tickl
ebac
ks.
iii) N
C3R
s’ fu
ndin
g to
exa
min
e in
dica
tors
of f
ish
wel
l-bei
ng.
i) A
ctiv
e ev
alua
tion
of d
iffer
ent w
ays
to re
duce
ani
mal
suf
ferin
g an
d an
imal
nu
mbe
rs u
sed.
The
new
pro
ject
lice
nce
for t
his
wor
k do
es n
ot in
clud
e de
ath
as a
n en
d-po
int.
ii) H
as re
sulte
d in
a 2
5% to
50%
redu
ctio
n in
the
num
ber o
f fis
h ne
eded
for t
his
test
. A
calc
ulat
ion
of th
e nu
mbe
r of c
hem
ical
s re
quiri
ng F
SD
T te
stin
g in
Eur
ope
alon
e sh
ows
that
use
of s
tickl
ebac
ks in
this
test
w
ill re
sult
in a
bout
90,
000
few
er fi
sh b
eing
sa
crifi
ced.
iii) P
roje
ct re
port
dem
onst
ratin
g be
tter f
ish
wel
fare
in e
xper
imen
tal s
yste
ms,
but
als
o m
ore
wid
ely
in fa
rmed
fish
in a
quac
ultu
re.
i) U
nder
wat
er c
amer
as h
ave
been
est
ablis
hed
in
30 ta
nks.
Thi
s is
giv
ing
a cl
ear p
ictu
re o
f ani
mal
be
havi
our,
clin
ical
sig
ns a
nd w
elfa
re w
ithou
t the
nee
d to
dis
turb
the
fish
unne
cess
arily
for c
heck
s. F
ish
that
ar
e di
spla
ying
sig
ns o
f mor
bidi
ty c
an b
e re
mov
ed
befo
re th
ey d
ie, s
ubst
antia
lly re
duci
ng th
eir s
uffe
ring.
ii) T
he re
finem
ent o
f the
test
is c
ompl
ete
and
it is
now
ava
ilabl
e fo
r use
. The
new
mod
el s
peci
es
(stic
kleb
acks
) is
now
in th
e re
gula
tory
gui
delin
e (T
G23
4).
iii) T
his
is in
the
mid
dle
of th
e ex
perim
enta
l pha
se.
Pre
limin
ary
resu
lts in
dica
te th
at s
mal
l cha
nges
in th
e aq
uaria
mak
e la
rge
diffe
renc
es to
fish
beh
avio
ur. T
he
aim
is to
link
this
with
mar
kers
in th
e w
ater
that
can
be
mea
sure
d no
n-in
vasi
vely.
1.6
“Act
ual S
ever
ity”
repo
rtin
g in
Ann
ual
Stat
istic
s on
Use
of
Ani
mal
s in
Sci
ence
(HO
)
Impl
emen
t ret
rosp
ectiv
e re
porti
ng o
f the
“Act
ual
Sev
erity
” of a
ll sc
ient
ific
proc
edur
es o
n pr
otec
ted
anim
als
in li
ne w
ith th
e D
irect
ive
(201
0/63
/EU
). Th
is w
ill e
nabl
e us
to b
ette
r und
erst
and:
- lev
els
of o
vera
ll an
imal
suf
ferin
g in
term
s of
nu
mbe
rs o
f ani
mal
s ex
perie
ncin
g ea
ch c
ateg
ory
of s
ever
ity –
sub
-thre
shol
d, m
ild, m
oder
ate
or
seve
re;
- whi
ch p
roce
dure
s ar
e m
ost s
ever
e an
d in
whi
ch
spec
ies;
and
- whe
ther
3R
s im
plem
enta
tion
is h
avin
g an
im
pact
on
redu
cing
ove
rall
seve
rity.
i) C
ompl
etio
n an
d re
view
of p
ilot t
rial f
or
retro
spec
tive
(act
ual)
seve
rity
repo
rting
.ii)
Dev
elop
men
t of G
uida
nce
on re
cord
ing
Act
ual S
ever
ity.
iii) C
omm
ence
pro
ject
to m
ap p
heno
typi
ng
of G
A m
ouse
stra
ins
to a
ctua
l sev
erity
ca
tego
ries
com
men
ced
(with
ext
erna
l st
akeh
olde
rs e
.g. M
RC
Har
wel
l).iv
) Com
plet
ion
of a
naly
sis
of p
ilot d
ata
for
limite
d pu
blic
atio
n.v)
Pub
licat
ion
of fi
rst c
ompl
ete
year
of
retro
spec
tive
actu
al s
ever
ity d
ata.
vi) P
rovi
sion
of c
ompl
ete
year
dat
a to
the
EU
Com
mis
sion
.
i) C
ompl
eted
and
pub
lishe
d in
the
AS
RU
Ann
ual
repo
rt.3
ii) G
uida
nce
on A
ctua
l Sev
erity
pub
lishe
d on
the
Hom
e O
ffice
web
site
4
iii) P
heno
typi
ng p
roje
ct w
orks
hop
with
MR
C H
arw
ell
held
with
Hom
e O
ffice
Insp
ecto
rs. A
SR
U in
tend
to
publ
ish
mat
eria
l in
2015
as
a to
ol fo
r est
ablis
hmen
ts to
en
sure
effe
ctiv
e br
eedi
ng p
ract
ices
, spe
cific
ally
for G
A
anim
als.
iv) P
ilot d
ata
publ
ishe
d in
201
3 A
nim
als
in S
cien
ce
Reg
ulat
ion
Uni
t (A
SR
U) a
nnua
l rep
ort.
Firs
t ful
l yea
r da
ta to
be
publ
ishe
d in
Jul
y 20
15.
1.7
Cap
ture
of
info
rmat
ion
on s
cien
tific
ou
tput
s re
leva
nt to
3R
s an
d th
e im
plem
enta
tion
of 3
Rs
adva
nces
(MR
C a
nd B
BSR
C)
Res
earc
h C
ounc
ils to
impr
ove
the
capt
ure
of
info
rmat
ion
on s
cien
tific
out
puts
rele
vant
to 3
Rs
and
the
impl
emen
tatio
n of
3R
s ad
vanc
es in
fu
nded
pro
ject
s.D
ata
on 3
Rs
impl
emen
tatio
n an
d re
leva
nt
outp
uts
capt
ured
via
the
intro
duct
ion
of
new
que
stio
ns in
the
Res
earc
h C
ounc
ils’
com
pute
rised
dat
a-ga
ther
ing
syst
ems.
Enc
oura
gem
ent o
f oth
er c
harit
able
fund
ers
to d
o lik
ewis
e.
i) S
ucce
ssfu
l col
lect
ion
of c
aptu
red
data
.ii)
Pub
licat
ion
of a
naly
sis
of d
ata
colle
cted
.iii
) Oth
er m
ajor
cha
ritab
le fu
nder
s of
ani
mal
re
sear
ch a
ble
to c
olle
ct c
ompa
rabl
e da
ta.
A ne
w s
et o
f que
stio
ns a
bout
the
3Rs
has
been
in
trodu
ced
into
Res
earc
hfis
h, th
e on
line
syst
em
for c
olle
ctin
g in
form
atio
n on
rese
arch
out
puts
, ou
tcom
es a
nd im
pact
, and
rese
arch
ers
fund
ed b
y M
edic
al R
esea
rch
Cou
ncil
(MR
C),
Bio
tech
nolo
gy a
nd
Bio
logi
cal S
cien
ces
Res
earc
h C
ounc
il (B
BS
RC
) and
so
me
med
ical
cha
ritie
s s
ubm
itted
dat
a fo
r the
firs
t tim
e in
Nov
embe
r 201
4. T
he fi
rst a
naly
sis
of d
ata
on
impl
emen
tatio
n of
the
3Rs
and
outp
uts
rele
vant
to th
e 3R
s w
ill b
e av
aila
ble
in 2
015.
Stra
tegi
c P
riorit
y 1
3 ht
tps:
//ww
w.g
ov.u
k/go
vern
men
t/pub
licat
ions
/ani
mal
s-in
-sci
ence
-reg
ulat
ion-
unit-
annu
al-r
epor
t-201
34
http
s://w
ww
.gov
.uk/
gove
rnm
ent/u
ploa
ds/s
yste
m/u
ploa
ds/a
ttach
men
t_da
ta/fi
le/2
7601
4/N
otes
Act
ualS
ever
ityR
epor
ting.
21
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
1.8
Upd
ated
requ
irem
ents
fo
r app
licat
ions
whi
ch
incl
ude
anim
al re
sear
ch
(MR
C a
nd B
BSR
C)
Res
earc
h C
ounc
ils to
issu
e up
date
d re
quire
men
ts a
nd g
uida
nce
for a
pplic
atio
ns
whi
ch in
clud
e re
sear
ch in
volv
ing
the
use
of
anim
als.
Ens
ure
that
eve
ry re
sear
ch p
rogr
amm
e an
d pr
ojec
t pro
posa
l rec
eive
s ef
fect
ive
scru
tiny
befo
re it
is fu
nded
and
that
opp
ortu
nitie
s to
im
plem
ent s
cien
tific
adv
ance
s to
repl
ace,
redu
ce
or re
fine
anim
al u
se a
re n
ot m
isse
d.
i) D
rafti
ng a
nd is
suin
g of
new
gui
danc
e.ii)
Eva
luat
ion
of im
pact
of n
ew g
uida
nce.
Med
ical
Res
earc
h C
ounc
il (M
RC
) and
Bio
tech
nolo
gy
and
Bio
logi
cal S
cien
ces
Res
earc
h C
ounc
il (B
BS
RC
) ha
ve is
sued
revi
sed
guid
ance
for a
pplic
ants
abo
ut
info
rmat
ion
that
mus
t be
prov
ided
in p
ropo
sals
in
volv
ing
the
use
of a
nim
als.
A w
orks
hop
was
hel
d jo
intly
with
NC
3Rs
for B
oard
and
Pan
el m
embe
rs
in S
epte
mbe
r 201
4 to
pro
mot
e th
e im
porta
nce
of
impr
oved
scr
utin
y of
exp
erim
enta
l des
ign
in th
e pe
er
revi
ew p
roce
ss.
1.9
Hig
hlig
ht o
n ‘A
nim
al
Wel
fare
: Mea
sure
s an
d as
sess
men
t’
(BB
SRC
and
NC
3Rs)
Dis
sem
inat
ion
even
t: B
BS
RC
join
t hig
hlig
ht
with
NC
3Rs
on ‘A
nim
al W
elfa
re: M
easu
res
and
asse
ssm
ent’.
16 p
roje
cts
fund
ed to
talli
ng n
early
£5.
8m.
