REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS in accordance with Article 58 of Directive 2010/63/EU on the protection of animals used for scientific purposes
Date: 2017-11-08
Institutions: Directorate-General for Environment, European Commission
Subjects: animal experimentation, animal welfare, bio-ethics, protection of animals, scientific research, veterinary inspection

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 8.11.2017  COM(2017) 631 final  REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS in accordance with Article 58 of Directive 2010/63/EU on the protection of animals used for scientific purposes {SWD(2017) 353 final}  
 
 
REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE 
COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE 
COMMITTEE OF THE REGIONS 

in accordance with Article 58 of Directive 2010/63/EU on the protection of animals used 
for scientific purposes 

1. Introduction 

In  2010,  the  EU  adopted  Directive  2010/63/EU  on  the  protection  of  animals  used  for 
scientific purposes ("the Directive") updating and replacing the 1986 legislation. All uses of 
live animals for research or education, and testing must be carried out in compliance with this 
Directive. This report is in response to the Directive's Article 58 that requires a review of the 
Directive by 10 November 2017. 

1.1 

Policy Objectives and Purpose 

The Directive has three key objectives:  

  Ensure efficient  functioning of the EU internal market and enhance competitiveness 
and  innovation  of  the  EU  research  industry  through  the  creation  of  a  level  playing 
field.  

  Ensure high standards of welfare for animals used for scientific purposes. 
 

Improve  transparency  to  the  general  public  of  the  performance  of  research 
establishments in terms of animal use and welfare. 

Critical  to  enhancing  the  welfare  of  animals  is  the  effective  application  of  the  'Three  Rs': 
Replace, Reduce and Refine the use and care of animals used for scientific purposes. 

The Directive sets out requirements on: 

  The replacement and reduction of the use of animals in procedures and the refinement 

of the breeding, accommodation, care and use of those animals. 

  The origin, breeding and marking of animals. 
  The operations of breeders, suppliers and users. 
  The  evaluation  and  authorisation  of  projects  involving  the  use  of  animals  in 

procedures. 

1.2 Scope and Timing of the Review Report 

This review aims to assess how well the Directive's objectives are achieved and whether it is 
fit  for  purpose  or  needs  updating  given  the  latest  scientific  and  ethical  developments.  The 
review  takes  into  account  advances  in  the  development  of  non-animal  alternatives  -  in 
particular those replacing non-human primates. It incorporates conclusions from a feasibility 
study on the progress towards using second and/or higher generation non-human primates, as 
required under Article 10.  

The  Directive  took  effect  on  1  January  2013,  however,  the  last  national  legislation  was 
adopted only in 2015. Also, the common standards for animal accommodation and care only 

2 

 
 
 
 
entered  into  force  on  January  2017.  At  the  time  of  this  review,  European  Commission 
conformity  checks  were  still  ongoing,  including  a  number  of  enquiries  and  infringement 
cases in progress, possibly leading to changes to some national legislation.  

Factual information on practical implementation of the Directive by Member States is not due 
until  2018.  National  statistical  data  were  published  for  the  first  time  in  2015,  but  trends  of 
animal  use  at  EU  level  will  not  be  known  before  2019.  Information  on  retrospective 
assessments of projects will become available from 2019. Therefore, a full REFIT evaluation 
of  the  Directive  will  be  undertaken  after  2019  when  better  information  is  available  and 
sufficient time has lapsed for the Directive's implementation to enable an assessment of any 
changes in welfare and use practices. 

For all these reasons, the legally required completion date of this review comes quite early. 
Therefore  the  report  can  only  give  preliminary  indications  of  progress,  problem  areas  and 
good practice. 

The  consultation  methodology,  analysed  results  and  recommendations  on  improving  the 
implementation and application of the Directive are found in the accompanying staff working 
document (SWD)1. 

3. Key issues found 

The  Directive's  framework  is  generally  considered  to  be  a  sound  foundation  for  the 
regulation of animals used for scientific purposes. 

The preliminary indications are that the impact of the Directive varies among Member States. 
This is to a great extent influenced by national legislations in place prior to the Directive. For 
those  with  existing,  mature  project  evaluation  and  authorisation  processes,  the  Directive's 
transposition into national legislation required relatively few adjustments. However, for those 
with no previous requirements or formal structures for project evaluation the implementation 
has been more challenging.   

