Guidance on the FSA Consultation on Precision Breeding

November 27, 2023 by Staff Reporter

We have had many requests for guidance in filling in the Food Standards Agency (FSA) consultation on the deregulation of genetically modified precision-bred organisms (GMO/PBOs).

We can’t stress enough how disappointing it is that the FSA proposes to remove consumers’ right to know what they are eating in favour of an untransparent and unenforceable system that treats laboratory created, genetically modified precision-bred organisms as if they were the product of traditional breeding.

It is important that everyone who is interested in, or concerned about, the food and farming system and the provenance and quality of the food we eat and grow, to responds to this consultation.

The FSA has not made it easy to give a considered response. Indeed, we and others have submitted an official complaint to the Agency about this. But, while our complaint is being considered we will, nevertheless, be responding to the consultation. We hope you will too, and that the guidance below is helpful.

The Basics

There are two ways to respond to the FSA’s consultation:

You can use the online form.
Or you can submit a letter via email to precisionbreeding@food.gov.uk

If you choose to submit a letter do the following:

Make the subject header clear, e.g. SUBMISSON: Consultation on proposals for the regulation of precision-bred organisms used for food and animal feed.
At the top of your letter say you are submitting your response as a individual/small business/etc and request that you receive an email acknowledgement that your response has been received.
Say if you want your answers to remain confidential or not
Consider a short introductory paragraph on why you are responding – do you support the FSA’s plans to remove certain products of modern biotechnology from the scope of GM regulations? If not, what concerns you about the FSA’s plans? How will it affect you personally?
Try to address your points in the same order as they appear on the online form (see below).
The FSA discourages respondents from talking about labelling because labelling is not provided for in the Genetic Technology Act – but the Act can be changed to include mandatory labelling if enough of us demand it and so we suggest, given that labelling is vital for consumer information and trust, for transparency and enforcement, that you talk about labelling anyway.

The FSA has produced a consultation pack with additional information, but be warned, this pack is (as our complaint to the FSA details) full of misleading information.

You don’t need any expert knowledge to respond. In fact, it is valuable for you to respond as a potential consumer, citizen and end user of unregulated genetically modified precision-bred organisms. It’s OK to be angry about these proposed changes, but however you respond please aim to be firm but polite.

When you respond remember:

Keep your comments focused on the FSA’s/government’s deregulatory proposals.
You don’t have to answer every question. The online form allows you to make a short submission by just filing in the first page.
The longer consultation only has 6 main questions but underneath each main question is a series of sub-questions. You can choose to answer only those questions where you have a strongly held view or particular expertise.
Most of the questions follow a similar pattern: multiple choice (agree/disagree) followed by space for free text. You do not have to put anything in the free text boxes if you don’t want to or don’t feel confident to.
We provide some more guidance below, but it is important that, if you use the free text spaces, to use your own words. Copy and paste responses are generally disregarded.

Closing date for responses is 8 January 2024.

The Questions

Questions 1 and 2

These questions cover the pre-market authorisation and ‘triage’ process which FSA proposes which places genetically modified precision-bred organisms into one of two categories, or tiers. Once the Defra Secretary of State has accepted the self-certification statement of a biotech developer about a particular GMO/PBO:

Tier 1 products go straight to market without any additional scrutiny
Tier 2 products may require additional scrutiny but after this process can also go straight to market

Neither tier 1 nor tier 2 GMO/PBOs will be labelled.

For question 1, the first three sub-questions (Q1a-1c) gauge how much you agree/disagree with the tier 1. There are then four sub-questions (Q1d-1g) which are free text. Some thoughts you may wish to consider here are:

Changing from regulation to no regulation at all is not proportionate, especially since the safety profiles of these new GMOs have yet to be established.

The FSA is an independent government agency, but it does not appear to have done any independent thinking about GMO/PBOs. Instead, it is just following a highly contested government narrative that GMO/PBOs are the same as natural or traditionally bred foods and that self-certification is appropriate and safe. Allowing the developers of genetically modified organisms to self-certify the status and safety of their laboratory creations is not a proper audit process and does not fulfil the FSA’s mandate for “food you can trust”.

