Consultation on Regulatory Framework for the Use of Genome Edited Crops in Food and Animal Feed

Singapore Food Agency

Consultation Period: 20 Dec 2023 - 19 Feb 2024

Status: Closed

Detailed Description

Aim

1. The Singapore Food Agency (SFA) is seeking feedback from the food and animal feed industry, as well as interested parties, on a proposed regulatory framework for the use of genome edited (GEd) crops¹ in food for human consumption and animal feed. This applies to both imported, as well as locally developed, cultivated, and processed crops.

Background

2. Modern biotechnology has accelerated the breeding of new crop varieties with desirable agronomic traits, such as disease resistance, drought tolerance, and improved nutrition, for use as food and animal feed. These traits can bring benefits for the farmer and the consumer.

3. Genome editing represents a set of modern biotechnological tools that allow crop developers to make precise changes within an organism’s genome.² Examples of genome editing tools that have been used to generate new food crop varieties include zinc finger nucleases (ZFN), transcription activator-like effector nucleases (TALENs), and Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) nucleases.

4. Genome editing has been employed to expedite the breeding of new crop varieties that could have been generated via conventional breeding³. This is because genome editing can be used to generate precise changes in an organism’s genome that are equivalent to the changes that naturally arise during conventional crop breeding. SFA considers such GEd crops to be equivalent to conventionally bred crops. For example, genome editing tools can be used to breed a new tomato variety that could have been bred using via cross breeding between two other tomato varieties.

5. Genome editing can also be employed to generate new crop varieties that could not have been plausibly generated via conventional breeding techniques. For example, corn DNA could not be inserted into a tomato via conventional breeding techniques. SFA considers such GEd crops to be equivalent to genetically modified organisms (GMOs). GMO crops and genome edited (GEd) crops equivalent to GMOs are subject to SFA’s GMO pre-market safety assessment and approval. Please refer to the Conditions related to Genetically Modified Crops on SFA’s website for further information on the GMO pre-market safety assessment and approval process: https://www.sfa.gov.sg/food-import-export/commercial-food-imports

6. Presently, there are no explicit regulatory pathways for GEd crops to be used in food and/or animal feed in Singapore. Crop developers may choose to submit their GEd crop under the existing GMO pre-market safety assessment and approval process. However, this process would likely not be fit for purpose for GEd crops that are equivalent to conventionally bred crops.

7. SFA has taken note of updated regulations or regulatory guidance in Canada, Japan, the United Kingdom, and the United States to exempt GEd crops that are equivalent to conventionally bred crops from GMO pre-market safety assessment. These updated regulations or regulatory guidance provide clarity to crop developers on whether their GEd crop would be subject to the GMO pre-market safety assessment and approval process.

8. SFA has therefore developed a science-based, risk-proportionate regulatory framework to provide regulatory clarity to crop developers seeking to use GEd crops in food and animal feed.

Regulatory framework for the use of GEd crops in food and animal feed

9. A crop developer intending to sell a GEd crop in Singapore for use as food and/or animal feed must first determine whether said crop contains foreign DNA.⁴ If the crop does not contain foreign DNA, SFA encourages the developer to notify SFA on the crop (Pathway A). A non-exhaustive list of examples of GEd crops that are considered to not contain foreign DNA include:

   1. A crop with a non-functional gene arising from cellular repair of a targeted DNA strand break (i.e., gene knock-out).

   2. A crop containing a targeted single base pair substitution in any part of the genome.

   3. A crop (host) where an endogenous gene has been substituted with a homologous gene variant (i.e., allele) originating from another crop that can reproduce with said host via conventional breeding (e.g., breeding between two tomato varieties).

10. If the crop contains foreign DNA, said crop will need to undergo SFA’s pre-market safety assessment (Pathway B). A non-exhaustive list of examples of GEd crops that are considered to contain foreign DNA include:

    1. A crop containing DNA from a bacterial, animal, viral sources, or containing DNA sequences not found in nature.

    2. A crop containing DNA from another crop that cannot undergo conventional breeding with the GEd crop (e.g., insertion of corn DNA into tomato).

11. Pathways A and B are depicted in the flowchart below:

12. SFA encourages developers seeking to use GEd crops that fall under Pathway A for food and/or animal feed to notify SFA by providing information on such crops to SFA via an Information Checklist (see Annex I). Upon submission of complete information requested in the Information Checklist for a GEd crop, SFA will determine if SFA agrees with the developer that said GEd crop does not contain foreign DNA and is therefore equivalent to conventionally bred crops. If SFA agrees with the developer that said GEd crop is equivalent to conventionally bred crops, SFA will inform the developer that the crop would not need to undergo GMO pre-market assessment.

13. To promote transparency towards consumer acceptance, a List of GEd crops that have completed notification will be made publicly available on SFA’s website. Only the common / scientific name of the crop, commercial / proprietary name, marketed traits, and intended use (as food and/or feed) will be made publicly known. Business confidential information submitted by developers will not be disclosed outside of SFA without the developer’s explicit consent.⁵

14. Crop developer intending to use GEd crops that fall under Pathway B for food and/or feed are required to seek GMO pre-market safety assessment and approval for such crops. SFA expects that the GMO pre-market safety assessment and approval process to take 12 – 18 months upon receipt of complete information as required by GMAC.

FAQs

15. SFA understands that genome editing is a new technology and anticipates that there will be questions on various aspects of the regulatory framework for the use of GEd crops in food and animal feed. SFA has prepared a list of FAQs and replies in Annex II.

Request for Comments

16. SFA invites feedback and comments on the regulatory framework on the use of GEd crops in food and animal feed detailed in paragraphs 9 to 14. All submissions should be clearly and concisely written and should provide a reasoned explanation for any proposed revisions. Please submit your feedback and comments in the form of the table provided in Annex III.

17. Submissions should reach SFA no later than 6:00 p.m. (Singapore time; UTC+8), 19 February 2024, through email to the following address: tan_yong_quan@sfa.gov.sg (Dr Tan Yong Quan, Scientist, Risk Assessment and Communication Department, National Centre of Food Science).

18. Feedback and comments on the regulatory framework will be consolidated and a summary will be published, together with SFA’s responses, on the SFA website after the close of the consultation exercise.

¹ A crop is a plant, a macroscopic fungus (e.g., mushroom), or a macroscopic alga (e.g., seaweed), that is grown for subsistence.

² The genome of an organism includes its entire hereditary material content, which is made from deoxyribonucleic acid (DNA). The genome includes, but is not limited to, the chromosomal DNA, mitochondrial DNA, chloroplast DNA and plasmid DNA.

³ Conventional crop breeding techniques include selective breeding, cross breeding, somatic hybridization and mutagenesis via ionizing radiation or chemical mutagens, but excludes molecular biotechnology techniques such as genome editing and genetic modification (GM).

⁴ Foreign DNA refers to DNA sequences derived from a source organism, or DNA sequences not found in nature, that is introduced into a host organism’s genome. DNA that can be introduced into a host via conventional breeding techniques is not regarded as foreign DNA.

⁵ Please note that SFA does not sign non-disclosure agreements (NDA) with companies for the purposes of evaluating the information submitted, as SFA employees are bound to the preservation of secrecy under Section 34 of the Singapore Food Agency Act 2019.

Annex I - Information Checklist to notify SFA of GEd crop for use as food and or feed [PDF, 115 KB]

Annex II - FAQs [PDF, 121 KB]

Annex III - Table to provide feedback and comments [PDF, 105 KB]