Transcript No Slide Title
REGULATORY MECHANISMS, GUIDELINES AND PROTOCOLS FOR TRANSGENIC CROPS; FOOD AND FEED SENARIO
Dr. T.V. Ramanaiah Scientist-F Department of Biotechnology, Ministry of Science & Technology CGO Complex, Lodi Road, New Delhi - 110 003 Short-Term Orientation Course on Biosafety and Biotech Regulations 6 th -11 th Feb, 2006 at TERI
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Biosafety
Protecting human & animal health and environment from the possible adverse effects of the products of modern biotechnology Precautionary Approach is adopted for assessment of Biosafety
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Objectives of Regulations
To facilitate & regulate Modern biotechnology work at different stages to achieve the objectives of biosafety.
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BIOSAFETY REGULATIONS & GUIDELINES
* International: Cartagena Protocol on Biosafety OECD Guidelines * Country specific: USA, EU, Canada, Australia, Egypt, Japan, China, Philippines, Thailand, India, Pakistan, etc.
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GENETICALLY MODIFIED ORGANISMS (GMOs) AND r-DNA PRODUCTS GOVERNED BY
Environment (Protection) Act, 1986
Came into force from 23.05.1986
Rules, 1989 on GMOs
Notified on 05.12.1989
Came into force from 01.10.1993
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TRANSGENIC CROPS ARE ALSO GOVERNED BY
Industries (Development & Regulation) Act, 1951 - New Industrial Policy & Procedures, 1991
Seeds Act, 1966
Seeds Rules, 1968
Seeds (Control) Order, 1983
Seeds Policy, 1988, 2002
Protection of Plant Varieties and Farmers’ Rights Act, 2001
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The Indian Environment (Protection) Act (EPA), 1986
Came into force from 23.5.1986.
Provides protection and improvement of Environment.
“Environment” includes water, air and land and the interrelationship , which exists among and between water, air and land, and human beings, other living creatures, plants, microorganism and property
“Environmental pollutant” means any solid, liquid or gaseous substance present in such concentration as may be, or tend to be, injurious to environment.
“Environmental pollution” means the presence in the environment of any environmental pollutant.
contd ......
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Some Important Sections of EPA
Section -15
Whoever fails to comply with or contravenes the act or any rules can be punished with imprisonment for a term up to 5 years, or with a fine up to Rs. 100,000 or with both.
If failure or contravention continues beyond one year, the offender may be punishable with imprisonment which may extend up to 7 years.
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Rules for the Manufacture, Use / Import / Export and Storage of Hazardous Microorganisms, Genetically Engineered Organisms or Cells (Rules 1989)
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Notified in exercise of powers under sections 6,8 & 25 of the EPA, 1986 on 5 th Dec’89.
* Rules are came into force from 01.10.1993.
Application of Rules :
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Manufacture, import and storage of microorganisms and Gene-technological products.
* Genetically engineered organisms, microorganisms and cells and correspondingly to any substances and products and food stuffs, etc. * Sale, any kind of handling, exportation, importation, production, manufacture, processing, storage, drawing off, packaging, repackaging of GMOs and drugs & pharmaceuticals, food stuffs etc. from GMOs and Gene technology products.
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Approval and prohibitions, etc. under Rules, 1989
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No person shall import, export, transport, manufacture, process, use or sell any GMOs, substances or cells except with the approval of the GEAC.
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Use of pathogenic organisms or GMOs or cells for research purpose shall be allowed under the Notification, 1989 of the EPA, 1986.
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Any person operating or using GMOs for scale up or pilot operations shall have to obtain permission from GEAC.
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Deliberate or unintentional release of GMOs not allowed.
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Production in which GMOs are generated or used shall not be commenced except with the approval of GEAC.
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Approval and prohibitions, etc. under Rules 1989
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GEAC supervises the implementation of rules and guidelines.
* GEAC carries out supervision through SBCC, DLC or any authorized person.
* If orders are not complied, SBCC/DLC may take suitable measures at the expenses of the person who is responsible.
* In case of immediate interventions to prevent any damage, SBCC and DLC can take suitable measures and the expenses incurred will be recovered from the person responsible.
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Approval and prohibitions, etc. under Rules 1989
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* All approvals shall be for a period of 4 years at first instance renewable for 2 years at a time.
