Appendix 1: Genetic Technology (Precision Breeding) Bill: Government Response
Letter from the Rt. Hon. Lord Benyon, Parliamentary Under Secretary of State at the Department for Environment, Food and Rural Affairs, to the Rt Hon. the Lord McLoughlin CH, Chair of the Delegated Powers and Regulatory Reform Committee
I would like to thank your committee for its report following its review of the provisions in the Genetic Technology (Precision Breeding) Bill. I welcome the report and the debate at Committee Stage which followed its publication. As the minister responsible for the Bill in this House, I am committed to ensuring the powers in the Bill are proportionate, and subject to the appropriate level of Parliamentary scrutiny. The Government has carefully considered the Committee’s recommendations and I have set out our response to each recommendation below.
Powers to prescribe the information that must be provided to the Secretary of State by a person who wishes to release or market a precision bred organism (paragraph 14)
Committee view
The Committee stated that, without further justification, the power provided to Ministers in clauses 4(3) and 6(2) is considered “inappropriate”. The Committee consider the information that those who propose to release or market precision bred organisms are to be required to provide to the Secretary of State is a matter of “significant public interest”.
Government response
Clause 4 sets out the notification requirements for release of a precision bred plant or animal (precision bred organism or PBOs) and clause 6 sets out the notification requirements for the marketing of such organisms. While releases of PBOs will not need to be authorised, the information contained in release notices will enable the Government to exercise oversight and, insofar as that information can be required to be published pursuant to regulations to be made under clause 18(1), provide transparency over such releases. The information provided in a marketing notice would serve these functions too and will also be used to confirm that the organism is precision bred.
While the content of these notices will serve some important purposes, we do not feel it is appropriate to set out the content requirement on the face of the Bill. Precision breeding is a rapidly developing area, and it is important that we have the ability to adjust our requirements for the form and content of the notice, and any accompanying information from time to time. We will seek expert, independent advice on the technical details to ensure that the requirements are appropriate and up to date.
Regulations under clause 4(3) will set out what information must be provided in a release notice and any associated information requirements which we believe are administrative in nature, for example the types of persons which can be specified in a release notice, or the form such a notice needs to be given in.
We anticipate that the content and information required in a release notice will initially be equivalent to that in the Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022, which Parliament debated and agreed under the affirmative procedure last year.
Regulations under this power may also prescribe who may be specified in notices to release precision bred organisms. The intention is to allow notifiers to specify organisations and groups of individuals to carry out releases, allowing research institutes to nominate farmers who can then carry out field trials.
Regulations under Clause 6 will set out what information must be provided in a marketing notice and any associated information requirements which we believe are administrative and technical in nature.
A marketing notice will need to contain detailed technical information that enables the advisory committee to provide a report to the Secretary of State on whether it considers the organism to be precision bred. The criteria for this assessment are already established in Part 1 of the Bill, and the content requirements of the marketing notice will have to reflect these criteria by setting out technical and administrative details of the evidence that must be provided to satisfy the Secretary of State that those criteria are fulfilled. This will include evidence of the genetic changes made, and a confirmation that all functional transgenes have been removed. ACRE will analyse this evidence and provide a recommendation to the Secretary of State for Environment, Food and Rural Affairs on whether the organism is precision bred. If more evidence is required, ACRE may request additional information to aid their decision. Furthermore, ACRE will publish guidance to help researchers and developers with the technical details.
While we remain of the belief that the matters to be set out in regulations under these powers are administrative in nature, the Government acknowledges these provisions are of significant public interest, and we accept the Committee’s concerns. While we do not believe that it would be appropriate for the content requirements of these notices to be set out on the face of the Bill as these requirements would be expected to change over time as the technology and the industry develop, we are tabling amendments to change the Parliamentary procedure from negative to affirmative for both powers. These changes will increase the level of Parliamentary scrutiny when the powers are used to prescribe the information that must be provided to the Secretary of State by a person who wishes to release or market a precision bred organism.
Power to make provision requiring a person to carry out an environmental risk assessment before they import or otherwise acquire a precision bred organism (paragraph 18)
Committee view
The Committee views that the issue of whether a person who wishes to import or otherwise acquire a precision bred organism should have to carry out an environmental risk assessment “may be considered significant in policy terms” and stated that “unless the Minister can provide the House with a convincing justification for leaving this entirely to ministerial regulations–and subject to negative procedure scrutiny–the power in clause 17(1) is inappropriate”.
