THIRD WORLD NETWORK BIOSAFETY INFORMATION SERVICE
Dear Friends and Colleagues
Consumers Call for Regulation of New Genetic Engineering Techniques
New genetic engineering (GE) techniques have been developed which were not in existence when current laws on genetically modified organisms (GMOs) were drafted. The Trans Atlantic Consumer Dialogue (TACD) has published a new resolution on consumer concerns about these new GE techniquesand makes recommendations to the EU and US authorities for a framework that guarantees the adequate protection of consumers.
The resolution cites that all the new GE techniques produce GMOs, which are products of “modern biotechnology” as defined by Codex Alimentarius Principles, and they should therefore be regulated as such. This means that countries could require safety assessments and labelling of food derived from these new GE techniques without these being considered as non-tariff trade barriers with reference to the WTO.
The resolution also cites the risks to human health and the environment. For example, GE crops produced using these new GE techniques might produce toxins, allergens or altered nutrients that could harm human health. The resolution therefore calls for risks to human health, animal welfare and the environment to be assessed before products derived from new GE techniques are placed on the market or released into the environment. In particular, there should be mandatory pre-market human health evaluation that will screen all foods produced using new GE techniques for potential hazards.
The resolution explains that although the choice of whether to eat or not to eat GE foods should remain with consumers, this right to choose can be undermined by the mixing of GE products with conventional non-GE products, as a result of commercial production or field trials. Therefore, it is fundamental to ensure traceability through the segregation of GE products – including those produced using new GE techniques – from traditional products. The right to choose also requires non-GE supplies of crops and animals to be maintained and GE products to be labelled as such.
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Malaysia
Email: twn@twnetwork.org
Websites: https://biosafety-info.net/and http://www.twn.my/
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RESOLUTION ON CONSUMER CONCERNS ABOUT NEW GENETIC ENGINEERING TECHNIQUES
Trans Atlantic Consumer Dialogue (TACD)
Doc No: FOOD 39/16
http://tacd.org/wp-content/uploads/2016/09/TACD-Resolution-new-genetic-engineering-techniques_with-appendix_7-September.pdf
Introduction
This resolution builds on TACD’s February 2000 Resolution: Consumer Concerns about Biotechnology and Genetically Modified Organisms (GMOs), by considering the implications of new genetic engineering techniques for TACD’s existing recommendations in this area. TACD considers that new genetic engineering techniques will create genetically modified organisms (GMOs) that require risk assessments and labelling, consistent with the aforementioned TACD February 2000 Resolution, and more recent resolutions regarding international trade of products of modern biotechnology. Risks to human health, animal welfare and the environment must be assessed before products derived from these new techniques are placed on the market or released into the environment. Products must also be labelled in accordance with consumers’ rights to know and choose what they are buying, including what they eat.
Recommendations
TACD urges the EU and US governments to:
· Regulate products of new genetic engineering techniques as genetically modified organisms (GMOs);
· Strengthen regulatory systems to include mandatory pre-market human health evaluation that will screen all foods produced using new genetic engineering techniques for potential hazards;
· Develop strong systems of pre-market environmental safety evaluation and post-market monitoring;
· Fully consider the welfare of animals altered using new genetic engineering techniques prior to approval;
· Adopt mandatory labelling rules for all food produced using new genetic engineering techniques;
· Adopt and enforce strict rules for corporate liability and mandatory insurance for companies that want to release organisms altered using new genetic engineering techniques into the environment;
· Establish and maintain systems to ensure that identity-preserved supplies of non-genetically-engineered ingredients remain available.
New genetic engineering techniques
Currently, genetically modified organisms (GMOs) are mainly plants grown as commodity crops, for use in human food, animal feed, clothing (cotton) and biofuels, although a genetically engineered salmon has been approved in both the US and Canada.
Genetic engineering involves altering the genetic material of organisms using artificial laboratory techniques. Genes, which are made up of the chemical known as DNA, act as instructions to make molecules called proteins or to produce non-coding RNAs. Changing the genes of a plant or animal can change its properties or traits e.g. how it responds to disease, pesticide products or lack of water.
There are currently two main methods that are used to genetically modify plants that are available commercially: altered DNA is inserted using a bacterium that has the ability to infect plants and insert DNA into a plant’s genome; or minute gold, tungsten, or silver particles are coated with the new DNA and fired into plants’ cells. More recently, many new methods have been developed to change the DNA of plants and animals, so they have new traits. Collectively many of these new genetic engineering techniques are referred to as “gene editing,” Gene editing will not be used only for crops but also for trees, farm animals, fish and insects with a wide range of new properties.
