Annex 17

(Art. 6)

Establishments handling organisms

1 Principles

¹The risk report must contain all the information required by the enforcement authority in order to verify and assess, in accordance with Article 7, the risk posed by the establishment to the public or the environment. This includes, in particular, all the information listed in numbers 2–5.

²In justified cases, certain items of information may be omitted or replaced by others which are equally valid or more appropriate.

³The scope and degree of detail of the information given for each item will depend on the specific circumstances; in particular, consideration is to be given to the nature of the establishment, the hazard potential, the surrounding area and the safety measures. Items marked with an asterisk (*) are generally only applicable to production facilities.

⁴Documentation used for the risk report, particularly test results, empirical data, literature references, results of calculations and detailed analyses, are to be kept at the disposal of the enforcement authority.

2 Basic data

21 Establishment and surrounding area

– Description of the establishment, together with a site plan, including any permits or planning approvals, – characterisation of the establishment, – names of the persons responsible, – information on the surrounding area, together with a general plan.

22 Activities involving organisms

– Risk assessment in accordance with Article 8 of the Containment Ordinance of 9 May 2012¹; in particular, the identity and characteristics of the organisms and the nature and scale of the activity, – the purpose of the contained use, – the culture volumes,

• the nature of the intended product and of any by-products which are or may be produced in the course of the activity.

23 Installation

– Description of the sections of the installation,

• the maximum number of persons working in the installation and of persons working directly with the microorganisms.

24 Waste, wastewater and exhaust air

– Types and quantities of waste and wastewater arising from the use of organisms, – ultimate form and destination of inactivated wastes.

25 Safety measures

– Class of the activity in accordance with the Containment Ordinance – measures specified in the Containment Ordinance, – measures taken to prevent major accidents, – measures taken to limit the effects of major accidents.

3 Analysis

31 Methods

– Description of the methods used.

32 Hazard potentials

– Overview and characterisation of the main hazard potentials.

33 Main major accident scenarios

– Possible causes of major accidents, – description of significant release events and their effects, based on dispersal considerations, – description of the extent of possible harm to the public or damage to the environment, – estimate of the likelihood of occurrence, given the safety measures in place.

4 Conclusions

– Account of the risk, given the safety measures in place, – estimate of the risk posed by the establishment.

5 Summary of the risk report

– Characterisation of the establishment and of the main hazard potentials, – description of the safety measures, – description of the main major accident scenarios, – estimate of the risk posed by the establishment.