As participants in the iGEM Competition, we have come to accept the ability to modify genes as an obvious fact, one that does not require much reflection on our end. At the same time, whilst we understand such possibility is granted to us by law, not many realise the extent to which law may incentivise, guide, shape and, at times, limit our efforts. It originates from politics, creates institutional procedures, gives life to new businesses, dictates the pace of scientific progress, and affects consumer choices. In this, law reflects the perceptions of its creators while its creators reflect diversity of the country’s citizens. In this, law is diverse.
In this collaboration, we aimed at creating a document that would illustrate that very depth and diversity of law. For this reason, the first issue we discussed is law-related politics, the second, its bureaucracy, thirdly, law’s impact on business, fourth, on science and finally on consumer behaviour. Willing to gain an even deeper understanding of GMM legislations, we have invited teams 15 from different countries to participate in these collaborative efforts. In the end, the final document has been created by 137 iGEMers from 10 teams, 10 countries, 7 different iGEM tracks and 5 continents.
The institutional bodies that enforce the laws regarding the use of GMMs differ a lot across the world. In many countries in Asia (Japan, Indonesia, and Korea) and Canada, ministries and departments are responsible for enforcing the laws of GMMs. The kinds of ministries enforcing the laws as well as their numbers vary from country to country, but usually, the large organizations are in charge.
On the other hand, countries like India, Brazil, the United States, and Australia have more specialized committees or institutions of biotechnology and biosafety and these committees are responsible for enforcing the laws.
In the European Union, the European Commission is responsible for enforcing the GMO laws to be followed by all member countries. Chile doesn’t have a clear regulation for biotechnology but has responsible institutions when commercing or trading.
We can distinguish two different administrative ways in which countries decided to regulate the use of GMMs. One way government regulate GMMs is by establishing a special, often non-governmental, organization, which usually also acts as an information center in the field of synthetic biology. The other way involves assigning conventional ministries to regulate the use of GMMs in their respective fields.
The European Union, Australia, and Indonesia belong to the first group. For example, in Australia, Gene Technology Regulator Advisory Committee takes charge of making decisions on products’ approval. Competent authorities in the European Union and The Biosafety Commission and The Technical Team for Biosafety in Indonesia have similar roles.
Brazil, Canada, Chile, Korea, India, Japan and the US belong to the second group, where conventional ministries are responsible for their respective fields. Even though the names of these ministries might differ amongst the countries, it seems to be a more prevalent way to regulate GMO. Additional information centers might be present to help the ministries make decisions, nonetheless.
The legal requirements in the European Union, Australia, Brazil, Japan, Indonesia, and India are very similar. All uses of GMOs require risk assessments to be run before the start of the production. The exact procedures related to obtaining permissions to use GMOs in the production vary, however, according to the target use of the final products or the way the GMOs are handled in the production process. As a general rule, products related to human health as well as those used as food or feed have to follow stricter GMO procedures, such as obtaining approvals from several ministries or labeling your final products in a prescribed manner. Environmental release of GMOs is also given serious attention although the procedures are not as tight, just as in the case of contained GMO use. Usually, the target use also dictates which Ministry will be responsible for the evaluation and approval of the planned GMO use. These could include Ministries of Agriculture, Health, Food, Fisheries, Forestry, Environment and much more.
In Korea, the procedure is also similar but it requires a payment of an examination fee that costs 4000 dollars. In the USA, GMO plants are considered equivalent to non-GMO plants and do not require much further approval; only if the plant expresses a protein that is significantly different from any protein originally expressed, will a respective institution be required to approve of such use. In Chile, on the other hand, it is forbidden to commercialize GMOs as only seed exportation is allowed.
It can be noticed all countries participating in this collaboration, share the standard protocols of good practices in a laboratory, which includes the following:
• Reduce the risk of manipulation to the maximum.
• Identify the level of risk.
• Use of necessary safety equipment for each activity.
• Maintain the necessary information and supervision with trained personnel.
