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RS 814.912.21 Order of 3 November 2004 on transboundary movements of genetically modified organisms (Cartagena Order, OCart)

Original Language Title: RS 814.912.21 Ordonnance du 3 novembre 2004 sur les mouvements transfrontières des organismes génétiquement modifiés (Ordonnance de Cartagena, OCart)

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814.912.21

Guidelines for the Transboundary Movement of Genetically Modified Organisms

(Cartagena Order, OCart)

On 3 November 2004 (State 1 Er June 2012)

The Swiss Federal Council,

See art. 19, para. 2, let. A, of the Federal Act of March 21, 2003 on Genetic Engineering 1 , having regard to the Cartagena Protocol of 29 January 2000 on Biosafety to the Convention on Biological Diversity (Cartagena Protocol) 2 ,

Stops:

Section 1 General provisions

Art. 1 Scope of application

1 This order regulates transboundary movements of genetically modified organisms.

2 It does not apply to the transboundary movement of medicinal products for human use containing genetically modified organisms.

Art. 2 Definitions

In this order, the following means:

A. 1
Use in the environment: Any use in the environment within the meaning of s. 3, let. I, of the order of 10 September 2008 on the release into the environment (ODE) 2 ;
B. 3
Genetically modified organism: Any genetically modified organism within the meaning of s. 3, let. D, ODE
C. 4
Confined environment, Any enclosed environment within the meaning of s. 3, let. H, of the order of 9 May 2012 on contained use (OUC) 5 ;
D.
Transboundary movement, The import, export and transit of genetically modified organisms;
E.
Biosafety Clearing House, The International Centre for the Prevention of Biotechnological Risk in the Meaning of Art. 20 of the Cartagena Protocol.

1 New content according to the c. 7 of Schedule 5 to the O of 10 seven. 2008 on the release into the environment, in force since 1 Er Oct. 2008 ( RO 2008 4377 ).
2 RS 814.911
3 New content according to the c. 7 of Schedule 5 to the O of 10 seven. 2008 on the release into the environment, in force since 1 Er Oct. 2008 ( RO 2008 4377 ).
4 New content according to the c. 11 of annex 5 to the O of 9 May 2012 on contained use, in force since 1 Er June 2012 ( RO 2012 2777 ).
5 RS 814.912

Section 2 Requirements for transboundary movements of genetically modified organisms

Art. 3 Duty Due Diligence

Any person who imports, exports or transacts genetically modified organisms must:

A.
Act with the precautions that the situation requires so that genetically modified organisms, their metabolites and the waste formed cannot endanger animals, the environment or, indirectly, the human being;
B.
Handling, packaging, labelling and transporting them, taking into account relevant national and international provisions;
C.
Provide supporting documentation for each transboundary movement within the meaning of s. 4.
Art. 4 Supporting Documentation

1 In the event that genetically modified organisms are used in the environment, the documentation shall contain the following information:

A.
A clear indication that they are genetically modified organisms;
B.
The unique identifier within the meaning of the Annex to Commission Regulation (EC) No 65/2004 of 14 January 2004 1 Establishing a system for the development and allocation of unique identifiers for genetically modified organisms or, in the absence of this identifier, the specification of the identity of organisms with their features and characteristics Relevant;
C.
The safety rules to be observed in the handling, storage, transportation and use of these organisms;
D.
The name and address of the person to contact for any additional information;
E.
The name and address of the recipient;
F.
A declaration certifying that the movement complies with the requirements of the Cartagena Protocol applicable to the exporter.

2 In the case where genetically modified organisms are intended to be processed or used directly for human or animal feed or when they are medicinal products for veterinary use, the indication according to para. 1, let. A, must be supplemented by an indication to the effect that these are genetically modified organisms which must under no circumstances be introduced directly into the environment.

3 In the case where genetically modified organisms are intended to be used in a confined environment, only the requirements of para. 1, let. A to e.


1 OJ L 10, 16.01.2004, p. 5. The text of the R is available from the Federal Office of the Environment (OFEV), 3003 Berne.

Art. 5 Importing

1 Any person who intends to import genetically modified organisms that will be the subject of a use in the environment shall enjoy an authorization within the meaning of s. 17 or 25 ODE 1 . 2

2 Any person who intends to import genetically modified organisms that will be the subject of a confined use must comply with the requirements of ss. 4, 15 and 25 OUC 3 . 4


1 RS 814.911
2 New content according to the c. 7 of Schedule 5 to the O of 10 seven. 2008 on the release into the environment, in force since 1 Er Oct. 2008 ( RO 2008 4377 ).
3 RS 814.912
4 New content according to the c. 11 of annex 5 to the O of 9 May 2012 on contained use, in force since 1 Er June 2012 ( RO 2012 2777 ).