GEAC shall have powers to revoke approvals in case of: a) any new information on harmful effects of GMOs.
b) GMOs cause such damage to the environment as could not be envisaged when approval was given.
c) Non compliance of any conditions stipulated by GEAC.
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COMPETENT AUTHORITIES 1. Recombinant DNA Advisory Committee (RDAC) 2. Review Committee on Genetic Manipulation (RCGM) 3. Institutional Biosafety Committee (IBSC) 4. Genetic Engineering Approval Committee (GEAC) 5. State Biotechnology Co-ordination Committee (SBCC) 6. District Level Committee (DLC)
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Recombinant DNA Advisory Committee (RDAC) Main functions
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Review developments in Biotechnology at National and International level.
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Recommend suitable and appropriate safety regulations for India in r-DNA research, use and applications.
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Review Committee on Genetic Manipulation
Main functions
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To bring out manuals of guidelines specifying procedures for regulatory process on GMOs in research, use and applications including industry with a view to ensure environmental safety. To review all on going r-DNA projects involving high risk category and controlled field experiments.
To lay down procedures for restriction or prohibition, production, sale, import & use of GMOs both for research and applications.
To permit experiments with category III risks and above with appropriate containment.
To authorize imports of GMOs/ transgenes for research purposes.
To authorize field experiments in 20 acres in multi-locations in one crop season with up to one acre at one site.
To generate relevant data on transgenic materials in appropriate systems.
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Institutional Bio-Safety Committee (IBSC)
Main functions
• • • • • • •
To note and to approve r-DNA work.
To ensure adherence of r-DNA safety guidelines of government.
To prepare emergency plan according to guidelines.
To recommend to RCGM about category III risk or above experiments and to seek RCGM’s approval.
To inform DLC and SBCC as well as GEAC about the experiments where ever needed.
To act as nodal point for interaction with statutory bodies.
To ensure experimentation at designated location, taking into account approved protocols.
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Genetic Engineering Approval Committee (GEAC)
Main functions
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To permit the use of GMOs and products thereof for commercial applications.
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To adopt procedures for restriction or prohibition, production, sale, import & use of GMOs both for research and applications under EPA.
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To authorize large scale production and release of GMOs and products thereof into the environment.
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To authorize agencies or persons to have powers to take punitive actions under the EPA.
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State Biotechnology Co-Ordination Committee (SBCC)
Main functions
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Powers to inspect, investigate and to take punitive action in case of violations of statutory provisions through the State Pollution Control Board or the Directorate of Health etc.
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To review periodically the safety and control measures in various institutions handling GMOs.
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To act as nodal agency at State level to assess the damage, if any, due to release of GMOs and to take on site control measures.
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District Level Committee (DLC)
Main functions
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To monitor the safety regulations in installations.
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Have powers to inspect, investigate and report to the SBCC or the GEAC about compliance or non compliance of r-DNA guidelines or violations under EPA.
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To act as nodal agency at District level to assess the damage, if any, due to release of GMOs and to take on site control measures.
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r-DNA GUIDELINES 1990 1994 1998 1999 “ Recombinant DNA Safety Guidelines” “ Revised Guidelines for Safety in Biotechnology” “ Revised Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts ” “Guidelines for Generating pre-clinical and Clinical data for r-DNA based Vaccines, Diagnostics and other Biologicals
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COVERAGE OF REVISED GUIDELINES- 1998 * Recombinant DNA Research on plants and statutory bodies dealing with r- DNA work.
* Classification of Genetic Engineering Experiments on plants a. Category - I b. Category - II c. Category - III * Containment measures followed in above categories.
* Green House / Design for Field evaluation of transgenic plants.
* Monitoring - cum - Evaluation Committee.
* Biosafety aspects of the transgenic plants.
* Import and shipment of genetically modified plants for research use only.
* Toxicity guidelines for testing transgenic plants and plant parts.
* Application for seeking approval under EPA for transgenic crops.
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CLASSIFICATION OF GENETIC ENGINEERING EXPERIMENTS CATEGORY - I
Work involving defined gene(s)/DNA of microbial, plant and animal origin which are
Generally Considered as safe
for humans, animals & plants. Routine recombinant DNA experiments in lab. IBSC can approve the experiments.