Yet  there  are  some  preliminary  indications  that  the  Directive's  implementation  will  deliver 
some  of  the  changes  and  results  as  envisaged.  For  example,  stakeholders  consider  the 
creation  of  Animal  Welfare  Bodies  (AWB)  an  effective  requirement  that  is  already 
contributing  positively  to  improving  animal  use  and  care  practices.  Other  positive  effects 
reported  include  raised  standards  in  care,  accommodation  and  research  practices,  enhanced 
Three Rs awareness, promotion of a culture of care, growing recognition within the research 
increasing 
community of 
transparency. 

link  between animal welfare  and  good  science,  and 

the 

Areas  identified  by  stakeholders  as  needing  further  attention  and  progress  include  the 
efficiency and consistency of project evaluation and authorisation processes as well as access 
to, and quality and transparency of information on the use of animals.  

The sections below describe the key findings in view of the Directive's three main aims. 

1 SWD(2017) 353  

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Section 1 - Harmonisation of legislation within the EU 

About  one  third  of  the  user  respondents  thought  that  the  Directive  had  started  harmonising 
some important aspects, thereby already creating a more level playing field, particularly with 
respect to the harmonisation of animal care and accommodation practices.  

However, in some Member States the requirements for project evaluation and authorisation 
led  to  concerns  over  additional  bureaucracy,  costs  and  delays.  Unlike  regulations,  EU 
directives  do  not  specify  operational  processes.  There  are  concerns  that  the  differences  in 
structures and financial resourcing, in particular for project evaluation and authorisation, may 
become limitations to achieving the harmonisation objectives.  

Project evaluation and authorisation 

Consistency and efficiency in the project evaluation and authorisation process, and outcomes 
in  and  between  Member  States  are  essential  for  achieving  a  level  playing  field  for  the 
scientific community, along with the desired welfare and scientific benefits. In many Member 
States,  similar  processes  were  in  place  before  the  Directive,  so  no  major  changes  or 
improvements  were  reported.  However,  many  scientists  have  yet  to  submit  a  project 
application  under  the  new  system  and  are  still  using  authorisations  issued  under  previous 
legislation. Transitional measures for existing authorisations run until January 2018. 

Member States developed differing structures to meet the Directive's requirements. In some, 
single  national  authorities  deal  with  all  applications  in  the  country.  In  others,  there  are 
regional  committees,  or  committees  within  user  establishments,  often  integrated  with  the 
AWB.  

Despite variations in structures, approx. half the users considered the project evaluation and 
authorisation processes to be effective and efficient. Some stakeholders raised concerns about 
the  implications  of  these  different  structures,  in  particular  with  respect  to  achieving 
impartiality  and  proportionality.  Some  users  expressed  frustration  and  confusion  about 
bureaucracy and duplications involved in project applications in some Member States. 

Other issues raised include: 

 

Inconsistent  approaches  between  Member  States  on  how  projects  of  different  sizes, 
nature and complexity are categorised and handled. 

  Delays in communicating authorisation decisions beyond the 40 or 55 day deadlines 

despite financial fees in some Member States for the project application. 

  Additional  bureaucracy  due  to  information  requirements  that  are  in  excess  of  those 

required in the Directive for harm-benefit assessments. 

  More efficiency needed in dealing with amendments to authorised projects. 
  Limited progress on the implementation and use of multiple generic projects and the 

simplified administrative procedure.  

The EU guidance2 on project evaluation to assist these processes was well distributed by most 
Member States. 

One  of  the  main  roles  of  the  National  Committee  is  to  ensure  a  harmonised  approach  to 
project evaluation.  Less than 25%  of the users considered that the National Committee had 

2 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/project_evaluation/en.pdf  

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been  effective  in  promoting  a  coherent  approach  partly  reflecting  the  fact  that  many 
committees are still not well established.   

Scope of the Directive  

The Directive's scope had been extended to include: 

  New species and life forms (e.g. cephalopods, foetal forms). 
  Use of animals in basic research, education and training. 
  Use of animals in routine production.   