BB
SR
C w
orki
ng w
ith N
C3R
s to
ens
ure
that
ou
tput
s ar
e ca
ptur
ed a
nd d
isse
min
ated
to
ensu
re b
ette
r mon
itorin
g an
d as
sess
men
t of
wel
fare
in th
e fu
ture
.D
isse
min
atio
n ev
ents
dur
ing
the
cour
se o
f th
e pr
ogra
mm
e.
Pla
ns fo
r dis
sem
inat
ion
even
t in
sprin
g 20
15.
1.10
Vet
erin
ary
vacc
ine
test
ing
(VM
D a
nd D
efra
)
Rev
iew
of b
atch
test
ing
of b
iolo
gica
ls s
uch
as
vete
rinar
y va
ccin
es.
Iden
tific
atio
n of
are
as fo
r pos
sibl
e re
plac
emen
t in
the
batc
h te
stin
g of
vac
cine
s, e
spec
ially
are
as
of s
uch
test
ing
invo
lvin
g an
imal
s w
here
the
repl
acem
ent o
f the
test
wou
ld h
ave
the
bigg
est
impa
ct in
redu
cing
num
ber o
f ani
mal
s us
ed.
A re
port
setti
ng o
ut th
e nu
mbe
r of a
nim
als
used
dur
ing
in-p
roce
ss a
nd fi
nal p
rodu
ct
test
ing
of b
atch
es o
f vac
cine
s re
leas
ed b
y th
e V
MD
.
A re
port
was
pub
lishe
d in
Apr
il 20
14 e
liciti
ng
cons
ider
able
inte
rest
am
ong
vete
rinar
y m
edic
ines
re
gula
tors
thro
ugho
ut E
urop
e. A
sho
rt pr
esen
tatio
n w
as g
iven
to th
e Im
mun
olog
ical
Wor
king
Par
ty o
f the
C
omm
ittee
for M
edic
inal
Pro
duct
s fo
r Vet
erin
ary
Use
(C
VM
P) a
nd a
pos
ter a
bout
the
repo
rt pr
esen
ted
at
the
50th
Ann
iver
sary
Con
fere
nce
of th
e E
urop
ean
Dire
ctor
ate
for t
he Q
ualit
y of
Med
icin
es (E
DQ
M).
In
2014
, fur
ther
pre
sent
atio
ns w
ere
give
n to
the
Eur
opea
n M
edic
ines
Age
ncy
Ad
Hoc
Joi
nt E
xper
t Gro
up o
n th
e 3R
s an
d at
a V
eter
inar
y Va
ccin
es c
onfe
renc
e in
B
russ
els.
Stra
tegi
c P
riorit
y 1
22
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
1.11
Hum
an V
acci
ne
test
ing
(PH
E)
Dev
elop
men
t of 3
Rs
tech
niqu
es fo
r use
in
hum
an v
acci
ne d
evel
opm
ent.
i) W
orki
ng w
ith a
cade
mic
and
clin
ical
par
tner
s to
de
velo
p a
BC
G m
odel
that
allo
ws
asse
ssm
ent
of e
ffica
cy o
f nov
el T
B v
acci
nes
whi
ch re
fine
the
use
of a
nim
al m
odel
s.ii)
Act
ivel
y de
velo
ping
cel
l-bas
ed a
ssay
s fo
r the
ch
arac
teris
atio
n of
the
man
ufac
turin
g pr
oces
s an
d th
e ba
tch
rele
ase
of th
e pr
oduc
t, ev
alua
ting
the
pote
ntia
l to
repl
ace
toxi
city
rele
ase
test
s.
i) Th
is m
odel
has
the
pote
ntia
l to
refin
e th
e cu
rren
t tes
t to
allo
w fu
rther
dev
elop
men
t to
take
pla
ce a
t hum
an c
linic
al tr
ials
sta
ge.
ii) If
dev
elop
ed, t
he T
oxin
Neu
tralis
atio
n A
ssay
test
will
repl
ace
the
curr
ent p
oten
cy
test
resu
lting
in a
redu
ctio
n in
the
num
bers
of
ani
mal
s us
ed a
nd th
e se
verit
y of
the
test
ing.
i) Th
e us
e of
adv
ance
d lu
ng im
agin
g, in
non
-hum
an
prim
ates
, has
led
to th
e es
tabl
ishm
ent o
f mor
e re
fined
ef
ficac
y st
udie
s fo
r TB
vac
cine
s an
d th
erap
eutic
s by
redu
cing
the
chal
leng
e do
se th
at n
eeds
to b
e gi
ven.
Thi
s ha
s re
sulte
d in
less
dis
ease
sev
erity
and
sh
orte
ning
the
time
take
n to
dem
onst
rate
effi
cacy
, in
add
ition
to a
redu
ctio
n in
the
num
ber o
f ani
mal
s us
ed. F
urth
erm
ore,
fund
ing
has
been
pro
vide
d fo
r the
de
velo
pmen
t of a
wel
fare
ass
essm
ent s
yste
m th
at w
ill
quan
tify
refin
emen
t stra
tegi
es. T
his
will
be
publ
ishe
d in
due
cou
rse.
Sof
twar
e w
ill b
e la
unch
ed to
allo
w th
e re
sear
ch c
omm
unity
to a
pply
the
wel
fare
ass
essm
ent
in a
use
r-fri
endl
y m
anne
r.ii)
The
in v
itro
com
pone
nt o
f the
ass
ay (T
oxin
ne
utra
lisat
ion
assa
y) h
as b
een
deve
lope
d an
d va
lidat
ed. T
he d
evel
opm
ent o
f the
in v
ivo
com
pone
nt
is n
ear c
ompl
etio
n an
d th
e va
lidat
ion
will
be
com
plet
ed
this
yea
r. Th
is w
ill th
en le
ad to
a re
duct
ion
in b
oth
the
num
ber a
nd s
ever
ity o
f ani
mal
pro
cedu
res
requ
ired
for
the
batc
h re
leas
e as
says
.
1.12
Dev
elop
men
t of n
on-
anim
al te
chno
logi
es
(TSB
and
NC
3Rs)
Tech
nolo
gy S
trate
gy B
oard
(TS
B) d
evel
opm
ent
of n
on-a
nim
al te
chno
logi
es.
Com
petit
ion
to fu
nd e
arly
sta
ge fe
asib
ility
stu
dies
in
vest
igat
ing
nove
l non
-ani
mal
tech
nolo
gies
to
impr
ove
prod
uct d
evel
opm
ent a
cros
s a
rang
e of
in
dust
ries.
Up
to £
4 m
illio
n fu
ndin
g av
aila
ble.
Indu
stry
and
sec
tor i
nfor
med
of c
ompe
titio
n in
aut
umn
2013
and
aw
ards
mad
e in
201
4.O
utpu
t fro
m th
e fu
nded
stu
dies
will
be
nove
l non
-ani
mal
tech
nolo
gies
that
pr
oduc
e ap
proa
ches
that
are
‘fit
for
purp
ose’
.
Bus
ines
s-le
d fe
asib
ility
stu
dies
wer
e fu
nded
und
er
the
first
non
-ani
mal
tech
nolo
gies
cal
l (In
nova
te U
K’s
em
ergi
ng te
chno
logi
es a
nd in
dust
ries
prog
ram
me)
. Th
e to
tal b
udge
t was
£4
mill
ion
with
fund
ing
from
In
nova
te U
K, t
he N
atio
nal C
entre
for t
he R
epla
cem
ent,
Ref
inem
ent a
nd R
educ
tion
of A
nim
als
in R
esea
rch
(NC
3Rs)
, Eng
inee
ring
and
Phy
sica
l Sci
ence
s R
esea
rch
Cou
ncil
(EP
SR
C),
Bio
tech
nolo
gy a
nd
Bio
logi
cal S
cien
ces
Res
earc
h C
ounc
il (B
BS
RC
) and
D
efen
ce S
cien
ce a
nd T
echn
olog
y La
bora
tory
(Dst
l). A
ro
ad m
ap fo
r the
non
-ani
mal
tech
nolo
gies
pro
gram
me
is b
eing
pre
pare
d fo
r pub
licat
ion
by In
nova
te U
K w
ith
inpu
t fro
m N
C3R
s an
d ot
her e
xper
t gro
ups.
Con
sorti
a w
orks
hops
wer
e he
ld in
thre
e lo
catio
ns in
the
UK
th
roug
hout
Feb
ruar
y 20
15.
Stra
tegi
c P
riorit
y 1
23
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
5 ht
tps:
//ww
w.g
ov.u
k/re
sear
ch-a
nd-te
stin
g-us
ing-
anim
als
6 ht
tp://
ww
w.h
se.g
ov.u
k/re
ach/
reso
urce
s/18
anim
alte
stin
g.pd
f 4
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
1.13
Ens
ure
gove
rnm
ent
depa
rtm
ents
and
ag
enci
es c
onsi
der t
he
3Rs
whe
n co
mm
issi
onin
g or
fund
ing
rese
arch
in
volv
ing
anim
als
(GC
S an
d C
SAs)
Gov
ernm
ent C
hief
Sci
entis
t and
Dep
artm
enta
l C
hief
Sci
entif
ic A
dvis
ers
(CS
As)
to e
nsur
e th
at g
over
nmen
t dep
artm
ents
and
age
ncie
s co
nsid
er th
e 3R
s w
hen
com
mis
sion
ing
or fu
ndin
g re
sear
ch in
volv
ing
anim
als.
Com
mitm
ent f
rom
dep
artm
ents
and
thei
r ag
enci
es o
n th
e 3R
s in
clud
ing
polic
y st
atem
ents
ov
erse
en b
y th
e C
SA
s.
i) A
ll go
vern
men
t dep
artm
ents
incl
udin
g
DH
, MoD
, Def
ra, H
O, B
IS a
nd a
genc
ies
have
sta
tem
ents
on
thei
r web
site
s.
Sta
tem
ent u
ploa
ded
on G
ov.U
K, l
inke
d to
all
rele
vant
D
epar
tmen
ts th
at re
gula
te o
r fun
d re
sear
ch in
volv
ing
anim
als,
incl
udin
g H
ome
Offi
ce, D
H, B
IS, D
efra
and
M
oD.5
1.14
“M
inim
isat
ion
of
anim
al te
stin
g” le
afle
t
(Def
ra a
nd H
SE)
As
UK
Com
pete
nt A
utho
rity
for R
EA
CH
, D
efra
and
HS
E a
lread
y pr
oduc
e a
leaf
let
entit
led
“Min
imis
atio
n of
ani
mal
test
ing”
. Thi
s is
a p
opul
ar p
ublic
atio
n an
d pr
ovid
es a
brie
f su
mm
ary
of th
e op
portu
nitie
s th
at a
re a
vaila
ble
to R
EA
CH
regi
stra
nts
to m
inim
ise
the
amou
nt o
f an
imal
test
ing
need
ed to
com
ply
with
RE
AC
H
regi
stra
tion.