Government response
We believe the powers in this clause are justified. The scientific advice from the Advisory Committee for Releases to the Environment, supported by the Royal Society, the Royal Society of Biology, and the Roslin Institute, is that PBOs pose no greater risk to the environment than their traditionally bred counterparts. As a result, clause 41 removes PBOs from Part VI of the Environmental Protection Act 1990. This means that, among other things, precision bred organisms will no longer be subject to the restrictions in that Part that are designed to control the exposure of genetically modified organisms to the environment, including requirements for prior authorisation of releases of such organisms into the environment. It also means that the provisions in section 108 of that Act will no longer apply to PBOs. This is the existing statutory provision which would require an environmental risk assessment before a precision bred organism is imported or acquired. In practice, this requirement currently applies in relation to PBOs imported or acquired to be kept under contained use conditions. The Genetically Modified Organisms (Contained Use) Regulations 2014 control the use of precision bred organisms under contained use conditions, such as laboratories. These regulations apply during the stage of development before a GMO is released into the environment. The Government considers that they are appropriate and operate in accordance with their intended purpose, and it is not necessary for the Genetic Technology (Precision Breeding) Bill to amend these Regulations or any other requirements of the contained use regime.
Therefore, the power in Clause 17 will be used to retain the proportionate environmental risk assessment requirements that currently apply to precision bred organisms imported or acquired for use under contained use conditions. The Government believes that it is appropriate to retain these requirements through regulations rather than on the face of the Bill to ensure that this can be done in the most effective and accessible manner. Section 108 of the Environmental Protection Act 1990 was drafted to cover numerous situations, but this provision has only been brought into force partially. It is now desirable to separate out the risk assessment requirements that currently apply to precision bred organisms imported or acquired for use under contained use conditions, into a clear and accessible provision that would meet modern drafting standards. It is also desirable in the interests of accessibility and transparency for substantive requirements relating to the contained use regime to be set out in regulations which relate specifically to that regime, rather than in a Bill which deals principally with the release and marketing of organisms.
As the intention is only to retain specific requirements which exist currently and do not require updating, the Government considers the negative procedure to be appropriate in this instance.
Power to prescribe information that must be included in the precision breeding register (paragraph 24)
Committee view
The Committee considers the obligation imposed on the Government to keep a public “precision breeding register” as a means of delivering transparency is “an important matter of public interest”. The Committee view that it is “important that the provision prescribing that information is subject to the appropriate level of parliamentary scrutiny” and “unless the Minister can provide the House with a convincing justification for it, the power in clause 18(1) is inappropriate”.
Government response
Clause 18(1) imposes a duty on the Secretary of State to establish and maintain a register containing information in relation to various matters arising under the Bill.
This clause enables information relating to a wide range of matters relating to precision bred organisms to be made public, in the interest of transparency and public reassurance. It is intended that this would provide a high level of transparency, and that the information would be published as soon as reasonably practicable.
The range of information that this clause would enable to be published includes, but is not limited to, information relating to the release and marketing notices, reports from the advisory committees, as well as enforcement notices. It is not practicable to specify on the face of the Bill details setting out specifically which information about these matters will need to be published, as the contents of many of the notices and other documents will themselves be prescribed by regulations which will need to be updated from time to time to reflect technological developments and industry practice in what is a rapidly developing area.
The Government acknowledges these provisions are of significant public interest, and we accept the Committee’s concerns, therefore we are tabling an amendment to change the Parliamentary procedure from negative to affirmative.
This change will increase scrutiny when powers are used to prescribe information that must be included in the precision breeding register. The Government hopes the change of procedure from negative to affirmative will provide reassurance.
Power to prescribe the circumstances in which the health or welfare of an animal is to be regarded as “adversely affected by any precision bred trait” (paragraph 29)
Committee view
The Committee views that defining the circumstances in which the health or welfare of an animal is to be regarded as “adversely affected by any precision bred trait” for the purposes of the Bill is “significant in policy terms and is a matter of public interest”. The Committee requested justification of leaving this definition to ministerial regulations and considered “unless the Minister can provide the House with a convincing justification for it, the power in clause 25(1) is inappropriate”.
Government response
Clause 25 enables clarification to be provided on the particular circumstances in which the health or welfare of a relevant animal or its qualifying progeny is, or is not, to be regarded as being adversely affected by any precision bred trait for the purposes of clause 11(3) or 15(1)(b). Clause 11(3) relates to the requirement for an animal welfare declaration to be provided when an application for a precision marketing animal marketing authorisation is made, whilst clause 15(1)(b) relates to the revocation of a precision bred animal marketing authorisation on the basis of post-marketing health and welfare concerns.
