Genome Editing Guidelines
Technical guidance for applicants and stakeholders on the regulatory provisions for genome editing processes and products in Zimbabwe.
Table of Contents
- List of Tables
- Abbreviations
- Interpretations
- 1. Genome Editing Guidelines
- 1.1 Scope
- 1.2 Objectives
- 1.3 Genome Editing
- 3. Application and Review Process
- 4. Considerations for regulation
- Annex: Pre-Submission Form NBA (GED1)
A complete guide for prospective applicants undertaking genome editing work in Zimbabwe.
Regulatory Framework for Genome Editing
Genome editing has emerged as a transformative tool in biotechnology, enabling precise modifications to DNA. These guidelines ensure that genome editing is applied responsibly to address scientific challenges and minimise risks in Zimbabwe. They promote regulatory compliance and support innovative, collaborative biotechnology research and development to benefit humanity.
Genome Editing Guidelines
1.1 Scope
These guidelines shall be read in line with the National Biotechnology Authority Act [Chapter 14:31] of 2006 and Regulations made thereunder. Information contained in these guidelines is directed to all persons, institutions or bodies wishing to carry out genome editing work ranging from containment, confined field trial and general release.
1.2 Objectives
The objective is to provide technical guidance and information to applicants and stakeholders on general regulatory provisions for genome editing processes and products in Zimbabwe.
1.3 Genome Editing
Genome editing (GEd) involves the alteration of the genetic material of a living organism by inserting, replacing, or deleting a DNA sequence, typically with the aim of improving some characteristic or correcting a genetic disorder. The introduced change could range from alteration of a single base to deletion or replacement of a DNA sequence and such changes could be identical or comparable to natural mutations or obtainable through conventional mutagenesis.
Genome editing techniques include Base Editing, Prime Editing, Transcription Activator-like Effector Nucleases (TALENs), Zinc Finger Nucleases (ZFNs), Oligonucleotide-Directed Mutagenesis (ODM) and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR).
Developments in genome editing have revolutionized our ability to make precise modifications to DNA, opening new frontiers in medicine, agriculture, industrial processes and the environment. These advancements underscore the need for robust guidelines to ensure safe and equitable utilization of these technologies.
Examples of genome editing in Africa:
- In Kenya, Sorghum bicolor resistant to the parasitic weed striga has been successfully produced through genome editing.
- Still in Kenya, preliminary research suggests that genome editing particular genes can shorten the cooking time of ordinary beans.
- In Mozambique, research is ongoing to develop liguleless sorghum, which is more suited for the production of biofuel and fodder.
Table 1: Overview of genome editing applications in various economic sectors
| Sector | Genome Editing Applications |
|---|---|
| Agriculture |
|
| Health |
|
| Environment |
|
| Industry |
|
Therefore, devising appropriate guidelines for research, development and general release of genome editing products is essential.
Application and Review Process
A prospective applicant for genome editing activities shall submit a requisite pre-submission form, NBA (GEd) 1 to the Authority (NBA) providing applicant's details, organism information, molecular techniques, genome edited product and declaration by applicant.
Upon receipt of the requisite pre-submission form, the Authority shall determine whether the activity or end product should be regulated under the GMO Regulations i.e., Statutory Instrument 105 of 2026 or otherwise (see Figure 1 below). The outcome of the determination shall be communicated to the applicant within fourteen (14) working days. The Authority shall determine all applications on a case-by-case basis.
NBA reserves the right to review this outcome if new scientific information becomes available.
Considerations for regulation of genome edited processes and products
The scope of these regulatory guidelines is limited to processes and products which utilise genome editing techniques such as base editing, prime editing and site-directed nucleases (SDN) and other nucleases with similar functions. The application of the aforementioned nucleases are categorised into three groups as indicated in Table 2 below.
Table 2: Categories of Gene editing events
| Category | Description | GMO Classification |
|---|---|---|
| Site-Directed Nuclease (SDN)-1 |
|
Non GMO |
| Site-Directed Nuclease (SDN)-2 |
|
Non GMO |
| Site-Directed Nuclease (SDN)-3 |
|
GMO |
Determination of regulatory status of Genome Editing activity or end product
Process flow for determining whether a genome editing activity or end product is regulated under the NBA Act of 2006 or otherwise.
NBA (GEd) 1
within 14 working days
regulated under SI 105 of 2026?
Not regulated under GMO Regulations
Regulated under GMO Regulations
NBA reserves right to review
Abbreviations
Interpretations
- "prospective applicant" means any person submitting a prerequisite Form NBA (GED1) pursuant to the provisions of the National Biotechnology Authority Act [Chapter 14:31].
- "genome editing" means altering the DNA sequence of an organism at specific positions by deleting, replacing or inserting nucleotides using various techniques which induce breaks in the DNA.
Pre-Submission Form — NBA (GED1)
Requisite pre-submission form on genome editing activities in Zimbabwe. This form will guide in determining whether genome editing activities (organisms or end products) are regulated under the NBA Act of 2006 or otherwise.
I Applicant Details
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Responsible person details
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1.2 Project co-funders or sponsors or partners
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II Organism Information
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III Molecular Techniques
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IV Genome Edited Product
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*Where the required data is not available, the application shall be subjected to the National Biotechnology Authority Act [Chap. 14:31] of 2006 and its enabling Regulations.
V Declaration by Applicant
I hereby certify that the above information is true and accurate to the best of my knowledge