This
initi
ativ
e w
ill e
nsur
e ne
w in
form
atio
n ab
out a
dvan
ces
in in
vitr
o te
stin
g, p
artic
ular
ly
of ir
ritan
ts, i
s co
mm
unic
ated
to U
K-b
ased
dut
y ho
lder
s.
i) U
pdat
e th
e pu
blic
atio
n “M
inim
isat
ion
of a
nim
al te
stin
g” w
hich
is p
opul
ar a
nd
effe
ctiv
e in
pro
mot
ing
the
3Rs
in th
is a
rea.
ii) E
ncou
rage
the
Eur
opea
n C
hem
ical
s A
genc
y (E
CH
A) t
o si
mila
rly u
pdat
e its
gu
idan
ce in
this
are
a fo
r tho
se w
ith
regi
stra
tion
dutie
s in
201
8.
The
revi
sed
leaf
let h
as b
een
publ
ishe
d by
the
RE
AC
H
UK
Com
pete
nt A
utho
rity.
6
Stra
tegi
c P
riorit
y 1
24
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Stra
tegi
c Pr
iorit
y 2:
Influ
enci
ng th
e up
take
and
ado
ptio
n of
3R
s ap
proa
ches
glo
bally
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
2.1
NC
3Rs
inte
rnat
iona
l sc
ienc
e-le
d pr
ogra
mm
es
2.1.
1 H
uman
tiss
ues
and
phar
mac
eutic
al
deve
lopm
ent
prog
ram
mes
(NC
3Rs
and
MH
RA
)
NC
3Rs/
MH
RA
join
t wor
king
gro
up o
n hu
man
tis
sue
for s
afet
y ph
arm
acol
ogy
– Jo
int
wor
king
gro
up to
gen
erat
e an
evi
denc
e ba
se
to s
uppo
rt th
e us
e of
hum
an ti
ssue
to re
duce
an
imal
s in
saf
ety
phar
mac
olog
y st
udie
s. T
he
grou
p co
nsis
ts o
f 25
phar
mac
eutic
al c
ompa
nies
, co
ntra
ct re
sear
ch o
rgan
isat
ions
, aca
dem
ics
and
regu
lato
rs fr
om th
e U
K, E
urop
e an
d U
SA
. Thi
s fo
rms
the
basi
s of
a w
ider
pro
gram
me
of w
ork
on th
e us
e of
hum
an ti
ssue
for b
asic
and
app
lied
rese
arch
, inc
ludi
ng in
the
area
s of
ast
hma
and
pain
.
An
evid
ence
bas
e is
dev
elop
ed to
su
ppor
t the
use
of h
uman
tiss
ue to
re
duce
the
use
of a
nim
als
in s
afet
y ph
arm
acol
ogy
stud
ies.
Dat
a ha
ve b
een
colle
cted
on
hum
an ti
ssue
-bas
ed
assa
ys fo
r saf
ety
phar
mac
olog
y st
udie
s an
d ha
ve s
how
n th
at th
e us
e of
hum
an ti
ssue
is li
mite
d; m
ainl
y fo
cuse
d on
car
diov
ascu
lar a
ssay
s an
d w
ider
use
is in
hibi
ted
by
conc
erns
abo
ut th
e re
gula
tory
acc
epta
bilit
y of
the
data
ge
nera
ted.
Acc
ess
to ti
ssue
is a
pro
blem
. The
dat
a ar
e be
ing
prep
ared
for p
ublic
atio
n. A
n on
line
hub
to s
uppo
rt hu
man
tiss
ue u
se fo
r saf
ety
phar
mac
olog
y st
udie
s w
ill
be la
unch
ed in
201
5 to
pro
mot
e be
tter a
cces
s to
tiss
ue
and
stan
dard
ope
ratin
g pr
oced
ures
for a
ssay
s.
NC
3Rs/
MH
RA
join
t wor
king
gro
up o
n re
cove
ry
anim
als
in p
harm
aceu
tical
dev
elop
men
t –
Join
t wor
king
gro
up to
con
side
r pot
entia
l op
portu
nitie
s fo
r min
imis
ing
the
use
of re
cove
ry
anim
als
(rat
s, d
ogs
or n
on-h
uman
prim
ates
) in
phar
mac
eutic
al d
evel
opm
ent.
The
grou
p co
nsis
ts
of 3
2 ph
arm
aceu
tical
com
pani
es, c
ontra
ct
rese
arch
org
anis
atio
ns a
nd re
gula
tors
from
the
UK
, Eur
ope
and
US
A, i
nclu
ding
the
FDA
.
Pot
entia
l opp
ortu
nitie
s ar
e id
entif
ied
to
min
imis
e th
e us
e of
reco
very
ani
mal
s in
ph
arm
aceu
tical
stu
dies
.
Ana
lysi
s ha
s be
en c
ondu
cted
on
data
for 2
59 s
tudi
es
and
137
com
poun
ds to
exp
lore
whe
ther
the
use
of
reco
very
ani
mal
s ca
n be
redu
ced.
Rec
over
y an
imal
s ar
e us
ed to
det
erm
ine
whe
ther
any
adv
erse
effe
cts
obse
rved
are
reve
rsib
le. T
he d
ata
anal
ysis
has
sho
wn
that
it is
pos
sibl
e to
redu
ce th
e us
e of
reco
very
ani
mal
s by
66%
in s
tudi
es to
sup
port
first
-in-h
uman
clin
ical
tria
ls,
avoi
ding
the
use
of th
ousa
nds
of a
nim
als
wor
ldw
ide.
It
has
show
n th
at w
here
reco
very
ani
mal
s ar
e ne
eded
it is
no
t nec
essa
ry to
incl
ude
them
for a
ll do
se g
roup
s or
all
stud
ies.
The
dat
a an
alys
is w
as p
ublis
hed
in th
e jo
urna
l R
egul
ator
y To
xico
logy
and
Pha
rmac
olog
y in
201
4.
25
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
2.1.
2 C
hem
ical
saf
ety
prog
ram
me
(NC
3Rs,
HSE
and
PH
E)
NC
3Rs
wor
king
gro
up o
n th
e fix
ed
conc
entr
atio
n pr
oced
ure
(che
mic
al s
afet
y)
– Th
is w
orki
ng g
roup
sup
ports
the
inte
rnat
iona
l ad
optio
n of
the
fixed
con
cent
ratio
n pr
oced
ure
(FC
P) f
or a
cute
inha
latio
n to
xici
ty te
stin
g. T
he
NC
3Rs
is w
orki
ng w
ith in
hala
tion
toxi
city
exp
erts
fro
m c
ontra
ct re
sear
ch o
rgan
isat
ions
, aca
dem
ia,
and
othe
r gov
ernm
ent b
odie
s, to
mak
e th
e FC
P
mor
e ob
ject
ive
to e
ncou
rage
wid
er a
dopt
ion
of
the
appr
oach
acr
oss
Org
anis
atio
n fo
r Eco
nom
ic
Co-
oper
atio
n an
d D
evel
opm
ent (
OE
CD
) Mem
ber
Sta
tes.
Obj
ectiv
e sc
orin
g sy
stem
to e
ncou
rage
w
ider
ado
ptio
n of
FC
P ac
ross
OE
CD
m
embe
r sta
tes.
Focu
s ha
s be
en g
iven
on
build
ing
a ca
se fo
r evi
dent
to
xici
ty in
stea
d of
dea
th o
f the
ani
mal
s as
the
end-
poin
t fo
r inh
alat
ion
toxi
city
stu
dies
. Evi
dent
toxi
city
is k
ey to
th
e FC
P bu
t the
re a
re c
once
rns
from
som
e co
untri
es
abou
t how
to re
cogn
ise
it. E
vide
nt to
xici
ty is
def
ined
as
the
clin
ical
sig
n(s)
that
pre
dict
sev
ere
toxi
city
or d
eath
at
the
next
hig
hest
dos
e us
ed. A
naly
sis
on in
hala
tion
toxi
city
dat
a w
as c
ondu
cted
on
188
subs
tanc
es a
t tw
o or
m
ore
conc
entra
tions
. The
re is
evi
denc
e to
sup
port
the
use
of e
vide
nt to
xici
ty a
nd p
repa
ratio
ns a
re n
ow in
pla
ce
for p
ublic
atio
n an
d fo
r dis
cuss
ion
at th
e O
EC
D. T
his
is
inte
rnat
iona
l par
ticip
atio
n fro
m re
gula
tors
and
CR
Os
from
Nor
th A
mer
ica,
Eur
ope
and
Kor
ea.
2.2
Rev
iew
of O
ECD
Tes
t G
uide
lines
2.2.
1 Sy
stem
atic
revi
ew o
f O
ECD
Tes
t Gui
delin
es to
ad
dres
s 3R
s.
(Def
ra a
nd P
HE)
Sys
tem
atic
revi
ew o
f Org
anis
atio
n fo
r Eco
nom
ic
Co-
oper
atio
n an
d D
evel
opm
ent (
OE
CD
) Tes
t G
uide
lines
(TG
s) to
add
ress
3R
s.In
liai
son
with
indu
stry
par
tner
s as
wel
l as
regu
lato
ry a
utho
ritie
s, w
e w
ill re
view
TG
s w
here
a
pote
ntia
l to
repl
ace,
redu
ce o
r ref
ine
anim
al
stud
ies
is id
entif
ied.
Cur
rent
wor
k is
on
skin
and
ey
e se
nsiti
satio
n an
d irr
itatio
n (s
ee a
lso
Act
ion
1.14
). P
ropo
sed
addi
tiona
l wor
k is
on
the
acut
e de
rmal
toxi
city
. All
are
area
s w
here
the
a re
view
of
the
prot
ocol
s w
ould
not
onl
y ad
dres
s 3R
s bu
t pr
ovid
e an
adv
ance
in s
cien
ce.
i) A
dopt
ion
of T
G u
nder
revi
ew T
G43
0 an
d TG
431
– S
kin
irrita
tion
and
corr
osio
n.ii)
Sub
mit
prop
osal
to O
EC
D fo
r rev
iew
of
the
use
of b
oth
gend
ers
in th
e ac
ute
derm
al to
xici
ty a
ssay
(TG
402)
.iii
) Com
men
ce re
view
of d
ata
for t
he
use
of b
oth
gend
ers
in th
e ac
ute
derm
al
toxi
city
ass
ay (T
G40
2).
