Biosafety Policies and Laws PDF

National Biosafety Policies and Laws 1  CONTENTS What is the Need of Biosafety Regulation ??? Timeline of Biosafety Policy in India Recombinant DNA Safety Guidelines, 1990 Guidelines for Research in Transgenic Plants and Guideline...

National Biosafety Policies and Laws 1  CONTENTS What is the Need of Biosafety Regulation ??? Timeline of Biosafety Policy in India Recombinant DNA Safety Guidelines, 1990 Guidelines for Research in Transgenic Plants and Guidelines for evaluation of Transgenic Seeds, Plants and Plant Parts Guidelines for Generating Pre-clinical and Clinical Data for rDNA Vaccines, Diagnostics and Other Biologicals, 1999 Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants Guidelines and SOPs for Confined Field Trials of Regulated GE Plants PBT 510, BIOSAFETY, IPR & BIOETHICS 2 What is the Need of Biosafety Regulation ??? To Safeguard ourselves and Our Biological Resources PBT 510, BIOSAFETY, IPR & BIOETHICS 3  Careless Use of Agrochemicals Destruction of Potential Risk to killing non-target Natural Habitats human and Biological Entities and Environment due and Developing Mismanagement to Indiscriminate Resistance of Agricultural use of GMO’s and Against Targeted Input Resources their products. Organisms. PBT 510, BIOSAFETY, IPR & BIOETHICS 4 Timeline of Biosafety Policy in India Biological safety has not been, historically, a strong public policy thrust in Indian agriculture. PBT 510, BIOSAFETY, IPR & BIOETHICS 5  Under this act, the rules and The Ministry of Environment procedures for the manufacture, India’s first embrace of a & Forests had import, use, research and release formal national biosafety enacted Environment and of GMOs as well as products policy started with Protection Act in 1986 to made by the use of such emergence of rDNA provide for the protection and organisms were notified by agricultural and human MoEF through their Notification improvement of environment health technologies in the No. 621 in Official Gazette of and the related matters. 1980s Govt. of India on December 5, Nm 1989. PBT 510, BIOSAFETY, IPR & BIOETHICS 6  Drugs and Cosmetics 1.Revised Rules (8th Amendment), 1.Recombinant 1.Revised 1988 Guidelines for DNA Safety Guidelines for In India, all recombinant Research in Guidelines and Safety in products are considered Transgenic to be new products as Regulations Biotechnology Plants and per the current Drugs 1990 1994 and Cosmetics Rules. Guidelines 1998 PBT 510, BIOSAFETY, IPR & BIOETHICS 7  1.Guidelines For Generating Pre- 1.Guidelines for the clinical And Clinical Safety Assessment of Guidelines and SOPs 1.Protocols for Food Data For R-DNA Foods Derived from for Confined Field and Feed Safety Based Vaccines, Genetically Trials of Regulated Assessment of GE Diagnostics And Engineered Plants – GE Plants – 2008 crops – 2008 Other Biologicals, 2008 1999 PBT 510, BIOSAFETY, IPR & BIOETHICS 8  Recombinant DNA Safety Guidelines, 1990 (Revised in1994) Scope of guidelines Guidelines Mechanisms of implementation Checklist for laboratories PBT 510, BIOSAFETY, IPR & BIOETHICS 9  Scope of Guidelines Research involving GEO’s Research involving Genetic Transformation of green plants and animals Research in r-DNA technology for vaccine Development Large scale production and Deliberate/accidental release of organisms, plants, animals & products derived by r-DNA technology But the issues relating to Genetic Engineering of human embryos, use of embryos and foetuses in research and human germ line gene therapy are excluded from the scope of the guidelines. PBT 510, BIOSAFETY, IPR & BIOETHICS 10  Guide lines For research activities The guidelines employ the concept of physical The guidelines have been classified into 3 and biological containment and the principle categories. of good laboratory practices Based on the level of the associated risk, The term "Containment" is used to describe requirement for the approval of competent the safe methods for managing infectious authority is envisaged. agents in the laboratory environment where they are being handled or maintained. Category I: Exempt category (Self cloning Types of containment experiments) 1. Biological containment (BC) Category II: intimation to competent authorities (experiments involving non- 2. Physical Containment (PC) pathogenic DNA vector systems) And 4 Bio-safety levels have been made with Category III: Review and approval of Good laboratory practice guidelines competent authority (Toxin gene cloning, antibiotic resistant gene etc.) PBT 510, BIOSAFETY, IPR & BIOETHICS 11  For large scale experiments For release to the environment The guidelines categorize experiments beyond 20 The guidelines specify appropriate containment liters capacity for research and industrial purposes facilities depending on the type of organisms handled as large-scale experiments/operations. and potential risks involved. In case of plants, this limits is beyond 20 acres area. The guidelines require the interested party to The guideline gives principles of occupational safety evaluate rDNA modified organism for potential risk and hygiene for large-scale practice and containment. prior to application in agriculture and environment Safety criteria have also been defined in the like properties of the organism, possible interaction guidelines. with other disease causing agents and the infected wild plant species. Physical containment conditions that should be ensured for large-scale