EFSA assessment EU 1099/2009
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EFSA assessment EU 1099/2009 EFSA assessment EU 1099/2009 Document Transcript

  • EFSA supporting publication 2013:EN-530 Suggested citation: European Food Safety Authority, 2013. Outcome of a public consultation on the Draft Guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing. EFSA supporting publication 2013:EN-530, 20 pp. Available online: www.efsa.europa.eu/publications © European Food Safety Authority, 2013 TECHNICAL REPORT Outcome of a public consultation on the Draft Guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing1 European Food Safety Authority2, 3 European Food Safety Authority (EFSA), Parma, Italy ABSTRACT The European Food Safety Authority (EFSA) carried out a public consultation to receive input from the scientific community and all interested parties on the Draft Guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing. The guidance was prepared by the EFSA Panel on Animal Health and Welfare (AHAW Panel) and endorsed by the Panel for public consultation by written procedure on 10 July 2013. The written public consultation for this document was open from 15 July 2013 to 18 September 2013. EFSA received comments from six parties. EFSA and its AHAW Panel wish to thank all stakeholders for their contributions. The current report summarises the outcome of the public consultation, and includes a brief summary of the comments received and how they were addressed. The AHAW Panel prepared an updated version of the Guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing that takes into account the questions and comments received. This Guidance was discussed and adopted at the AHAW Plenary meeting on 27 November 2013, and is published in the EFSA Journal. © European Food Safety Authority, 2013 KEY WORDS stunning, welfare, reporting guidelines 1 On request from EFSA, Question No EFSA-Q-2013-00598, approved on 28 May 2013. 2 Correspondence: AHAW@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the members of the Working Group on the guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing: Charlotte Berg, Howard Browman, Mohan Raj and Antonio Velarde for the preparatory work on this output and the hearing experts: Haluk Anil, Karen von Holleben, Marien Gerritzen and Rebecca Garcia and EFSA staff: Andrea Gervelmeyer for the support provided to this output.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 TABLE OF CONTENTS Abstract .................................................................................................................................................... 1 Table of contents ...................................................................................................................................... 2 Background as provided by EFSA ........................................................................................................... 3 Terms of reference as provided by EFSA ................................................................................................ 3 Consideration ........................................................................................................................................... 4 1. Public consultation .......................................................................................................................... 4 1.1. Comments received................................................................................................................. 4 1.2. Assessment of comments........................................................................................................ 4 Appendices............................................................................................................................................... 5 Appendix A. Explanatory text for the public consultation on the draft guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing ..................................................................................................................................... 5 Appendix B. Full list of comments received on the draft guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing……….. ..................................................................................................................................... 6
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 BACKGROUND AS PROVIDED BY EFSA Council Regulation (EC) No 1099/2009 on the protection of animals at the time of killing defines “stunning”  in  Article  2  (f)  as  “any  intentionally  induced  process  which  causes  loss  of  consciousness   and sensibility  without  pain  including  any  process  resulting  in  instantaneous  death”.  Annex  I  of  the   Regulation lists the stunning interventions and related specifications. Article 4 on stunning interventions  regulates  that  “animals  shall  only  be  killed  after  stunning in accordance with the methods and specific requirements related to the application of those methods set out in Annex I of the Regulation”  and  “that  the  loss  of  consciousness  and  sensibility  shall  be  maintained  until  the  death  of   the  animal”.  Furthermore, the methods referred to in Annex I which do not result in instantaneous death shall be followed as quickly as possible by a procedure ensuring death such as bleeding, pithing, electrocution or prolonged exposure to anoxia. Article 4 (2) of the Regulation allows the Commission to amend Annex I to this Regulation as to take account of scientific and technical progress on the basis of an opinion of the EFSA. Any such amendments shall ensure a level of animal welfare at least equivalent to that ensured by the existing methods. Several studies assessing the efficacy of modified protocols of stunning interventions listed in Annex I or new stunning interventions have been submitted to the Commission who has requested EFSA's view on the studies, and it is likely that more studies of stunning intervention efficacy will be carried out and submitted to EFSA for assessment. Inconsistencies with reporting of intervention studies in the animal health area have been documented in the past and the lack of harmonization of designing and  reporting  intervention  studies  investigating  stunning  interventions’  efficacy  has  been  