Geac

Genetic engineering approval committee

1. TOPIC GEAC – GENETIC ENGINEERING APPRAISAL COMMITTEE SUBMITTED BY - GAURAV REG. No. – H2018-111-M SUBMITTED TO - DR. D.K. Mehta Dept. of Seed science and Technology

2. Indian Seed Industry Status According to the report, the Indian seeds market reached a value of US$ 3.6 Billion in 2017, exhibiting a CAGR compound annual growth of around 17% during 2010-2017. Indian seeds market is further expected to grow at a CAGR of 14.3% during 2018-2023, reaching a value of more than US$ 8 Billion by 2023.

3. What is Genetic Engineering ? Genetic engineering , the artificial manipulation, modification, and recombination of  DNA  or other  nucleic acid  molecules in order to modify an organism or population of organisms. Genetic engineering is used by scientists to enhance or modify the characteristics of an individual organism.

4. GM technology adoption has reduced pesticide use by 37%, increased crop yield by 22%, and increased farmer profits by 68% (“A Meta-Analysis of the Impacts of Genetically Modified Crops”, published in  PLOS One  by Wilhelm Klümper and Matin Qaim in 2014

5. GMO Scenario In India Bt cotton yield was hovering around 300 kg/ha at the time of introduction of Bt cotton (2002) have increased to an average of over 500 kg/ha, converting India from a cotton-importing country to the largest exporter of raw cotton. There was a small dip for a couple of years and the yield has now increased to over 550 kg/ha.

6. CONT . The GEAC cleared Bt brinjal for commercialization on 14 October 2009. Following concerns raised by scientists, farmers and anti-GMO activists, the GOI officially announced on 9 February 2010 that it needed more time before releasing Bt brinjal, Indian Environment Minister Jairam Ramesh saying that there is no overriding urgency to introduce Bt brinjal in India "until we arrive at a political, scientific and societal consensus”.

7. Why No Genetic Engineering Genetic engineering creates dangerous side effects. GMOs can harm the environment and can cause loss of diversity. Genetic engineering creates dangerous side effects by producing toxins, allergens, and in some cases carcinogens.

8. Role of regulatory bodies A regulatory agency is an government body that is created by legislature to implant and enforce law. Regulatory authorities are commonly set up to enforce safety and standards, and/or to protect consumers in markets where there is a lack of effective competition or the potential for the undue exercise of market power.

9. GEAC . . It is the organization engaged in the assessment of activities that involve the large-scale usage of hazardous microorganisms and recombinants in industrial production as well as research from an environmental point of view. Its mandate is to ensure that only safe and environmentally harmless activities are done. The organization also appraises proposals related to the release of genetically engineered organisms and products into the environment, including experimental field trials.

10. Regulatory bodies around the world GM crops cannot be grown, either for experiments or commercial farming, without approval by the appropriate regulatory agency, in the UK by DEFRA Department for Environment, Food and Rural Affair. All applications to develop a GM crop within the EU are assessed by the European Food Safety Authority (EFSA) In USA department like FDA, EPA and USDA Mostly around the world GMOs are regulated pursuant to health, safety, and environmental legislation governing conventional products .

11. Applicants form for submitting application to GEAC Application for confined field trials. Application for environment approval of clinical trials/ Pharmaceutical/ veterinary drugs derived from LMO/ Hazardous microorganisms. Application for Environmental Approval of Transgenic Plants (Genetically Modified Plants.) Application for import of food as living modified organism LMO/ per se food / feed / processing. Application for import of processed food/ products derived from living modified organism(LMO) and GMO

12. Approval process for commercial release of GM crops Initially, the company developing the GM crop undertakes several biosafety assessments including, environmental, food, and feed safety assessments in containment. This is followed by Bio-safety Research Trials which require prior approval of the regulators, the GEAC and the (RCGM) Review Committee on Genetic Manipulation. Approval for environmental release is accorded by the GEAC after considering the findings of bio-safety studies. Finally, commercial release is permitted only for those GM crops found to be safe for humans and the environment .

13. Cont . Standing Committee recommended that all research and development activities on transgenic crops be carried out only in containment (in laboratories) and that ongoing field trials in all states be discontinued

14. Composition The Genetic Engineering Appraisal Committee (GEAC) was constituted under the Ministry of Environment, Forest and Climate Change ( MoEFCC ) as the apex body under the ‘Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989’ in accordance with the EPA, 1986 The ministry’s Special Secretary/Additional Secretary is the Chairman of the GEAC. It is co-chaired by a representative of the Department of Biotechnology.

15. Currently, the GEAC has twenty-four members and meets once every month to carry out its prescribed activities. Expert members : Director General of (ICAR) Indian Council of Agricultural Research, Director General of (ICMR) Indian Council of Medical Research, Director General of Council of Scientific and Industrial Research, Director General of Health Services, Plant Protection Adviser, Directorate of Plant Protection, Quarantine and storage, Chairman, Central Pollution Control Board and three outside experts in individual capacity.

16. Genetic Engineering Appraisal Committee Functions To appraise activities involving the large-scale use of hazardous microorganisms and recombinants in research and industrial production from the environmental angle. To appraise proposals relating to release of genetically engineered organisms and products into the environment including experimental field trials. The committee or any persons authorized by it has powers to take punitive action under the Environment Protection Act.

17. Biosafety capacity building initiatives in India The four thrust areas of the project under which several activities have been implemented are: Risk Assessment and Risk Management (RARM), Handling, Transport, Packaging and Identification (HTPI) of LMOs, Socio-Economic Considerations (SECs) Public Awareness (PA) - Release of biosafety publication on international biodiversity day. State biosafety capacity building workshops.

18. Cont. GEAC meets on second Wednesday of every month to consider various application and policy issues. The date and agenda of next meeting can be accessed through the website. Participation at Conference Of Parties(COP) –(MOP) Meeting of parties

19. Criteria's for standard safety tests: Study of the introduced DNA and the new proteins or metabolites that it produces. Analysis of the chemical composition of the relevant plant parts , measuring nutrients, anti-nutrients as well as any natural toxins or known allergens. Assess the risk of gene transfer from the food to microorganisms in the human gut . Estimate how much of a normal diet the food will make up; Estimate any toxicological or nutritional problems revealed by this data in light of data on equivalent foods; Additional animal toxicity tests if there is the possibility that the food might pose a risk.

20. Recent incident of unauthorized GM production in India Cultivation of Herbicide tolerant ( Ht ) soybean was found in Gujarat a few years ago. Subsequently, complaints were filed. Andhra Pradesh government cancelled licences of some seed companies for their role in distribution of unapproved herbicide  tolerant (HT) cotton seeds, the Telangana 

21. Bt brinjal has been developed by Mahyco - Monsanto Biotech and found to be grown by by farmers in Haryana against which complaint have been field in the Genetic Engineering Appraisal Committee (GEAC) These activists demanded "criminal proceedings" be initiated against the responsible for the distribution of GM seeds.

22. The resumption of GEAC meetings is a welcome move for the Rs 10,000 crore seed industry in India which has been waiting for the field trials for their newly developed GM crops with different traits like drought resistance, salt tolerance and others for the past two years. The private sector has invested more than Rs 1,000 crore on research and claimed it was incurring losses due to no progress in GEAC .

23. THANK YOU