Aug 27, 2003

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New Genetic Engineering Act

Obstacles to plant genetic engineering

(27 August) An amended Genetic Engineering Act is intended to transpose into German law several new pieces of EU legislation that are already in force. The German ministry of consumer protection has now submitted a bill. A key aim of the legislation, as well as protecting against potential risks, is safeguarding coexistence. The cultivation of genetically modified crops is subjected to far-reaching rules and regulations.

A first preliminary draft from the Ministry for Consumer Protection, the leading ministry in genetic engineering issues, was made public as far back as the spring. The “trial balloon” was clearly criticised by the ministries concerned, particularly the ministries of economics, research and justice. Now, Germany’s Minister for Consumer Protection, Renate Künast, has presented a revised version. It remains to be seen whether it will receive a friendlier reception from the other departments, since Künast is once again tackling some hot potatoes.

Example: Liability

The existing liability regulations for the use of GMOs are to be widened. The idea is that a farmer who grows transgenic plants must compensate his neighbours for losses caused by transfer, mixing or other contamination. The neighbouring farmer shall be deemed to have incurred a loss if his harvest can no longer be sold without being labelled as containing GMOs or may no longer be used for its intended purpose.

A GMO user is deemed to be liable in principle, i.e. in case of doubt he is liable even if there is no concrete evidence of fault, unless he can demonstrate that he has fulfilled his obligation to take precautionary action. If there is more than one possible party at fault, they will be jointly liable.

Example: Coexistence

Anyone growing genetically modified crops must ensure that humans, animals, plants and the environment are “not significantly impaired” by the transfer of GMO traits, mixing or other contamination. In the view of the German Ministry of Consumer Protection, this would be the case, for instance, if the EU threshold value for labelling of 0.9 per cent were exceeded or if an organic farmer were no longer able to market his harvest as organic produce because of GMO contamination.

For farmers this will mean having to abide by new rules of good farming practice. These will include avoiding outcrossings to neighbouring properties and to wild plants, e.g. by observing minimum distances, choice of varieties, controlling volunteer plants and natural pollen barriers. Genetically modified products must be stored separately from conventional produce, and means of transport and containers must be cleaned. The Ministry of Consumer Protection intends to regulate further details of good farming practice in a regulation along with new provisions concerning the reliability and expert knowledge of users of genetic engineering.

Example: Freedom of choice

Freedom of choice and transparency for consumers come top of the agenda for Consumer Protection Minister Künast. The new Genetic Engineering Act is therefore expressly designed to safeguard non-GM production of food and feed.

Example: Public register

There is to be a public register with details of field trials and cultivation involving genetically modified plants. The plan is for every citizen to be able to find out online whether GMOs are being grown in his/her area, to what extent and what traits the plants exhibit.

Only those who can demonstrate a “legitimate interest” will be able to request the precise location of the plots concerned and the name of the genetic engineering user. The purpose of this is for organic farmers, for instance, to be able to find out where in their neighbourhood genetically modified plants are being grown. The consumer protection ministry had originally planned to make the precise locations available to everyone.

Example: Protection and promotion objectives

Alongside protective measures, the current Genetic Engineering Act of 1990 has the aim of creating clear, firm legal foundations for researching, developing, using and promoting genetic engineering. This promotional objective is to be removed in the amended Act. The sole purpose of the Act is to be “to make provisions for the protection of life and health of humans, the environment and its complex dynamics, of animals and plants and of material goods, against dangers and risks posed by genetic engineering methods and products”.

Behind schedule

The motive for the pending amendment to the Genetic Engineering Act is the European Deliberate Release Directive, which was supposed to be transposed in all member states of the European Union by 17 October 2002. This Directive regulates the deliberate release and placing on the market of GMOs and prescribes a higher standard of safety than the previous Directive of 1990. Germany is now almost a year behind schedule and infringement proceedings are pending. The new Genetic Engineering Act is therefore intended to transpose the provisions of the Deliberate Release Directive into German law:

• All consents to market GMOs will be restricted to ten years – with the possibility of an extension.
• The seller of a GMO is obliged to monitor the effects of the transgenic organism as part of a monitoring plan.
• The Genetic Engineering Act adopts the new EU labelling threshold for food and feed. Adventitious GMO presence of up to 0.9 per cent does not require labelling, provided the GMO in question is authorised.

New expert commissions

Since it is likely that in future there will be increasing numbers of applications for the release or placing on the market of GMOs and since relatively short processing and decision deadlines have been set at EU level, the Central Commission for Biological Safety (CCBS) is to be split into two. One expert commission is to be responsible for genetic engineering facilities and a second commission for deliberate releases and placing on the market.

Both bodies will come under the Federal Office of Consumer Protection and Food Safety (BVL). Their members, who will not be subject to instructions, are to be appointed by the consumer protection ministry for three years. The commissions will examine and assess safety-related issues, provide opinions on them and advise the federal government.

New allocation of responsibilities

In addition, the bill provides that the deliberate release of a GMO will be authorised only if, in compliance with the precautionary principle, all necessary safety precautions have been taken to minimise outcrossings.

In future, the authorising authority will be the Federal Office of Consumer Protection and Food Safety (BVL). For releases and placing on the market, the Federal Agency for Nature Conservation (BfN) must first give its agreement (consent), while the Robert Koch Institute, which has been the responsible organisation until now, and the Bundesinstitut für Risikobewertung (Federal institute for risk assessment) need only be consulted. The Federal Biological Research Centre for Agriculture and Forestry (BBA) and/or the Federal Research Centre for Viral Diseases of Animals must make a statement. In ecologically sensitive areas, the use of authorised genetically modified organisms in agriculture is to be permitted only if the nature conservation authority responsible approves.

Outcome uncertain

Consumer protection minister Künast’s bill marks the start of what is likely to be a long-winded legislative procedure riddled with conflict. Only once the ministries involved have come to an agreement will there be a government proposal passed by the cabinet, which can then go before the parliament for deliberation. At the moment it is impossible to predict when and in what form the new Act will eventually be agreed.