CATEGORY - II
Work involving defined gene(s)/DNA of microbial, plant and animal origin which are non- pathogenic to humans and animals but can have implications on plants and insects. Lab & Green House/Net House experiments in contained environment (except contained limited field trials.) IBSC can approve the experiments with intimation to RCGM.
CATEGORY - III
Work involving defined gene(s)/DNA of microbial, plant and animal origin which can cause alterations in the biosphere and does not fall in category I & II . All experiments including Lab, Green House, limited contained field trials and limited experimental field trials etc. of category I & II. Experiments to be carried out only after RCGM’s approval.
Monitoring - cum - Evaluation Committee (MEC)
Main functions
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To undertake field visits at the experimental site (s).
To review the design of experiments / trials and collection of data during limited open field trials.
To collect information on the comparative agronomic advantages of transgenic crop. To assess and advise on the risks and benefits from the use of transgenic plants.
To assist in collecting, consolidating and analyzing field data for evaluating environmental risks emanating from transgenic plants.
To recommend those transgenic crops which would be found to be environmentally safe and economically viable to RCGM and to GEAC for consideration to release into the environment.
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Amendments in the Guidelines Defining small experimental field trials: Small experimental field trials should be limited to a total of 20 acres in multi-locations in one crop season. In one location, where the experiment is conducted with transgenic plants, the land used should not be more than one acre. Any experiment beyond these limits in one crop season would require the approval of GEAC.
Large scale experiments: Experiments using fermentors beyond 20 ltrs capacities exclusively for research purposes only to produce sufficient material/ products of GMOs required for generating pre-clinical and other relevant data required to establish the product for commercial use would not be included in the category of large scale experimentation/ operations.
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Protocol for development Transgenic crops Institutional Biosafety Committee (IBSC)
Examination & forwarding applications for approval of RCGM
Review Committee on Genetic Manipulation (RCGM)
Green house experiments, contained field trials, toxicity and allergenicity studies Farmer’s Field trials by
Company ICAR
trials
Monitoring-cum- Evaluation Committee (MEC) Review Committee on Genetic Manipulation (RCGM) Genetic Engineering Approval Committee (GEAC)
Evaluation of data and Environmental clearance of the event/ gene 25
CONSTITUTION OF TASK FORCES ON BIOSAFETY REGULATIONS
Ministry of Agriculture constituted a Task Force on ‘Applications of Agricultural Biotechnology’ Ministry of Environment & Forests constituted a Task Force on ‘Recombinant Pharma Sector’ 26
Protocol-I For New Transgenic Event Institutional Biosafety Committee (IBSC)
Preparation and/submission of application data
Review Committee on Genetic Manipulation (RCGM)
Evaluation of application data from IBSC* Approval for Laboratory and Green House Trials & contained field trials. For generation of environmental, toxicity and allergenicity data. Evaluation/monitoring of contained field trials through
Monitoring-cum- Evaluation Committee (MEC) Genetic Engineering Approval Committee (GEAC)
Approval for large scale Field Trials and Evaluation Protocol** Concurrent Farmer’s Field trials by
Company ICAR
trials for VCU involving SAUs and other appropriate State Agencies
Genetic Engineering Approval Committee (GEAC)
Evaluation of data and Environmental clearance of the event/ gene
Ministry of Agriculture
Approval for commercial release/notification/registration of variety(ies) / hybrid(s) by
DAC/ICAR DAC/ICAR
Ministry of Agriculture & State Governments Post-release monitoring and vigilance 27
Protocol-II: For Released Event/ Gene Institutional Biosafety Committee (IBSC)
Preparation/submission of application data
Review Committee on Genetic Manipulation (RCGM)
Case verification and Bio-safety clearance (Need based trials)
Genetic Engineering Approval Committee (GEAC)
Approval for large scale Field Trials and Evaluation Protocol* Farmer’s Field trials by
Company ICAR
trials for VCU
Genetic Engineering Approval Committee (GEAC)
Evaluation of data for Environmental clearance of the event/ gene
DAC/ ICAR, Ministry of Agriculture
Approval for commercial release/ notification/ registration of variety(ies)/ hybrid(s)
DAC/ ICAR
Ministry of Agriculture & State Governments Post-release monitoring 28
Biosafety parameters on Transgenic crops
A.
General information
Rationale for the development
Description of the host plant
Mode of Pollination
Centres of Origin/diversity of the crop species
Geographical distribution of the target crop and sexually compatible plant species including wild relatives
contd .......