FSA appears to be relying heavily on the advice of the Advisory Committee on Novel Foods and Processes (ACNFP). However, it is clear most ACNFP members have declared commercial or institutional conflicts of interest. This means that where there is doubt, the benefit of that doubt will always be for the developer rather than for precaution and safety.

The main beneficiaries of this two-tiered approach are the developers who are being allowed to self-certify the status of their precision-bred organism. Consumers and businesses that wish to or legally must (e.g. organic) remain GM-free do not benefit and the removal of labelling means that GMO/PBO products does not fulfil the FSA promise for “food that is what it says it is”.

Question 2 follows a similar format and is asks for views on the tier 2 process.

The first four sub-questions (Q2a-Q2d) gauge how much you agree/disagree with the tier 2 approach. The next three questions (Q2e – Q2g) are free text. Some thoughts you may with to consider here are:

The premise that precision-bred organisms are different from GMOs is scientifically unsound and a poor basis for regulatory decisions. Precision-bred organisms are GMOs, as the Genetic Technology Act 2023 makes clear. Precision breeding is a marketing term, not a scientific discipline, and these new GMOs carry all the same risks, uncertainties, and novel challenges of older style GMOs. If they are to be allowed onto the market, they should be fully regulated and labelled.

FSA has not produced or provided any research or estimate of what percentage of GMO/PBOs will fall into each category. Independent estimates suggest that upwards of 94% of GMO/PBOs will fall into the tier 1 category, and therefore enter the market unlabelled and untraceable.

The process as proposed by the FSA has no meaningful barriers to implementing the deregulatory agenda. By failing to understand the impact of an unregulated market on consumers but also on food businesses and farmers, FSA has failed in its duty to all these groups.

Question 3

This question concerns the FSA’s plans to create a public register held on a government website, as an alternative to on-product labelling.

The first sub-question (Q3a) gauges how much you agree/disagree with this approach. The next two questions (Q3b-Q3c) are free text. Some things you may wish to consider are:

It is not clear if the proposed public register is separate from the register which Defra must create or if it will simply be a mirror of information held elsewhere on the government web platform. Given that Defra has largely failed in its duty to consider independent scientific information about GMO/PBOs, a mirror site could not be considered a source of independent information for consumers but instead a source of government propaganda.

It is not clear how user friendly the register will be – e.g. whether it will include the name of products that include GMO/PBOs, and how consumers are expected to use it to aid their food choices in supermarkets, restaurants and other food outlets.

FSA consumer surveys have shown that most consumers would not use, or know to use, the register unless there is product labelling. Without being alerted to the presence of GMO/PBOs on a food label, there is no trigger to look for further information on a government website.

A public register is not a substitute for product labelling. The public register does not adequately inform consumers of the nature of the food they may be buying. The FSA’s own research has shown that without product labelling to alert consumers to the presence of GMO/PBOs in a food item, there is no reason for consumers to consult a register. This finding of the FSA consumer surveys was left out of the consultation information pack.

Without labelling, businesses will find it difficult to avoid PBOs in their food supply and farmers will not be able to choose what they feed their animals.

Question 4

This question looks at the traceability of GMO/PBOS in the food/feed system and gauges views on the proposal that these require no special traceability beyond what it already in place for non-GMO food/feed.

The first sub-question (Q4a) gauges how much you agree/disagree with this approach. The next three questions (Q4b-Q4d) are free text. Some things you may wish to consider are:

The traceability provisions in general food law, known as ‘one up/one down’, are inadequate in an increasingly long and complex food chain. With one up/one down, traceability can be easily lost in commodity products that are blended (e.g. milk from multiple farms in a dairy) or dissected and mixed through the supply chain (e.g. animals for meat production). During product recall and food safety investigations, auditing via a one up/one down trail of records is tedious and time consuming. This is a disadvantage if, for instance, a PBO were to cause widespread allergic reactions or toxic effects. It may also be beyond what many small and medium size businesses are able to implement. In addition, a consumer experiencing a reaction to a particular PBO food would not report it because there would nothing to alert them to the fact that this is a GM/precision-bred organism. Thus end-to-end traceability would not be possible with the FSA’s proposed system.