specifically   identified as a drawback to assessing the proposed stunning interventions in previous EFSA opinions4 . Therefore it is important to provide clear guidance to researchers on how these studies will be assessed by EFSA, i.e. what minimum eligibility criteria, reporting quality criteria and further study quality criteria need to be fulfilled for a given study so that it can be considered for assessment as a potential alternative to the stunning methods and related specifications listed in Council Regulation (EC) No 1099/2009. TERMS OF REFERENCE AS PROVIDED BY EFSA The European Food Safety Authority requests the Animal Health and Welfare Panel to develop a guidance document which defines the criteria against which studies evaluating the efficacy of stunning interventions regarding animal protection during stunning will be assessed. The guidance should comprise a checklist of reporting quality criteria, eligibility criteria and further study quality criteria, accompanied with the scientific reasoning for each checklist item. It should also provide a description of the guidance development process and explain how studies will be evaluated. The guidance should cover mechanical, electrical and gas methods for the main livestock species (bovines, sheep, goats, pigs, poultry, and rabbits). Work done on the critical appraisal of scientific studies by the Scientific Assessment Support Unit of EFSA should be considered during the preparation of the guidance document. A public consultation of the guidance document will also be made before adoption of the guidance in November 2013. 4 Scientific Opinion on the electrical requirements for waterbath stunning equipment applicable for poultry. EFSA Journal 2012;10(6):2757 [80 pp.]. doi:10.2903/j.efsa.2012.2757
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 CONSIDERATION 1. Public consultation In line with EFSA’s policy on openness and transparency, a web-consultation on the draft scientific output was carried out from 15 July 2013 to 18 September 2013 in order to receive comments from the scientific community, stakeholders and all interested parties. The public consultation was published on-line with an invitation for submission of written comments by 18th September 2013. The comments had to be sent exclusively by means of on-line submission form. Interested parties were invited to submit comments and to refer to the line and page numbers. Technical criteria for not considering the comments were also presented (Appendix A). EFSA received comments from six interested parties. The comments were submitted by two private institutes, a public institution, one national authority of an EU Member State, one regional authority of an EU Member State and industry. A seventh comment was not eligible. All eligible comments were recorded and assessed by the ad hoc Working Group of the AHAW Panel on the guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing with the support of hearing experts at a physical meeting. The working group members agreed on the changes to the guidance document (Appendix B). 1.1. Comments received The majority of the comments received concerned the eligibility criteria for the different intervention methods. Several parties suggested additional specifications of parameters to be included with view to properly characterising the stunning intervention. Some suggestions focussed on improving the clarity of the guidance document. 1.2. Assessment of comments The AHAW Panel considered all relevant comments in finalising the guidance document. Details of the assessment and consequent changes made in finalising the guidance document can be found in Appendix B.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 APPENDICES Appendix A. Explanatory text for the public consultation on the draft guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing In  line  with  EFSA’s  policy  on  openness  and  transparency  and  in  order  for  EFSA  to  receive  comments   from   the   scientific   community   and   stakeholders,   EFSA’s   Panel   on   Animal   Health   and   Welfare   (AHAW) has launched an open consultation on the draft Guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing. This document defines the assessment process and the criteria that will be applied to studies on alternative stunning methods to determine their eligibility for further assessment. Interested parties are invited to submit written comments by 08 September 2013. Comments regarding the clarity, comprehensiveness, relevance and practicality of the assessment process and the evaluation criteria presented in the guidance are welcome. Please use exclusively the electronic template provided with the documents to submit comments and refer to the line and page numbers. Please note that comments submitted by e-mail or by post cannot be taken into account and that a submission will not be considered if it is: • submitted after the deadline set out in the call • presented in any form other than what is provided for in the instructions and template • not related to the contents of the document • contains complaints against institutions, personal accusations, irrelevant or offensive statements or material • is related to policy or risk management aspects, which is out of the scope of EFSA's activity. EFSA will assess all comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the relevant EFSA Panel and taken into consideration if found to be relevant.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 6 Appendix B. Full list of comments received on the draft guidance on the assessment criteria for studies evaluating the effectiveness of stunning interventions regarding animal protection at the time of killing Contributor Section Comment received EFSA comment EU Member State national authority 1 General comments 1. Where a 1099/2009 method complies however a new process is developed (i.e. captive bolt stunning on a different position to that generally done for a given species) are researchers expected to follow this protocol? 2. There are several references across the document to monitoring indicators – it would be helpful that this are consistent with the monitoring indicators paper currently on draft given that both documents are been prepared under the umbrella of 1099/2009. 