Art. 6 Exporting

1 Any person who intends to export genetically modified organisms for the first time to a particular country for use in the environment must first obtain the consent of the competent national authority of that country.

2 The application to that effect shall contain at least the information specified in Annex I.

3 A copy of the application and the decision of the importing country must be submitted to the Federal Office of the Environment (OFEV) 1 .


1 The designation of the administrative unit has been adapted in accordance with Art. 16 al. 3 of the O of 17 Nov 2004 on Official Publications (RS 170.512.1 ). This mod has been taken into account. Throughout the text.

Art. 7 Requirement to keep an export register

1 Anyone who exports genetically modified organisms that will be used in the environment must maintain a register of annual exports classified according to the organisms and their quantity and the country of destination.

2 This information must be made available to the OFEV upon request.

3 They must be kept at least 30 years after the last export.

Section 3 Tasks of the authorities

Art. 8 Tasks for the OFEV

The OFEV is the focal point for issues related to the transboundary movement of genetically modified organisms. Its tasks include the following:

A.
Liaises with the Secretariat as defined in s. 24 of the Convention of 5 June 1992 on biological diversity 1 ;
B. 2
It maintains a public record of non-confidential information contained in applications and decisions under s. 6, para. 3; the confidentiality of information is governed by s. 55 ODE 3 .
C.
It advises exporters in the event of non-compliance by a country with the import of time limits under the Cartagena Protocol;
D.
Informing the Federal Office of Public Health, the Federal Office for Agriculture, the Federal Office for Food Safety and Veterinary Affairs 4 And the Swiss Institute for Therapeutic Products, according to their competences defined by the ODE and OUC 5 , transboundary movements and the possible unintentional transboundary spread of genetically modified organisms;
E.
Periodically publishes a report on transboundary movements of genetically modified organisms;
F.
It makes available forms for accompanying documentation within the meaning of s. 4.

1 RS 0.451 . 43
2 New content according to the c. 7 of Schedule 5 to the O of 10 seven. 2008 on the release into the environment, in force since 1 Er Oct. 2008 ( RO 2008 4377 ).
3 RS 814.911
4 The designation of the administrative unit has been adapted to 1 Er Jan 2014 pursuant to Art. 16 al. 3 of the O of 17 Nov 2004 on Official Publications (RS 170.512.1 ). This mod has been taken into account. Throughout the text.
5 RS 814.912

Art. Participation in the international exchange of information mechanism

1 OFEV publishes, through the Biosafety Clearing House, the following information and documents:

A.
Federal legislation relevant to the application of this order;
B.
Any international agreement concluded by Switzerland on the transboundary movement of genetically modified organisms;
C.
The name and address of the federal authorities referred to in s. 8, let. D, and 10;
D.
Any decision concerning the importation, release or experimental release of genetically modified organisms;
E.
Any decision concerning the use in the environment of genetically modified organisms intended for processing, or to be used directly for human or animal feed. Such publication shall contain at least the information requested in Annex 2 and intervene within 15 days after notification of the decision;
F.
Summaries of available biological safety studies as well as summaries of other relevant environmental studies;
G.
Information on cases of unintentional transboundary movements;
H.
Reports established under s. 8, let e.

2 Federal authorities referred to in s. 8, let. D, put the information and documents within the meaning of para. 1 available to the Office of the European Parliament.

Art. 10 Measures in the case of unintentional transboundary movements

1 In the event of an extraordinary event which may result in the transboundary movement of genetically modified organisms, the cantons concerned shall notify the OFEV and inform the population, the neighbouring cantons and the regional authorities Competent in neighbouring countries.

2 The OFEV shall notify the competent national authorities of neighbouring countries of the incident.

3 The notification addressed to the authorities of the neighbouring countries shall contain at least the following information:

A.
The estimated quantities and traits and characteristics of genetically modified organisms;
B.
The circumstances and timing of the release and the use of genetically modified organisms;
C.
The potential hazards to humans, animals and the environment, as well as potential harm to biological diversity and the sustainable use of its components;
D.
Possible risk management measures.