A pr
opos
al to
upd
ate
TG40
2 ha
s be
en a
ccep
ted
by
the
OE
CD
. Dat
a ha
ve b
een
gath
ered
to s
uppo
rt th
e re
duct
ion
in th
e us
e of
ani
mal
s fo
r acu
te d
erm
al to
xici
ty
test
. A
repo
rt w
ill b
e su
bmitt
ed to
OE
CD
in A
pril
2015
. W
orki
ng w
ith S
wis
s O
EC
D p
artn
ers
to a
men
d TG
203
(Fis
h A
cute
Tox
icity
Tes
t) to
redu
ce n
umbe
rs o
f fis
h an
d pr
omot
e ea
rly te
rmin
atio
n fo
r mor
ibun
d in
divi
dual
s,
thus
avo
idin
g un
nece
ssar
y su
fferin
g. P
ropo
sal t
o be
co
nsid
ered
furth
er a
t OE
CD
Nat
iona
l Co-
ordi
nato
rs
mee
ting
in A
pril
2015
.
2.2.
2 R
epro
duct
ive
toxi
colo
gy (E
OG
RTS
)
(Def
ra a
nd H
SE)
The
Ext
ende
d O
ne G
ener
atio
n R
epro
duct
ive
Toxi
city
Stu
dy (E
OG
RTS
) offe
rs a
muc
h m
ore
flexi
ble
stud
y de
sign
than
the
tradi
tiona
l tw
o-ge
nera
tion
appr
oach
(OE
CD
TG
416)
. The
E
OG
RTS
has
bee
n sh
own
to g
ener
ate
suffi
cien
t in
form
atio
n fo
r reg
ulat
ory
purp
oses
with
out t
he
man
dato
ry p
rodu
ctio
n of
a s
econ
d ge
nera
tion.
Th
e E
OG
RTS
use
s ab
out h
alf t
he n
umbe
r of
anim
als
– re
duci
ng fr
om 2
,600
to 1
,400
rats
per
te
st. I
t was
ado
pted
by
the
OE
CD
into
its
test
gu
idel
ines
in 2
009.
i) In
ass
ocia
tion
with
com
pete
nt
auth
oriti
es fr
om o
ther
key
EU
Mem
ber
Sta
tes,
to p
rom
ote
the
adop
tion
of th
e E
OG
RTS
in th
e E
U.
ii) T
o co
mpl
ete
the
proc
ess
by a
chie
ving
ad
optio
n of
the
EO
GR
TS in
the
RE
AC
H
Test
Met
hods
Reg
ulat
ion.
Agr
eem
ent h
as b
een
reac
hed
at th
e R
EA
CH
Arti
cle
133
Com
mitt
ee o
n re
visi
ons
to th
e R
EA
CH
info
rmat
ion
anne
xes
to a
ccom
mod
ate
the
Ext
ende
d O
ne G
ener
atio
n R
epro
duct
ive
Toxi
city
Stu
dy (E
OG
RTS
) (O
EC
D T
G44
3).
Form
al a
dopt
ion
is d
epen
dent
on
the
polit
ical
pro
cess
es.
Stra
tegi
c P
riorit
y 2
26
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
2.3
Influ
ence
regu
lato
ry
fram
ewor
ks w
hich
requ
ire
anim
al te
stin
g
2.3.
1. A
dver
se O
utco
me
Path
way
s fo
r che
mic
als
(PH
E an
d D
efra
)
Adv
erse
Out
com
e Pa
thw
ays
– In
tern
atio
nal
Dev
elop
men
t of N
ew A
ppro
ache
s to
Che
mic
als
Test
ing.
His
toric
ally,
iden
tifyi
ng a
dver
se e
ffect
s of
ch
emic
als
has
relie
d on
usi
ng la
rge
num
bers
of
anim
als
to te
st th
eir t
oxic
ity, o
ne b
y on
e. If
we
coul
d id
entif
y th
e ch
ain
of li
nked
eve
nts
from
an
initi
al c
hem
ical
impa
ct a
t the
mol
ecul
ar le
vel
to re
spon
ses
at h
ighe
r bio
logi
cal l
evel
s, w
e m
ight
be
able
to u
se in
vitr
o te
chni
ques
suc
h as
ge
nom
ics
to p
redi
ct im
pact
s up
to th
e le
vel o
f an
orga
nism
or e
ven
popu
latio
ns. T
his
wou
ld o
ffer
way
s of
redu
cing
the
need
for t
ests
usi
ng in
tact
an
imal
s, a
s w
ell a
s sp
eedi
ng u
p th
e as
sess
men
t of
che
mic
als.
The
con
cept
of A
dver
se O
utco
me
Pat
hway
s (A
OP
s) o
ffers
a m
echa
nist
ic w
ay to
de
scrib
e su
ch a
seq
uent
ial c
hain
of c
ausa
lly
linke
d ev
ents
. In
2012
, the
OE
CD
laun
ched
a
new
pro
gram
me
to d
evel
op A
OP
s, in
whi
ch th
e U
K is
col
labo
ratin
g.A
ppro
pria
te A
OP
s to
be
valid
ated
and
in
corp
orat
ed in
to O
EC
D T
est M
etho
ds to
olki
t as
qui
ckly
as
poss
ible
, via
out
puts
of U
K-
fund
ed re
sear
ch m
ade
avai
labl
e to
the
OE
CD
pr
ogra
mm
e.
Thre
e re
leva
nt p
roje
cts
are
unde
rway
:i)
UK
–Jap
an c
olla
bora
tive
proj
ect –
C
ritic
al re
view
of k
ey k
now
ledg
e ga
ps to
su
ppor
t AO
Ps
for O
EC
D te
st g
uide
lines
fo
r aqu
atic
org
anis
ms.
Del
iver
y of
crit
ical
re
view
of k
ey k
now
ledg
e ga
ps to
sup
port
AO
Ps
for O
EC
D te
st g
uide
lines
for
aqua
tic o
rgan
ism
s de
liver
ed b
y U
K a
nd
Japa
n.ii)
Def
ra-fu
nded
pro
ject
(Cra
nfie
ld
Uni
vers
ity) –
In S
ilico
Pre
dict
ions
of
In v
ivo
Toxi
city
: Are
inte
rspe
cies
ex
trapo
latio
ns o
ff ta
ngen
t? F
inal
repo
rt pu
blis
hed
on a
ccur
acy
of in
ter-
spec
ies
extra
pola
tions
of i
n si
lico
pred
ictio
ns o
f in
vivo
toxi
city
.iii
) Def
ra-fu
nded
pro
ject
(Cef
as,
Uni
vers
ities
of B
irmin
gham
and
Li
verp
ool)
– Th
e us
e of
sys
tem
s to
xico
logy
to re
cons
truct
mol
ecul
ar
AO
Ps
– ca
n ch
emic
al m
ixtu
re to
xici
ty
be p
redi
cted
to a
id e
nviro
nmen
tal r
isk
asse
ssm
ent a
nd re
gula
tion?
Fin
al
repo
rt pu
blis
hed
on th
e us
e of
sys
tem
s to
xico
logy
to re
cons
truct
mol
ecul
ar
AO
Ps.
Pub
lic H
ealth
Eng
land
(PH
E) i
n co
llabo
ratio
n w
ith
inte
rnat
iona
l par
tner
s is
taki
ng fo
rwar
d a
larg
e pi
ece
of w
ork
to im
prov
e in
vitr
o m
etho
ds in
toxi
city
test
ing
for g
enot
oxic
and
non
-gen
otox
ic c
arci
noge
ns. T
his
is a
lo
ng-te
rm p
roje
ct w
hich
will
lead
to re
duct
ion
in a
nim
al
test
ing
and
impr
ovem
ents
in te
stin
g st
rate
gies
.
Stra
tegi
c P
riorit
y 2
27
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
2.3.
2 A
ppro
ache
s fo
r ph
arm
aceu
tical
s
(MH
RA
and
VMD
)
Har
mon
isat
ion
of a
ppro
ache
s w
ithin
re
gula
tory
fram
ewor
ks:
- Har
mon
ise
appr
oach
es w
ith re
spec
t to
the
3Rs,
and
pro
mot
e th
eir u
ptak
e in
pha
rmac
eutic
al
deve
lopm
ent.
- Con
tribu
te to
ong
oing
exp
lora
tion
of a
ltern
ativ
es
to u
sing
ani
mal
s in
test
ing
of h
azar
dous
m
ater
ials
.S
uppo
rt th
e ha
rmon
isat
ion
of g
loba
l reg
ulat
ory
stan
dard
s. U
nles
s al
l reg
ulat
ors
acce
pt a
n al
tern
ativ
e to
an
anim
al te
st, t
he a
nim
al te
st
wou
ld s
till b
e ca
rrie
d ou
t by
indu
stry
to e
nsur
e w
ides
prea
d m
arke
ting
– es
sent
ially
per
form
ing
to th
e ‘lo
wes
t com
mon
dom
inat
or’ (
and
high
est
anim
al u
se) d
espi
te b
ette
r and
mor
e ec
onom
ic
test
s be
ing
avai
labl
e.
Con
tinue
to w
ork
with
oth
er re
gula
tory
age
ncie
s to
inte
rpre
t IC
H (I
nter
natio
nal C
onfe
renc
e on
H
arm
onis
atio
n of
Tec
hnic
al R
equi
rem
ents
for
Reg
istra
tion
of P
harm
aceu
tical
s fo
r Hum
an U
se)
and
VIC
H (V
eter
inar
y IC
H) f
lexi
bly,
esp
ecia
lly in
lig
ht o
f em
ergi
ng m
arke
ts w
hich
are
kno
wn
to b
e le
ss fl
exib
le.
Con
tinue
to in
sist
on
adhe
renc
e of
OE
CD
Goo
d La
bora
tory
Pra
ctic
e (G
LP) r
equi
rem
ents
to a
void
du
plic
atio
n of
stu
dies
, esp
ecia
lly im
porta
nt fo
r em
ergi
ng m
arke
ts w
hich
are
not
par
ty to
the
Mut
ual A
ccep
tanc
e of
Dat
a pr
oced
ures
. P
rovi
de a
cha
lleng
e to
indu
stry
for a
lread
y au
thor
ised
pro
ject
s an
d hi
ghlig
ht w
here
they
are
pe
rform
ing
unne
cess
ary
anim
al te
stin
g an
d se
t ou
t our
exp
ecta
tions
for c
hang
e.
i) M
HR
A en
gage
d at
Eur
opea
n an
d w
ider
in
tern
atio
nal l
evel
s w
ith p
harm
aceu
tical
re
gula
tors
to p
rom
ote
the
upta
ke o
f the
3R
s an
d ha
rmon
ise
appr
oach
es a
t all
stag
es o
f pha
rmac
eutic
al d
evel
opm
ent.
ii) M
HR
A en
cour
agin
g th
e us
e of
mul
tiple
en
d-po
ints
in o
ne s
tudy
to w
ork
to
redu
ce th
e us
e of
ani
mal
s –
an e
xam
ple
wou
ld b
e in
clud
ing
geno
toxi
city
test
ing
in
anim
als
in o
ther
toxi
city
stu
dies
.iii
) VM
D a
nd M
HR
A in
fluen
cing
the
deve
lopm
ent a
nd re
visi
on o
f Eur
opea
n P
harm
acop
oeia
mon
ogra
phs
such
that
, w
here
ver f
easi
ble,
test
ing
in a
nim
als
is
repl
aced
or r
emov
ed o
r ref
ined
. (Th
is
crea
tes
a w
ider
out
reac
h th
an s
impl
y th
e E
U a
s m
ore
coun
tries
are
sig
ned
up to
th
e ph
arm
acop
eia.