Many  Member  States  already  covered  some  or  all  of these under  their previous  legislation. 
No  major  issues  were  raised  on  the  scope,  apart  from  a  few  instances  of  additional 
administrative burden. 

Education and training 

Free movement of personnel in the sector within the EU is one of Directive's aims. However, 
education and training remain Member State competence. The users' majority view was that 
ensuring and maintaining staff competence was addressed satisfactorily. Some differences in 
expectations  of  training  requirements  between  Member  States  were  reported,  hence 
duplication of training is sometimes still required. To facilitate a more harmonised approach, 
the  European  Commission  developed  an  EU  Framework  guidance3  for  education  and 
training,  and  a  voluntary  EU-wide  Education  and  Training  Platform  in  Laboratory  Animal 
Science (ETPLAS) was established. 

Harmonisation of welfare standards 

Many stakeholders stated that the Directive was beginning to harmonise standards of animal 
care and accommodation. The costs of complying with the new standards, noted as a potential 
issue in the Directive's ex-ante Impact Assessment, raised few concerns so far.   

The lack of standards for cephalopods and certain fish species, including appropriate methods 
of killing (cephalopods) were identified as omissions. 

The  level  playing  field  intention  of  Article  2  was  seen  by  some  stakeholders  as  a  potential 
barrier  to  improving  animal  welfare  standards.  However,  the  Directive  allows  for  technical 
adaptation  to  progress  via  delegated  powers,  ensuring  that  any  improvements  to  animal 
welfare standards identified can, if well-founded, be adopted and applied EU-wide.   

Section  2  -  Animal  Welfare  and  the  Three  Rs;  application  and  development  of 
alternatives approaches 

Measures to improve animal welfare and the application of the Three Rs form the core of the 
Directive. The benefits of high welfare standards to animals and to the quality of science are 
widely recognised. 

There  are  already  significant  positive  indicators  of  the  benefits,  in  particular  the  higher 
awareness  within  establishments  of  animals'  welfare  needs,  with  AWB  playing  a  key  role. 
Users  and  other  stakeholders  both  reported  benefits.  Over  half  the  users  considered  that 
animal welfare had been improved by applying the new housing and care practices, including 
e.g. enrichment and better trained and competent care staff.  

3 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf  

5 

 
 
                                                            
Responsibility for ensuring that alternative approaches are applied lies with researchers and 
care  staff,  supported  by  AWB  and  Designated  Veterinarian,  and  those  carrying  out  project 
evaluation.  Almost  half  of  the  users  agreed  that  project  evaluation  had  improved  the 
implementation  of  the  Three  Rs  and  animal  welfare.  However,  views  were  divided  among 
stakeholders and depending on whether measures were in place prior the Directive. 

Crucial elements include provision of appropriate education and training, the role and tasks of 
AWB,  and  the  tools  available  for  obtaining  up-to-date  and  relevant  Three  Rs  information. 
Inspections are important in maintaining animal welfare standards. 

The review report has taken into account progress with alternatives but it is not intended to 
measure the development, validation or uptake of alternative approaches. It evaluates whether 
the  measures  contained  in  the  Directive  are  fit-for-purpose.  Given  the  early  stages  of 
implementation  of  the  Directive's  requirements  on  the  development  and  validation  of 
alternative approaches, more time will be needed for their evaluation.   

Animal Welfare Bodies, AWB 

The  Directive  requires  each  establishment  to  have  an  AWB  with  the  main  objective  to 
facilitate continuous day-to-day application of the Three Rs. In general, Member States, users 
and  stakeholder  organisations  all  welcomed  this  requirement.  The  interactions  among 
scientists, care staff and veterinarians are viewed very positively, and the AWB is recognised 
as the promoter of a good culture of care. Of particular value is the inclusion of a Designated 
Veterinarian and the expertise on experimental design. 

In some Member States, however, users reported that the role of AWB is unclear when also 
involved  in  the  preliminary  evaluation  of  projects.  As  the  tasks  for  AWB  and  project 
evaluation differ, it is critical that there is awareness of the specific requirements, and that the 
competencies are appropriate for these separate processes. In such cases it is vital that all the 
core tasks, as required by the Directive, are addressed. 