4 In the event of an extraordinary event in installations within the meaning of Art. 1, para. 2, para. b, et al. 3, let. B, of the order of 27 February 1991 on major accidents 1 , the information and alarm provisions of this order are also applicable.

5 The OFEV registers notifications from abroad and informs the cantons concerned. They shall inform the public in an appropriate manner.


Art. 11 Monitoring

1 The OFEV ensures that the export provisions of genetically modified organisms that will be used in the environment are complied with.

2 It orders the measures required if the export provisions give rise to disputes.

3 With regard to the monitoring of the provisions on the import and transit of genetically modified organisms and the requirement of the measures required, the competences are defined by the OUC 1 And ODE 2 .


Art. 12 Training and Development

The OFEV ensures that meetings are held as required to ensure the training and development of persons performing tasks under this order.

Art. 13 Performing tasks by third parties

The OFEV may assign tasks to third parties, in particular with regard to the compilation of statistics.

Section 4 Final provisions

Art. 14 Amendment of the law in force

... 1


1 The mod. Can be viewed at RO 2012 2777 .

Art. 15 Entry into force

This order shall enter into force on 1 Er January 2005.

Annex 1

(art. 6)

Information to be included in the application to be submitted in accordance with Art. 6

A.
Name and address of exporter;
B.
Name and address of importer;
C.
Name of the genetically modified organism, a unique identifier within the meaning of the Annex to Commission Regulation (EC) No 65/2004 of 14 January 2004 1 Establishing a system for the development and assignment of unique identifiers for genetically modified organisms, if this identifier exists, and an indication of the group to which the organism belongs within the meaning of s. 6 OUC 2 ;
D.
Anticipated date of the transboundary movement;
E.
Common name and taxonomy, point of collection or acquisition, and characteristics of the receiving organism relevant to biological safety;
F.
Centres of origin and genetic diversity centres of the receiving body and donor agencies, when these centres are known, and description of habitats where organisms can persist or proliferate;
G.
Common name and taxonomy, point of collection or acquisition, and characteristics of the organism or donor agencies relevant to biological safety;
H.
Description of the nucleic acid or genetic modification introduced, the technique used, and the characteristics of the resulting genetically modified organism;
I.
Intended use of genetically modified organisms or products derived from them, namely processed material originating from genetically modified organisms, which contains new detectable combinations of material Replicable genetics obtained through the use of modern biotechnology;
J.
The quantity or volume of genetically modified organisms to be transferred;
K.
Risk assessment conducted in accordance with Annex 4 ODE 3 ;
L.
Proposed methods for the safe handling, storage, transportation and safe use of genetically modified organisms, including packaging, labelling, documentation, disposal methods and emergency procedures To follow where applicable;
M.
Legal status in Switzerland of the genetically modified organism;
N.
Decisions taken by other states in response to an application for the export of the genetically modified organism;
O.
Statement that the above information is accurate.

1 JO n O L 10 of 16 January 2004, p. 5. The text of the Regulation is available from the OFEV, 3003 Berne.
2 RS 814.912
3 RS 814.911


State 1 Er January 2014

Annex 2

(art. 9, para. 1, let. (e)

Information to be provided under s. 9, para. 1, let. E

A.
Name and address of the applicant;
B.
The name and address of the authority issuing the decision;
C.
Name and identity of the genetically modified organism;
D.
Description of the genetic modification, the technique used, and the characteristics of the resulting genetically modified organism;
E.
Unique identifier within the meaning of the Annex to Commission Regulation (EC) No 65/2004 of 14 January 2004 1 Establishing a system for the development and allocation of unique identifiers for genetically modified organisms;
F.
Common name and taxonomy, point of collection or acquisition, and characteristics of the receiving organism relevant to biological safety;
G.
Centres of origin and genetic diversity centres of the receiving body and donor agencies, when these centres are known, and description of habitats where organisms can persist or proliferate;
H.
Common name and taxonomy, point of collection or acquisition, and characteristics of the organism or donor agencies relevant to biological safety;
I.
Permitted uses of genetically modified organisms;
J.
Risk assessment conducted in accordance with Annex 4 ODE 2 ;
K.
Proposed methods for the safe handling, storage, transportation and safe use of genetically modified organisms, including packaging, labelling, documentation, disposal methods and emergency procedures To be followed where applicable.

1 JO n O L 10 of 16 January 2004, p. 5. The text of the Regulation is available from the OFEV, 3003 Berne.
2 RS 814.911


State 1 Er January 2014