New genetic engineering techniques still produce GMOs
Although the new laboratory methods used are different, all new genetic engineering techniques still produce genetically modified organisms (GMOs). These organisms have genetic material that has been altered in a laboratory to give them new properties or traits. The definition of “modern biotechnology” by the Codex Alimentarius Commission is instructive for understanding how to regulate the GMOs produced by the new techniques.
The Codex Alimentarius Commission is the food standards organisation of the United Nations, jointly run by the World Health Organisation (WHO) and the Food and Agriculture Organisation (FAO) of the United Nations. Its main goal is to protect the health of consumers and promote fair practices in international food trade. Codex Alimentarius standards, guidelines and codes of practice are recognised by the World Trade Organisation (WTO) as presumptively authoritative standards and guidelines for the resolution of disputes concerning food safety and consumer protection. Codex principles state that a pre-market risk assessment should be undertaken for all food derived from modern biotechnology. The Codex Principles use the following definition of modern biotechnology:
“Modern Biotechnology” means the application of:
i) In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or
ii) Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombinant barriers and that are not techniques used in traditional breeding and selection.
The term “in vitro nucleic acid techniques” means any technique that alters the genetic material of an organism (which consists of nucleic acids, e.g. DNA and RNA) in the laboratory. In vitro (meaning “in glass” in Latin) refers to the technique of performing a given procedure in a controlled environment outside of a living organism. The new genetic engineering techniques, e.g. RNAi or gene/genome editing technologies, invariably involve “in vitro nucleic acid techniques,” and so must be considered to be products of “modern biotechnology.” Given the Codex standards and guidelines are referenced by WTO, this means that countries could require safety assessments and labelling of food derived from these new genetic engineering techniques and such assessments would not automatically be considered as non-tariff trade barriers, e.g., such safety assessments would be considered trade legal.
There are currently 188 Codex Members, including the United States and the European Union (EU), which have agreed these standards.
EU law and GMOs
In the EU, GMOs produced using new genetic engineering techniques fall within the definition of GMOs used in current legislation and therefore should continue to be regulated under these laws. The basic laws governing GMOs in the EU are Directive 2001/18, Regulation 1829/2003 and Regulation 1830/2003. Whether an organism is regulated as a GMO or not is determined by Directive 2001/18, which defines a “genetically modified organism” on the basis of the process by which it has been created. According to the law, it is an “organism, with the exception of human beings, in which the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination” (Article 2.2).
This definition is legally and scientifically sound because it is the process of genetic engineering that invariably leads to both intended and unintended outcomes, including also unpredictable changes to the DNA and its functioning, which may compromise the final product’s health and environmental safety.
The EU Directive lists a number of processes as resulting in GMOs that fall under the EU definition. However, this list is explicitly open-ended (‘inter alia’) so that the Directive can be applied to technical developments in genetic engineering. One example of a GM process is the insertion of genetic material (e.g. stretches of nucleic acid such as RNA or DNA) prepared outside the organism (‘in vitro’) into a host organism, which causes an alteration of the organism’s own genetic make-up.
Importantly, it is only the characteristics of the process, not the characteristics of the resulting organism, which determine whether or not an organism is a GMO. In terms of determining whether an altered organism is a GMO, it is irrelevant whether the intended genetic alteration could, in theory, also arise from mutations that are induced by chemicals or radiation, or that occur spontaneously. It is also irrelevant whether the inserted genetic material originates from a crossable species, or whether such genetic material is present in the final product.
The Directive mentions two processes of genetic modification whose products are exempt from the scope of the law. These are mutagenesis and cell fusion between crossable organisms. However, these processes are only exempt “on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms”. This means that organisms whose genetic material has been altered using RNA or DNA sequences prepared outside the cell, or using GMOs, cannot be exempt from the law.
The exemptions are presented as a closed list. They encompass “certain techniques of genetic modification which have conventionally been used in a number of applications and have a long safety record” (Recital 17). None of the new techniques can claim to have such a “long safety record”. The list is part of the Directive, which specifies that the precautionary principle must be taken into account when interpreting it.
