NOTES

1. It was agreed that the text required review with a view to eliminating repetitions. This could be done on the basis of clustering of similar paragraphs.

2. Views were expressed that the order of paragraphs 9 and 10 should be reversed.

3. This issue might be addressed under another article dealing specifically with the powers and functions of the Organization.

4. This issue might be addressed under another article dealing specifically with the issue of confidentiality.

5. Paragraph 1 bis was proposed by one delegation as an alternative to the existing paragraphs 1 to 8.

6. Delegations expressed different views about the appropriate location of any agreed definition. One view was that any agreed definitions should compose an article of the final document. Another view was that any agreed definitions should be contained in an appropriate annex.

7. A view was expressed that other categories also needed to be considered.

8. A view was expressed that any proposal to define Article I terms, as proposed in paragraphs 1 to 5 of the section, would have the effect of amending the Convention outside the legal provisions of Article XI, contrary to the mandate of the Group. Another view was expressed that defining those terms is indispensable for the purposes of a verification mechanism and will not have the effect of amending the Convention.

9. Views were expressed that the definitions in paragraphs 6 to 8 and their placement should be discussed further.

10. Views were expressed that this term would not need to be defined here because the concepts shall be elaborated in the appropriate declaration trigger(s).

11. Ibid.

12. Delegations differ on the need to define this term.

13. Ibid.

14. Ibid.

15. This definition should be used in the context of annual declarations of certain categories of facilities and incorporated there as appropriate.

16. Delegations differ on the need to define this term.

17. Ibid.

18. A view was expressed that definitions contained in paragraphs 28 to 30 should be inserted in Category II.

19. Views were expressed that the application of threshold limits to the possession of biological agents and toxins is not a useful means to strengthen the Convention and could undermine the provisions of Article I; this would clearly be outside the mandate of the Group. Peaceful quantities of an agent cannot be defined independently of the particular circumstances of the use, which means that fixed thresholds cannot be used. There would be a risk of a threshold for work for defence purposes being used to conceal offensive activities. The application of threshold limits could provide inaccurate impressions of the scale of activities at a facility because the self-replicating nature of microorganisms means that an agent amount at or below a threshold could be exceeded within a matter of hours. Finally, even small quantities of biological agents and toxins could, depending upon their intended purpose, violate the object and purpose of the Convention. Another view was that the establishment of threshold quantities of biological agents and toxins is essential for an effective verification regime under the BTWC. Such threshold limits do not contradict in any way the mandate of the Group, since the mandate specifies that the Group shall, inter alia, consider "definitions of terms and objective criteria, such as lists of bacteriological (biological) agents and toxins, their threshold quantities ...". This approach does not affect the scope of Article I of the Convention.

20. Specific values must be determined by the Ad Hoc Group.

21. Paragraphs 5 to 12 reflect BWC/AD HOC GROUP/WP.385. They were not discussed during the fifteenth, sixteenth, seventeenth, eighteenth or nineteenth session of the Ad Hoc Group.

22. Views were expressed that this paragraph should be deleted in this place, because the revision of declaration formats is already covered in Article XIV on amendments.

23. Further consideration is needed on whether definitions of terms used in the triggers should appear here, in the declarations section, or whether they should appear in the article on definitions. This reference is included here without prejudice to the final resolution of this question.

24. Views were expressed that this language be consistent with that in the list of equipment.

25. The format developed by the Friend of the Chair on CBMs for data on transfers and transfer requests may need to be appropriately modified to take into account the provisions of guidelines for strengthening implementation of Article III that may be provided for in the Protocol. Further consideration of the need for such guidelines is required.

26. Views were expressed that this section should be removed to Article VII. Other delegations considered that this section should remain here for further discussion.

27. Views were expressed that this section should be removed to Annex G on CBMs or be addressed in Article X of the Protocol on national implementation measures.

28. Some delegations expressed strong reservations over the inclusion of this section.

29. It was noted that definitions for these terms already existed in paragraph 8 of Article II. The question was raised of which formulations were the more appropriate to use in the context of visits, and where they should be located.

30. Some delegations considered that this topic requires further conceptual work before the specific conditions on selection can be finalized.

31. The language in paragraphs 46 to 48 was developed by the Friend of the Chair at the request of the Ad Hoc Group. It was not discussed during the seventeenth, eighteenth or nineteenth session of the Ad Hoc Group.

32. The view was expressed that very elaborated and detailed declaration formats would highly increase the possibility of delayed submission of declarations by the States Parties. It was suggested that this section should be reviewed in the light of the final shape of the declaration formats.

33. Suggestion by the Friend of the Chair as a further appropriate cross-reference.

34. This paragraph would be retained under the first alternative of paragraph 4.

35. This text is a suggestion from the Friend of the Chair as a possible option for further consideration on the handling of undeclared facilities in the context of the declaration clarification procedures. It was not discussed during the seventeenth, eighteenth or nineteenth session of the Ad Hoc Group.

36. The format on transfers developed by the Friend of the Chair on CBMs on "Data on transfers and transfer requests and on production" in pages 208-209 of BWC/AD HOC GROUP/39 would need to be modified in this context. Paragraph 2 above may be considered for Annex.

37. Further consideration should be given to possible humanitarian implications of such a prohibition.

38. This paragraph is being retained for the time being. Its subtitle, content and placement need to be reconsidered in view of BWC/AD HOC GROUP/WP.369 submitted by the Group of NAM and Other States.