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Biosafety parameters on Transgenic crops
B. Biosafety Parameters: 1. Genetic and Molecular parameters
Genetic analysis including copy number of inserts
Stability of the gene,
Level, site(s) and duration of expression of transgene
Characterization of expressed gene product
Efficacy/utility of gene product
Compositional analysis
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Biosafety parameters on Transgenic crops
2.
Environmental parameters
Gene flow Implications of out-crossing Effect on target and non-target organisms Effect on soil biota Contd….
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Biosafety parameters on Transgenic crops
3.
Toxicity parameters including histo-pathological studies (need based)
Food/feed safety evaluation in animals such as: * Effect on small laboratory animals * Effect on livestock animals (representative goat studies of large animals) * Effect on birds/ avian species * Effect on fish Contd….
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Biosafety parameters on Transgenic crops
4. Allergenicity parameters (need based)
Primary skin irritation test in rabbit/ guinea pigs
Irritation to mucous membrane test in rabbit/ guinea pig
Immunological responses in suitable animal system
Contd….
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Biosafety parameters on Transgenic crops
C.
Agronomic parameters
Efficacy of the gene at phenotypic level
Yield
Growth and developmental parameters
Responses to major diseases and insect-pests
Quality parameters
Economic evaluation/ cost: benefit ratio
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GUIDELINES FOR TOXICICTY AND ALLERGENICITY EVALUATION OF TRANSGENIC SEEDS, PLANTS AND PLANT PARTS Guidelines for Toxicity evaluation of transgenic seeds
Acute oral toxicity test of transgenic seeds in Rat Sub-chronic (90 days) oral toxicity test of transgenic seeds in Rat Sub-chronic oral toxicity – Goats – 90 days study Feeding studies of transgenic plants/plant parts in Lactating Crossbred Dairy Cows Feeding studies of transgenic plants/plant parts in Chicken.
Feeding studies of transgenic plants/plant parts in Catfish Primary skin irritation test of transgenic seeds in Rabbit Irritation to mucous membrane test of transgenic sees in female Rabbit Skin sensitization test of transgenic seeds in Guinea pigs
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GUIDELINES FOR TOXICICTY AND ALLERGENICITY EVALUATION OF TRANSGENIC SEEDS, PLANTS AND PLANT PARTS Guidelines for Toxicity evaluation of transgenic vegetables
Acute oral toxicity test of transgenic vegetables in Rat
Sub-chronic (90 days) oral toxicity test of transgenic vegetables in Rat
Primary skin irritation test of transgenic vegetables in Rabbit
Irritation to mucous membrane test of transgenic vegetables in female Rabbit
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GUIDELINES FOR TOXICICTY AND ALLERGENICITY EVALUATION OF TRANSGENIC SEEDS, PLANTS AND PLANT PARTS Guidelines for Toxicity evaluation of transgenic leaves
Sub-chronic (90 days) oral toxicity test of transgenic leaves in male Rabbit Protocol for Allergenicity testing of genetically transformed products in Animal Model
Passive Cutaneous Anaphylaxis (PCA) test
Pransnitz-Kustner (PK) test
Radioallergosorbent (RAST)/RAST inhibition test
Enzyme Linked Immunosorbent Assay (ELISA)
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Agencies Involved in Environmental release of transgenic crops/ food products by imports MoA/ICAR, MoH&FW, DBT Applicant GEAC Commercial Release
38 MoE&F
GM Food & Feed Scenario
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No GM Food / Feed approved so far in India
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GM Food crops are being developed by several applicants
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Policies on labeling, traceability etc are yet to be finalized
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Agencies Involved in Rules,1989 of EPA 1986 Min. of Environment GOVERNMENT OF INDIA Dept. of Biotechnology Applicant GEAC
Large Scale Imports, Production and Release
SBCC DLC RCGM IBSC PI/ Applicant Monitoring -cum Evaluation Committee
R&D, Limited experimental field trials and imports for R&D.
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Summary of r-DNA Research in India
Number of Institutions engaged ~ 240 Number of Institutions engaged in ~ 95 transgenic research (60+35) Number of Private Institutions ~ engaged in r-DNA therapeutics Other Institutions engaged in basic work ~ 50 95
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TRANSGENIC CROPS APPROVED GOBALLY
Sl. No.