)iv
) VM
D p
artic
ipat
ing
in th
e C
XM
P 3R
s gr
oup
whi
ch is
inte
nded
to id
entif
y an
d pr
ogre
ss a
reas
for r
egul
ator
y ch
ange
w
hich
can
ena
ble
redu
ced
test
ing
in
anim
als.
v) V
MD
and
MH
RA
activ
ely
chal
leng
ing
indu
stry
for a
lread
y au
thor
ised
pro
ject
s an
d hi
ghlig
htin
g w
here
they
may
be
perfo
rmin
g un
nece
ssar
y an
imal
test
ing.
S
ettin
g ou
t our
exp
ecta
tions
for c
hang
e.vi
) Def
ra p
roje
ct to
revi
ew a
ccur
acy
of
inte
r-sp
ecie
s ex
trapo
latio
ns o
f in
silic
o pr
edic
tions
of i
n vi
vo to
xici
ty.
i) M
HR
A st
aff h
ave
been
eng
aged
at E
U S
afet
y W
orki
ng
Par
ty a
nd In
tern
atio
nal I
CH
leve
l pro
mot
ing
the
3Rs
in
new
/revi
sed
guid
elin
es.
MH
RA
staf
f als
o di
scus
sed
the
3Rs
with
del
egat
es fr
om C
hina
’s F
DA
.ii)
MH
RA
staf
f hav
e be
en in
volv
ed w
ith th
e re
visi
on o
f E
U a
nd In
tern
atio
nal g
uide
lines
pro
mot
ing
mul
tiple
end
-po
ints
in o
ne s
tudy
. M
HR
A st
aff h
ave
also
pro
mot
ed th
is
view
in s
cien
tific
adv
ice
mee
tings
with
pha
rmac
eutic
al
com
pani
es a
nd a
cade
mic
gro
ups.
iii) R
equi
rem
ent f
or a
saf
ety
test
to b
e ca
rrie
d ou
t in
the
targ
et s
peci
es fo
r eac
h ba
tch
of v
eter
inar
y va
ccin
es
prod
uced
has
bee
n de
lete
d fro
m th
e E
urop
ean
Pha
rmac
opoe
ia –
this
requ
irem
ent h
as n
ow b
een
dele
ted
from
all
mar
ketin
g au
thor
isat
ions
sav
ing
appr
oxim
atel
y 5,
000–
6,00
0 an
imal
s pe
r yea
r.Ve
terin
ary
Inte
rnat
iona
l Con
fere
nce
on h
arm
onis
atio
n (V
ICH
) is
wor
king
on
guid
elin
es fo
r wai
ving
bat
ch s
afet
y te
sts
for v
eter
inar
y va
ccin
es. T
his
will
not
affe
ct th
e E
U
beca
use
the
requ
irem
ent f
or th
ese
test
s ha
s al
read
y be
en re
mov
ed fr
om th
e E
urop
ean
Pha
rmac
opoe
ia, a
nd
cons
eque
ntly
from
all
vacc
ines
aut
horis
ed in
the
EU
, but
sh
ould
eve
ntua
lly re
duce
the
num
ber o
f ani
mal
s us
ed
for t
his
purp
ose
wor
ldw
ide.
Hum
ane
end-
poin
ts h
ave
been
intro
duce
d in
to th
e ‘ra
bies
vac
cine
s (i
nact
ivat
ed) f
or v
eter
inar
y us
e’
mon
ogra
ph a
long
with
an
alte
rnat
ive
batc
h po
tenc
y te
st b
ased
on
sero
logi
cal r
espo
nses
inst
ead
of v
irule
nt
chal
leng
e. U
ptak
e of
this
alte
rnat
ive
met
hod
has
been
sl
ow b
ecau
se o
f the
nee
d fo
r pro
duct
-spe
cific
val
idat
ion.
Stra
tegi
c P
riorit
y 2
28
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
iv) T
he g
roup
has
revi
ewed
all
Com
mitt
ee fo
r Med
icin
al
Pro
duct
s fo
r Vet
erin
ary
use
(CV
MP
) and
Com
mitt
ee fo
r M
edic
inal
Pro
duct
s fo
r Hum
an u
se (C
HM
P) g
uide
lines
w
ith a
vie
w to
redu
cing
reco
mm
ende
d an
imal
num
bers
an
d re
mov
ing
unne
cess
ary
anim
al te
sts.
Fol
low
ing
this
re
view
, one
gui
delin
e on
vet
erin
ary
vacc
ines
is to
be
with
draw
n an
d a
revi
sed
vers
ion
of a
gui
delin
e re
mov
ing
the
optio
n fo
r in
vivo
test
s, a
t the
requ
est o
f JE
G 3
Rs,
is
bein
g pr
esen
ted
to C
VM
P fo
r end
orse
men
t.Ve
terin
ary
vacc
ines
aut
horis
ed v
ia th
e E
urop
ean
cent
ralis
ed p
roce
dure
are
bei
ng re
view
ed w
ith a
vie
w to
id
entif
ying
ani
mal
test
ing
proc
edur
es th
at m
ight
be
able
to
be
mod
ified
or r
epla
ced
acco
rdin
g to
3R
s pr
inci
ples
. Th
is is
ong
oing
.v)
The
Vet
erin
ary
Med
icin
es D
irect
orat
e (V
MD
) has
pu
blis
hed
a re
port
on a
nim
al u
sage
dur
ing
qual
ity
cont
rol t
estin
g of
vet
erin
ary
vacc
ines
dur
ing
2007
to
2012
and
hav
e gi
ven
pres
enta
tions
on
this
at t
he J
EG
3R
s m
eetin
g an
d th
e Ve
terin
ary
Vacc
ines
con
fere
nce.
Th
is h
as e
nabl
ed th
e id
entif
icat
ion
of v
acci
nes
that
re
quire
the
use
of p
artic
ular
ly la
rge
num
bers
of a
nim
als
to b
e id
entif
ied,
faci
litat
e m
onito
ring
trend
s an
d ev
alua
te
the
impa
ct o
f oth
er in
itiat
ives
, suc
h as
cha
nges
to
Eur
opea
n P
harm
acop
oeia
mon
ogra
phs.
As
a re
sult
of th
e ab
ove
men
tione
d st
udy,
clo
strid
ial
vacc
ines
hav
e be
en id
entif
ied
as u
sing
par
ticul
arly
larg
e nu
mbe
rs o
f ani
mal
s. T
he V
MD
has
writ
ten
to a
ll of
the
man
ufac
ture
rs o
f vet
erin
ary
clos
tridi
al v
acci
nes
aski
ng
abou
t pla
ns fo
r ref
inin
g th
e m
etho
ds to
redu
ce th
e nu
mbe
rs o
f ani
mal
s us
ed o
r to
repl
ace
them
by
in v
itro
met
hods
.
Stra
tegi
c P
riorit
y 2
29
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
2.3.
3. P
rom
ote
3Rs
in
food
saf
ety
regu
latio
n
(FSA
and
Cef
as fo
r Mou
se
bioa
ssay
repl
acem
ent)
(FSA
for o
ther
op
port
uniti
es)
Upt
ake
of 3
Rs
and
rese
arch
/risk
ass
essm
ent
to p
rom
ote
alte
rnat
ives
.- P
rom
ote
upta
ke o
f 3R
s in
food
saf
ety
regu
latio
n an
d su
ppor
t tes
ting
requ
irem
ents
in th
e U
K a
nd
EU
.- P
rom
ote
and
supp
ort r
esea
rch
and
risk
asse
ssm
ent t
o un
derp
in a
dopt
ion
of a
ltern
ativ
es
to a
nim
al-b
ased
test
ing
for f
ood
safe
ty w
here
this
ca
n be
don
e w
hile
mai
ntai
ning
an
adeq
uate
leve
l of
con
sum
er p
rote
ctio
n.
Key
opp
ortu
nitie
s ex
ist:
- rep
lace
mou
se b
ioas
say
in te
stin
g fo
r she
llfis
h bi
o to
xins
(i a
nd ii
).- c
ontin
ue to
enc
oura
ge th
e E
urop
ean
Com
mis
sion
and
oth
er M
embe
r Sta
tes
to
cons
ider
the
3Rs
prin
cipl
es w
hen
dete
rmin
ing
the
need
for a
nim
al s
tudi
es in
the
risk
asse
ssm
ent o
f G
enet
ical
ly M
odifi
ed O
rgan
isim
s (G
MO
s) (i
ii).
- eng
agem
ent w
orld
wid
e w
ith fo
od ri
sk
asse
ssm
ent a
nd re
gula
tory
bod
ies
to d
evel
op
and
harm
onis
e ap
proa
ches
and
to re
flect
thes
e an
d th
e 3R
s in
new
or u
pdat
ed fo
od re
gula
tions
an
d te
stin
g re
quire
men
ts. U
nles
s al
l reg
ulat
ors
acce
pt a
n al
tern
ativ
e to
an
anim
al te
st, t
he a
nim
al
test
may
stil
l be
carr
ied
out b
y in
dust
ry to
ens
ure
wid
espr
ead
acce
ss to
mar
kets
des
pite
bet
ter a
nd
mor
e ec
onom
ic te
sts
bein
g av
aila
ble
(iv).
- con
side
r the
mos
t app
ropr
iate
mea
ns o
f ge
nera
ting
data
on
appr
oved
food
che
mic
als,
in
clud
ing
hum
an s
tudi
es w
here
thes
e ar
e et
hica
l an
d ap
prop
riate
(v).
