The Form Playbook Interview: Emily Miles, FSA, on food startups and regulation
Every month we interview a leader in venture, start-ups and regulation for The Form Playbook, our newsletter supporting founders building the future of regulated markets.
This month we spoke to Emily Miles, CEO of the Food Standards Agency. Prior to this Emily had a wide ranging career in senior roles across government and regulators, with a particular focus on environment and food policy as well as policing and home affairs. Now, Emily is leading the FSA as it adapts to new and growing responsibilities post-Brexit, including how it supports innovation in food like gene editing and alternative proteins. We caught up to discuss how this is going, and what it means for startups.
Our takeaways from the interview:
- The Food Standards Agency has two big projects to enable food innovation led by startups: it’s developing new regulations to allow gene editing in plant and animal production (aka ‘precision breeding’), and undertaking reforms to novel foods regulations to speed up approvals for products like alternative proteins.
- But the FSA is under-resourced: As the regulator has taken on more domestic activity post-Brexit, capacity constraints have limited the pace of its work on innovation, with novel foods reforms not expected until 2025/26. It’s a good example of how even deregulation often requires more resource, not less.
- The FSA also exemplifies how structural incentives can be challenging for innovation: The regulator’s first priority is public safety, and currently their mandate is only to consider risk, not benefit (unlike e.g. medical products). But they’re working to correct this and to support emerging technologies, e.g. by trialing new systems in parallel to old regimes, developing better pre-application guidance for startups, and building stronger internal understanding of frontier innovations.
FORM: Emily, you’ve had an incredible career across government and regulators, often in roles that require “getting stuff done”, for example in policing. What’s at the top of your list at the FSA for the next 6–12 months?
EMILY MILES: Our first priority for the next few months is making sure we provide a good service for what we call official controls, and on regulated products.
Official controls involve FSA staff inspecting, auditing and assuring businesses in England and Wales producing meat, wine and dairy. The largest part of this is in meat, where we have inspectors in every abattoir.
On regulated products, we receive applications for food, additives, animal feed, and food contact materials, to be authorised for sale. Our scientists, and expert advisory committees, review the evidence dossiers that are submitted, and make sure we’ve got enough information to form a judgment that will keep consumers safe.
We’re also starting to think about how we reform our framework for regulated products. The FSA Board has challenged us to consider a wide range of options for radical reform of our Regulated Products frameworks.
We have joint responsibility for the authorisation of Regulated Products with Food Standards Scotland; and we advise ministers in Wales and England on these matters; so the development of any reform plans will be taken forward in consultation with the devolved nations and their ministers. Food policy is a devolved matter.
New arrangements for border controls are also a priority. We welcome the Border Target Operating Model (BTOM), which sets out a new regime for imported food and feed products entering the UK.
The controls address a gap in consumer protection which the FSA highlighted last year in our annual report on food standards. The proposals will help the FSA in its work to respond to food incidents both nationally and globally. These checks will apply to whole world, not just EU, and will help to ensure that the requirements on business are necessary and reflect the risks to food safety. We are proud to have worked across government — particularly devolved governments — to develop a more proportionate intelligence led system.
We are also focussed on implementing the Windsor Framework that will facilitate the movement of agri-food goods within the UK. We’re working closely with our delivery partners in district councils, other government departments and industry to set out more detail on the arrangements, implement any changes to processes, and provide readiness support as needed.
Our priority is to ensure Northern Ireland consumers receive the same level of robust public health protection as the rest of the UK, whilst making the process of getting compliant goods to consumers as smooth as possible for traders.
Another of our important priorities is to develop new regulations for precision bred food and feed following the introduction of the Precision Breeding Act. Food you can trust cuts across our entire mission and businesses will be able to innovatively bring new products which provide potential benefits to consumers whilst ensuring consumers can be confident that precision bred food is safe.
Precision breeding precisely changes the DNA of plants or animals where changes must be equivalent to those that could have been made using traditional breeding methods. Our role involves establishing a regulatory framework which regulates precision bred organisms (PBOs) for use in food and feed to be safe for consumers whilst allowing businesses to realise food products which could provide sustainability and health benefits for consumers.
We have undertaken great care to understand what stakeholders and consumers think as we continue to develop the policy. We engaged in deliberative workshops with consumers and consulted with trade associations, scientific institutes, NGOs and many more. Our policy is underpinned by expert advice by scientific advisory committees and research including consumer studies.
We’re now in the process of preparing for our September Board Meeting on 20 September and have published our recent paper on draft proposals for the precision breeding framework. We will directly advise Ministers on the approval of all PB foods and processes for sale or use in the England market and are developing this advice in line with principles of proportionality and safety agreed by the FSA Board.