1.
CROP (bxn) TRAIT Canola Herbicide Tolerance (CP4EPSPS) Herbicide Tolerance (PAT) Herbicide Tolerance COUNTRY YEAR Canada US Japan Canada US Japan Australia Canada Japan 1995 1999 1996 1995 1995 1996 2003 1997 1998 Herbicide Tolerance (ALS)
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Canada 1995 contd…
Sl. No.
CROP TRAIT COUNTRY YEAR 2. Carnation Increased shelf life Australia Herbicide Tolerance European Union 1995 1998 3. Chicory Herbicide Tolerance European Union USA 1996 1997 4. Cotton Insect Tolerance USA Australia Japan China Mexico South Africa Argentina India 1995 1996 1997 1997 1997 1997 1998 2002 Herbicide Tolerance USA 1994 (bxn gene) Japan 1997 contd…
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Sl. No.
CROP TRAIT Cotton Herbicide Tolerance (bxn gene) Insect Tolerance COUNTRY YEAR USA 1997 Japan 1998 Cotton Herbicide Tolerance (ALS gene) USA 1996 Cotton Herbicide Tolerance (CP4EPSPSgene) USA Japan Australia Argentina 1995 1997 1999 2000 Cotton Herbicide Tolerance (CP4EPSPSgene) Insect Tolerance USA Cotton Herbicide Tolerance (PATgene) USA 2003 Cotton Insect Tolerance (Cry1Ac+Cry1F genes)
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USA Contd… 2004
Sl. No.
5.
CROP TRAIT Linseed Herbicide Tolerance (ALS gene) COUNTRY YEAR Canada USA 1996 1999 6.
Maize Insect Tolerance Herbicide Tolerance (CP4EPSPS gene) USA Canada Japan Maize Herbicide Tolerance (PAT gene) USA Canada Japan Argentina 1996 1996 1997 1995 1996 1997 1998 Maize Herbicide Tolerance (PAT gene) Insect Tolerance USA Canada Japan Argentina 1995 1996 1996 1996 EU 1997 Contd…
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Sl. No. CROP TRAIT Maize Herbicide Tolerance (PAT gene) COUNTRY YEAR USA Canada 1996 1996 Maize Herbicide Tolerance Maize Insect Tolerance (DAM gene) ( cry3Bb1 gene) USA USA Canada USA 1998 2003 2003 7. Melon 8. Polish Canola Herbicide Tolerance (PAT gene) Canada 1998 Polish Canola Herbicide Tolerance (CP4EPSPS gene) Canada 1997 9. Potato Potato Delayed Ripening Insect Tolerance (cry3A gene) USA Canada Insect Tolerance (cry3A gene) USA Herbicide Tolerance (CP gene) Canada 1995 1995 1999 1999 Contd…
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Sl. No.
CROP TRAIT 10.
Rice Herbicide Tolerance (PAT gene) 11. Soybean Herbicide Tolerance (CP4EPSPS gene) COUNTRY YEAR USA 1999 USA 1994 Argentina 1996 Japan 1996 Canada 1995 Uruguay 1997 Mexico 1998 Brazil 1998 South Africa 2001 Soybean Herbicide Tolerance ( PATgene) Soybean Modified Oil (fad gene)
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USA 1996 Canada 1999 Japan 1999 USA 1997 Canada 2000 Japan 1999 Contd…
Sl. No.
12.
CROP TRAIT COUNTRY YEAR Squash Resistance to viral infection (cp gene) USA 1994 13.
Sugarbeet Herbicide Tolerance (CP4EPSPS gene) USA 1998 Sugarbeet Herbicide Tolerance (PAT gene) 14.