- cle
ar g
uida
nce
on th
e re
quire
men
ts fo
r au
thor
isat
ion
of n
ovel
food
s an
d pr
oces
ses
(vi).
i) S
ucce
ssfu
l rep
lace
men
t of m
ouse
bi
oass
ay in
con
trols
on
shel
lfish
toxi
ns
in U
K.
ii) S
eek
com
mitm
ent f
rom
Com
mis
sion
to
ensu
re o
ther
EU
Mem
ber S
tate
s re
plac
e m
ouse
bio
assa
y.iii
) Key
opp
ortu
nitie
s to
influ
ence
in
clud
e w
hen
the
EU
FP
7 “G
RA
CE
” pr
ojec
t com
es to
frui
tion,
and
whe
n th
e C
omm
issi
on’s
two-
year
feed
ing
stud
y w
ith G
M m
aize
is c
ompl
eted
.iv
) FS
A an
d its
inde
pend
ent s
cien
tific
ad
viso
ry c
omm
ittee
s ar
e en
gage
d at
EU
an
d w
ider
inte
rnat
iona
l lev
els,
incl
udin
g st
rong
eng
agem
ent w
ith th
e E
FSA
, th
e C
omm
issi
on, J
EC
FA a
nd C
odex
A
limen
tariu
s.v)
Pro
duci
ng th
e m
ost a
ppro
pria
te
mea
ns to
gen
erat
e da
ta o
n ap
prov
ed
food
che
mic
als,
incl
udin
g hu
man
stu
dies
w
here
thes
e ar
e et
hica
l and
app
ropr
iate
.vi
) FS
A pr
ovid
e cl
ear g
uida
nce
to
indu
stry
on
the
requ
irem
ents
for
appl
icat
ions
for a
utho
risat
ion
of n
ovel
fo
ods
and
proc
esse
s on
whe
re a
nim
al
test
ing
is a
nd is
not
nec
essa
ry fo
r ap
prov
al.
i) an
d ii)
The
mon
itorin
g of
she
llfis
h to
xins
for o
ffici
al
cont
rol p
urpo
ses
in th
e U
K u
ses
anal
ytic
al c
hem
istry
m
etho
ds. T
here
was
no
repo
rted
use
of m
ouse
bi
oass
ays
in th
e la
test
per
iod
for w
hich
Hom
e O
ffice
st
atis
tics
on a
nim
al u
se a
re a
vaila
ble.
EU
Mem
ber
Sta
tes
have
als
o m
oved
the
maj
ority
or a
ll of
thei
r te
stin
g to
the
anal
ytic
al c
hem
istry
met
hods
and
it is
an
ticip
ated
that
this
will
repl
ace
the
mou
se b
ioas
say
in
the
few
rem
aini
ng la
bora
torie
s sh
ortly
.iii
) The
GR
AC
E p
roje
ct is
due
to fi
nish
in N
ovem
ber
2015
. Onc
e th
e fin
al re
port
and
reco
mm
enda
tions
are
pu
blis
hed
the
Com
mis
sion
has
mad
e a
com
mitm
ent
to re
view
the
nece
ssity
for m
anda
tory
90-
day
feed
ing
stud
ies
as p
art o
f the
risk
ass
essm
ent f
or G
MO
s.
FSA
will
of c
ours
e re
min
d th
e C
omm
issi
on o
f thi
s co
mm
itmen
t whe
n th
e tim
e co
mes
.7
It is
of n
ote
that
a n
ewer
EU
-fund
ed re
sear
ch p
roje
ct
calle
d G
-Tw
YS
T, w
hich
sta
nds
for,
‘GM
Tw
o Ye
ar S
afet
y Te
stin
g’, i
s lo
okin
g at
long
er-te
rm s
afet
y te
stin
g fo
r G
MO
s. T
his
proj
ect l
asts
for f
our y
ears
and
doe
s no
t en
d un
til A
pril
2018
. No
info
rmat
ion
is y
et a
vaila
ble,
bu
t it i
s po
ssib
le th
e C
omm
issi
on m
ay s
eek
to d
elay
a
deci
sion
on
anim
al te
stin
g un
til th
is p
roje
ct is
co
mpl
eted
.8
iv) F
ood
Saf
ety
Age
ncy
(FS
A) s
uppo
rted
by it
s in
depe
nden
t sci
entif
ic a
dvis
ory
com
mitt
ees
cont
inue
s to
hav
e st
rong
eng
agem
ent w
ith E
urop
ean
Food
S
afet
y A
utho
rity
(EFS
A),
the
Com
mis
sion
, Joi
nt E
xper
t C
omm
ittee
on
Food
Add
itive
s (J
EC
FA) a
nd C
odex
A
limen
tariu
s. F
SA
cont
inue
s to
cha
mpi
on p
ropo
rtion
ate
and
appr
opria
te te
stin
g w
hich
mai
ntai
ns a
dequ
ate
cons
umer
pro
tect
ion.
7 ht
tp://
ww
w.g
race
-fp7.
eu/c
onte
nt/p
roje
ct (n
ote
web
link)
8 ht
tp://
ww
w.g
-twys
t.eu/
Stra
tegi
c P
riorit
y 2
30
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
v) H
isto
rical
ly F
SA
have
use
d hu
man
stu
dies
to
inve
stig
ate
issu
es w
ith a
ppro
ved
food
che
mic
als
whe
neve
r app
ropr
iate
e.g
. with
caf
fein
e an
d pr
egna
ncy
and
to in
vest
igat
e al
lege
d si
de e
ffect
s of
asp
arta
me
and
that
this
app
roac
h w
ill c
ontin
ue to
be
embe
dded
in
thei
r fut
ure
scie
nce
stra
tegy
vi)
Reg
ardi
ng n
ovel
fo
ods,
we
plan
to c
onsu
lt th
e A
CN
FP a
t the
nex
t C
omm
ittee
mee
ting
on 2
9 A
pril
rega
rdin
g gu
idan
ce to
ap
plic
ants
for m
inim
isin
g th
e us
e of
ani
mal
s in
the
risk
asse
ssm
ent o
f nov
el fo
ods.
The
gui
danc
e w
ill d
raw
at
tent
ion
to th
e st
atut
ory
requ
irem
ents
for a
nim
al te
stin
g in
the
regu
latio
ns a
nd h
ighl
ight
are
as id
entif
ied
whe
re
alte
rnat
ives
are
acc
epta
ble.
2.4
Cos
met
ics
alte
rnat
ives
(BIS
and
indu
stry
with
su
ppor
t fro
m H
O a
nd
FCO
– s
ee a
lso
2.5
belo
w)
Wor
k pl
an b
eing
dev
elop
ed to
influ
ence
oth
er
non-
EU
cou
ntrie
s in
usi
ng a
ltern
ativ
es to
ani
mal
te
stin
g in
brin
ging
cos
met
ics
to m
arke
t (se
e al
so 2
.5 b
elow
) Con
side
r opt
ions
of h
ow th
e E
U s
yste
m (r
elia
nce
on in
gred
ient
saf
ety)
cou
ld
be a
dapt
ed fo
r thi
rd c
ount
ries
such
as
Chi
na to
fa
cilit
ate
trade
.
i) P
aper
dev
elop
ed.
ii) O
utlin
e of
geo
grap
hies
and
type
s of
te
st w
here
we
thin
k th
ere
is re
dund
ant
anim
al te
stin
g to
targ
et fo
cus.
iii) O
ptio
ns fo
r rev
isin
g (p
ossi
bly
base
d on
the
EU
mod
el) i
nclu
ding
opp
ortu
nitie
s fo
r ref
orm
iden
tifie
d (e
.g. i
n C
hina
).
Hom
e O
ffice
Offi
cial
s ho
sted
a v
isit
by a
sen
ior
dele
gatio
n of
offi
cial
s fro
m th
e C
hina
Foo
d &
Dru
g A
dmin
istra
tion
(CFD
A) t
o di
scus
s w
ays
in w
hich
hu
man
saf
ety
can
be a
ssur
ed th
roug
h rig
orou
s ris
k as
sess
men
ts w
hich
do
not i
nclu
de u
nnec
essa
ry a
nim
al
data
. Dem
onst
rate
d w
as b
est p
ract
ice
in c
osm
etic
saf
ety
test
ing
and
show
case
of U
K e
xper
tise
in th
e 3R
s w
ith
a pa
rticu
lar f
ocus
on
non-
anim
al te
stin
g m
etho
ds. T
he
prog
ram
me
incl
uded
vis
its to
the
Nat
iona
l Cen
tre fo
r th
e 3R
s (N
C3R
s); U
nile
ver;
Wal
gree
ns B
oots
Alli
ance
; an
d m
eetin
gs w
ith th
e E
U C
omm
issi
on a
nd C
osm
etic
s E
urop
e as
wel
l as
UK
gov
ernm
ent t
eam
s.H
avin
g es
tabl
ishe
d a
cons
ortiu
m w
ith th
e co
mpa
nies
(U
nile
ver,
Wal
gree
ns B
oots
Alli
ance
, L’O
real
, and
P
roct
or &
Gam
ble)
and
UK
, EU
and
Chi
nese
trad
e as
soci
atio
ns (C
TPA
, Cos
met
ics
Eur
ope
and
CA
FFC
I) an
d in
par
tner
ship
with
the
EU
Com
mis
sion
(DG
E
nter
pris
e) a
wor
ksho
p w
as p
lann
ed fo
r Mar
ch 2
015
in B
eijin
g to
exp
lain
the
prin
cipl
es o
f saf
ety
risk
asse
ssm
ents
with
indu
stry
-led
exam
ples
. As
the
UK
/EU
is
a w
orld
lead
er in
this
fiel
d an
d is
stro
ngly
pos
ition
ed
to s
uppo
rt C
hina
in d
evel
opin
g th
e sk
ills
to c
arry
out
and
ev
alua
te s
afet
y ris
k as
sess
men
ts a
mon
g bo
th it
s S
ME
s an
d its
regu
lato
rs th
roug
h th
e de
velo
pmen
t of a
Ris
k A
sses
smen
t Tra
inin
g P
rogr
amm
e de
sign
ed fo
r Chi
na.
The
wor
ksho
p is
the
first
sta
ge in
the
proc
ess
that
will
co
ntin
ue fr
om A
pril
2015
onw
ards
.
Stra
tegi
c P
riorit
y 2
31
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
2.5
Dev
elop
ing
Act
ion
Plan
prio
ritie
s in
to a
n ef
fect
ive
inte
rnat
iona
l co
mm
unic
atio
n an
d in
fluen
cing
str
ateg
y
(FC
O, H
O a
nd B
IS-S
IN)
Usi
ng B
IS-S
IN G
loba
l Par
tner
ship
Fun
d, to
su
ppor
t a U
K c
olla
bora
tion
with
Chi
na (e
.g.