You’ve been candid about the fact that the FSA’s ambitions around innovation are constrained by limited resources. Meanwhile countries like Singapore and even the US have taken steps to approve cultivated meat products in the last year or so. In what ways would extra resource allow the FSA to do more — and more quickly — when it comes to innovation?
Extra resource would allow the FSA to employ more people so we could consider applications faster. It also takes people to develop radical reform ideas that could reshape the way we regulate certain products and save us time in the long run. We really want to be able to respond to innovative and emerging food technologies but our current resource constraints and the legal strictures of the current regimes, mean we can’t do as much as we’d like.
Reform of Regulated Products legislation and approval processes could make it easier for businesses to do the right thing by the consumer, while also removing unnecessary barriers to innovation.
Options such as conditional authorisation — where we allow products on the market subject to certain conditions, and more quickly than now; and increased international collaboration — where we rely on other regulators’ assessments of safety — would allow safe products to gain market access quicker. So, we want to consider those. But we need to always make sure that we have protected consumers’ safety. The reason why the FSA was established, was because consumers’ interests had been neglected. Doing so actually damages the reputation of UK food, so is not good for business, or for consumers.
Any change would require us to change the law, which takes time.
For the moment, current capacity to work on regulatory reform is focused on developing a new regime for precision-bred (gene edited) food and feed. That is taking up a fair bit of our time.
Even with the necessary resources, it can be hard for regulators to be “risk on” when it comes to embracing new technologies, given they often have a strong public safety element to their role, or are required to operate within inflexible legislative parameters. From your experience are there ways to promote — and reward — sensible risk taking and bold action from regulators?
Ultimately trust is incredibly valuable. If it’s lost, it costs businesses and the UK dearly. Having an authoritative and thoughtful FSA view on whether something is safe is pretty precious because it commands consumer and trading partner confidence. We need to come to our judgements on the back of science and evidence, with the consumer interest firmly at heart.
In that context, though, there are definitely ways regulators can support innovation and emerging technologies without compromising public safety. We can do things like trial new systems in parallel while still running the old regime (we are doing this with large enterprise food hygiene inspections at present — see https://www.food.gov.uk/board-papers/achieving-business-compliance-programme#summary ), take a proportionate approach so that not every type of product is treated the same, think hard about whether we demand a renewal application by exception or as routine (currently for some regimes like food and feed additives, it’s routine that there be a 10-year renewal point). We’re also wondering how to assess benefits alongside risk — something that is done in regulation of medicines, but not done in regulation of food.
It’s also important that regulators stay across industry developments so that we can anticipate what might be coming and do some of the thinking before really novel applications arrive with us formally. Or, put another way, regulators must have a strong understanding of the sectors they regulate and where regulations impact on industry. They can embed horizon scanning into their work and use these insights to build their knowledge and capability to deal with new, innovative and emerging technologies.
Providing guidance to applicants on the regulatory requirements is important, as is speed and agility in decision making. They should also promote market and consumer confidence in the regulatory regime through robust science and evidence-based risk analysis.
We often see regulators struggle to engage with innovators, especially early-stage startups. Similarly, startups are often nervous to speak to regulators. Do you have any advice for those seeking to follow and engage with the FSA’s work around reform and innovation, or broader ideas on how to increase that connectivity?
The FSA has useful guidance on its website for anyone applying to go through the risk analysis process. Alongside Food Standards Scotland, we’ve recently launched a new system for businesses to make applications for Regulated Products. It’s designed to make it easier for applicants to understand what information is required to submit a good-quality, complete application for their product and will be particularly helpful for new businesses and those that don’t traditionally recognise themselves as food or feed businesses, like start-ups. There are detailed checklists for each regime and applicants can log in to see progress updates.
We’re also considering how to deliver pre-application support to gain insight on the challenges innovators and startups experience and how best the FSA and other Government Departments could support them.
Timely discussions are really important. For new technologies and innovative products, we encourage early engagement to develop knowledge and understanding with the relevant teams in the FSA. Prospective applicants may contact the RegulatedProductsEngagement@food.gov.uk team who will arrange the appropriate support and engagement with FSA officials. This will help us spot challenges sooner rather than later and allows time for the applicant to gather the evidence necessary to build a good quality application.
Finally, the tagline of your work is “food you can trust”, which is a responsibility that the FSA shares with food producers. Do you have any advice for innovators in the way that they build public buy-in to their new foods, especially those that are genuinely novel, like cultivated meat?
We have built a level of trust with consumers through the openness and transparency of our work and our robust approach to food safety. Food businesses can help support food you can trust by providing good quality applications, which clearly set out the potential risks and mitigations which will allow us to continue to deliver quality risk assessments. By doing this, they will help the FSA support food innovators and to maintain trust that food is safe and is what it says it is.
This interview was published on The Form Playbook, our newsletter supporting founders building the future of regulated markets:
