Gene Technology Act (GTA)

By Steph2
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In The Matter OfGene Technology Act (GTA)
Exhibit A
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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 General Principles

Art. 6 Protection of human beings, animals, environment and biological diversity

1 Genetically modified organisms may only be handled in such a way that they, their metabolic products or wastes: a. cannot endanger human beings, animals or the environment; b. do not harm biological diversity or the sustainable use thereof. 2 Genetically modified organisms may be released for experimental purposes if: a. the information sought cannot be obtained through experiments in contained systems; b. the experiment also contributes to research on the biosafety of genetically modified organisms; c. they do not contain genes inserted by gene technology which cause resistance to antibiotics used in human or veterinary medicine; and d. according to the current state of knowledge, the dispersal of these organisms and their new traits can be excluded and the principles of paragraph 1 cannot otherwise be contravened. 3 Genetically modified organisms lawfully intended for use in the environment may only be put into circulation if they do not contain gene technologically inserted resist

Art. 7 Protection of production without genetically modified organisms and freedom of choice

Genetically modified organisms may be handled only in such a way that they, their metabolic products or wastes do not impair production that does not involve genetically modified organisms, or limit consumers’ freedom of choice.

Art. 8 Respect for the dignity of living beings

1 In animals and plants, modification of the genetic material by gene technology must not violate the dignity of living beings. In particular, violation is deemed to have occurred if such modification substantially harms species-specific properties, functions or habits, unless this is justified by overriding legitimate interests. In evaluating the harm, the difference between animals and plants must be taken into consideration. 2 Whether the dignity of living beings has been respected is determined on a case-by-case basis, by evaluating the severity of the harm suffered by animals or plants against the significance of the legitimate interests. Legitimate interests are, in particular: a. human and animal health; b. guaranteeing food security; c. the reduction of harm caused to the environment; d. the preservation and improvement of environmental conditions; e. securing a substantial economic, social or environmental benefit for society; f. increasing knowledge. 3 The Federal Council det

Art. 9 Genetic modification of vertebrates

Genetically modified vertebrates may only be produced and put into circulation for purposes of research, therapy, or diagnostics in human or veterinary medicine.

Art. 10 Activities in contained systems

1 Any person who handles genetically modified organisms which may not be released for experimental purposes (Art. 11) nor put into circulation (Art. 12) is required to take all containment measures necessary in particular due to the hazards for human beings, animals or the environment that these organisms represent. 2 The Federal Council shall introduce a notification or authorisation procedure for activities in contained systems.

Art. 11 Experimental releases

1 Any person who intends to release for experimental purposes genetically modified organisms which may not be put into circulation for use in the environment (Art. 12) requires federal authorisation. 2 The Federal Council determines the requirements and the procedure. In particular, it regulates: a. the consultation of experts; b. the guarantee of funding for measures with which any hazards or harm can be identified, averted or eliminated; c. the provision of information for the public.

Art. 12 Putting into circulation

1 Genetically modified organisms may be put into circulation only if the Confederation has granted authorisation. 2 The Federal Council determines the requirements and the procedure, and regulates the provision of information to the public.

Art. 12a Opposition procedure

1 Applications for authorisations for experimental releases of genetically modified organisms and for putting into circulation genetically modified organisms for lawful use in the environment are published by the authorising authority in the Official Federal Gazette and made available for public inspection for 30 days. 2 Any person who is a party in accordance with the Federal Act of 20 December 1968 on Administrative Procedure may file opposition with the authorising authority during the inspection period. A party who fails to file opposition is excluded from subsequent proceedings.

Art. 12a — Inserted by No I of the FA of 19 March 2010, in force since 1 Aug. 2010 (AS 2010 3233; BBl 2009 5435). Para. 2 — SR 172.021

Art. 13 Inspection of authorisations

1 Authorisations are regularly inspected to determine whether they may continue to apply. 2 Authorised persons must voluntarily inform the authorising authority of new findings that could lead to a re-evaluation of hazards or harm as soon as they become aware of these findings.

Art. 14 Exceptions to the notification or authorisation requirement; self‑supervision

1 The Federal Council may simplify the requirement to notify or obtain authorisation or may grant exemptions if, according to the current state of knowledge or experience, a violation of the principles of Articles 6–9 can be excluded. 2 If there is no authorisation requirement for an activity in contained systems or for putting into circulation certain genetically modified organisms, the person or company responsible shall monitor compliance with the principles of Articles 6–9 themselves. The Federal Council enacts regulations covering the form, extent and monitoring of the self-supervision.

Section 2 Special Provisions

Art. 15 Informing the recipients

1 Any person putting organisms into circulation must: a. inform the recipient of the properties that are significant for the implementation of Articles 6–9; b. instruct the recipient in such a way that the principles of Articles 6–9 are not violated if the organisms are handled appropriately. 2 Instructions from producers and importers must be followed. 3 The supply to agricultural or forestry enterprises of genetically modified organisms that are subject to a labelling requirement requires the written permission of the enterprise owner.

Para. 3 — Expression in accordance with No I of the FA of 19 March 2010, in force since 1 Aug. 2010 (AS 2010 3233; BBl 2009 5435). This amendment has been made throughout the text.

Art. 16 Product flow segregation

1 Any person handling genetically modified organisms must take appropriate care to avoid undesired mixing with non-genetically modified organisms. 2 The Federal Council enacts regulations on product flow segregation and on measures to prevent contamination, taking account of international recommendations and foreign trade relations.

Art. 17 Labelling

1 Any person putting genetically modified organisms into circulation must label them as such for the benefit of the recipient, in order to ensure freedom of choice for the consumer under Article 7 and to prevent product fraud. The labelling must contain the words «genetically modified». The Federal Council determines the details. 2 The Federal Council lays down threshold values below which labelling is unnecessary for mixtures, articles and products that unintentionally contain traces of genetically modified organisms. 3 Traces of genetically modified organisms are considered to be unintentional if the person responsible for providing labelling proves that the product flows have been carefully monitored and recorded. 4 The Federal Council regulates the labelling of products, in particular of foodstuffs and additives obtained from genetically modified organisms. 5 It regulates how organisms that are not genetically modified may be labelled as such when they are put into circulation. It

Art. 18 Access to files and public information

1 The right to access information in official documents relating to the handling of genetically modified organisms or products obtained from them is governed by Article 10g of the Environmental Protection Act of 7 October 1983. 2 After consulting the affected party, the authorities may publish information gathered during enforcement (Art. 24 para. 1) and results from surveys or monitoring, insofar as these are of general interest. They may pass on this information in accordance with a federal act or international agreement to a foreign authority or international organisation. Manufacturing and trade secrecy are reserved.

Para. 1 — SR 814.01 Para. 1 — Amended by Art. 2 No 3 of the Federal Decree of 27 Sept. 2013 (Aarhus Convention), in force since 1 June 2014 (AS 2014 1021; BBl 2012 4323).

Art. 19 Further Federal Council regulations

1 The Federal Council enacts further regulations governing the handling of genetically modified organisms, their metabolic products and wastes if, due to their properties, methods of use or quantities used, the principles of Articles 6–9 could be contravened. 2 In particular, it may: a. regulate their transport, import, export and transit; b. ban or restrict the handling of certain organisms or establish an authorisation procedure for handling them; c. prescribe measures to combat certain organisms or to prevent their occurrence; d. prescribe measures to prevent any harm to biological diversity and to its sustainable use; e. prescribe long-term studies of the handling of certain organisms; f. hold public consultations in connection with authorisation procedures.