Description of Austrian Regulations on Genetic Engineering
The Austrian Gene Technology Act (BGBl. Nr. 510/1994, i.d.g.F) has entered into force in January 1995 and has been amended in 1998 (1. Änderung des Gentechnikgesetzes BGBl. I Nr. 73/1998), in 2002, 2004 and 2005. It regulates the main aspects of biotechnology and genetic engineering: contained use of genetically modified organisms (GMOs), deliberate release of GMOs into the environment, the placing on the market of products that contain GMOs and the application of biotechnology in human medicine, such as gene analysis and gene therapy. Furthermore the act lays down the rules for the installation and work of an Advisory Board on Genetechnology (Gentechnikkommission) and its three scientific committees, for strict liability for damages due to genetic engineering and punishment for offences against the law.
The second amendment to this act entered into force in July 2002 (2. Änderung des Gentechnikgesetzes BGBl. I Nr. 94/2002). It mainly contains the transposition of Council Directive 98/81/EC (of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms) into national law and guarantees the adaptation of the legal framework to the actual state of science and technology.
A third amendment to this act entered into force in December 2004 (3. Änderung des Gentechnikgesetzes BGBl. I Nr. 126/2004). It is mainly dedicated to the implementation of the new Directive on Deliberate Release of GMOs into the Environment (Directive 2001/18/EC of the European Parliament and the Council), which replaced Directive 90/220/EEC while maintaining a high level of protection and safety.
A fourth amendment to this act entered into force in December 2005 (4. Änderung des Gentechnikgesetzes BGBl. I Nr. 127/2005) and aimed at a state-of-the-art adapting of the law in the field of gene-analysis and gene-therapy.
The Ordinance on Work with GMOs in Contained Use (Systemverordnung 2002 BGBl. Nr. 431/2002) regulates this part of the law in more detail, such as risk assessment, the classification of GMOs, the necessary equipment of laboratories according to classification and scale, qualification of staff, safety aspects and the measures to be taken in case of accidents. It entered into force in December 2002 and implements the new Council Directive 98/81/EC (see articles above).
The Ordinance on Deliberate Release of GMOs into the Environment Freisetzungsverordnung BGBl. II Nr. 260/2005) is also based on the Gene Technology Act and contains in more details the requirements that have to be considered by applicants for the approval of a deliberate release of GMOs in Austria.
The Ordinance on Public Hearings (Anhörungsverordnung BGBl.Nr. 61/1997, i.d.F. BGBl. II Nr. 164/1998) has entered into force in 1997 and has been amended in 1998. It prescribes in more details the administrative procedures that have to be considered in those cases where the above named Gene Technology Act requires a mandatory public hearing. These cases are: applications for deliberate release of GMOs into the environment and contained use of GMOs in higher classes and at large scale.
In five cases, namely the placing on the market of three genetically modified maize lines (MON810; MON 863; T 25) as well as the placing on the market of two genetically modified oilseed rapes (GT 73; Ms8/Rf3 and Ms8xRf3), Austria has issued a ban for the import respectively cultivation of these products into Austria. The measures were taken in accordance with Article 16 of Directive 90/220/EEC respectively Article 23 of Directive 2001/18/EG and led to the publication of five ordinances dealing with this subject:
With regard to maize MON 810 and T 25, Austria lifted partially its original ban (BGBl. II Nr. 175/1999; BGBl. II Nr. 120/2000) due to two Decisions taken by the EC on 8th of May 2008 (2008/470/EC; 2008/495/EC) that Austria has to lift its ban with regard to the import of use for food and feed purposes but reaffirmed its ban on the cultivation of these two maize lines (Verbot des Inverkehrbringens des gentechnisch veränderten Maises Zea Mays L., Linie T 25 zum Zweck des Anbaus in Österreich, BGBl. II Nr. 180/2008; Verbot des Inverkehrbringens des gentechnisch veränderten Maises Zea Mays L., Linie MON 810 zum Zweck des Anbaus in Österreich, BGBl. II Nr. 181/2008).
With regard to maize MON 863, a new importban was set into force on 16th July 2008, prohibiting the import and use as feed in Austria up to 1st October 2010 (Verbot des Inverkehrbringens des gentechnisch veränderten Maises Zea Mays L., Linie MON 863, BGBl. II Nr. 257/2008). This ban was reaffirmed for another three years up to November 2015 by the Ordinance "Verlängerung des Verbots des Inverkehrbringens von gentechnisch verändertem Mais der Linie MON863 um drei Jahre", BGBl. II Nr. 319/2012.
Concerning the import ban of genetically modified oilseed rape (OSR), in the year 2006 the import of OSR GT 73 (valid until 31st December 2008) and in the year 2008 OSR Ms8/Rf3 and Ms8xRf3 (valid until 1st October 2010) have been prohibited (Verbot des Inverkehrbringens von gentechnisch verändertem Raps aus der Ölrapslinie GT 73 in Österreich, BGBl. II Nr. 157/2006; Verbot des Inverkehrbringens von gentechnisch verändertem Raps aus den Ölrapslinien Ms8, Rf3 und Ms8xRf3 in Österreich und Aufhebung der Verordnung betreffend das Verbot des Inverkehrbringens von gentechnisch verändertem Mais BT 176 in Österreich, BGBl. II Nr. 246/2008 - Due to the phasing out of genetically modified maize Bt 176, the respective Ordinance has been lifted in the same Ordinance!)