39. This paragraph will need to be revisited in the light of progress on the relevant sections of Article III and Annex D.

40. The title of this Article may be reconsidered, if necessary, in the light of discussions on the content of this Article.

41. The scope and objectives of the review process need further consideration in conjunction with section E.

42. The issue addressed in paragraph 4 (j) is also being examined under Article VI (assistance and protection against biological and toxin weapons). Careful consideration was recommended to avoid possible overlaps.

43. A view was expressed that the issue of reporting is already reflected in paragraph 31 of this Article. Another view was expressed that action to be taken under this paragraph is distinct from that of paragraph 31.

44. A view was expressed that further consideration should be given to the placement of this section in the rolling text.

45. The content of this paragraph would need to be viewed in the context of subparagraph (c) of paragraph 10 of this Article. The placement of this paragraph may need to be reconsidered.

46. There were proposals to the effect of deleting this section or moving it to another part of the Protocol that might deal with BTWC Article III matters. However, it was also pointed out that this section had no relevance with regard to Article III provisions of the Convention.

47. There are divergent views on the placement of the language contained in section G, whether in Article I (general provisions) or this Article.

48. A delegation expressed the view that this issue needs further consideration, and reserved the right to come back to it.

49. Language in this paragraph needs to be updated in the light of further developments of the structural elements in Article III. Delegations reserved the right to return to this issue after further consideration.

50. Language in this subparagraph needs to be updated in the light of further developments of the related elements in Article III. Delegations reserved the right to return to this issue after further consideration.

51. Language in this paragraph needs to be updated in the light of further developments of the structural elements in Article VII. Delegations reserved the right to return to this issue after further consideration.

52. Proposals were made that this may be 5 per cent or 10 per cent or a figure decided by the Ad Hoc Group.

53. Proposals were made that the implementation of waiver provisions shall only begin from the submission of initial declarations.

54. On-site activities refer to activities as provided for in Article III, section D, subsection II, and section G, as well as Annex D. Further consideration needs to be given to this cross-reference and whether the coverage and scope of this cross-reference are appropriate.

55. The question of the location of the First Review Conference, including whether this should be at the Seat of the Organization (Geneva, Switzerland or The Hague, Netherlands) and/or at the same location as the review conferences of the Convention, will have to be addressed after further consideration of the location of the Seat.

56. The view was expressed that further consideration needs to be given to microorganisms carrying nucleic acid sequences coding for pathogenic properties of listed agents and toxins. Another view was expressed that further consideration also needs to be given to nucleic acid sequences coding for toxins. The view was expressed that live-attenuated microorganisms such as registered or recognized internationally vaccine strains should not be included as part of the lists.

57. Ibid.

58. The view was expressed that review of and change to the list shall be addressed in Article III, section A and Article XIV.

59. This agent is also included among ovine and swine pathogens.

60. It was suggested that since these items are not agents or toxins they should be discussed in an appropriate section.

61. A list of equipment may also have utility in the context of [any] guidelines on [all] transfers of dual-use items.

62. ED is an effective dose of a biological agent (LD50, ID50) determined through experiments on model animals with the use of certain means of infection under normal conditions.

63. Specific value of the parameter is to be agreed upon in advance.

64. Ibid.

65. Ibid.

66. PFU - plaque forming unit.

67. The toxins have been selected among those reflected in the list of pathogens and serve only as examples.

68. The text of Annex B has been deleted. Some delegations noted that it might nevertheless be desirable later in the negotiations to include some of the text on procedures for visits in an annex.

69. Final agreement on this issue is directly related to agreement on the size of the initial investigation area.

70. Paragraphs 1 and 2 may in future be placed in Article III, section G.

71. It was proposed to include this element in Article VIII.

72. This section reproduces format 3 of BWC/AD HOC GROUP/WP.318. It was not discussed during the twelfth, thirteenth, fourteenth, fifteenth, sixteenth, seventeenth, eighteenth or nineteenth session of the Ad Hoc Group.

73. A view was expressed that it would be better to use the term "facility" and refer to the definition in Article II.

74. A view was expressed that the format should state that the locations of animal holding areas may be excluded from such maps.

75. Only the delegations which saw this format I as the format for biodefence facilities wanted to retain this question in this place.

76. If high biological containment (BL3 - ...) is agreed as a declaration trigger, this question may not be necessary.

77. The list as developed in the rolling text, Annex A, section II should be used.

78. Only the delegations which saw this format I as the format for biodefence facilities wanted to retain this question in this place.

79. The items from the list of agents and toxins in Annex A will be included here later, when that list is agreed.

80. Delegations which saw this format I as the format for biodefence facilities did not want to keep this paragraph.

81. A view was expressed that the unit "dose" as used in the tables below may need further elaboration for the declaration of facilities producing specific immunogenic components of vaccines as opposed to finished vaccine products.

82. The list as developed in the rolling text, Annex A, section II should be used.

83. This appendix reproduces parts of BWC/AD HOC GROUP/WP.384. It was not discussed during the fifteenth, sixteenth, seventeenth, eighteenth or nineteenth session of the Ad Hoc Group.

84. The list of sampling equipment will depend on whether analyses will be done on-site or off- site.

85. In order to provide time, as necessary, for any conceptual discussions on certain issues, this time-table should be regarded as indicative and subject to adjustment in the light of developments in the negotiations.

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