We acknowledge that the content of any regulations made under clause 25 is likely to be a matter of public interest. However, we consider that our approach is justified by the level of detail that may be needed as identifying the necessary detail in relation to precision bred traits, likely to be a technical and complex matter and may vary according to the precision bred animal. It is therefore appropriate for the detail to be properly informed by engagement with experts and stakeholders. With this mind, we recently commissioned research to help us to gather the scientific evidence required to assist in the development of regulations under clause 25(1).
Furthermore, it may be necessary to change the criteria in which the health or welfare of a relevant animal or its qualifying progeny is, or is not, to be regarded as being adversely affected by any precision bred trait over time to reflect developments in scientific understanding. Regulations under clause 25 are subject to the affirmative procedure in acknowledgement of the relative importance and the likely public interest in the detailed criteria that may be included in the regulations.
Powers to make provision for regulating the placing on the market of food and feed produced from precision bred organisms (paragraph 38)
Committee view
The Committee views that “the Government have failed to justify the inclusion of skeleton clauses in Part 3 of the Bill that leave it entirely to ministerial regulations to determine the substance of the regulatory regime that is to govern the placing on the market of PBOs for food and feed use; and accordingly, unless the Minister can provide the House with a convincing justification for the delegations of power in clauses 26, 27, and 28, those powers are inappropriate”.
Government response
The Government wishes to reassure the Committee that the Food Standards Agency (FSA), which is the department primarily responsible for developing recommendations to Ministers on the new regulatory framework for PBOs for food and feed use recognises the importance of the concerns highlighted by the Committee in relation to Part 3 of the Bill. We trust that this response will provide reassurance about the plans for the powers given to the FSA in clauses 26, 27, and 28.
As an independent Government department, the advice the FSA gives to ministers is driven by its statutory responsibilities to protect public health and represent consumer interest in relation to food. The FSA already implements processes for authorising food and feed products, such as novel foods, that are well established. The detailed regulatory design for PBOs for food and feed use will conform in all respects to the requirements of existing food law and will be consistent with the existing administrative processes for authorising food and feed products which are well-established and well-understood by industry and other stakeholders.
To assist the Committee, we have set out below more detail about these requirements and the process for regulated products approvals.
Food law
The purpose of food law is to ensure “a high level of protection of human health and consumers’ interest in relation to food” (Article 1 of retained Regulation (EC) No 178/2002). In order to achieve this, food law is based on risk analysis (Article 6 of retained Regulation (EC) No 178/2002), and these requirements will be at the forefront of the considerations when developing recommendations to Ministers about the regulatory framework for authorising PBOs for food and feed use.
The Regulated Products Service
The FSA intends to build a proportionate regulatory regime for PBOs for food and feed use which is based on a two-tiered authorisation process. This will be developed as part of the regulated products service.
The FSA, alongside Food Standards Scotland, already has responsibility for managing applications for new regulated food and feed products to be placed on the GB market. The information required in an application comprises of administrative, technical, and safety information, including the developers’ details, the identity of the food or feed, the compositional data and nutritional information, as well as toxicological information and allergenicity.1
Clause 26
FSA proposals for the regulatory framework for authorisation of PBOs for food and feed use will be based on the expert advice of the Advisory Committee for Novel Foods and Processes (ACNFP), extensive consumer research and engagement with key stakeholders in the food industry. The objective for the framework is to ensure that the products that go through the assessment process may be brought to market under a shortened timeframe (compared to other regimes), without compromising food safety or consumer confidence.
The FSA has proposed a tiered approach that is proportionate, transparent, and based rigorously on the science and evidence. The ACNFP and its Products of Genetic Technologies (PGT) sub-committee have begun to define the criteria for which tier a precision bred organism could be assessed under. The criteria are likely to include:
- whether the organism would otherwise require assessment as a novel food;
- whether there is an impact on the nutritional quality that would potentially be disadvantageous, e.g., a significantly higher level of a nutrient;
- whether there is a significant increase in a toxicologically relevant component that would represent a safety concern, e.g., a compound increased to deter insects that could be a safety concern in humans.;
- whether there is a significant change in the allergenicity of the organism, e.g., significant increased levels of gluten in wheat flour.
Products similar to those that have already been obtained through traditional breeding, where the risks are well-understood, and where none of the above criteria apply are likely to be recommended to be placed in Tier 1. The FSA expects Tier 2 to be more in-depth and rigorous than assessment under Tier 1. It is important to note that under these proposals all products would be assessed rigorously and a decision about whether to treat products as Tier 1 or Tier 2 would be based on evidence.