3. It would be helpful to have a statement to flag up that all research studies need to conform with experimental animal legislation and be carried out under license issued by the authorities of the relevant country in which the research takes place. 4. In some industries there are internationally agreed procedures for testing under ISO (nanotechnology is one example). I wonder if there is scope for exploring agreed testing ISO standards for some of the stunning processes to ensure consistency amongst specific parts of research studies and ensure they are comparable (i.e. EEG or ECoG). I did enquire within the British Standards Institute and it would be possible to do (though would take some time to get it agreed) however I have not been able to take forward or explore further yet. 5. We have funded a research project looking at stunning piglets and goat kids by concussion as this is not currently permitted by 1099/2009, however has been common practice within industry on farm in the past – given that this opinion considers LAPS, should it also include concussion by a blow to the head ? We are not aware of results at this stage, therefore I cannot 1. The AHAW Panel will follow the guidance in assessing any new stunning method, be it a stunning procedure included in the Regulation with changed parameters or a completely new stunning procedure. 2. The indicators mentioned in the guidance are consistent with those listed in the EFSA scientific opinions on monitoring procedures at slaughterhouses. 3. A statement on the need for humane endpoints in research and ethical approval of research has been added to the document. 4. Applying internationally agreed upon procedures for testing under ISO standards, while commendable, is beyond the scope of the mandate. 5. The criteria and rules defined in this document apply also to back-up stunning methods used in slaughterhouses. While no detailed eligibility criteria for interventions other than those already defined in the Regulation can be provided in this document, the intervention has to be reported in sufficient detail and the outcome eligibility criteria must be fulfilled.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 7 comment on whether we will request in the future EFSA to review this method for inclusion. Public institution Assessment 1. This comment is a general one about the methodology proposed. Overall, this guidance document provides valuable information about the different aspects that should be considered when assessing new stunning method and may be considered as a good basis for the development of such studies. However, it seems that the proposed methodology intends to apply to completely new stunning method. As an example, it is written  that  “Indicators  for  recognising  a  successful  stun   should be applied in slaughterhouse settings, after their correlation with EEGs has been demonstrated in  controlled  environment  studies”  but,  on  an  other  side,     EFSA  will  produce  an  opinion  on  “Monitoring   procedure  at  slaughterhouse”    that  includes  a  list  of   indicators for assessing stunning efficiency. Therefore we can suppose that this list may be used to assess signs of uncounsciousness/consciousness without the need of revalidation, in particular when assessing new variant of well known method (eg captive bolt for bovine). 2. Furthermore, Regulation (EC) N° 1099/2009 allows the Commission to amend Annex I on the basis of new scientific  evidence  and  that  “Any    such    amendments     shall ensure a level of animal welfare at least equivalent    to    that    ensured    by    the    existing    methods”.   But, in the guidance document, there is no reference to the comparison to existing methods. In my opinion, the possibility to assess a new stunning method in comparison to existing methods especially when based on the same general principle may be an alternative to laboratory studies. 3. Field study is of particular importance to assess the variability of the results obtained with a stunning method. Key parameters are relevant parameters but details provide in tables seems sometimes difficult to measure in practice and not very useful. On the contrary, it seems to me that there is no information on 1. The indicators mentioned in this document to assess unconsciousness and absence of pain, distress and suffering are in agreement with the EFSA opinions on monitoring procedures at slaughterhouse. 2. Any new stunning method, be it a stunning procedure included in the Regulation with changed parameters or a completely new stunning procedure, needs to be assessed both in laboratory and under slaughterhouse conditions as described in the guidance. 3. The guidance specifies that for each stunning intervention description, the target parameters and their variances need to be reported. 4. The scope of this document is limited to scientific evidence for welfare at stunning.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 8 the definition of the objective. For example, when assessing a new stunning, we will analyse average and variability compared to expected values. Guidance to choose expected values may be more relevant than some requirements on detailed parameter. In conclusion, I think that comparison to existing method and analyse of the variability in slaughterhouse should be an alternative to lab/field study in particular when assessing new method based on the same general principle of existing method. This option should be evaluated by expert panel. 