As for the oilseed rape lines GT73 as well as Ms8, Rf3 and Ms8xRf3 the respective import bans have beeen renewed for another three years by two Ordinances (Verlängerung des Verbots des Inverkehrbringens von gentechnisch verändertem Raps aus der Ölrapslinie GT73 in Österreich um weitere drei Jahre, BGBl. II Nr. 318/2012; Verlängerung des Verbots des Inverkehrbringens von gentechnisch verändertem Raps aus der Ölrapslinie Ms8, Rf3 und Ms8xRf3 in Österreich um drei Jahre, BGBl. II Nr. 317/2012).
On 28th April 2010 a national safeguard measure on GM potato EH92-527-1 was set into force (Verordnung über das Verbot des Inverkehrbringens gentechnisch veränderter Kartoffelerzeugnisse (Solanum tuberosum L. Linie EH92-527-1) zum Zweck des Anbaus in Österreich, BGBl. II Nr. 125/2010). Also this ban was reaffirmed by an Ordinance for another three years up to November 2015 (Verlängerung des Verbots des Inverkehrbringens gentechnisch veränderter Kartoffelerzeugnisse (Solanum tuberosum L. Linie EH92-527-1) zum Zweck des Anbaus in Österreich um drei Jahre, BGBl. II Nr. 339/2012).
The Ordinance on Labelling of products that contain GMOs (Gentechnik-Kennzeichnungsverordnung, BGBl. II Nr. 5/2006) prescribes a mandatory labelling for products that contain or consist of GMOs.
The Ordinance on GMO-Registers (Gentechnik-Registerverordnung BGBl. II Nr. 141/2006) prescribes the data that the "GMO-Register" (see below) has to contain and what kind of data the Federal Länder have to transmit to the Ministry of Health in case of cultivation of GMOs within their territory.
The "GMO-Register" (Gentechnikregister gemäß § 101c Abs. 1 und 2 GTG) continuously lists up those products that have been approved under Directive 90/220/EEC, Directive 2001/18/EC, EU Regulation (No) 258/97 and EU Regulation 1829/2003/EC. Further more data of deliberate releases and/or cultivation of GMOs would be made publically available (at the moment in Austria not relevant).
The Ordinance on Genetically Modified Seed (Saatgut-Gentechnik-Verordnung, BGBl. II Nr. 478/2001) has been passed by the Minister for Agriculture and prescribes a mandatory labelling for all genetically modified seed varieties covered by Directive 90/220/EEC. Furthermore the ordinance sets up thresholds for accidental contamination of conventional seed with genetically modified seed.
The Ordinance on Arable Land for the Production of Seed (Saatgut-Anbaugebiete-Verordnung BGBl. II Nr. 128/2005) has been passed by the Minister for Agriculture and prescribes that contained areas for the production of seeds (determined list) have to be defined to ensure the quality of seed.
The Ordinance on Thresholds of certain Genetically Modified Organisms in Feed (Futtermittel-GVO-Schwellenwert-Verordnung BGBl. II Nr. 394/2001) sets up a threshold of 1 % for accidental or technically unavoidable contamination of feed with GMOs.
Another Ordinance passed by the Minister for Agriculture (AEV Gentechnik BGBl. II Nr. 350/1997) regulates a limitation for emissions in waste water resulting from work with GMOs in containment.
The Ordinance on the Protection of Employees against Hazards caused by Biological Agents (Verordnung biologische Arbeitsstoffe -VbA BGBl. II Nr. 237/1998) has been passed by the Minister for Labour, Health and Social Affairs in 1998. It prescribes measures to be taken to avoid risks and dangers for employees resulting from work with biological agents such as equipment, hygiene, handling of agents, reduction of exposure, vaccination of employees etc. An annex contains a classification of organisms.
Eight of nine Federal Länder of Austria enacted special laws to ensure coexistence in their territory and the safety of fauna and flora. The Land Vorarlberg covers these aspects in their law on nature protection (Gentechnik-Vorsorgegesetze der Länder)
The chapters of the "Book of Genetechnology" (Gentechnikbuch gemäß § 99 GTG) are resolved upon by the Advisory Board on Gene Technology and document the present "state of the art" in the field of biotechnology and genetic engineering taking into account the pace at which modern biotechnology is advancing. The book has the legal status of an objectified expert opinion. If necessary chapters of the book can be published as an ordinance and thus enter into force like a law.
The first chapter deals with requirements for laboratories and hospitals where gene analysis is carried out and was published in 1998; in 2008 this chapter has been completely revised. The second chapter was published in 2002 and deals with genetic counselling; it is currently under revision. The third chapter was published in 2005, contains a list of risk assessed bacteria for activities in contained use facilities and updated in 2007, covering also viruses, fungi and parasites. In 2006 a fourth chapter has been added, containing a checklist for the inspection of facilities for molecular genetic testing on humans. It contains a list of criteria (technique, equipment, location, staff, quality controll, data protection etc.) that are obligatory for institutions offering genetic analysis. Regular inspections of laboratories by the competent authority are carried out according to this list. Shortcomings have to be improved in order to keep the institution's approval.
The "Codex Alimentarius Austriacus" (Österreichisches Lebensmittelbuch) contains a guidance about the definition of "GMO-free" products. (Codexrichtlinie zur Definition der "Gentechnikfreiheit") This guidance applies for foodstuffs that are labelled as "without use of gene technology".