Containment Ordinance (ContainO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Section 1 Examination of Notifications and Authori
Art. 17 Federal Coordination Centre for Biotechnology
1 The Confederation operates a Coordination Centre for Biotechnology within the Federal Office for the Environment (FOEN). 2 The Coordination Centre has the following administrative duties: a. it accepts notifications and authorisation applications under Articles 8–12 as well as notifications under the Ordinance of 25 August 1999 on the Protection of Employees from Dangerous Organisms; b. it examines the notifications and authorisation applications, requests any missing information within 20 days and confirms to the person filing the notification or application that the document is complete; c. it forwards complete notifications and authorisation applications to the competent federal office (Art. 18 para. 1) for a decision and to the specialist agencies (Art. 18 para. 2) for an opinion; d. it gives notice of receipt of notifications and authorisation applications in the Official Federal Gazette and makes these notifications and authorisation applications available for public inspection
Para. 2 let. a — SR 832.321 Para. 2 let. f — Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 18 Competent federal office and specialist agencies
1 The following offices are competent to take the decisions required in connection with activities subject to notification or authorisation: a. the Federal Office of Public Health (FOPH) where the main risk of an activity concerns human beings; b. the FOEN for all other activities. 2 The following are the specialist agencies: a. for all activities, the FOPH, the FOEN, the Federal Ethics Committee on Non-Human Biotechnology (ECNH), the specialist agency appointed by the canton, and, at its request, the State Secretariat for Economic Affairs (SECO); b. for activities in Classes 2‒4, the Swiss National Accident Insurance Fund (SUVA); c. for activities in Classes 3 and 4 and applications under Article 12 paragraph 3 letter a, the SECB; d. for activities with organisms pathogenic to animals, the Federal Food Safety and Veterinary Office (FSVO); e. for activities with organisms pathogenic to plants and alien organisms subject to a containment obligation, the Federal Office for Agriculture (F
Para. 2 let. d — The name of the federal office was changed on 1 Jan. 2014 in accordance with Art. 16 para. 3 of the Publications Ordinance of 17 Nov. 2004 (AS 2004 4937). The change has been made throughout the text. Para. 4 — SR 916.401 Para. 4 — The name of this administrative unit was modified in application of Art. 16 para. 3 of the Publications Ordinance of 17 Nov. 2004 (SR 170.512.1) on 1 May 2013.
Art. 19 Notification procedure
1 The competent federal office verifies whether the requirements of Articles 4–7 have been met. In doing so, it takes account of any opinions from the specialist agencies. 2 The competent federal office may prohibit the activity entirely or in part if there is reason to assume that the requirements of Articles 4–7 have not been met. It communicates its decision within 90 days of confirmation of its completeness to the notifying person, the specialist agencies, and the Federal Coordination Centre for Biotechnology. 3 If the competent federal office fails to issue a decision within the said period, Class 1 activities subject to notification and changes to Class 2 activities of which the office has already been notified are deemed to be in compliance with this Ordinance, unless this is contradicted by substantial new findings.
Para. 3 — Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 20 Authorisation procedure
1 The competent federal office verifies whether the requirements of Articles 4–7 and 13 have been met. In doing so, it takes account of the opinions received from the specialist agencies. 2 The competent federal office decides on the authorisation application within 90 days of confirmation of its completeness. Authorisation is valid for a maximum of five years. 3 If there is a risk in delay, and in particular if a rapid diagnosis of new microorganisms is required, the competent federal office may, following a provisional examination of the risk determination and assessment and having informed the specialist agencies, grant authorisation limited until the conclusion of the ordinary procedure. 4 The competent federal office communicates its decision to the applicant, the specialist agencies and the Federal Coordination Centre for Biotechnology.
Art. 21 Authorisation to modify, replace or omit certain special safety measures
1 Within 90 days of confirmation that the application is complete, the competent federal office authorises requested deviations from special safety measures provided the requirements (Art. 12 para. 3 let. a) are met. In doing so, it takes account of the opinions received from the specialist agencies. 2 The competent federal office communicates its decision the applicant, the specialist agencies and the Federal Coordination Centre for Biotechnology.
Art. 22 Standard deadlines
1 If additional information must be submitted in order to consider notifications and authorisation applications, the standard deadlines in this Section are extended accordingly. 2 If the competent federal office is unable to comply with the deadline for issuing a decision under this Section, it notifies the notifying person or applicant and the specialist agencies before expiry of the deadline and informs them when the decision is to be expected.
Section 2 Monitoring in Establishments
Art. 23 Duties of the cantons
1 The cantons monitor shall compliance with the duty of care, the containment obligation and the safety measures. 2 They also verify by means of spot checks whether: a. the documentation required by Article 4 paragraph 3 has been prepared and preserved; b. notification has been given or authorisation granted, if required, for an activity that has been carried out; c. the information on the organisms to be used and the activity given in the notification or authorisation application corresponds with the organisms actually used and the activity carried out; d. a significant change in the proposed activity has been made such that the risk determination and assessment under Article 7 paragraph 3 must be repeated; e. public liability is guaranteed. 3 The samples, detection methods and materials required for monitoring are made available to the cantons. 4 If the monitoring shows cause for complaint, the canton in question orders the required measures to be taken and inform the Federal Coordin
Art. 24 Duties of the Confederation
1 If the requirements for a notified activity or an authorisation are not met despite a complaint from the canton, the competent federal office, having consulted the canton, shall prohibit the continuation of the notified activity or revoke authorisation. 2 The competent federal office decides based on information provided by the canton whether an activity that is only documented is subject to the notification or authorisation obligation or not.