4. My last comment is a more practical one. The methodology proposed is a very detailed one. But there is a risk that it may be applicable in a very limited number of situation because we can suppose that a very few manufacturers will be able to carry out the whole process due to resources needed and limited market. EU Member State national authority 1 1. Introduction 1. It would be helpful to know why stunning methods used outside slaughterhouses are outside the scope of this guidance? Annex 1 includes both stunning methods type and there is no reason why the laboratory assessment scrutiny process cannot be the same. 2. General aspects applicable to stunning methods– it would be helpful to review the structure of this section as it could be made more clear: Page 6 - Figure 2 – part 1 column 3 – suggest that bullets are numbered and correlated with the relevant explanatory paragraphs through this section (1-5); bullet 1 – suggest  to  add  “and   key  parameters”  at  the  end;;  page  6  - Paragraph 3 – this correlates with bullet 5 from figure 2, part I column 3 if a number correlation is included; Page 6 - Paragraph 4 – this correlates with bullet 2; Page 7 – paragraph 4 –this correlates with bullet 2 ; Page 7 – paragraph 5 – this correlates with bullet 3 ; Page 7 – paragraph 6 – this correlates with bullet 4 3. There is a requirement to re-stun and sacrifice animals as they regain consciousness – it may be important to flag up that this should be done in accordance with 1. A clarification was added that the scope of this document is limited to stunning methods used at slaughter and does not include depopulation nor on-farm killing. 2. The editorial comments have been addressed in the document. 3. A comment on humane endpoints in research and the need for ethical approval of research has been added to the document. 4. While it is certainly important to study a relevant number of animals, the required minimum number is a study- specific decision. 5. This editorial comment has been addressed in the document. 6. The suggestion to add  “In  addition  animal  welfare indicators should be recorded until the time to loss of consciousness”  was accepted.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 9 relevant legislation under the Animal Scientific Procedures – for some methods, such as high concentration CO2 exposure there may need to be a requirement to use a different stunning method for re- stunning – again it may be helpful to flag this up. 4. Page 7 – paragraph 2 – does the guidance intend to specify how many animals EFSA expects data from? 5. Page 7 – paragraph 3 – second  line  replace  “been”  for   “are” 6. I  suggest  to  add  “In  addition  AW  indicators  should  be   recorded  until  the  time  to  loss  of  consciousness”  as  per   B in section 2.1 EU Member State national authority 1 2. Approach Page 8 - paragraph 4 (for the outcome) – it would be helpful to clarify the two possible combinations = [A+C] or [B+C] to avoid confusion between the insertion of OR / AND as some may read this as A or [B+C] The suggestions to change the formatting were followed in the document. EU Member State national authority 1 2.3. Methodological quality criteria Page 9 – paragraph 2 – line  2  “compared  against  those  of   related  studies”.  This  may  not  always  be  possible  as  a   current problem is that many studies are not comparable in the inmediate future (i.e. water bath electrical stunning papers).  Suggest  adding  “where  possible”. The  sentence  was  modified  to  “Appraisal  of  a  study’s  external   validity (i.e. its generalizability outside the study population) requires that its results be assessed in the context of related studies.”  to  account  for  this  comment. EU Member State regional authority 1 2.1. Eligibility criteria Se puede deducir que el objetivo fundamental de todo el documento es el control de un correcto aturdimiento ya que se  basa  en  que  “  la  pérdida  de  la  conciencia  deberia   mantenerse  hasta  la  muerte  del  animal“  tal  como se indica en las líneas 2 y 3 de la pàgina 8. Esto no siempre es así por los motivos siguientes : 1.- “  Hay  métodos  de  aturdimiento  donde  los  animales   pueden recuperar la consciencia durante los procedimientos dolorosos subsiguientes ( pàgina 4, consideración 24 del reglamento 1099/2009 sobre protección de los animales en el  sacrificio  )  “. 2.- Un corte incorrecto/incompleto de los vasos sanguineos. 3.- En el caso del vacuno, la llegada importante de sangre al cerebro a través de las arterias craneales. Por todo ello, siempre hay que tener 2 tipos de controles/indicadores en los mataderos : This comment is not related to the scope of this guideline document as it refers to monitoring procedures at slaughterhouses.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 10 a) De un correcto aturdimiento. b) De ausencia de vida antes del escaldado/faenado tal como establece el Anexo III, punto 3.2 del Reglamento 1099/2009. Y así hay que tenerlo presente en la elaboración de guias/dictámenes. EU Member State national authority 1 3.1. Intervention 1. Page 9 – would the paper not need to demonstrate compliance with relevant Article 3 requirements of Regulation 1099 (i.e that it is humane) prior to demonstrating whether it is simple stunning or not? 2. Page 9 – 3.1 – line 3 – Article 4.1 of Regulation 1099 defines simple stunning as those methods which do not result in instantaneous death. This includes both reversible and irreversible methods therefore the guidance draft text needs amending to reflect this. Suggest  replacing    “it  needs  to  be  demonstrated  whether   the method is a simple stunning method or an irreversible  stunning  method”  by  “it  needs  to  be   demonstrated whether the [the method results in instantaneous death (stunning) or not (simple stunning). For simple stunning method it shall demonstrate whether the stun is reversible  or  not]  “ 1. The need to demonstrate compliance with relevant Article 3 requirements of Regulation 1099 (i.e that it is humane) is covered in the introduction of the document. 2. This comment has been addressed by modifying the phrase  to  “it  needs  to be demonstrated whether the method results in immediate unconsciousness and whether  the  stun  is  reversible  or  not”.   EU Member State national authority 1 3.1.1.1. Penetrative captive bolt 1. Page 10 – Table 1 - bolt dimension/mass and velocity – it may be helpful to consider the energy necessary to stun an animal type as this will influence the parameters covered here 2. Page 10 – Table 1 - type and size of animal – you may wish  to  include  “dimensions”  as  this  are  very  relevant   of animal restraint purposes (i.e. will the head restraint fit?, is the restraining box suitable? Is the distance between the head of the animal and the slaughterman suitable?) 3. Page 10 – Table 1 – equipment maintenance – it may be helpful to include a reference to manufacturer instructions here. 1. This can be derived from the mass and velocity which need to be reported. 2. It is stated in the guidance document that authors are expected to provide any information relevant to describing the restraining system used. It is considered that the detailed description of species and breed, age and weight of the animals provides the information needed to assess the study under scrutiny regarding this parameter. 3. The comment regarding equipment maintenance has been addressed  in  the  document  by  adding  “Where manufacturer maintenance instructions are available, provide  the  details  and  how  they  were  implemented.”