Tomato Increased Shelf life (ACC gene)USA USA 1998 Canada 2001 1995 Tomato Insect Tolerance Tomato Delayed ripening (SAMase gene) USA USA 1998 1996 Tomato Delayed ripening (ACCD gene) Tomato Delayed ripening ( PG gene) USA 1995 USA 1992 Mexico 1995, Japan 1996
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Transgenic crops approved for conducting contained limited field trials including multi-location field trials during 2005 Sl. No Crop Institute 1. Brinjal Mahyco, Mumbai Sungro Seeds, N. Delhi IARI, N. Delhi 2. Cabbage Sungro Seeds, N. Delhi 3. Cauliflower Sungro Seeds, N. Delhi Transgene
cry1Ac cry1Ac cry1F cry1Ac cry1Ab
4. Corn Monsanto, Mumbai Metahelix, Bangalore
cry1Ab Turbo-Mu
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Sl. No Crop 5. Cotton Institute Ajeet Seeds, Aurangabad Ankur Seeds P.Ltd., Nagpur Bioseed, Hyd Emergent P. Ltd, Hyd Ganga Kaveri, Hyderabad Green Gold, Aurangabad JK Agri Genetics, Hyderabad Kaveri Seeds Co. P. Ltd, S’bad Krishidhan Seeds, Jalna Mahyco, Mumbai Metahelix, Bangalore Nandi Seeds Pvt. Ltd Mehbubnagar Namdhari Seeds Pvt. Ltd, Bangalore Nath Seeds, Aurangabad Nuziveedu Seeds, Hyderabad Transgene
cry1Ac, cryX cry1Ac, cryX cry1Ac, cryX cry1Ac, cryX cry1Ac
GFM cry1A
cry1Ac cry1Ac cry1Ac, cryX cryX cry1Ac cry1Ac cry1Ac
GFM cry1Aa
cry1Ac, cryX
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Sl. No. Crop Institute Transgene Cotton Prabhat. Hyderabad Pravardhan, Hyderabad Proagro, Hyderabad Rasi Seeds Ltd., Attur Syngenta India Ltd., Pune Tulsi Seeds, Guntur UAS, Dharwad Vibha Agrotech Ltd. Hyderabad Vikki’s Agrotech, Hyderabad Vikram Seeds Ltd, Ahmedabad Zuari Seeds Ltd. Bangalore 6. Groundnut ICRISAT, Hyderabad 7. Mustard UDSC, New Delhi
cry1Ac cry1Ac cry1Ac cryX Vip-3A cry1Ac, cryX cry1Ac cry1Ac cry1Ac cry1Ac
GFM cry1A coat protein of IPCV
barnase & barstar
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Sl. No Crop 8. Okra Institute Mahyco, Mumbai 9. Pigeonpea ICARISAT, Hyderbad 10. Rice IARI, N. Delhi Mahyco, Mumbai Metahelix, Bangalore 11. Tomato IARI, New Delhi Mahyco, Mumbai Transgene
cry1Ac cry1Ac cry1Ac, cry1Aa +cry1B cry1Ac
NHX gene
antisense replicase gene of tomato LCV cry1Ac
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CROPS UNDER FIELDTRIALS 13 crops under various stages of contained field trials
Include brinjal, cotton, cabbage, groundnut, pigeon pea, mustard, potato, sorghum, tomato, tobacco, rice, okra and cauliflower Traits include insect resistance, herbicide tolerance, virus resistance, nutritional enhancement, salt tolerance, fungal resistance, etc
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COMMERCIAL USE IN INDIA
Only one crop approved i.e. Bt. cotton containing Cry1Ac gene Three hybrids approved in 2002, one in 2004 and 16 hybrids in 2005 More hybrids under large scale trials Large scale trials underway for Bt cotton containing Cry1Ac & Cry2Ab genes
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Bt. COTTON AREA UNDER CULTIVATION
2002 – 72,000 acres 2003 – 2,30,000 acres 2004 – 13,10,000 acres 2005 – 31,02,067 acres
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Benefits of Bt Technology
Benefits of Bt Technology in a given crop = Genetic potential of the crop in yield + Factor Bt – differences in in-put costs Factor Bt can be defined as “Realizable benefits
a
of Bt Technology depends on the levels of target pest infestation.” a= amount saved due to reduction in the number of sprays + crop saved due to Bt protein Net benefit depends on the procurement price of the cotton 56
CONCLUSIONS
All GMOs and r-DNA products are controlled commodities under the Rules- 1989 OF EPA- 1986.
The Rules & Procedures under EPA are compliance friendly. The Competent Authorities and their roles are well defined. Familiarity with the Rules & Procedures is essential for compliance. The EPA to provide safe products to the society on existing scientific knowledge.
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CONCLUSIONS
Biosafety is real concern
Biosafety regulations required to assess the safety of transgenic crops before its release in to environment
Biosafety concerns need to be addressed in a scientific manner
Continuous evolution of Biosafety Regulations are required
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THANK YOU
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