Chi
nese
Ass
ocia
tion
for L
abor
ator
y A
nim
al
Sci
ence
– C
ALA
S) f
or a
two-
day
sem
inar
, fun
ded
join
tly b
y U
K G
over
nmen
t and
the
rele
vant
ph
arm
aceu
tical
and
cos
met
ics
indu
strie
s, fo
r in
vite
d ex
perts
(gov
ernm
ent,
acad
emia
and
in
dust
ry) f
rom
Chi
na a
nd o
vers
eas
(UK
/EU
/US
) to
be h
eld
in B
eijin
g.
i) O
rgan
ise
sem
inar
in B
eijin
g to
sup
port
deve
lopm
ent o
f sta
ndar
ds fo
r ani
mal
ca
re, w
elfa
re a
nd e
thic
al u
se in
rese
arch
.ii)
Wor
k to
war
ds e
ndor
sem
ent o
f CA
LAS
st
anda
rds
by C
hine
se a
utho
ritie
s.iii
) Ini
tiate
a d
ialo
gue
on h
arm
onis
ing
phar
mac
eutic
al s
afet
y te
stin
g gu
idel
ines
an
d de
velo
p a
forw
ard
plan
.iv
) Exp
lore
a s
trate
gy to
cea
se a
nim
al
test
ing
of c
osm
etic
s in
Chi
na w
here
ver i
t is
not
sci
entif
ical
ly n
eces
sary
.
A st
rong
wor
king
rela
tions
hip
with
the
Chi
nese
A
ssoc
iatio
n fo
r Lab
orat
ory
Ani
mal
Sci
ence
s (C
ALA
S)
has
been
est
ablis
hed.
In M
arch
201
4 U
K g
over
nmen
t of
ficia
ls, w
ith C
ALA
S, h
eld
a sc
ene-
setti
ng s
emin
ar in
B
eijin
g th
at m
appe
d ou
t opp
ortu
nitie
s fo
r UK
–Chi
na
co-o
pera
tion
in th
e de
velo
pmen
t of s
tand
ards
for t
he
wel
fare
of r
esea
rch
anim
als
and
thei
r eth
ical
use
in
Chi
na.
Sup
port
has
been
giv
en to
CA
LAS
in d
evel
opin
g an
imal
w
elfa
re a
nd e
thic
al re
sear
ch s
tand
ards
and
it w
as
dem
onst
rate
d, th
roug
h vi
sits
to th
e U
K, h
ow th
ese
can
be m
ade
com
para
ble.
A fa
mili
aris
atio
n ex
erci
se w
ith
our r
egul
ator
y sc
hem
e de
mon
stra
ted
our a
ppro
ach
to d
evel
opin
g st
anda
rds
in th
e U
K. A
s pa
rt of
this
th
e de
lega
tion
visi
ted
both
indu
stry
and
aca
dem
ic
esta
blis
hmen
ts to
see
sta
ndar
ds b
eing
impl
emen
ted
in
prac
tice.
In p
artn
ersh
ip w
ith C
ALA
S a
sec
ond
UK
–Chi
na S
emin
ar
has
been
org
anis
ed to
be
held
in M
arch
201
5 w
hich
will
su
ppor
t the
furth
er d
evel
opm
ent o
f cur
rent
vol
unta
ry
stan
dard
s fo
r res
earc
h an
imal
car
e, w
elfa
re a
nd e
thic
al
use
to b
ecom
e m
anda
tory
nat
iona
l sta
ndar
ds in
Chi
na.
Inte
rnat
iona
l lob
byin
g, in
fluen
cing
and
evi
denc
e-ga
ther
ing
com
mun
icat
ions
man
aged
by
FCO
S
cien
ce a
nd In
nova
tion
Net
wor
k, in
par
tner
ship
w
ith B
IS a
nd H
ome
Offi
ce le
ads,
thro
ugh
the
FCO
glo
bal s
truct
ure.
Inte
rnat
iona
l Act
ion
Pla
n pr
iorit
ies
deliv
ered
: Del
iver
y P
lan
partn
ers
with
an
inte
rnat
iona
l com
pone
nt to
thei
r ac
tivity
abl
e to
acc
ess
FCO
net
wor
k ef
ficie
ntly
/effe
ctiv
ely
with
tim
ely
inpu
t of
inte
rnat
iona
l fee
dbac
k an
d ev
iden
ce a
s re
quire
d.
The
Hom
e O
ffice
, in
colla
bora
tion
with
indu
stry
and
the
Eur
opea
n C
omm
issi
on, i
s cr
eatin
g S
cien
ce In
nova
tion
Net
wor
k (S
IN) t
oolk
it. O
nce
deve
lope
d th
is w
ill b
ecom
e th
e to
ol w
hich
the
Sci
ence
and
Inno
vatio
n N
etw
ork
in
FCO
pos
ts w
ill u
se to
pro
mot
e bo
th a
nim
al w
elfa
re a
nd
its b
enef
icia
l im
pact
s to
hum
an w
ell-b
eing
. The
pla
n is
to
targ
et E
mba
ssie
s, in
clud
ing
Bra
zil,
Indi
a an
d Ta
iwan
, w
ho c
an ta
ke o
n th
e w
ork
of e
ngag
ing
on th
e 3R
s re
gard
ing
cosm
etic
s te
stin
g to
a lo
cal l
evel
. B
razi
l is
the
wor
ld’s
third
larg
est c
osm
etic
s m
arke
t. D
iscu
ssio
ns h
ave
been
initi
ated
to s
uppo
rt pr
opos
ed
legi
slat
ion
whi
ch w
ill b
an a
nim
al te
stin
g of
fini
shed
co
smet
ic p
rodu
cts
and
prom
ote
acce
ptan
ce o
f ove
rsea
s (e
.g.U
K) g
ener
ated
non
-ani
mal
test
dat
a.
Stra
tegi
c P
riorit
y 2
32
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Title
/lead
org
anis
atio
n(s)
Act
ions
pub
lishe
d in
the
Del
iver
y Pl
anM
easu
res
of s
ucce
ss a
nd k
ey
mile
ston
es p
ublis
hed
in th
e D
eliv
ery
Plan
Prog
ress
3.1
Impr
ovin
g pu
blic
un
ders
tand
ing
of a
nim
al
rese
arch
(BIS
)
Impr
ovin
g pu
blic
und
erst
andi
ng o
f the
con
text
of
anim
al re
sear
ch a
nd th
e lic
ensi
ng fr
amew
ork.
- Rev
iew
the
resp
onse
s to
ani
mal
rese
arch
qu
estio
ns c
onta
ined
with
in th
e P
ublic
Atti
tude
s S
urve
y 20
14 m
anag
ed b
y S
cien
ce a
nd S
ocie
ty
and
IPS
OS
Mor
i.- O
ffice
of L
ife S
cien
ces
(OLS
) lea
ding
Pol
l on
anim
al re
sear
ch.
Pre
viou
s po
lls (B
IS) s
how
an
enha
nced
pub
lic u
nder
stan
ding
of
the
regu
lato
ry fr
amew
ork
with
in
whi
ch a
nim
als
are
used
in th
e U
K.
i) 20
14 p
oll l
aunc
hed.
ii) E
vide
nce
of e
nhan
ced
publ
ic
unde
rsta
ndin
g th
roug
h ne
w p
oll
resu
lts.
In M
arch
201
4 B
usin
ess
Inno
vatio
n an
d S
kills
(BIS
) ran
tw
o pa
ralle
l pub
lic o
pini
on s
urve
ys o
n th
e us
e of
ani
mal
s in
sc
ient
ific
rese
arch
. One
sur
vey
was
exa
ctly
the
sam
e as
the
prev
ious
iter
atio
n (O
ct 2
012
– th
e te
nth
wav
e of
rese
arch
in
this
ser
ies)
and
a n
ew s
urve
y w
ith s
ome
addi
tiona
l qu
estio
ns a
nd u
pdat
ed la
ngua
ge.
The
surv
ey in
dica
ted
that
aro
und
two-
third
s of
the
publ
ic
cont
inue
to a
ccep
t the
use
of a
nim
als
for m
edic
al re
sear
ch
whe
re th
ere
is n
o va
lidat
ed a
ltern
ativ
e. T
he re
sear
ch a
s a
who
le p
rovi
des
an e
vide
nce
base
for f
utur
e po
licy
and
enga
gem
ent a
nd to
pro
vide
evi
denc
e fo
r the
sec
tor t
o un
derp
in th
eir p
ublic
eng
agem
ent.9
3.2
Incr
ease
d tr
ansp
aren
cy
abou
t act
ual s
ever
ity
(HO
)
Dis
aggr
egat
ion
of d
ata
to re
port
proc
edur
es
acco
rdin
g to
thei
r act
ual s
ever
ity.
Mor
e cl
early
sep
arat
e th
e nu
mbe
r of p
roce
dure
s as
soci
ated
with
the
bree
ding
of n
on-h
arm
ful
GM
ani
mal
s (in
volv
ing
no s
uffe
ring)
from
pai
nful
pr
oced
ures
in a
nim
als.
Bet
ter i
nfor
m th
e pu
blic
ab
out w
hat a
nim
al re
sear
ch c
ompr
ises
(lar
gely
m
ild o
r sub
-thre
shol
d) a
s w
ell a
s to
iden
tify
the
mos
t sev
ere
proc
edur
es a
nd d
evel
op w
ays
to
redu
ce th
at s
ever
ity.
i) C
ompl
etio
n an
d re
view
of p
ilot t
rial
for r
etro
spec
tive
(act
ual)
seve
rity
repo
rting
.ii)
Dev
elop
men
t of g
uida
nce
on
reco
rdin
g ac
tual
sev
erity
.iii
) Pub
licat
ion
of fi
rst c
ompl
ete
year
of
retro
spec
tive
actu
al s
ever
ity d
ata.
iv) P
rovi
sion
of c
ompl
ete
year
dat
a to
the
EU
Com
mis
sion
.
i) A
n ac
tual
sev
erity
pilo
t stu
dy w
as c
arrie
d ou
t ove
r a tw
o-m
onth
per
iod
in A
ugus
t and
Sep
tem
ber 2
013.
The
resu
lts
wer
e pu
blis
hed
in th
e 20
13 A
SR
U a
nnua
l rep
ort.10
ii) T
he re
sults
of t
he p
ilot i
nfor
med
the
deve
lopm
ent o
f gu
idan
ce o
n ac
tual
sev
erity
, pub
lishe
d on
the
Hom
e O
ffice
w
ebsi
te.11
iii) T
he fi
rst c
ompl
ete
year
of d
ata
will
be
publ
ishe
d as
par
t of
the
Ann
ual S
tatis
tics
on th
e us
e of
Ani
mal
s in
Sci
entif
ic
Pro
cedu
res
in 2
015.
iv) T
he fi
rst c
ompl
ete
year
of d
ata
will
be
subm
itted
to th
e E
urop
ean
Com
mis
sion
whe
n av
aila
ble.