National Committees 

National  Committees  should  facilitate  a  coherent  approach  to  project  evaluation,  promote 
good animal welfare and exchange good practice within the Member States and at EU level. 
In general, expectations are not yet met with a number of National Committees not yet fully 
established. Nevertheless, some committees are already active, developing guidance material, 
networks, and sharing best practices.  

Training and education, and requirement for named responsible persons  

In  those  Member  States  that  previously  lacked  formal  high  quality  training  and  education 
programmes,  substantial  benefits  were  reported 
the  Directive's 
requirements  –  including  the  appointment  of  a  person  formally  responsible  for  overseeing 
training and competence. Benefits included better animal welfare, better recognition of pain, 
distress  and  suffering,  and  better  understanding  of  animal  behaviours  and  needs.  However, 
between  Member  States  considerable  variability  remains  in  the  training  required  before 
animal procedures can be started.  

to  meeting 

thanks 

Many users remain unaware of the EU guidance on training4 and other guidance documents 
by  Member  States  or  National  Committees  so  there  is  clearly  room  for  improved 

4 http://ec.europa.eu/environment/chemicals/lab_animals/pdf/guidance/education_training/en.pdf  

6 

 
 
                                                            
communication on these. There also appear to be some challenges with the recognition and 
implementation  of  the  role  for  a  "person  responsible  for  the  provision  of  species-specific 
information", in particular with their input into accessing information relating to the Three Rs 
in  the  relevant  area  of  science.  Additional  guidance  for  this  role  could  be  valuable.  The 
requirement for a Designated Veterinarian was welcomed and contributed to better practices 
in surgery, anaesthesia, analgesia and euthanasia. 

Inspections by Member States 

Quantitative data on inspections will not be available from Member States before late 2018. 
However, a few stakeholder responses suggested that the revised inspection requirements are 
helping  to  change  the  attitudes  of  scientists  and  technicians,  leading  to  improved  animal 
welfare  and  awareness  of  the  Three  Rs.  This  includes  improvements  in  experimental 
protocols,  better  monitoring  the  animals  and  severity  assessments,  improved  environmental 
enrichment and health monitoring.  

Application of existing alternatives  

The  term  ‘alternatives’  in  the  context  of  the  Directive  includes  any  tools  or  strategies 
implementing the “Three Rs” which: 

  Obtain the required information without the use of live animals. 
  Use fewer animals whilst obtaining the same level of information. 
 

Improve  the  way  procedures  are  carried  out  so  as  to  cause  less  pain,  distress  or 
suffering, or improve welfare. 

Animals may only be used when there are no non-animal alternatives available to achieve the 
scientific objective. At this stage of the Directive's implementation, it is too early to assess its 
impact  on  the  promotion  and  uptake  of  alternatives.  Nevertheless,  stakeholders  confirmed 
some positive developments: 

  The  important  influence  of  AWB,  project  evaluators  and  competent  authorities  in 

challenging the need of the proposed use of animals.  

  The importance of inspection programmes to check compliance with the Three Rs and 

continued application of new alternatives throughout the life of the project.  

  The  formal  establishment  of  the  European  Union  Reference  Laboratory  for 
Alternatives to Animal Testing (EURL ECVAM) which plays a valuable role in co-
ordinating validation of alternative approaches as well as in maintaining databases of 
information on alternatives. 

However, responses identified four key issues hindering a more rapid uptake of alternatives: 
lack  of  knowledge;  insufficient  communication/spreading  of  information;  acceptability,  and 
cost.  Organisations  pointed  to  shortcomings  in  training  on,  and  searching  for,  alternatives. 
Some AWB have not yet developed suitable information strategies for alternatives. 

Users  indicated  that  studies  on  some  aspects  of  biology  continue  to  need  in  vivo 
experimentation and alternative methods are unlikely to be available in the foreseeable future. 
Many  stakeholders  felt,  however,  that  there  is  significant  scope  for  the  replacement  of 
animals used for educational purposes where many alternatives are already available, but not 
always  taken  up.  Further  separation  of  educational  purposes  within  the  statistics  would  be 
helpful. 