FSA says there is a lack of evidence that PBOS are intrinsically riskier to consumers. This is a distortion of the facts; absence of evidence is not the same thing as proof of safety. PBOs are so new that there is no evidence at all on their safety or risks. Developers, encouraged by the promise of unfettered access to the marketplace and of no regulation at all, have shown they do not wish to undertake this research. In the face of this uncertainty, the precautionary principle – the very opposite of what the FSA is proposing – should apply.

The FSA recently commissioned a literature review on detectability. The Government narrative is that GMO/PBOs are identical to traditionally bred and/or naturally occurring organisms and therefore cannot be detected. The literature review, conducted by an eminent government scientist, disagreed with this and concluded that the scientific literature shows that detection methods do exist, that they can be developed further, and that detection is a cornerstone of traceability and necessary to support enforcement. The FSA rejected the conclusion of its own literature review in favour of the deregulatory agenda it is now pursuing. The FSA is not ‘following the science’ and this is to the detriment of a food system people can trust.

Question 5

This question considers enforcement. FSA is proposing that Local Authorities and Port Health Authorities in England should be responsible for enforcement (they are already responsible for enforcement where GMOS are concerned). No special or new power for criminal prosecutions is being proposed.

The first three sub-questions (Q5a-Q5c) gauge how much you agree/disagree with this approach. The next four sub-questions (Q5d-Q5g) are free text. Things you may wish to consider are:

What FSA is proposing in essentially the maintenance of the status quo since it is already the duty of local authorities and port health authorities to enforce existing GMO regulations. How can these authorities do their job if the products are not labelled and if traceability is limited to insufficient one up/one down systems? The proposal amounts to kicking the can down the road rather than dealing responsibly with the challenges of new GMOs in the food system.

Question 6

This question considers the wider impact of deregulation of GMO/PBOs.

The first six questions (Q6a-Q6f) gauge how much you agree/disagree with this approach. The last question (Q6g) is free text. Things you may wish to consider are:

The consultation pack says quite clearly that FSA has not performed a full impact assessment on the impacts of deregulation.

The only impacts the FSA recognises is the inconvenience caused – to 75 plant breeding businesses, 346 Local Authorities and 37 Port Health Authorities – by the few hours it will take to read the new regulations.

Familiarisation with the new rules is not the only impact of deregulation. When contamination occurs or a food product is recalled due to a safety concern, for example, it can result in significant economic losses for everyone involved in the supply chain, including farmers, processors, distributors and retailers. In its consideration of impacts, the FSA has ignored:

- The large non-organic farming and food sector which includes non-GM, organic, artisanal, UK geographical indication (GI) schemes and natural food businesses for whom loss of certification or status can cause economic and reputational loss.
- Impacts on trade, especially where UK regulations differ from those of trade partners.
- Consumer’s right to know what they are eating and their ability to judge this at point of sale.
- The cost and economic losses associated with a product recall if a PBO causes a toxic or allergic reaction. These have a profound effect on the UK economy including food hypersensitivity-related hospitalisations costing, according to FSA figures, approximately £80 million a year. For major retailers cross-contamination or the presence of unwanted allergens can cost, on average, £1 million per recall.

In place of a full and thorough impact assessment, FSA has chosen to rely upon the information in an earlier Defra Impact Assessment which was published with the draft Genetic Technology Bill. This impact assessment was found to be “not fit for purpose” by the government’s Regulatory Policy Committee because it:

- Did not adequately considered and discussed the full range of potential impacts arising from the creation of a new sub-category of GMO.
- Did not sufficiently considered and discussed the full range of impacts on small- and medium-sized businesses.
- Needed to explain more clearly how the introduction of a new sub-category will not undermine the stated policy intention of reduced regulatory burden.
- Needed to include greater discussion of the impacts arising from labelling and traceability.
- Needed to revisit the assumption relating to the devolved administrations (DAs) and what impact this will have on them across the various scenarios.
- Failed to include a detailed assessment of the competition, innovation, consumer and environmental impacts.