APPENDIX B

ANNUAL DECLARATIONS

DECLARATION OF CURRENT DEFENSIVE BIOLOGICAL AND TOXIN PROGRAMMES [AND/OR ACTIVITIES]

1. Name of State Party:

..............................................................................................................................................

2. This declaration relates to the calendar year:

..............................................................................................................................................

3. At any time in the previous year, have you conducted any programmes and/or activities as specified in Article III, section D, subsection I, paragraph 9?

YES / NO

If yes, complete the remainder of this format.

4. Describe the general objectives of any such programmes and/or activities specified in Article III, section D, subsection I, paragraph 9 (50 lines or less):

..............................................................................................................................................

..............................................................................................................................................

..............................................................................................................................................

[5. Indicate by ticking the appropriate box if research and development, testing or evaluation [or production [for distribution, sale or storage]] has been carried out in the following areas:

    Research and development   Testing or evaluation   [Production [for distribution, sale, or storage]]
Detection/Diagnostic techniques            
Decontamination            
Prophylaxis            
Physical protection            
Treatment            
Studies on pathogenicity/virulence            
Genetic modification            
[Other characteristics of agents]            
Toxinology            
[Toxicology]            
Aerobiology            
Vector (insect) ecology            
[Fermentation]            
[Other related activities]            

]

OR

[

    Research and development   Testing or evaluation
Prophylaxis        
Pathogenicity/virulence        
Diagnostic techniques        
Detection        
Aerobiology        
Medical treatment        
Toxinology/toxicology        
Physical protection        
[Production fermentation capacities]        

]

6. Summarize the principle objectives of the programmes and/or activities in the areas indicated in question 5 above:

..............................................................................................................................................

..............................................................................................................................................

..............................................................................................................................................

For the programmes and/or activities in the areas indicated in question 5 above:

7. State:

(a) The total funding:

..............................................................................................................................................

(b) Affiliation of sources of funding (tick all that apply):

Ministry/Department/Agency of Defence     Wholly / Partially
Other government ministry/department/ agency     Wholly / Partially
Non-government     Wholly / Partially
International organization     Wholly / Partially

8. For the personnel employed, including those contracted for more than six [person months]:

(a) Estimate the total number of personnel:

[..............................................................................................................................................]

OR

[___ 0 - 10 ___ 11 - 25 ___ 26 - 50 ___ greater than 50]

[(b) Estimate the total person years of effort:

[..............................................................................................................................................]

OR

[___ 0 - 10 ___ 11 - 25 ___ 26 - 50 ___ greater than 50]]

[(c) Give a detailed break-down of the following personnel categories:

  Scientific personnel including engineers Technical assistance/ support personnel
[Military] personnel    
[Civilian personnel]    
Contract personnel*    
* Contract employees who have worked for more than 6 [person] months in the reporting period.

]

OR

[(c) Estimate the percentage of person-years that are full-time active duty military:

___ none ___ 1 - 25 per cent ___ 26 - 50 per cent
___ 51 - 75 per cent ___ 76 - 100 per cent  

(c) bis Estimate the percentage of person-years that are full-time civilian ministry/department/agency of defence employees (include on-site contractors):

___ none ___ 1 - 25 per cent ___ 26 - 50 per cent
___ 51 - 75 per cent ___ 76 - 100 per cent ]

[9. Indicate:

[(a) All biological agents and/or toxins they worked with:

..............................................................................................................................................]

(b) All agents and/or toxins listed in Annex A that were produced including amounts produced of each agent and/or toxin (in ranges):

..............................................................................................................................................

(c) All biological agents on which genetic modification was being done, if any of the following work was carried out:

(i) Insertion of a nucleic acid sequence coding for any pathogenicity/ virulence factor or for any toxin or subunit of any toxin, into an agent listed in Annex A;

(ii) Insertion of a nucleic acid sequence coding for any pathogenicity/ virulence factor from an agent or for a toxin listed in Annex A, or for a subunit of such toxin, into any microorganism, resulting in a genetically modified organism with disease causing or toxic properties:

..............................................................................................................................................

[(iii) All biological agents on which genetic modification was conducted to enhance pathogenicity, virulence, stability or resistance to antibiotics or chemical or physical methods of disinfection, or which altered the host range, the infection route or the ease of identification or diagnosis:

..............................................................................................................................................]