7 

 
 
Development and validation of new alternatives 

Welfare  organisations  expressed  frustration  at  the  slow  progress  towards  validation  and 
acceptance of new alternative methods. Validation and regulatory acceptance processes vary 
between  different  regulatory  areas,  which  are  not  directly  regulated  by  this  Directive. 
Nevertheless, there is evidence of investment and activity advancing this field. The Directive 
contributes towards these objectives through obligations on Member States and the European 
Commission.   

For validation, Member States have appointed laboratories for carrying out validation studies 
(European  Union  Network  of  Laboratories  for  the  Validation  of  Alternative  Methods,  EU-
NETVAL).  Some  Member  States  provide  funds  for  the  work  but  more  is  needed.  For 
regulatory  input,  Member  States  have  nominated  single contact  points  for  giving advice  on 
the regulatory relevance and suitability of new alternative approaches proposed for validation 
(Preliminary  Assessment  of  Regulatory  Relevance  PARERE  Network)  to  accelerate 
validation and uptake in the regulatory field. 

Many Member States have increased their activities in promoting alternatives, e.g., increasing 
research funding, voluntary development of Three Rs centres, supporting educational events 
and  other  information  dissemination  efforts.  Half  of  the  Member  States  have  submitted 
voluntary  reports  detailing  the  actions  taken  towards  the  development,  validation  and 
promotion of alternative methods5. 

The  remit  of  EURL  ECVAM  was  enlarged  to  include  basic  and  applied  research.  Users 
requested EURL ECVAM to continue broadening its activities from being mainly regulatory 
toxicology  to  other  areas  of  science.  The  EURL  ECVAM  report6  describes  the  current 
structures and progress supporting development, validation, regulatory uptake and promotion 
of alternatives.  

Section 3 - Improved transparency  

The  Directive  introduced  elements  aimed  at  improving  transparency  and  in  particular, 
requirements for non-technical project summaries, project evaluations process and statistical 
information.  

Most  Member  States,  users  and  scientific  stakeholders  thought  that  the  requirements  for 
publication of non-technical project summaries and revised annual statistical data contributed 
towards improving transparency, although the full impact has yet to materialise. However, an 
important proportion of the animal protection organisations expressed reservations about the 
impact,  so  far,  of  the  Directive  on  improving  transparency.  This  reflects,  in  part,  the  early 
stage of the Directive's implementation at the time of the review.  

Non-technical project summaries 

Non-technical  project  summaries  must  report  information  on  the  objectives  and  benefits  of 
the project, numbers and types of animals to be used, the predicted harm to the animals as a 
result  of  the  procedures  applied,  and  compliance  with  the  Three  Rs.  Most  Member  States 
stated  that  publication  of  the  summaries  is  helping  to  improve  transparency  although  some 
reservations  were  expressed  by  animal  protection  groups  who  pointed  to  significant 

5 http://ec.europa.eu/environment/chemicals/lab_animals/3r/advance_en.htm  
6 Annex II to Staff Working Document SWD(2017) 353 

8 

 
 
                                                            
differences  in  quality  and  a  lack  of  appropriate  balance,  e.g.  too  much  emphasis  put  on 
generic, sometimes unrealistic benefits and insufficient information on harm.  

Project Evaluation 

Only  a  few  Member  States  have,  so  far,  published  their  project  evaluation  processes.  It  is 
expected  that  Member  State  information  will  be  available  at  the  time  of  the  Commission 
implementation report in 2019.  

Statistical information 

Member States published statistical data on the use of animals for scientific purposes for the 
first  time  in  2015,  however,  very  few  did  so  with  the  level  of  detail  required  by  the 
Commission Implementing Decision 2012/707/EU. 

It  is  too  early  to  determine  the  impact  of  the  new  reporting  requirements  on  improving 
transparency, but for the first time information is provided inter alia on the genetic status of 
the animals, the actual experienced severity, and origin and species of non-human primates.  

