Last year, the
Despite taking legislative action, there are concerns that the
The deregulatory agenda
Prior to its enactment, and while the
What are precision bred organisms?
Under the Genetic Technology Act, an organism is considered to be "precision bred" if:
-
Any feature of its genome results from the application of modern biotechnology.
- Every feature of its genome that results from the application of modern biotechnology is stable.
- Every feature of its genome could have resulted from traditional processes, whether or not in conjunction with selection techniques, or natural transformation.
- Its genome does not contain any feature that is a result of any artificial modification technique (other than modern biotechnology).
- To remove the process of laying legislation after ministerial authorisation of a regulated product, which currently slows down the approval process. Instead the authorisation would be added to an official register, following a ministerial decision, which the FSA said will speed up the process.
In the case of plants, "traditional processes" includes sexual fertilisation, spontaneous mutation, in vitro fertilisation, polyploidy induction, embryo rescue, grafting, induced mutagenesis, or somatic hybridisation or cell fusion of plant cells of organisms which are capable of exchanging genetic material by any of the previously mentioned processes. Transgenic GMOs are excluded and continue to be regulated under the GMO regulations.
The purpose of the legislation
The purpose of the new legislation is to allow gene editing without the need for specific complex approvals under the current GMO regime - at least in
The FSA ran a consultation on proposals for the new framework for the regulation of food or feed produced from PBOs (including both plant and animal PBOs). It published its response on
Although it is intended that the regulatory framework will apply to both plant and animal PBOs, it is anticipated that applications for regulatory approval of plant PBOs will open before applications relating to animal PBOs.
Two-tiered approach
In the recent response to its consultation, the FSA has confirmed that its proposal revolves around introducing a two-tiered regulatory approach for pre-market authorisation, meaning that those PBOs similar to traditionally bred organisms would benefit from a simpler route to market.
Tier 1 would be for those PBOs where the safety risks are understood and are not of concern, which would be determined by using a triage criteria set by FSA. Once determined, businesses would need to notify the FSA that its food or feed falls within the criteria for Tier 1. The FSA would then acknowledge receipt of the notification and place the PBO on the public register.
The Tier 2 regulatory route would be for those PBOs where the safety risks require further scrutiny, meaning the authorisation process would be more rigorous. This route would require an application to the FSA and completion of an FSA safety assessment.
Triage questions to determine whether a PBO would be Tier 1 or Tier 2 include inquiries around novelty, composition (including allergenicity) and other safety concerns.
The FSA's proposed regulatory framework is similar to the proposed EU framework in that they both seek to develop a simpler and more proportionate market authorisation system for NGT plants/PBOs via a two-tiered approach. The
The two regimes may also diverge in relation to the definitions applied to plants to determine which tier they fall into. The scope of plants falling within the
This could add a layer of complexity, cost and administrative burden on businesses wanting to place products on both the
Product labelling
Another key difference between the FSA's proposed approach compared to the EU's proposed approach, in particular the
The
However, the FSA's latest consultation response highlighted that respondents were concerned with the absence of mandatory labelling. The FSA reiterated that the issue of labelling is the responsibility of the government but it would pass on these concerns to the government. At time of writing, mandatory labelling requirements are not included in the FSA's proposal.
Other regulatory considerations
Although the purpose of the new legislation in the
However, the "regulated products regime", which includes novel foods, is currently undergoing a review by the FSA. Two proposals to reform the regime have been put forward:
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To remove renewal requirements for various food products, including food or feed containing, consisting of or produced from GMOs.
A consultation on these new proposals was launched on 3 April and the FSA noted that it hopes to introduce these legislative changes ahead of the general election. The consultation closes on
This recent development highlights the regulator's desire to modernise and expedite authorisation procedures. The FSA has stated that failing to take urgent action will result in an inability to cope with the increasing caseload, further underscoring the pressing need for progress in this space.
Patent rights
Unlike the
This means that plants and animals can be patented where they are not "exclusively obtained by means of an essentially biological process" and if the invention is not confined to a particular plant or animal variety. Therefore, plants or animals that are produced by a technical process, such as gene editing that modifies the genetic characteristics of the plant or animal are, in theory, patentable.
However, this position could be impacted by the
At this stage, it seems that gene-edited plants and animals falling within the scope of the Genetic Technology Act could be patentable (subject to the usual patentability requirements). This is be good news for players seeking to make investment into developing agri-tech inventions - the ability to secure robust patent protection may well incentivise investment.
Although the
Specifically, out of the 450 regulated product applications, including novel foods and genetically modified products, submitted since
However, the FSA's recent activity illustrates its commitment to translating the deregulation benefits of the Genetic Technology Act into practice. The drafting of legislation for the new regulatory framework for PBOs in
However, the potential impact an upcoming
The suspected divergence between the EU and
Businesses should also begin to have conversations around the proposed two-tier system and how this may affect the timeline for getting products to market. This could include considering whether there are any early-stage decisions that can be made to potentially reduce the risk profile of a PBO, and, as such, also reduce the associated regulatory burdens.
With the regulation of GMOs being a devolved issue in the
Businesses operating in this space should continue to monitor the evolving regulatory landscapes in the
This is the second Insight in our series on the deregulation of gene editing in plants. The first part of the series looked at theregulatory changes proposed in the EU.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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