(d) The total fermentation/bioreactor capacity available (in ranges):

..............................................................................................................................................

(e) Whether vaccines were produced:

YES / NO

[If yes, list the facilities involved:

..............................................................................................................................................]

(f) Whether protective equipment/material was tested or evaluated using open-air release of microorganisms/toxins or their simulants at test ranges:

YES / NO

[If yes, list the test ranges involved:

..............................................................................................................................................]

(g) Whether aerosol chambers were used for studies of microorganisms/toxins or their simulants:

YES / NO

[If yes, list the facilities involved:

..............................................................................................................................................]

(h) Whether the programmes and/or activities are regularly reviewed, and if so by which organization:

..............................................................................................................................................]

[10. Indicate, whether any of the work was conducted under contract or through collaboration with industry, academic institutions or in other non-defence facilities?

YES / NO

If yes,

(a) What proportion of the total funds indicated in question 7 (a) was devoted to these contracted, collaborating or other facilities:

..............................................................................................................................................

(b) Summarize the objectives of any such work:

..............................................................................................................................................

..............................................................................................................................................

..............................................................................................................................................

(c) Was any such work carried out by an international organization?

YES / NO

If yes, indicate the area of work, according to question 5 above, and list the facilities involved:

..............................................................................................................................................

(d) Was any such work carried out in another State Party/State?

YES / NO

If yes, indicate the area of work, according to question 5 above, and list the facilities involved:

..............................................................................................................................................]

11. Provide a diagram of the organizational structure of the programmes and/or activities described in question 4 above and the reporting relationships including all the facilities mentioned in the paragraphs above:

..............................................................................................................................................

[12. List the names of all facilities triggered for declaration in accordance with Article III, section D, subsection I, paragraph 9 (b), and provide a short description of the activity(ies) that triggered the declaration:

..............................................................................................................................................

..............................................................................................................................................

..............................................................................................................................................]

13. Indicate the publication policy for the declared programmes and/or activities described in question 4 above:

Publishing in the open literature and/or at open scientific/technical meetings YES / NO
Scientific/technical reports on limited distribution only YES / NO
No publications or reports YES / NO

OR

[5. Describe in summary form the following research and development, if applicable, that was performed as part of the programmes and/or activities declared pursuant to question 4 above:

(a) Aerobiology

..............................................................................................................................................

(b) Decontamination

..............................................................................................................................................

(c) Detection

..............................................................................................................................................

(d) Diagnostic techniques

..............................................................................................................................................

(e) Medical treatment

..............................................................................................................................................

(f) Physical protection

..............................................................................................................................................

(g) Prophylaxis

..............................................................................................................................................

(h) Studies on pathogenicity and virulence

..............................................................................................................................................

(i) Toxinology

..............................................................................................................................................

6. Estimate the overall effort devoted to the programmes and/or activities described in question 4 above by indicating which range applies:

___ Less than 50 person years

___ 51 to 500 person years

___ Greater than 500 person years

7. Affiliation of sources of funding (tick all that apply):

Ministry/Department/Agency of Defence     Wholly / Partially
Other government ministry/department/ agency     Wholly / Partially
Non-government     Wholly / Partially
International organization     Wholly / Partially

8. Describe in summary form the major elements of the programmes and/or activities described in question 4 above and the relationships between these elements:

..............................................................................................................................................

..............................................................................................................................................

..............................................................................................................................................

9. Indicate if aspects of the programmes and/or activities described in question 4 above were conducted under contract with any of the following affiliations/organizations:

___ industry ___ academia ___ other non-defence/non-military

If yes, estimate the percentage of the total funds for any such programmes and/or activities that were expended in these contracted facilities:

___ none ___ 1 - 25 ___ 26 - 50 ___ 51 - 75 ___ 76 - 100

10. Indicate the types of microorganisms and/or toxins worked on in the programmes and/or activities described in question 4 above (tick all that apply):

___ Human pathogens:

___ Bacteria ___ Viruses ___ Rickettsia

___ Toxins

___ Fungi

___ Animal pathogens (other than human)

___ Plant pathogens]

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