Difference between revisions of "Team:IIT Delhi/GMM legislation"
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| − | <button class="accordion back2" style="font-weight: bold;"> | + | <button class="accordion back2" style="font-weight: bold;">2. Who regulates the use of GMMs on a case-by-case basis?</button> |
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| − | <h2 id="pfont1"> | + | <h2 id="pfont1"> 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. <br> |
| + | |||
| + | 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. <br> | ||
| + | |||
| + | 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. | ||
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| − | <button class="accordion back3" style="font-weight: bold;"> | + | <button class="accordion back3" style="font-weight: bold;">3. What legal requirements do I have to fulfill in order to be able to use GMMs in my business?</button> |
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| − | <h2 id="pfont1"> | + | <h2 id="pfont1"> 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. <br> |
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| − | + | 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. | |
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| − | <button class="accordion back4" style="font-weight: bold;"> | + | <button class="accordion back4" style="font-weight: bold;">4. As an employer who exposes their workers to biological agents, what safety measures am I obliged to adopt?</button> |
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| − | <h2 id="pfont1"> | + | <h2 id="pfont1">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. | |
| + | |||
</h2> | </h2> | ||
Revision as of 18:22, 30 October 2017
SUMMARY
The credits for accomplishment of this project goes to the dedication, commitment and enthusiasm shown by a large number of people and parties from multiple disciplines. It gives us immense pleasure and gratification to acknowledge their support and assistance towards the execution of the project.
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.
Mr.Balbir Singh
Mr. Balbir is the lab-in-charge at Laser and 3-D Printing Lab at IIT Delhi. He provided us with access to his lab and was pivotal to the laser-etching which was used in the Microfluidic Chamber. Epilog LASER FUSION M2™, used for laser etching, was managed by him as well.
We would like to express our special gratitude towards iGEM Glasgow team for providing the biological parts ( pPhlF, RBS+PhlF + T, pSrpR, RBS + SrpR + T).
Mr. Lavlesh Bhanot
Mr. Lavlesh Bhanot is the Course Manager of Professional Ethics and Social Responsibility (PESR) committee IIT Delhi. He helped us in conducting the workshop under the course of Ethics and Social Responsibility. We thank him for his interest and assistance.
Mrs. Charu Maini
Mrs. Charu Maini is the Principal of DAV Public School, Sector 48,49, she played a significant role in spreading our message to other schools in Delhi. We thank her for the assistance.
Mr. Tarun Gulyami
Mr. Tarun Gulyami is the Head of Biology Department, DAV Public School, Sector 14, he showed his keen interest towards the workshop conducted and was interested to send India’s first High School team at iGEM. We appreciate his support and enthusiasm.
We would also like to thank Prof. Sangeeta Kohli (Department of Mechanical Engineering)
And Prof. P. V. Madhusudhan Rao (Mechanical Engineering Department) for their support to conduct human practices at Institute level.
Mr. Sunil, General Accountant, Prompt Enterprises has given tremendous amount of his time towards the formalities and documentation of the funding from Prompt Enterprises.
Prompt enterprises Pvt Ltd.
Without the support of our title sponsor ‘Prompt enterprises pvt ltd’ it wouldn’t have been possible to carry out our financial requirement whether it is for the lab resources or fees or travelling expenses.
Snapgene
We would also like to express our gratitude towards Snapgene for providing us access to the software. It turned out to be of immense use for designing the biological parts.
We thank our previous sponsors for their valuable support:
Mahindra, Coding Blocks, DHL, Medanta, Woodland, Department of Biotechnology (DBT), Govt. of India.
Wetlab
Kshitij Rai, Saksham Sharma, Abhilash Patel, Pulkit Srivastava, Sashi Kalan, Pratyush Maini, Divya Choudhary, Siddhesh Gandhi.
Computational Modelling
Abhilash Patel, Tarun Mahajan, Kshitij Rai, Pulkit Srivastava, Shreya Johri.
Human Practices
Milind Zode, Tanuj Garg, Kshitij Rai, Pulkit Srivastava, Ishank Pahwa, Nipun Gupta.
Wiki Development
Pratyush Maini, Divya Choudhary.
Creative, Design and Content Development
Divya Choudhary, Pratyush Maini, Kshitij Rai, Varuni Sarwal, Preeti Raj, Abhishek Kumar, Shreya Johri, Tanuj Garg, Milind Zode.
Marketing
Tanuj Garg, Nipun Gupta, Ishank Pahwa, Pratyush Maini, Divya Choudhary, Pulkit Srivastava, Sashi Kalan, Milind Zode.
We would like to thank our institute
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