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 11 EU Member State national authority 1 3.1.1.2. Non- penetrative captive bolt 1. Page 10 -3.1.1.2 – line 2 – need to include poultry alongside rabbits and hares. 2. Page 11 – Table 2 – comments on energy / animal dimensions / reference to manufacturer instructions as per Table 1 above. 1. The species was added to the text. 2. The suggested changes were made in the document. Private institute 1 3.1.2. Electrical stunning methods 1. Page 12 Table 3 Description line 2: wrong spelling “report  the  mark:space  ratio”  (not  marks-spaced ratio) Page 12 Table 3 2. Maximum stun-to-stick / kill interval: Describe also the method of sticking (which blood vessels have been cut (neck- or chest-cut) and how). 3. Maximum frequency /Lapse of frequency: Describe if the frequency in each cycle stays on one level or if and how it changes (many manufacturers use changing frequencies, sometimes we do not know what effect this has). 4. Description line 11: Provide information on the method used for and the time intervals between consecutive calibrations of the equipment (including transformer and electrodes). This is of importance because the cables and electrodes are often the reason for increasing electrical resistance leading to different current application. 5. Table 4 page 16 description line 17: spelling: shackling (l is missing) 1. The spelling error was corrected. 2. The comment was addressed by requesting a description of the exsanguination method applied in the study. 3. A respective specification was added to the waveform section of the table. 4. The  term  “equipment”  includes  all  components  of  the   stunning equipment used. Therefore, no change to the text was considered necessary. 5. The spelling error has been corrected. EU Member State national authority 1 3.1.2.1. Head- only and head-to- body stunning 1. Page 12- 3.1.2.1 – line  1  “at  the  moment”  – this implies this particular method may be subject to change – suggest consider a different wording to avoid confusion 2. Page 12 – Table 3 - minimum current level – there is 3 cycle equipment used in cattle – this should be included alongside assurances that the 2nd and 3rd cycles will not operate unless the first one is effective. 3. Page 13 – Table 3 – delivered minimum voltage – should research papers describe somewhere the mechanism by which the equipment works out the resistance to adjust minimum current as/if necessary? 4. Page 13 – Table 3 Max. Stun-stick time – final 2 lines. Why is the recommendation to only report the last 1. This point was changed accordingly in the guidance document. 2. This  comment  was  addressed  by  using  the  term  “multiple   cycle  system”.       3. The comment was addressed by adding the requirement to describe how the preset constant current was applied. 4. The recommendation has been deleted from the table. 5. While the pressure applied and the contact achieved are relevant points, it is not possible to measure/report them in an objective way. Optimisation of the current flow could be ascertained from the current profile, which is an outcome.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 12 animal that did not recover consciousness rather than all sampled animals? 5. Page 13 – Table 3 – electrode characteristics – suggest this  refers  only  to  “electrode”  and  not  to  “stunning   tongs”  as  these  fit  later  on  within  the  type  of  electrode row. Pressure required for good contact should be part of the electrode characteristics to consider. EU Member State national authority 1 3.1.2.2. Electrical waterbath stunning 1. Page 14 – line 2-3: what if the study tries to validate different currents to those in 1099? 2. Page 14 – line 8 – you could add the legal requirements that the electrode should cover the full length of the bath and that there should be breast support as per Annex II 5.7 and 5.8. 3. Page 15 – prevention of electrical shocks – there is a reference to other measures – note a breast comforter is a legal requirement (Annex II 5.8) 4. Page 16 – Table 4 – electrical resistance/impedance – leg keratinisation is considered – cleanliness and wet/dry state are also factors which could impact resistance and should be accounted for. 5. Page 16 – Table 4 – max. Shackle duration – this is now a legal requirement and should be stated so – Annex II 5.2 1. The  sentence  “  The  stunning  intervention  should  be   carried out in accordance with the minimum currents laid down in Table 2 of Annex I of Council Regulation (EC) No 1099/2009 and exposure to the currents shall be for a minimum  duration  of  at  least  4  seconds”  was  deleted.         2. The  sentence  “In  addition,  the  legislation  requires that the shackles shall be wetted before live birds are shackled and the birds should be hung by both legs. An alternative method of slaughter should be used if birds are too small for the waterbath stunner or if shackling is likely to induce or increase pain  (e.g.  in  visibly  injured  animal)”   was deleted. 3. The reference to breast comforters was considered not to be relevant for this section. 4. The  requirement  was  modified  to  “Provide  details  on  the   species, breed, age, sex and weight of the birds and on the  cleanliness  of  the  birds.”           5. The maximum duration permitted by law is stated in the text and it has been specified in the table that it is the legal limit. EU Member State national authority 1 3.1.3. Modified atmosphere stunning methods 1. Page 16 – 1st paragraph line4 – “this  method  is  only   allowed for pigs {FOR SLAUGHTER} – check consistency with 1099 Annex I 2. Page 17 – Animal stocking density – this should also report the animal species/type (i.e. hens / chickens / turkeys); Page 19 - Animal stocking density – this should also report the animal species/type 1. The statement was removed as it was misleading. 