experiments and production An independent review of potential risks should be have been specified in the guidelines. conducted on a case-to-case basis. PBT 510, BIOSAFETY, IPR & BIOETHICS 12 GOI - Government of India Institutional mechanism for implementation of DBT - Department of Biotechnology Biosafety guidelines RDAC - Recombinant DNA Advisory Committee IBSC - Institutional Biosafety Committee RCGM - Review Committee on Genetic Manipulation DOEn - Department of Environment GEAC - Genetic Engineering Approval Committee SBCC - State Biotechnology Coordination Committee PI - Principal Investigator (R&D/Industry/Others) FA - Funding Agency (Govt./Private & Public Institutions) PBT 510, BIOSAFETY, IPR & BIOETHICS 13 PBT 510, BIOSAFETY, IPR & BIOETHICS 14 Guidelines for Research in Transgenic Plants and Guidelines for evaluation of Transgenic Seeds, Plants and Plant Parts, 1998 PBT 510, BIOSAFETY, IPR & BIOETHICS 15  As per the guideline, a special Monitoring cum Evaluation Committee These guidelines covers areas of (MEC) has been set up by the RCGM to recombinant DNA research on plants monitor over a period of time, the including the development of transgenic impact of transgenic plants on the plants and their growth in soil for environment. molecular and field evaluation. The IBSC (Institutional biosafety committee) guidelines also deal with import and is the nodal organization at institutional shipment of genetically modified plants level under RCGM guidelines. of research use. PBT 510, BIOSAFETY, IPR & BIOETHICS 16  Guidelines for Generating Pre-clinical and Clinical Data for rDNA Vaccines, Diagnostics and Other Biologicals, 1999 PBT 510, BIOSAFETY, IPR & BIOETHICS 17  Department of SPECIFICATION & CHARACTERIZATION OF R - DNA VACCINES Biotechnology has issued & BIOLOGICAL PRODUCTS a set of guidelines for # Description of the method of sequence verification preclinical and clinical ( such as restriction enzyme mapping, PCR etc.) evaluation of rDNA vaccines, diagnostics and # Description on Identity-Physical, Chemical, Immunological and other biologicals in 1999 Biological wherever applicable to help in the production # Check for Potency (for recombinant vaccines & biologicals) of relevant data for # Take out General Safety Test which includes submission to Drug Controller General of Data on sterility tests as per Indian Pharmacopia guidelines. India. The guidelines Data on purity of recombinant product specially are on safety, purity, potency and Description of constituent materials like preservatives etc. effectiveness of the Data on stability of finished formulation, as per IP (Indian project. Pharmacopia) guidelines. PBT 510, BIOSAFETY, IPR & BIOETHICS 18  2) The manner in which PRECLINICAL rDNA products are TESTING Preclinical models delivered. This should The objectives of the include preclinical studies are to should consider Dose regimens define physiological, 1) Selection of Route of administration toxicological and appropriate animal Physiological parameters efficacious potential of r- species and their Pharmacokinetics DNA product prior to physiological state. Toxicological parameters initiation of human Immunological and studies. effectiveness parameters. PBT 510, BIOSAFETY, IPR & BIOETHICS 19 Guidelines for the Safety Assessment of Foods Derived from Genetically Engineered Plants 2008 Formulated by ICMR PBT 510, BIOSAFETY, IPR & BIOETHICS 20  The objective is to determine if Factors taken into account in the safety the GM food presents any new or assessment include The safety greater risks in comparison with Identity assessment of foods its traditional counterpart, or Source derived from GE whether it can be used Composition plants in these interchangeably with its Effects of processing/cooking guidelines is based traditional counterpart without Transformation process on the evaluation affecting the health or nutritional The recombinant DNA (e.g., stability of of these foods status of consumers, the inherent insertion, potential for gene transfer) relative to their objective is to establish the Expression product of the novel DNA conventional relative safety of the new product Possible secondary effects from gene counterparts that such that there is a reasonable expression or the disruption of the host have a history of certainty that no harm will result DNA or metabolic pathways safe use. from intended uses under the Potential intake and dietary impact of the anticipated conditions of introduction of the GM food processing and consumption PBT 510, BIOSAFETY, IPR & BIOETHICS 21 Guidelines and SOPs for Confined Field Trials of Regulated GE Plants – 2008 The purpose of these guidelines is to provide clear and concise information to help those individuals designated as members of monitoring teams in the monitoring agencies PBT 510, BIOSAFETY, IPR & BIOETHICS 22 PBT 510, BIOSAFETY, IPR & BIOETHICS 23 PBT 510, BIOSAFETY, IPR & BIOETHICS 24 PBT 510, BIOSAFETY, IPR & BIOETHICS 25  QUESTIONS ??? PBT 510, BIOSAFETY, IPR & BIOETHICS 26  Bibliography Web Links http://www.moef.nic.in/sites/default/files/biosafety/biosafety_regulations.htm http://www.dbtindia.nic.in/guidelines/guidelines-for-biosafety/ http://www.agbioworld.org/biotech-info/topics/dev-world/policies4.html Reprints “Biosafety in India Rethinking GMO Regulation”, LIANCHAWII, Economic and Political Weekly September 24, 2005 PBT 510, BIOSAFETY, IPR & BIOETHICS 27  Thank you PBT 510, BIOSAFETY, IPR & BIOETHICS 28