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 specialied 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, organisation, which usually also acts as an information centre 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 centres 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 labelling your final products in a predescribed 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 many more.

In Korea, the procedure is also similar but it requires a payment of a 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 express 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 commercialise 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:

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 legislations 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 food and other products differ across the world. Some countries within the Americas have little to no laws in place regarding GMO labelling. 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 labelling 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 labelling 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.

1. What institutional body enforces the laws regarding the use of GMMs?

• European Union

  European Commission is the institution responsible for proposing and implementing legislations applying to all member countries. Member countries may additionally restrict or prohibit the cultivation of GMMs in their territory. This possibility, however, is regulated by Directive (EU) 2015/412 adopted by the EU.

• United States

  Stemming from research from the University of Virginia and EMBO, the J. Craig Ventor Policy Center Team has concluded that the United States lack an agency that specifically focuses on enforcing laws regarding GMMs. Instead, legislation such as the Coordinated Framework for Regulation of Biotechnology and the President's Commission for studying Bio-ethical issues, which was established by Barack Obama. As of now, the regulatory agency with the most regulatory control on issues regarding synthetic biology is the United States Department of Agriculture (USDA).

• Australia

  In Australia, the use of GMMs is regulated under a nationwide legislative framework consisting of two main branches: the Gene Technology Regulator and Food Standards Australia New Zealand (FSANZ). Individual states and territories also have their own legislation in accordance with this framework.

• Brazil

  In Brazil, the Biosafety Law (Law 11105/05) sets the safety rules and fiscalisation of GMMs and its derivatives in the national territory. The National Technical Committee of Biosafety (CTNBio) is responsible for enforcing the laws and setting the rules for the construction, experimentation, cultivation, manipulation, transport, commercialization, consumption, release and discarding of GMMs and its derivatives.

• Japan

  In Japan, mainly Ministry of Agriculture, Forestry and Fisheries and Ministry of the Environment is responsible for the use of GMMs. With these ministries at the core, other institutions such as Ministry of Education, Culture, Sports, Science and Technology, Ministry of Health Labour and Welfare are also responsible for GMMs in each related field.

• Chile

  Chile doesn’t have a clear regulation for biotechnology. However, the Agricultural and Livestock Service is responsible for the importation, sowing and propagation of GMOs, also regulating the exportation of seeds (Law N° 3.557/82 actualised Law N°1523/2001). The Ministry of Health, on the other hand, regulates the labelling of food made with the use of GMOs (Article 107).

• Indonesia

  The laws regarding the use of GMMs are regulated by 4 ministries: The Ministry of Agriculture, The Ministry of Forestry and Plantation, The Ministry of Health, and The Ministry of Food and Horticulture. They created the Government Regulation of the Republic of Indonesia Number 21 year of 2005 (PP No. 21/2005) on Biosafety of GMO.

• Korea

  The usage of the GMMs in Korea is strictly regulated by the GMO Law, established on Jan 28, 2001. The Ministry of Trade, Industry and Energy takes charge of this law.

• India

  India is currently undergoing a massive overhaul in their laws and regulations regarding GMOs. Currently, there is a proposed “Regulations and guidelines on biosafety of recombinant DNA research and biocontainment, 2017’ draft that has been prepared and opened for comments. Currently, under the proposal, the following 6 bodies are in charge of enforcing laws regarding GMOs and GMMs:

  1. Recombinant DNA Advisory Committee (RDAC) - Advisory
  2. Institutional Biosafety Committee (IBSC) - Regulatory/ Approval
  3. Review Committee on Genetic Manipulation (RCGM) - Regulatory/ Approval
  4. Genetic Engineering Appraisal Committee (GEAC) - Regulatory/ Approval
  5. State Biotechnology Coordination Committee (SBCC) - Regulatory/ Approval
  6. Monitoring District Level Committee (DLC) - Monitoring

2. Who regulates the use of GMMs on a case-by-case basis?

• European Union

  sahndsfas

• United States

  hjjljkl