Risk assessment

Briefing - December 2015

Inherent risks and the need to regulate

Over the last 5-10 years there have been rapid developments in genetic engineering techniques (genetic modification). Along with these has come the increasing ability to make deeper and more complex changes in the genetic makeup and metabolic pathways of living organisms. This has led to the emergence of two new fields of genetic engineering that overlap with each other: synthetic biology and the so-called New Breeding Techniques (NBTs).

Article - August 2015

We owe a deep debt of gratitude to Dr Frances Kelsey, write Helena Paul & Philip Bereano. In 1960, she defied her bosses at the FDA to prevent the licensing of thalidomide in the USA, saving thousands from being born with serious deformities. Her tough approach to minimising the risk from new drugs contains lessons we ignore at our peril.

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Open Letter - January 2015

Open letter to the Commission on new genetic engineering methods

In the interest of protecting the environment and public health, genetically modified crops are subject to risk assessment, an authorisation process and labelling rules under EU law. All non-traditional breeding processes that change the structure of DNA using genetic engineering technologies or interfere with gene regulation fall within the scope of these GM regulations. Some are now calling on the European Commission to exempt new genetic engineering techniques from GM rules. The undersigned groups argue that such an exception could threaten the environment and our health, and would violate EU law.

Article - May 2011

The UK Nuffield Council on Bioethics proposes five ethical principles and a duty to develop biofuels instead of the Precautionary Principle

The Precautionary Principle advises society to be cautious about a technology or practice where there is scientific uncertainty, ignorance, gaps in knowledge or the likelihood of outcomes we did not predict or intend. It runs counter to the optimistic notion that any negative impacts from a technology can be addressed and may provide an opportunity to develop new solutions, so contributing to economic growth. The US Chamber of Commerce dislikes the precautionary approach and prefers: “the use of sound science, cost-benefit analysis, and risk assessment when assessing a particular regulatory issue.” Its strategy is therefore to: “Oppose the domestic and international adoption of the precautionary principle as a basis for regulatory decision making.”

Report - May 2008

An overview of risk assessment and risk management issues

Trees differ in a number of important characteristics from field crops, and these characteristics are also relevant for any risk assessment of genetically engineered (GE) trees. A review of the scientific literature shows that due to the complexity of trees as organisms with large habitats and numerous interactions, currently no meaningful and sufficient risk assessment of GE trees is possible, and that especially a trait-specific risk assessment is not appropriate. Both scientific literature and in-field experience show that contamination by and dispersal of GE trees will take place. Transgenic sterility is not an option to avoid the potential impacts posed by GE trees and their spread. Regulation of trees on a national level will not be sufficient because due to the large-scale dispersion of reproductive plant material, GE trees are likely to cross national borders. All this makes GE trees a compelling case for the application of the precautionary principle.