• Maintain an infection prevention protocol and equipment in case of emergency.
• Good hygiene of workers.
• Special conditions and restrictions on air circulation.
• Waste disposal protocols, among others.
In the United States, Australia, Brazil and Indonesia, these protocols for the manipulation of biological agents are all that is required to protect the workers involved. On the other hand, the European Union, Japan, and India also require medical records of all workers exposed to biological agents to be kept for a specified period of time. Japan additionally requires the employers to hold medical check-ups every 6 months for the exposed workers. The legislation of EU, Korea, Canada, Chile and India group biological agents according to the risk they might create. These groups, in turn, determine what safety measures are to be taken in each case.
In Korea, Canada and Chile, the facilities must also be located in an isolated or secluded location. Chile only requires it for biosafety levels 3 and 4. Finally, Korea and India require the existence of a decontamination room between the work area and the outside.
The legal requirements for disclosing GMOs within the food and other products differ across the world. Some countries within the Americas have little to no laws in place regarding GMO labeling. In the USA, there are no official obligations for companies to label any products containing GMOs. The same applies to Canada unless the food is likely to pose a health or safety risk to consumers, in which case full disclosure of GMOs is mandatory. The Brazilian government, which has until now required companies to label transgenic products with a T symbol, is (as of 2017) currently considering removing this law. Chilean government might be a notable exception as it prohibits the introduction into the market of any products containing GMOs.
In contrast, most of Europe, Asia and Oceania have strict guidelines surrounding labeling of GMO products. The European Union, Australia, India, and Indonesia all require the packaging of such products to be bear the label “this product contains genetically modified organisms”, although exceptions do exist in the form of medical products (in the European Union) and foods produced by animals fed with GMO foods (in Australia). Japan and Korea follow a percentage scale, with GMO labeling required if a product contains more than 5% and 1% genetically-modified ingredients respectively.
The documents related to GMM concern a wide range of issues like Manufacturing, Transportation, Safety, Environment, Health, etc.
When it comes to Biosafety, places like European Union, Australia, Brazil, Japan, Korea, India, and Indonesia clearly have got laws and regulations concerning biosafety and documents are supposed to be submitted in this regard. US and Canada do not seem to have any separate regulation regarding biosafety. However, in the US, Coordinated Framework for Regulation of Biotechnology (1986) ensures the safety of the public.
For GMMs products (food, drugs, cosmetics etc.), places like the European Union, United state, India, and Canada have a policy and law for the use and regulation of GMM products. To use GMM products in these countries, the government formalities should be done before use, as stated in their laws and policies. In Brazil, there is a registry for biological products. In Japan and Korea, there is no such law for GMM products. In Indonesia, supplementary documents must be submitted to use GMM biological foods and products. In Australia, there is no such law for GMM products.
In terms of international trade (export, import), countries like the United States, India, and Korea have clear laws detailing the procedures. They have taken permission and submission of documents to the law regarding this export and import of GMM uses. In European countries, these directly come under the laws of regulations of GMMs. There seem to be no specific laws regulating international GMM trade in Australia, Japan, Korea and Canada.
The most important documents related to GMMs are concerned with biosafety, food, trade and production processes. In places such as India, European Union, United States, Brazil, Japan, Canada, there are many different laws regulating each of these issues. On the other hand, Korea, Indonesia, and Australia have only one or two laws governing all these issues.
Discussion
As a final comment, we wanted to reflect on the principles standing behind any GMM related legislation: ensuring citizens’ safety. As any scientific field, synthetic biology makes enormous contributions to the development of a more sustainable future. iGEM teams alone have created numerous projects, thus helping solve environmental, medical and nutritional problems. When left unchecked, however, gene modification may interfere with natural biodiversity and lead to irreversible outcomes. Government’s laissez-faire approach to the field of synthetic biology is, therefore, hardly ever seen. Yet the crux of the matter seems to be finding the golden mean as banning GMOs altogether would not necessarily make the world a safer place.