2. It was specified that, in addition to animal density, which should be expressed as number and kg per m , the species, breed and age of animals need to be described.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 13 Private institute 1 3.1.3. Modified atmosphere stunning methods 1. Table 5 page 17, Description 1st line: Specify the initial CO2-concentration  …  and  how  long  they  are  exposed   within; Table 5 page 17, description line 7: also the time within lowest CO2 concentration is of importance and also the time in the highest CO2 concentration 2. Description to quality of the gas description line 13: besides humidity also the temperature within the stunning equipment can have an impact, chicken can bring a lot of temperature within stunning systems 3. Table  7  Description  3rd  line:  Specify  the  initial  …  and   how long they are exposed within. 4. Additional parameters in tables 5, 6 and 7 could be: Light inside the stunning system and visibility (is it possible to see the animals during the lapse through the system?) and vibration. 1. The  terms  “lowest”  and  “highest”  were  changed  to   “initial”  and  to  “final”  in  the  component  field  to  reflect   the text in the description field of the table. 2. It was specified that it needs to be reported how and when humidity of the gas and temperature inside the chamber were monitored, and, if needed, adjusted. 3. The  terms  “lowest”  and  “highest”  were  changed  to   “initial”  and  to  “final”  in  the  component  field  to  reflect the text in the description field of the table. 4. The working group considers that these issues are taken care of in the outcome assessment section where it is required that animals should be assessed for the absence of pain, distress and suffering before the loss of consciousness, which necessitates that animals can be observed during this period. Private institute 1 3.1.3.4. Low atmosphere pressure Table  8:  Under  the  Parameter  “Final  pressure”  also  the   concentration of O2 is of importance This sentence has been aligned with the respective specification from the EFSA Scientific Opinion on Low Atmosphere Pressure Systems for stunning. EU Member State national authority 1 3.1.3.4. Low atmosphere pressure 1. Page 21 – We have funded a research project looking at stunning piglets and goat kids by concussion as this is not currently permitted by 1099/2009 however it has been common practice within industry on farm in the past – given that this opinion considers LAPS should it also include concussion by a blow to the head ? We are not aware of results at this stage therefore I cannot comment on whether we will request in the future EFSA to review this method for inclusion. 2. Page 22 - Animal stocking density – this should also report the animal species/type 1. The guidance considers all new or modified legal stunning interventions and back-up stunning interventions used at slaughter known to the AHAW Panel at the initiation of the mandate. 2. It was specified that, in addition to animal density, which should be expressed as number and kg per m , the species, breed and age of animals need to be described.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 14 EU Member State regional authority 1 3.2.1. Onset of unconsciousness and insensibility En la pàgina 22, punto 3.2.1 sobre el inicio de la inconciencia, dice que  “  los  métodos  de  aturdimiento   deberian inducir la pérdida de la inconciencia de manera inmediata  (  por  ejemplo  en  menos  de  1  segundo  )  “,  EFSA   2004. Es por ello que en la elaboración de guias y dictámenes habria que recomendar de cara al futuro la sustitución progresiva del aturdimiento por CO2 en cerdos ( la inconciencia llega en 15-20 segundos ) . En la pàgina 2 del Reglamento CE 1099/2009 sobre protección de los animales en el sacrificio dice que actualmente por el tema económico no se recomienda la eliminación pero reconoce que es un debate a seguir en el futuro. Hay que recordar que hasta el año 2012 se utilizaba el CO2 en aturdimiento de conejos y que actualmente no está autorizado en esta especie por el citado Reglamento. This comment is not related to the content of the guidance document. EU Member State national authority 1 3.2.1. Onset of unconsciousness and insensibility 1. Page 22 – 3.2.1 line 3 (e.g. in less than one second) – I am concerned about this example – electrical stunning and captive bolt methods have to be immediate, however the time delay of 1 second is in my view unacceptable – at the moment delays to reach unconsciousness when applying electrodes should be within milliseconds figures – if, for example, an electrical stunning method takes on average 1 second to produce unconsciousness it should not be added to 1099. 2. Page 23 – final 2 paragraphs – Page 24 – final paragraph line 2-3 – there is a recommendation for collapse as indicator – check consistency for electrical stunning indicators in the scientific monitoring opinion to avoid confusion 3. Page 24 – bullet points – suggest to name A,B, C or include numbers as preferred and clarify if it should be A+B OR A+C // A+B OR C 4. Page 24 – final line – reference to electro immobilisation – it would be helpful to consider systems with 3 cycles (i.e. Jarvis box) as this would also 1. The example was removed from the document. 2. It has been assured that all references to the use of animal based measures for welfare made in the guidance document are consistent with the EFSA opinions on monitoring procedures at slaughterhouses. 3. The text has  been  changed  to  “Therefore,  in  laboratory   condition studies, unconsciousness and insensibility can be ascertained by the following EEG patterns: •  induction  of  a  generalised  epileptiform  activity  in  the   brain, which can be recognised from the predominance of 8–13 Hz high-amplitude EEG activity, followed by a quiescent EEG OR •  an  immediate  onset  of  a  quiescent  EEG   OR •  no  somatosensory,  visual  or  auditory  evoked  responses   or  potentials  in  the  brain  immediately  after  the  stunning”                               4. The document has been modified to consider also multiple cycle systems. 