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Biosafety Assessment and Regulations of Gene Editing


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Biosafety Assessment and Regulations of Gene Editing by Dr. Vibha Ahuja during the Regional Expert Consultation on Gene Editing in Agriculture and its Regulations Technical Session III

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Biosafety Assessment and Regulations of Gene Editing

  1. 1. Dr. Vibha Ahuja Biotech Consortium India Limited
  2. 2.  Gene editing describes a variety of molecular biology applications that enable targeted and precise alterations of the genomes of plants, animals and microorganisms, but  No single definition  No definitive list :varied techniques included.  Most definitions incorporate the idea of making targeted changes at a known location  Many agree that these changes are small but there is no shared definition of “small”  Also referred to as ‘New Plant Breeding Techniques’ or ‘Genome Editing Techniques’
  3. 3. Traits produced are generally possible to produce through conventional breeding Gene editing tools allow the generation of these traits much more efficiently.Gene editing doesn’t necessarily allow us to do things that weren’t possible before ◦ It makes them possible to do more easily ◦ With greater precision Most methods of gene editing require a transgenic intermediate step ◦ A transformed plant expresses the gene editing machinery ◦ But no transgenes are present in the final product Some methods can be accomplished in cell culture, without any need to transform plants
  4. 4. Most of the ongoing debate around regulation of gene edited plants has focused on whether they will be considered GMOs How to do a risk assessment for a gene edited plant?
  5. 5.  If there is no novel RNA or protein. Should it be categorized as genetically engineered and subject to regulation as a genetically engineered organism?  Is the existing risk assessment framework necessary for the safety assessment of gene edited organisms?  Would all information typical of conducting risk assessments for novel organisms be required for gene edited plants?
  6. 6. ◦ The products of gene editing have traits that are possible to create, at random, through conventional breeding methods ◦ Given enough time ◦ But have far fewer unintended effects in the genome than conventional breeding methods ◦ Unintended genomic effects are much less extensive than conventional breeding methods which have a history of safe use ◦ Similarly, the generated phenotypes could be produced through conventional breeding methods (for the most part) and would not be subject to risk assessment
  7. 7. Molecular characterizations ◦ Insertion site is known. Very simple molecular characterization should be possible ◦ “Off target” cutting is frequently mentioned ◦ But this is guaranteed to be far less extensive than chemical or radiation mutagenesis Characteristics of the introduced trait ◦ There is no transgene ◦ No “novel” protein is expressed Agrophenotypic characterization ◦ Should only be required to assess the introduced/edited trait ◦ Collecting huge amounts of measurements to assess potential unintended effects is not necessary CAN BE USED, BUT IS IT WORTHWHILE
  8. 8. Can genetic detection techniques be employed to differentiate between gene edited product and a similar product obtained by conventional breeding? An unknown, undisclosed modification which does not involve the incorporation of foreign sequences will be hard to detect and even if is detected, identifying how it was introduced,i.e targeted mutation using genome editing tools, conventional breeding,including random mutagenesis,or naturally occurring mutations is impossible.
  9. 9. There is no way to prove that a genomic change is the result of gene editing by examining the phenotype Detection requires knowledge of the specific gene edits that has been made Molecularly small nucleotide replacements,insertions or deletions are identical, whether they occurred spontaneously ,were induced by classicle mutagenesis or site specifically introduced via genome editing Enforcement of any regulations will be exceedingly difficult in most cases of gene editing, unless a foreign DNA originating from a noncrossable,sextually incompatible organism Effectively looking at voluntary compliance What will be the effect of unenforceable regulations on public trust ,the rule of law, scientific innovation and fairness to the regulated community ? Only those products such as SDN 3 with foreign DNA , where detection is possible may be subjected to safety assessment
  10. 10. Free global trade requires internationally harmonized regulations Different GMO definitions and therefore different regulation and authorization requirements would hinder international exchange especially if products are indistinguishable Need to streamline and increase collaboration amongst regulatory authorities Urgent need for international/regional harmonization
  11. 11. Gene-editing has come up in the discussions under the Cartagena Protocol as a potential ‘issue’ requiring further risk assessment guidance. Everywhere that it was mentioned in the recommendations to COP14MOP9, it was [bracketed]. Parties did not agree that it should be a specific issue.
  12. 12. Gene-editing is too broad to consider as ‘one’ issue. Applications of gene-editing must be considered on a case-by-case basis. Many applications of gene-editing would likely NOT meet the criteria for the need to develop separate/additional guidance on risk assessment. Living modified organisms produced through gene-editing do NOT pose challenges to existing risk assessment frameworks, guidance and methodologies. Hence gene editing not included in the decision for separate guidance
  13. 13. In India all GMOs and products thereof are regulated under Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/ Genetically Engineered Organisms or Cells, 1989 (Rules, 1989)” These rules have been notified under the Environment (Protection) Act, 1986.
  14. 14. The 1989 Rules cover Manufacture, import and storage of microorganisms and gene technological products Genetically engineered organisms/microorganisms and cells and correspondingly to any substance and products and food stuffs, etc., of which such cells, organisms or tissues form part New gene technologies in addition to cell hybridization and genetic engineering
  15. 15. “Gene Technology” means the application of the gene technique called genetic engineering, include self cloning and deletion as well as cell hybridisation; “Genetic engineering” means the technique by which heritable material, which does not usually occur or will not occur naturally in the organism or cell concerned, generated outside the organism or the cell is inserted into said cell or organism. It shall also mean the formation of new combinations of genetic material by incorporation of a cell into a host cell, where they occur naturally (self cloning) as well as modification of an organism or in a cell by deletion and removal of parts of the heritable material;
  16. 16. Regulations and Guidelines on Biosafety of Recombinant DNA Research and Biocontainment, 2017 (issued by DBT) have reference to gene editing under Plant Containment ◦ Experiments involving genome editing leading to SDN1-type mutations that are genetically indistinguishable from organisms which could have occurred naturally have been covered under Plant Biosafety Level 1 (PBSL-1). ◦ Experiments involving genome editing leading to SDN2 and 3 -type modifications covered under PBSL-2. Permission from IBSC is required before initiating the experiments in case of PBSL- 2, whereas intimation to the IBSC member secretary is required in case of PBSL-1. In certain cases, additional containment may be required and should be discussed with IBSC before initiation of work.
  17. 17. South Asia Biosafety Programme Dr Andrew Roberts, ILSI Research Foundation
  18. 18.