Stra
tegi
c Pr
iorit
y 3:
Pro
mot
ing
an u
nder
stan
ding
and
aw
aren
ess
abou
t the
use
of a
nim
als
whe
re n
o al
tern
ativ
es e
xist
9 ht
tps:
//ww
w.g
ov.u
k/go
vern
men
t/pub
licat
ions
/pub
lic-a
ttitu
des-
to-s
cien
ce-2
014
10 h
ttps:
//ww
w.g
ov.u
k/go
vern
men
t/pub
licat
ions
/ani
mal
s-in
-sci
ence
-reg
ulat
ion-
unit-
annu
al-r
epor
t-201
3 (p
age
12)
11
http
s://w
ww
.gov
.uk/
gove
rnm
ent/p
ublic
atio
ns/a
nim
als-
in-s
cien
ce-r
egul
atio
n-un
it-an
nual
-rep
ort-2
013
33
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery ReportTi
tle/le
ad o
rgan
isat
ion(
s)A
ctio
ns p
ublis
hed
in th
e D
eliv
ery
Plan
Mea
sure
s of
suc
cess
and
key
m
ilest
ones
pub
lishe
d in
the
Del
iver
y Pl
an
Prog
ress
3.3
Con
cord
at o
n O
penn
ess
and
Tran
spar
ency
(Aca
dem
ia, i
ndus
try,
hea
lth
char
ities
, fun
ders
, etc
.)
Con
cord
at o
n O
penn
ess
and
Tran
spar
ency
to
be m
ore
open
abo
ut th
e w
ays
in w
hich
ani
mal
s ar
e us
ed in
sci
entif
ic, m
edic
al a
nd v
eter
inar
y re
sear
ch in
the
UK
.- C
onco
rdat
on
Ope
nnes
s ab
out a
nim
al
rese
arch
agr
eed
betw
een
maj
or fu
nder
s,
rese
arch
org
anis
atio
ns a
nd in
dust
ry.
- IP
SO
S M
OR
I rep
ort o
n S
cien
cew
ise
supp
orte
d pu
blic
dia
logu
e se
ssio
ns w
ill d
eter
min
e pu
blic
ex
pect
atio
ns o
f ope
nnes
s, tr
ansp
aren
cy a
nd
com
mun
icat
ion
to in
form
the
deve
lopm
ent o
f the
C
onco
rdat
on
the
use
of a
nim
als
in re
sear
ch.
i) P
ublic
atio
n of
dec
lara
tion
on
open
ness
.ii)
Pub
licat
ion
of C
onco
rdat
.iii
) Ann
ual m
onito
ring
show
s pr
ogre
ss in
impl
emen
tatio
n.iv
) Pol
ls s
how
incr
ease
d pu
blic
un
ders
tand
ing
of th
e ro
le o
f ani
mal
re
sear
ch.
The
Con
cord
at w
as p
ublis
hed
in M
ay 2
014
and
sign
ed b
y 86
com
pani
es, u
nive
rsiti
es, m
edic
al re
sear
ch c
harit
ies
and
othe
r org
anis
atio
ns a
cros
s th
e U
K li
fe s
cien
ces
sect
or. I
t pu
ts th
e U
K li
fe s
cien
ces
sect
or a
t the
hea
d of
glo
bal e
fforts
to
incr
ease
ope
nnes
s an
d tra
nspa
renc
y in
ani
mal
rese
arch
. E
very
sig
nato
ry o
rgan
isat
ion
has
give
n a
clea
r com
mitm
ent
both
to fa
cilit
ate
grea
ter s
crut
iny
of th
eir a
nim
al re
sear
ch
and
to b
e vi
sibl
y ac
coun
tabl
e by
repo
rting
ann
ually
on
thei
r pr
ogre
ss to
war
ds im
plem
entin
g th
e C
onco
rdat
. Ins
titut
ions
in
volv
ed in
ani
mal
sci
ence
con
tinue
to s
ign
up to
the
Con
cord
at. A
‘one
yea
r on’
sto
ck ta
ke is
inte
nded
sho
rtly
to e
nsur
e si
gnat
orie
s ha
ve m
ade
clea
r ste
ps to
war
ds
impl
emen
tatio
n.
3.4
Rev
iew
of s
ectio
n 24
of
ASP
A
(HO
)
The
Gov
ernm
ent t
o re
view
sec
tion
24 o
f the
A
nim
als
(Sci
entif
ic P
roce
dure
s) A
ct 1
986
(AS
PA).
Sec
tion
24 p
rovi
des
for t
he p
rote
ctio
n of
in
form
atio
n, g
iven
in c
onfid
ence
, in
conn
ectio
n w
ith re
gula
tory
act
iviti
es u
nder
AS
PA. A
bre
ach
of s
ectio
n 24
can
resu
lt in
crim
inal
san
ctio
ns.
The
infle
xibl
e co
nfid
entia
lity
requ
irem
ents
of
sect
ion
24 a
re n
ow o
ut o
f ste
p w
ith g
over
nmen
t po
licy
on o
penn
ess
and
trans
pare
ncy
and
with
th
e ap
proa
ch ta
ken
in o
ther
legi
slat
ion,
suc
h as
the
Free
dom
of I
nfor
mat
ion
Act
(FO
IA).
The
inte
ntio
n is
to d
esig
n a
mor
e fle
xibl
e fra
mew
ork
that
will
pro
tect
pro
prie
tary
righ
ts, i
ntel
lect
ual
prop
erty
and
per
sona
l saf
ety,
pro
vide
gre
ater
tra
nspa
renc
y to
ass
ist p
ublic
und
erst
andi
ng,
and
not h
arm
the
com
petit
iven
ess
of th
e U
K in
th
e lif
e sc
ienc
es.
i) P
ublic
con
sulta
tion
on o
ptio
ns fo
r re
visi
on o
f sec
tion
24 c
omm
ence
d.ii)
Res
pons
e to
pub
lic c
onsu
ltatio
n re
view
ed a
nd p
refe
rred
opt
ion
prep
ared
.iii
) Pro
cess
es fo
r leg
isla
tive
chan
ges
(as
need
ed) p
ursu
ed le
adin
g to
re
visi
on o
f sec
tion
24.
The
publ
ic c
onsu
ltatio
n on
opt
ions
for t
he re
view
of s
ectio
n 24
was
pub
lishe
d an
d fo
ur b
road
opt
ions
wer
e of
fere
d.
Thes
e ra
nged
from
the
com
plet
e re
peal
of t
he s
ectio
n th
roug
h to
no
chan
ge. A
lmos
t 5,0
00 re
spon
ses
wer
e re
ceiv
ed, t
he m
ajor
ity th
roug
h th
e on
line
surv
ey s
yste
m.
Alm
ost w
ithou
t exc
eptio
n, re
spon
dent
s ex
pres
sed
a de
sire
fo
r inc
reas
ed o
penn
ess
and
trans
pare
ncy
in th
is fi
eld
whi
lst
reco
gnis
ing
the
need
to p
rote
ct th
e id
entit
ies
of p
eopl
e an
d pl
aces
as
wel
l as
info
rmat
ion
that
is a
cade
mic
ally
or
com
mer
cial
ly s
ensi
tive.
Fur
ther
dis
cuss
ions
with
st
akeh
olde
rs h
ave
refin
ed th
e pr
opos
als
and
we
will
revi
sit
thes
e in
the
next
Par
liam
ent.
Stra
tegi
c P
riorit
y 3
34
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
Glossary
3Rs The principles of replacement, reduction and refinement – an ethical framework for conducting scientific experiments using animals humanely
AHVLA Animal Health & Veterinary Laboratories Agency, an executive agency of Defra
ASPA Animals (Scientific Procedures) Act 1986 (as amended in 2012)
ASRU Animals in Science Regulation Unit, a unit of the Home Office responsible for regulating the use of animals in research under ASPA
AWERB Animal Welfare and Ethical Review Body, a requirement of each research establishment licensed under ASPA
BBSRC Biotechnology & Biological Sciences Research Council, an executive NDPB of BIS investing in bioscience research and training in the UK
BIS Department for Business, Innovation and Skills
Cefas Centre for Environment, Fisheries & Aquaculture Science, an executive agency of Defra
CFDA The Food and Drug Administration responsible for registration, including pharmaceuticals, medical devices and cosmetics, in China
Defra Department for Environment, Food and Rural Affairs
DH Department of HealthECHA European Chemicals Agency responsible for
the REACH RegulationEOGRTS Extended One-Generation Reproductive
Toxicity Study FCO Foreign & Commonwealth Office Fera Food & Environment Research Agency, an
executive agency of DefraFRAME Fund for the Replacement of Animals in
Medical ExperimentsFSA Food Standards Agency, a non-ministerial
department responsible for food safety and food hygiene across the UK
GA Genetically altered (applied to animals)GO-Science The Government Office for Science
which works within BIS and supports the Government Chief Scientific Adviser
HSE Health & Safety Executive, an executive NDPB of the Department for Work & Pensions and the UK competent authority for REACH
ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
in vitro research using methods in components of an organism (e.g. tissue culture, cells, subcellular extracts or purified molecules)
in vivo research using methods within a whole, living organism, usually an animal
MHRA Medicines and Healthcare Products Regulatory Agency, an executive agency of DH responsible for registration of human medicines, vaccines and other healthcare products in the UK
MRC Medical Research Council, an executive NDPB of BIS which aims to improve human health by supporting research in medical sciences
NC3Rs The National Centre for the Replacement, Refinement & Reduction of Animals in Research
NDPB Non-departmental public bodyOECD Organisation for Economic Co-operation and
DevelopmentPHE Public Health England, an executive agency
of DH which aims to protect and improve human health in the UK
REACH Registration, Evaluation, Authorisation & restriction of Chemicals, an EU regulation which addresses the potential impact of chemicals on human health and the environment
RSPCA Royal Society for the Prevention of Cruelty to Animals – a UK charity which aims to reduce the suffering of animals used in research
TSB Technology Strategy Board, an executive NDPB sponsored and funded by BIS
UFAW Universities Federation for Animal Welfare – an internationally recognised, independent, scientific and educational animal welfare charity which first promoted the concept of the 3Rs
US FDA US Food and Drug Administration, an operating division of the US Department of Health & Human Services responsible for ensuring that human and animal pharmaceuticals, medical devices and cosmetics in the USA are safe and effective
VICH The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
VMD Veterinary Medicines Directorate, an executive agency of Defra responsible for registration of veterinary medicines, vaccines and other animal health products in the UK
35
Our Commitment to Replace, Reduce and Refine the Use of Animals in Scientific Research – Delivery Report
ISBN: 978-1-78246-731-1