The EU Directive also applies to organisms that are derived from GMOs. This includes organisms produced through grafting on a GM rootstock, reverse breeding and some types of RNA directed DNA Methylation (RdDM). The functioning of these organisms could be impeded by compounds and metabolites of the GMO, giving rise to safety implications.
GMOs produced with new techniques continue to require risk assessments
New genetic engineering techniques will produce GMOs with properties which may pose risks to human health and the environment.
For example:
· New GM crops produced using new genetic engineering techniques might produce toxins, allergens or altered nutrients that could harm human health;
· Meat, milk or eggs from GM farm animals produced using new genetic engineering techniques, might also produce toxins, allergens or altered nutrients that could harm health;
· New GM plants intended to produce industrial chemicals or pharmaceuticals might inadvertently end up in the food chain.
Genetically modifying farm animals also raises concerns about animal welfare, including:
· A high failure rate for genetically engineered mammals often leads to many aborted, dead or deformed embryos;
· Genetically engineered animals may suffer as a result of the new genetically engineered trait e.g. if they are too heavy to walk easily, or over-produce milk;
· Herds or flocks of genetically engineered animals or birds may be more vulnerable to some diseases if they are all genetically similar;
· Genetic engineering technologies could be even more harmful as they may strive to push animals even further beyond their physiological limits.
These concerns also apply to GM animals produced using new genetic engineering techniques. It is highly troubling that such technologies will mainly be used to further intensify the livestock sector and will entrench the use of intensive animal farming systems with inherently poor welfare. New genetic engineering techniques have the potential to further damage the health and welfare of farm animals.
The long-term consequences of releasing GMOs into the environment are difficult to predict and the precautionary principle should be applied. For example:
· Genetically modified fish or insects may disperse long distances, including through human transport of their eggs. Ecosystems may be altered by releases of GM fish and insects in ways that are not easy to predict.
· Genetically modified trees have long life cycles and their pollen, seeds and vegetative material spreads over long distances;
· Genetically modified plants can spread through pollen or seeds and spread into new areas or cross with wild relatives.
In the EU, the open release of GMOs into the environment is regulated and all new products require risk assessments which consider the risks to the environment, animal welfare and human health. Similar risk assessments should be required for GMOs produced using new genetic engineering techniques, under the same legislation.
The World Trade Organisation’s Agreement on Sanitary and Phytosanitary measures (SPS Agreement) defines international standards, guidelines and recommendations for food safety as the standards, guidelines and recommendations established by the Codex Alimentarius Commission. This means that Codex has far reaching implications for resolving trade disputes. Although countries are not obliged to cite such standards, if a country’s regulations—such as those requiring safety assessments and labelling of food derived from these new genetic engineering techniques—are consistent with Codex, then such assessments would not automatically be considered as non-tariff trade barrier, provided other requirements were met, such as making assessments in a timely way.
Thus, a country that requires safety assessments of food produced using these new genetic engineering techniques could ban the import of such foods if they haven’t already been explicitly approved in the country of import. Thus, since there are no specific laws requiring GMOs to go through a food safety assessment in the United States and GMO plants in the US only go through a “Generally Recognised as Safe” process run by the companies themselves, food products produced using modern biotechnology, including gene edited products, may be banned from import into countries that do require such food safety assessments.
GMOs produced with new techniques must be labelled for consumers
Consumers have a fundamental right to know and choose what they are buying, including what they eat. Many consumers have concerns about the safety and nutritional content of GMOs, the welfare of GM farm animals, or about the environmental impacts of releasing GMOs into the environment.
Currently, there is a legal requirement for foods containing GMOs to be labelled in the EU. Foods containing GMOs produced using new genetic engineering techniques should also be labelled, under the same legislation that is used for existing GMOs. In the United States, state GMO labelling legislation has been passed in Vermont, Connecticut, Alaska and Maine and federal legislation has since been passed which will pre-empt such state laws and, although controversial, may require some form of GM labelling for some of the products of GMOs.
The choice of whether to eat or not to eat GM foods should remain with consumers, but this right to choose can be undermined by the mixing of GM products with conventional non-GM products, as a result of commercial production or field trials. Therefore, it is fundamental to ensure traceability through the segregation of GM products – including those produced using new genetic engineering techniques – from traditional products. If the manufacturer does not have full knowledge of the genetic status of the ingredients, the consumer’s right to be informed and right to choose will not be guaranteed.
The right to choose also requires non-GM supplies of crops and animals to be maintained and GM products to be labelled as such.