BioWorld International Correspondent
BRUSSELS, Belgium - European biotechnology officials are disappointed at the way the European Union has finalized new legislation on environmental liability. The new rules were adopted March 31, and they include measures that will impose additional controls on biotechnology.
Since the proposals emerged in January 2002 they have been hotly debated, not least by the European biotechnology sector, which was anxious that over-regulation might damage its interests.
The final text of the Environmental Liability Directive implements the "polluter pays principle." It will hold operators financially liable for remedying any environmental damage their activities cause. Actions related to the transport, use and release of genetically modified organisms would be dealt with under new controls aimed at operators who professionally conduct risky or potentially risky activities. Under that program, an operator could be held liable even if he has not committed any fault, although there are some provisions for exemption.
Some of the defenses potentially available are subject to tight conditions. Operators might be able to escape liability if they demonstrate that the damage was caused by activities or emissions expressly authorized by competent authorities and if they also can prove that they were not at fault or negligent. Exemptions also might apply if operators prove their activities or emissions were not considered likely to cause environmental damage according to the state of scientific and technical knowledge at the time the activity took place.
What that will mean for GMOs, according to a European Commission explanatory note issued the day after the legislation was adopted, is that "the directive will cover damage to protected species, natural habitats, water and soil [if the latter significantly risks causing harm to human health], if it has occurred during the contained use of GMOs, including their transport or during their deliberate release into the environment, including their placing on the market." But, in line with the general rule: "If the release of the GMO was specifically authorized or if it was not possible to anticipate the damaging effect on the basis of the state of scientific and technical knowledge at the time, and if the operator was not negligent, all of which the operator has to prove, the competent authorities can exempt him/her from liability. For example, an operator would be negligent and thus liable if s/he does not follow the instructions provided by the GMO manufacturer or the competent authority authorizing the release."
Personal injury and damage to goods and property from GMOs is not covered by the directive. Compensation for damage of that kind will continue to be governed by the civil liability systems at the national level. If GMOs destroy the crop of an organic farmer, he should be able to sue for compensation under the civil liability system in his country.
In the closing stages of the debate, the European biotechnology association, EuropaBio, had expressed "serious concerns" to the European Parliament that disallowing any defenses against environmental damage "would seriously undermine the legal certainty on which industry bases its business." Removing defenses puts the European economy at risk and punishes "companies that are investing to achieve the highest standards of safety and compliance and that upgrade their standards regularly." Operators "should not be held liable where they comply with their permit," it said.
Now that the debate is over, EuropaBio is adopting a philosophically resigned attitude to the limitations the legislation imposes on liability defenses. A spokesperson told BioWorld International that companies are optimistic that they will be able to live with the new rules, confident that their products and processes are not hazardous and will not create exposure to liability actions.
There is relief within the biotech sector that one of the earlier proposals - for a separate liability regime for biotechnology - has been dropped in the final version. EuropaBio had described the plan to create specific legislation on genetically modified organisms as discriminatory, unacceptable and unjustified, since GMOs already are subject to a strict EU legal framework. "We believe that the European biotech industry must take its responsibilities and comply with the European rules as do other European industries, but we are opposed to the setting in place of additional measures that clearly discriminate against the innovative biotechnology sector," it said as the debate reached its climax.
Center For Disease Prevention Approved
European Union ministers agreed Friday to create a new European Centre for Disease Prevention and Control, after a fast-track procedure sped the proposal through the EU in a record eight months.
The center should become operational in 2005, based in Stockholm, Sweden. It is in part a reaction to the outbreaks of severe acquired respiratory syndrome and bird flu.
"This new EU agency will enable Europe to be better prepared for future epidemics," said David Byrne, European commissioner for Health and Consumer Protection, as the ministers put their signature to the deal. The center will enable Europe to pool its disease-control expertise more effectively, allowing EU disease-outbreak investigation teams to be assembled quickly and efficiently.