5. The typing error has been corrected.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 15 cause immobilisation. I am also aware that there is an electrified landing platform for captive bolt stunned cattle used in some countries (not permitted in UK as we consider this does not allow recognition of effective stunning) - this may need to be addressed here or in the monitoring indicators scientific opinion. 5. Page 25 – line 8 from the bottom – there is a typo – remove  “to”  between  “Poultry”  and  “seems” Private institute 1 3.2.1.2. Electrical stunning 1. Electrical stunning : The list of EEG patterns ascertaining unconsciousness should be completed with the duration during which these symptoms occur (see Schütt-Abraham et al. 1983 cited in EFSA report on stunning and killing 2004, page 128) 2. Page 25: first paragraph last sentence: lack of response to painful stimuli this is not reasonable because external stimuli can lead to reflexes which must not necessarily mean, that the animal is suffering from it, I would suggest to wait and see what happens during the epileptic activity (tonic, tonic-clonic phase): Do symptoms occur, which are incompatible with a full epileptic fit? 3. Page 25 paragraph 7 last third: , hypercapnic hypoxia in poultry  to  seems  to  result  …  (to  must  be  erased) 1. The  text  has  been  changed  to  “Therefore,  in  laboratory   condition studies, unconsciousness and insensibility can be ascertained by the following EEG patterns: •  induction  of  a  generalised  epileptiform  activity  in  the   brain, which can be recognised from the predominance of 8–13 Hz high-amplitude EEG activity, followed by a quiescent EEG OR •  an  immediate  onset  of  a  quiescent  EEG   OR •  no  somatosensory,  visual  or  auditory  evoked  responses   or  potentials  in  the  brain  immediately  after  the  stunning” 2. It has been specified in the document that the sequence of presence of tonic seizures after removal of the current and apnoea during tonic seizures and lack of response to painful stimuli needs to be applied to ascertain the effectiveness of the stun. 3. The typing error has been corrected.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 16 Industry 3.2.1.2. Electrical stunning 1. Eligibility criteria to be complied with by stunning procedures determine that the procedure (to be proposed as an alternative) should be based on science and legislation, and its outcome should give rise to: immediate loss of consciousness and sensitivity OR absence of pain, suffering and distress until loss of consciousness and sensitivity AND duration of unconsciousness and insensitivity (until death) as follows  on  item  “2.1  Eligibility  criteria”.  Regarding   criteria  for  the  interventions’  outcome:  In  addition  to  the   animal welfare requisites defined in items A or B + C, it is suggested that product quality criteria should be included. Therefore, although the procedure is intended to protect animal welfare at the moment of slaughtering, meat quality criteria should be considered. By ensuring this requisite, ethical principles that pervade discussions on animal welfare, such as non-wasting of food and sustainability of production, will be respected. 2. Regarding criteria for loss of sensitivity and consciousness: The use of epilepsy as a reference for detecting a state of unconsciousness and insensitivity is controversial in literature, despite being well accepted. A number of authors noted that as opposed to mammals, birds not always demonstrate epilepsy following electrical stunning: "Chickens, unlike red meat species, do not show grand mal epilepsy in the brain following electrical  stunning.”  (RAJ,  2003).  “Poultry  do  not   usually produce the same type of epilepsy as the redmeat species when they are electrically stunned. So, for bird species the recommended minimum currents have  been  based  on  other  criteria.”  (GREGORY,  1992,   and GREGORY, 1998). In Brazil, laboratory studies (data not published yet) confirmed such findings by demonstrating that the onset of epilepsy varies considerably from one individual to another and is not always evidenced, even in birds that are visibly stunned and unconscious. This fact has been certified by means of clinical signal analyses (abolition of somatosensory 1. Meat quality is outside the remit of this document. It has to be acknowledged that for certain stunning methods, e.g. multiple bird waterbath stunning, meat quality and welfare targets are not reconcilable. 2. The interpretation of the referenced publications has changed in the light of recent scientific understanding of electrical waterbath stunning of poultry. In addition, significant technological developments in the digital recording and analysis of the EEG data also contributed to a better understanding of the neurophysiological basis of electrical stunning in poultry. Effective electrical stunning of poultry produces epileptiform activity in the brain (see references below) and therefore, the requirements in this guidance are scientifically valid. 1)    Raj,  A.B.M.  and  O’Callaghan,  M. 2004. Effect of amount and frequency of head-only stunning currents on the electroencephalograms and somatosensory evoked potentials in broilers. Animal Welfare, 13: 159-170. 2)  Raj,  A.B.M.  and  O’Callaghan,  M.  2004.  Effects  of   electrical water bath stunning current frequencies on the spontaneous electroencephalograms and somatosensory evoked potentials in hens. British Poultry Science, 45: 230-236. 3) Jackson, G. Raj, A.B.M., Lalies, M.D.M. and Hudson, A.L. 2004. Identification of 5-HT1B autoreceptors in hyperstriatal neurones of broiler chickens. British Journal of Pharmacology, 138: Proceedings supplement 175P. 4)  Raj,  A.B.M.,  O’Callaghan,  M.  and  Knowles,  T.  G.   2006. The effect of amount and frequency of alternating current used in water bath stunning and neck cutting methods on spontaneous electroencephalograms in broilers. Animal Welfare, 15: 7-18. 5)  Raj,  A.B.M.,  O’Callaghan,  M.  and  Hughes,  S.  I.  2006.   The effect of amount and frequency of pulsed direct current used in water bath stunning and neck cutting methods on spontaneous electroencephalograms in broilers. Animal Welfare, 15: 19-24. 6)  Raj,  A.B.M.,  O’Callaghan,  M.  and  Hughes,  S.  I.  2006.  
