Precision Breeding and Consumer Safety: A Review of Regulations for UK Markets

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

The authors present a clear and timely review of the regulatory landscape in the UK with respect to gene-edited organisms and consumer safety.

The manuscript could be improved by the addition of a brief summary of the state of play in respect of GMOs in crops and farmed animals. For example a note of the countries where food derived from GMOs is consumed and the scale of such consumption and the absence of adverse (physiological) effects on consumers.

Have any of the genetic changes created with GM-technology been mimicked using GE-technology? In particular have any of the GMO-derived foods that have been eaten by consumers been replicated using GE-technology - any such examples would be good case studies, especially in respect of consumer safety.

Case studies of crops where the GE-change is concerned with improved resilience to drought, flood or disease would be useful.

From a consumer safety perspective the GE-pigs appear to offer fewer risks than any of the three GE crops examples. Thus, although acceptance of GE-livestock products may be more challenging subjectively (the sentient animal dimension), based on the examples presented here the GE-plant products may objectively be more of a risk.

Author Response

Reviewer 1.

We thank reviewer 1 for their supportive and helpful remarks. We have addressed the comments as detailed below:

Reviewer’s comment:  The manuscript could be improved by the addition of a brief summary of the state of play in respect of GMOs in crops and farmed animals. For example a note of the countries where food derived from GMOs is consumed and the scale of such consumption and the absence of adverse (physiological) effects on consumers.

Our response: We have added text (lines 175-189) to describe the countries where food derived from GMOs is cultivated and presumably consumed, with the absence of adverse effects on consumers.

Reviewer’s comment:  Have any of the genetic changes created with GM-technology been mimicked using GE-technology? In particular have any of the GMO-derived foods that have been eaten by consumers been replicated using GE-technology - any such examples would be good case studies, especially in respect of consumer safety.

Our response:  We agree but are not aware of any commercialised GMOs that have been directly phenocopied using gene editing to generate near-market products. However, we have added some text (lines 189-193) to acknowledge this idea.

Reviewer’s comment:  Case studies of crops where the GE-change is concerned with improved resilience to drought, flood or disease would be useful.

Our response:  We agree. Indeed, there are many examples of gene editing to investigate and improve plant responses to biotic and abiotic stressors. We chose the three crop case studies because they targeted nutritional traits which we considered more relevant to the aims of our manuscript. We included the PRRS pig example to contrast the plant examples and because it is progressing along the pathway to commercialisation and there are comparatively good sources of information on the genetic and biochemical changes made.

Reviewer’s comment:  From a consumer safety perspective the GE-pigs appear to offer fewer risks than any of the three GE crops examples. Thus, although acceptance of GE-livestock products may be more challenging subjectively (the sentient animal dimension), based on the examples presented here the GE-plant products may objectively be more of a risk.

Our response:  We agree, and from our understanding of the FSA triage criteria, all of the case-studies used are likely to be tier 1 examples.

Reviewer 2 Report

Comments and Suggestions for Authors

Dear author

I am really pleased and impress to read the manuscript. All the necessary information which important has been explained well in the manuscript. However some additional information is needed, such as

Line 17. The abbreviation of PBO need to be explained first.

Line 173. Reason to select those 4 case studies need to be explained in brief.

One things I need you to add in the manuscript is the brief explanation about the differences between Gene Editing vs GMO. At least please add one or two paragraph to give a clear differences about this.

The selection of 4 case studies also need to be explained the reason.

Other necessary has been well writen in the manuscript.

Regards

Author Response

Reviewer 2.

We thank reviewer 2 for their supportive and helpful remarks. We have addressed the comments as detailed below:

Reviewer’s comment:   Line 17. The abbreviation of PBO need to be explained first.

Our response:  Done.

Reviewer’s comment:    Line 173. Reason to select those 4 case studies need to be explained in brief.

Our response:  Done. We added a justification for the four case studies on lines 195-201 and copied below.

These case studies were chosen as viable examples of foods that producers are likely to pursue for PBO status given their benefits to the food system and advanced stage of development. Our crop examples target a range of nutritional traits that we considered relevant to the aims of our manuscript and which capture any potential risks or challenges for the proposed regulatory system. The PRRS pig case study was included to contrast the plant examples and because it is relatively advanced along the pathway to commercialisation. There are also comparatively good sources of information on the genetic and biochemical changes made.

Reviewer’s comment:   One things I need you to add in the manuscript is the brief explanation about the differences between Gene Editing vs GMO. At least please add one or two paragraph to give a clear differences about this. The selection of 4 case studies also need to be explained the reason.

Our response:  This is complicated. In many jurisdictions, there could be some gene edited organisms that may be categorised as GMOs (eg. where editing machinery has facilitated the targeted insertion of a transgene into a safe-harbour genomic locus). The UK precision breeding legislation specifically identifies those gene edited organisms where there is no foreign DNA and where the genetic changes could have resulted from current plant breeding strategies. We have added new text (lines 56-65) which state how GMOs differ from PBOs and copied below.

Precision bred organisms (PBOs) possess mutations including deletions, inversions, substitutions, or additional DNA fragments, that could have been occurred obtained through conventional breeding approaches and where no foreign DNA remains in the resulting organism. These techniques differ from those used to generate GMOs, where the organism’s genome has been altered in a way that would not naturally occur through mating or natural recombination and are generated via transgenesis.