Section 4 – Results of the feasibility study on the progress to using second and/or 
higher generation purpose-bred non-human primates 

With the aim of ending capture of non-human primates from the wild for both scientific and 
breeding purposes, the Directive allows, after an appropriate transition period, the use only of 
non-human  primates  that  are  the  offspring  of  animals  which  have  been  bred  in  captivity 
(F2/F2+),  or  that  are  sourced  from  self-sustaining  colonies7.  The  understanding  of  self-
sustaining colony is that once closed, the colony no longer can be reopened. It is also implicit 
from  the  intentions  of  the  legislators  that  "other  colonies"  from  which  animals  can  be 
sourced, must be considered to be also self-sustaining captive-bred colonies, and from which 
no wild-caught animals can be obtained as breeders. 

The  current  deadline  in  the  Directive  Annex  II  is  set  at  November  2022,  apart  from 
Marmosets which have been required to be F2/F2+ since January 2013. Article 10 requires a 
feasibility  study  to  assess  the  appropriateness  of  Annex  II  deadlines,  and  to  propose 
amendments, where appropriate. The key findings and conclusions of the feasibility study are 
presented below. 

The majority of the species used within EU are already available as F2/F2+. 

The  main  species  of  concern  is  the  Cynomolgus  macaque  whose  global  supply  of  F2/F2+ 
animals  already  now  comfortably  exceeds  the  current  and  projected  EU  demand.  However, 
the additional five years (2017-2022) are needed to complete the transition, including Herpes 
B-virus-free animals from suppliers in Mauritius who are not yet able to fulfil the scientific 
demand with F2/F2+ animals.  

Considering  the  current  and  projected  EU  demand  of  the  relevant  species  and  their  supply 
from EU and non-EU countries, the impacts of the transition on science, animal welfare and 

7  Article  10  of  Directive  2010/63/EU:  .."For  the  purposes  of  this  Article  a  ‘self-sustaining  colony’  means  a 
colony in which animals are bred only within the colony or sourced from other colonies but not taken from the 
wild, and where the animals are kept in a way that ensures that they are accustomed to humans.".. 

9 

 
 
                                                            
health,  the  feasibility  study  does  not  support  altering  the  dates  set  out  in  Annex  II  of  the 
Directive. 

However,  to  facilitate  accurate  reporting  that  allows  measuring  the  progress  towards  the 
Directive  goals,  Commission  Implementing  Decision  2012/707/EU  should  be  adjusted  to 
obtain annual information on the generation of non-human primates supplied also from self-
sustaining colonies. 

5. Conclusions 

The  timing  of  this  review  in  the  early  stages  of  the  Directive's  implementation  makes  it 
premature to assess many aspects of its performance against policy objectives. However, it is 
clear that the majority of stakeholders consulted for this review consider the Directive to be 
relevant  and  necessary  for  creating  a  level  playing  field  within  the  EU  and  achieving  the 
animal  welfare  objectives  and  standards.    Therefore  no  amendments  to  the  Directive  are 
proposed  at  this  stage.  Furthermore,  and  drawing  from  the  conclusions  of  the  SCHEER8 
report9,  no  phasing-out  timetable  for  the  use  of  non-human  primates  is  proposed,  however, 
the  European  Commission  will  request  regular  updates  to  the  SCHEER  opinion  to  closely 
monitor progress.  

On  the  basis  of  the  Article  10  feasibility  study,  there  is  no  justification  to  prolong  the 
transitional period set out in Annex II for the use of second and/or higher generation purpose-
bred  non-human  primates.  However,  the  reporting  categories  in  Commission  Implementing 
Decision  2012/707/EU  will  be  amended  to  require  inter  alia  systematic  reporting  of  the 
generation  of  non-human  primates  used,  including  when  acquired  from  self-sustaining 
colonies.  

Finally,  once  sufficient  scientific  evidence 
is  available,  Annex  III  on  care  and 
accommodation  will  need  to  be  amended  to  incorporate  standards  for  cephalopods  and  to 
provide  more  details  for  some  groups  of  species.  Annex  IV  should  be  amended  to  provide 
appropriate killing methods in for cephalopods, and to align existing methods with latest the 
scientific knowledge on the basis of annual reports by Member States, where appropriate. 

8 Scientific Committee on Health, Environment and Emerging Risks 
9 https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_o_004.pdf 

10