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 17 evoked potentials (SEPs), induction of seizure and loss of muscle tone or physical reflexes following electrical stunning). In addition, cerebral impedance tests have shown that the  estimated  current  and  tension  measured  in  birds’   brains is not significantly affected by the use of 200 Hz frequency with a tension of 100 V and a current of 100 mA when compared to the electrical parameters recommended by the Regulation (EC) 1099/2009. Moreover, electrical parameters of the same magnitude acting on the brains of birds were unable to produce the same epilepsy effect in different individuals, although all birds have shown the absence of induced somatosensory, visual or aural signals. Therefore, the adoption of epilepsy as the only criteria for analyses of the stunning efficacy has important technical limitations. The suggestion is for consideration of the amount of electrical current that reaches birds' brain and its relation with clinical signals in birds (i.e. confirmation of an absence of induced somatosensory, visual or aural signals) to be considered as an additional criteria. Such methodological increment would consider a likely variation among individuals and the likelihood of the absence of epilepsy, thus avoiding the setbacks found in scientific literature and preserving the broadly accepted criteria of analyses based on the animal response. References: Gregory, N.G. 1998. Animal welfare and meat science. CABI Publishing, Wallingford,UK. Raj, A. B. M. (2003): A critical appraisal of electrical stunning in chickens.World`s Poultry Science Journal 59, 89-98 The effects of pulse width of a pulsed direct current used in water bath stunning and neck cutting methods on spontaneous electroencephalograms in broilers. Animal Welfare, 15: 25-30. Private institute 1 3.2.2. Absence of pain, distress and suffering until the loss of unconsciousness Page 29 second paragraph first sentence: at least one of the two  additional  …  (of  is  missing) The typing error has been corrected.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 18 and sensibility EU Member State national authority 1 3.2.2. Absence of pain, distress and suffering until the loss of unconsciousness and sensibility 1. Page 26 – 3.2.2 – line 1-2 this is very important and relates to my comment under 3.1 on humanness been a prerequisite before a stun method is taken further into research to look at simple stun etc. 2. Page 26 – line 3 – “mechanical  and  electrical  stunning   induce  immediate  unconsciousness”  – this should be considered carefully – this is the outcome, however whilst a new method is researched this needs to be demonstrated. Further it is important to ensure lack of pain, distress and suffering during the application of the stun method (i.e. a captive bolt that needs to rest in the animals head before shooting to achieve unconsciousness resulting in pain caused at the time of pressing the trigger) 1. This issue is taken into consideration in the section on general aspects of stunning research. 2. The sentence has been removed from the document. EU Member State national authority 1 3.2.3. Duration of unconsciousness and insensibility 1. Page 29 – 3.2.3 paragraph 1 line7 – researchers presenting new stun methods for 1099 should use indicators consistent with the monitoring indicators scientific opinion, unless new indicators are described for a given method, in which case they will have to be validated. 2. Page 29 – 3.2.3 paragraph 3 – reference to EFSA 2004 opinion on indicators –this should refer to the 1099 monitoring indicators opinion where possible. 1. Consistency with the EFSA scientific opinions on monitoring procedures at slaughterhouses has been assured in this document. 2. A reference to the EFSA scientific opinions on monitoring procedures at slaughterhouses has been added to the document.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 19 Private institute 2 3.2.3. Duration of unconsciousness and insensibility Duration of Unconsciousness and Insensibility During the Slaughter of Sheep Stunned Using Electronarcosis. My clinical records show there is a risk of sensibility where sheep are stunned by electronarcosis prior to slaughter. Particularly where sheep are hoisted after shackling and the completion of the incision of the carotids takes over 20 seconds from the stun. The tonic phase turns into the clonic phase, while the carotid incision initiates a fresh Grand Mal ,probably due to to a fresh Glutamate and Aspartate surge. These sheep show a 15 second traverse by the third eyelid of the eyeball during this surge. During this phase the corneal, palpebral and pupillary reflexes cannot be elicited. After this 15 seconds the corneal,palpebral and pupillary reflexes return until 40 seconds plus in lambs and 60 seconds plus in older sheep, timed from the incision of the carotids. Whereas un-hoisted lambs presented to the stunner in a vee restrainer have their carotids severed within 6 seconds of the completion of the electric stun. These lambs are within the tonic phase of the first Grand Mal, the incision of the carotids initiates an additional Grand Mal type seizure, which takes a further 15 seconds for the third eyelid to traverse the eyeball, after which no corneal or other reflex were found. Whereas one found that lambs which have undergone non- stunned slaughter remain on a cradle for 20 seconds or until unconsciousness prevails, when hoisted swinging in an inverted position, they can show corneal reflexes for over 60 seconds. Some of these lambs show in the first 15 seconds a partial or complete traverse of the third eyelid across the eyeball. These non-stunned hoisted lambs take longer to die than the electrically stunned hoisted lambs, with the non- hoisted lambs stunned and incised within 6 seconds taking least time to die. Hoisting and swinging of inverted sheep may distribute fresh blood to the Circle of Willis by increased gravitational force. This may be similar to the resuscitation of new born lambs by swinging them and increasing gravitational force within the lamb's circulation bathing its brain. The increase The points raised in relation to the prolonged stun to stick intervals are covered in the intervention eligibility criteria in the parameter on maximum stun to stick intervals.
  • Public consultation report on the Draft Guidance on stunning studies assessment criteria EFSA supporting publication 2013:EN-530 20 in blood supply to the Circle of Willis may lead to the increased risk of resurgence of sensibility which may occur as a single episode or a drifting in and out of consciousness. The use of non-lethal electronarcosis has been accepted by many Religious Authorities, as a reversible method of stunning sheep during slaughter to produce religiously approved sheep meat. This method is a commonly used also to stun sheep during slaughter for the secular market throughout the EU. The requirement to have animals continually unconscious between stunning and death set down in EC Regulation 1099/2009 is in doubt in the systems, where electronarcosis has been used for stunning prior to slaughter but has waned after hoisting or prolonged stun to stick intervals or both. All new systems proposed should be viewed against the effects of hoisting of long stun to stick intervals intrinsic to their operation in a slaughterhouse context. EU Member State national authority 1 5. Methodological quality Page 31 – 5 - paragraph 1 point 3 – “allow  broad   applicability of the results to populations [insert: AND EQUIPMENT] beyond those studied [insert: WHERE POSSIBLE]. For any stunning method, the more parameters that can be given to help validating different equipment which stuns following that method (i.e. energy delivered) the better. In relation to different populations this should only be done where possible (i.e. gas mixtures in broilers versus waterfowl] The  sentence  has  been  changed  to  “….3.  allow  broad   applicability of the results beyond any single study (= external validity)  “.  The  other  points  raised  in  the  comment  refer  to   intervention eligibility criteria and are taken care of in that section.