Section 3 Monitoring Transport
Art. 25
The responsibility for monitoring the transport of genetically modified or pathogenic organisms or alien organisms subject to a containment obligation and for ordering any measures is governed by the relevant transport regulations.
Section 4 Obtaining, Processing and Confidentialit
Art. 26 Lists of classified organisms
1 The FOEN maintains with consent of the FOPH, SECO, FSVO, FOAG and SUVA and after consulting the SECB a publicly accessible, non-conclusive list in which organisms are classified in one of the four groups according to the criteria in Annex 2.1. 2 The FOPH maintains with the consent of the FOEN and after consulting SECO, the FSVO, the FOAG, the Federal Office for Civil Protection, SUVA and the SECB, a publicly accessible, non-conclusive list of organisms with a high potential for improper use. 3 The FOEN and the FOPH shall take account of existing lists, in particular those of the European Union and its member states and of international organisations.
Art. 26 — Amended by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 27 Surveys
The FOEN and the FOPH may carry out surveys of all activities involving genetically modified, pathogenic and alien organisms in contained systems, in particular as to the type and number of and time schedule for these activities.
Art. 27a ECOGEN electronic database
1 Data required to conduct the following tasks are recorded and processed in the ECOGEN electronic database: a. the notification and authorisation procedures specified in Articles 19 and 20; b. reporting incidents under Article 16 paragraph 2; c. receiving information and reports on supervisory activities under Article 17 paragraph 2 letter j; d. providing information and advice under Article 17 paragraph 2 letter h; e. conducting other tasks relating to the implementation of this Ordinance. 2 The following persons have access to ECOGEN and may process the data it contains: a. employees of the Federal Coordination Centre for Biotechnology and of the offices and agencies responsible listed in Article 18 paragraphs 1 and 2: in accordance with their appointed tasks; b. persons making a notification or application: to the extent that the data concerns them.
Art. 27a — Inserted by No I of the O of 27 Sept. 2019, in force since 1 Jan. 2020 (AS 2019 3131).
Art. 28 Confidentiality of information
1 The authorities responsible for the enforcement of this Ordinance shall treat information as confidential where there is a legitimate and overriding interest in doing so. They classify this information as such when forwarding it to other authorities. 2 There is a legitimate interest in particular in preserving trade and manufacturing secrecy. 3 Any person submitting documents to the authorities must: a. indicate the information which is to be treated as confidential; and b. justify the need for confidentiality. 4 An authority that does not wish to accede to a request for confidentiality shall investigate whether the grounds given for confidentiality are justifiable. If its assessment differs from the proposal of the persons supplying the information, the authority, after hearing these persons, shall inform them in a ruling which information they do not find worthy of protection. 5 The following information shall always be accessible to the public: a. the name of the persons responsib
Section 5 Fees
Art. 29 Obligation to pay a fee
1 Any person who causes the Federal Coordination Centre for Biotechnology, the FOEN or the FOPH to provide a service or the offices to issue a ruling under this Ordinance must pay a fee. 2 Unless this Ordinance contains special regulations, the provisions of the General Fees Ordinance of 8 September 2004 apply.
Para. 2 — SR 172.041.1
Art. 30 Level of fees
1 The fees are as follows: Francs a. Examination of notifications under Article 19 100–2000 b. Examination of authorisation applications under Article 20 300–4000 c. Examination of authorisation applications under Article 21 100–4000 2 The fee is assessed on a time and material basis. If the work involved is unusually high, the fee may be increased by up to 50 per cent. 3 When examining applications for a re-assessment, fees of up to 50 per cent of the rates fixed may be charged. 4 For services without a fee rate, the fee amounts to 130–190 francs per hour.
Art. 31 Outlays
Outlays are the costs additionally incurred for an individual service, and in particular: a. remuneration for members of extra-parliamentary committees under the Government and Administration Organisation Ordinance of 25 November 1998; b. costs incurred in gathering evidence, conducting scientific investigations or special examinations or obtaining documents; c. costs of work that the Federal Coordination Centre for Biotechnology, the FOEN or the FOPH arranges to be carried out by third parties.
let. a — SR 172.010.1
Section 6 Guidelines, Basic and Continuing Profess
Art. 32
1 The FOEN and the FOPH may issue joint guidelines on the implementation of this Ordinance, in particular on the determination and assessment of the risks posed by the occurrence of organisms or activities with organisms, transport of organisms, safety measures and related quality controls. They consult the specialist agencies (Art. 18 para. 2) beforehand. 2 The FOEN and the FOPH jointly ensure, in consultation in particular with the SECB, that basic and continuing professional education events are held regularly for persons who carry out duties under this Ordinance.