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Plant Cell Reports

, Volume 38, Issue 12, pp 1449–1463 | Cite as

Genetic modification in Malaysia and India: current regulatory framework and the special case of non-transformative RNAi in agriculture

  • Jasdeep Kaur Darsan Singh
  • Nurzatil Sharleeza Mat Jalaluddin
  • Neeti Sanan-Mishra
  • Jennifer Ann HarikrishnaEmail author
Review

Abstract

Recent developments in modern biotechnology such as the use of RNA interference (RNAi) have broadened the scope of crop genetic modification. RNAi strategies have led to significant achievements in crop protection against biotic and abiotic stresses, modification of plant traits, and yield improvement. As RNAi-derived varieties of crops become more useful in the field, it is important to examine the capacity of current regulatory systems to deal with such varieties, and to determine if changes are needed to improve the existing frameworks. We review the biosafety frameworks from the perspective of developing countries that are increasingly involved in modern biotechnology research, including RNAi applications, and make some recommendations. Malaysia and India have approved laws regulating living modified organisms and products thereof, highlighting that the use of any genetically modified step requires regulatory scrutiny. In view of production methods for exogenously applied double-stranded RNAs and potential risks from the resulting double-stranded RNA-based products, we argue that a process-based system may be inappropriate for the non-transformative RNAi technology. We here propose that the current legislation needs rewording to take account of the non-transgenic RNAi technology, and discuss the best alternative for regulatory systems in India and Malaysia in comparison with the existing frameworks in other countries.

Keywords

RNA interference Gene silencing Regulation Risk assessment Non-transformative RNAi RNAi-based biopesticides 

Abbreviations

cDNA

Complementary DNA

DOB

Department of Biosafety

DBT

Department of Biotechnology

DLCC

District Level Coordination Committee

dsRNAs

Double-stranded RNAs

EFSA

European Food Safety Authority

EPA

Environmental Protection Agency

FIFRA

Federal Insecticide, Fungicide and Rodenticide Act

GEAC

Genetic Engineering Appraisal Committee

GMAC

Genetic Modification Advisory Committee

GM

Genetically Modified

GMO

Genetically Modified Organism

HSNO

Hazardous Substances and New Organisms

IBC

Institutional Biosafety Committee

IBSC

Institutional Biosafety Committees

LMO

Living Modified Organism

NBB

National Biosafety Board

NPBT

New Plant Breeding Techniques

NTOs

Non-target organisms

OGTR

Office of the Gene Technology Regulator

OECD

Organisation for Economic Co-operation and Development

RDAC

Recombinant DNA Advisory Committee

RCGM

Review Committee on Genetic Manipulation

RNAi

RNA interference

SAP

Scientific Advisory Panel

SBCC

State Biotechnology Coordination Committees

USDA

United States Department of Agriculture

Notes

Acknowledgements

We thank Dr. Abdullah Al Hadi Ahmad Fuaad for his constructive feedback. The opinions expressed in this article are those of the authors and do not necessarily reflect the position of any regulatory agency of India and Malaysia. Jasdeep Kaur was supported by the MyPhD scholarship under MyBrain15 program (Ministry of Education, Malaysia) and the Arturo Falaschi Fellowship Program (International Centre for Genetic Engineering and Biotechnology, ICGEB). Dr. Nurzatil Sharleeza Mat Jalaluddin was supported by University of Malaya Post-Doctoral Research Fellowship (PDRF) and Centre for Research in Biotechnology for Agriculture (CEBAR) Research University Grants (RU006-2017 and RU006-2018).

Author contribution statement

All authors were involved in conceptualisation of the paper and writing of the manuscript. JKDS and NSMJ were also involved in data collection and compilation. All authors read and approved the initial and revised versions of the manuscript.

Compliance with ethical standards

Conflict of interest

All authors report no declaration of interest.

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Copyright information

© Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Jasdeep Kaur Darsan Singh
    • 1
    • 2
  • Nurzatil Sharleeza Mat Jalaluddin
    • 1
  • Neeti Sanan-Mishra
    • 3
  • Jennifer Ann Harikrishna
    • 1
    • 2
    Email author
  1. 1.Centre for Research in Biotechnology for Agriculture (CEBAR), Level 3, Research Management and Innovation ComplexUniversity of MalayaKuala LumpurMalaysia
  2. 2.Faculty of Science, Institute of Biological SciencesUniversity of MalayaKuala LumpurMalaysia
  3. 3.International Centre for Genetic Engineering and Biotechnology (ICGEB)New DelhiIndia

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