The delegated powers in clause 26 will enable the implementation of a proportionate regulatory regime, which will build on the existing frameworks following expert scientific advice. This futureproofing is necessary as the specific technical details of the Precision Breeding Framework need to be science and evidence led. It is vital to take full account of the recommendations of the ACNFP as the detailed design of the regulatory approach is developed, and to not pre-empt their advice. The design of the regulatory regime for authorisation of precision bred organisms for food and feed use will be subject to full consultation, ministerial agreement and Parliamentary scrutiny.
Clause 27
The register for precision bred organisms authorised for food and feed uses is intended to be incorporated into the register of Regulated Food and Feed Products2 as part of ongoing work to provide public registers for all areas of regulated products used in food and feed. The format of the register is likely to align with the information provided on other registers and the FSA will carry out a public consultation on the proposal for the public register. The register will provide enforcement authorities, international trading partners and consumers with vital information about what precision bred organisms are permitted for use in food and feed in England.
The Register of Regulated Food and Feed Products is an online, searchable database of all regulated products authorised for use in the GB market. This includes registers of authorised feed additives, flavourings, smoke flavourings and genetically modified organisms for use in food and feed, as well as a public register showing the progress of validated regulated product applications submitted to the application service. The registers give details on the authorised food and feed, including information such as the product type, the organisation that has applied to the regulated products application service, the product name, a summary of the product, and the phase of assessment it is currently in.
While the FSA board has committed to a public register of authorised precision bred organisms for food and feed use, the use of delegated powers in Clause 27 is considered appropriate because the specific information displayed on the register will be determined following appropriate consultation to consider what is necessary for consumers, industry, and enforcement officials. This includes largely technical details and is dependent on the regulatory framework adopted for precision bred organisms for food and feed use. The consultation will follow on from the decision on what constitutes the entire regulatory framework and is therefore more appropriate to secondary legislation. This clause is subject to affirmative procedure to ensure appropriate level of parliamentary scrutiny of the details of what the public register will contain.
Clause 28
Full compliance with the new regulatory regime is crucial to ensure food safety and to maintain public trust in the food system. The delegated powers in clause 28 are appropriate because the specific details of the regulatory regime will inform how compliance is enforced. The information provided by the applicant for the authorisation process will help shape enforcement tools, and the public register. As it is necessary to wait for scientific advice and ministerial decisions on the implementation of measures under the delegated powers in clause 26, it follows that the provisions to be made clause 28 will also be determined at a later date, to dovetail with the regulations under clause 26.
Paragraph 32 & 37: discretion afforded to ministers and requirement for consultation
The FSA is under a legal duty to conduct an open and transparent public consultation on the detailed proposals for the new authorisation process for precision bred food and feed, which acts as a safeguard to the exercise of such a wide discretion. This is required under Article 9 of retained Regulation (EC) 178/2002 (General Food Law), which states that “There shall be open and transparent public consultation, directly or through representative bodies, during the preparation, evaluation and revision of food law, except where the urgency of the matter does not allow it”. This public consultation has not occurred yet, as it is intended to focus on specific proposals.
The FSA has been conducting consultation activities with relevant stakeholders and devolved administrations including stakeholder workshops, trade and industry forums, cross-government discussions and meetings with civil society and academia. These activities are feeding into development of the technical details of the regulatory framework. Furthermore, the FSA has conducted extensive research with consumers, with a research project on perceptions of gene editing3 published in July 2021 and a follow up project concluded in October 2022. A full report of the most recent project is due to be published in early 2023 and is intended to give an accurate view of the current perceptions of precision bred organisms in food and feed, which will assist the FSA with building and maintaining consumer trust in the regulatory process moving forward.
While clauses 26 to 28 provide delegated powers for ministers, the use of the affirmative procedure and the requirement under General Food Law to carry out public consultation, as well as the independent advice supported by science and evidence provided by the FSA, should provide reassurance that there will be sufficient opportunity for public and Parliamentary scrutiny on the future regulatory framework.
Paragraph 35 & 36: skeleton clauses
The implementation of a regulatory system for food and feed derived from precision bred organisms is a highly technical and complex area, which the Government considers is not appropriate for primary legislation. The high level of detail needed to implement the regulatory framework is considered more appropriate as secondary legislation, as we trust is evident from the justifications and explanations above. The complexity of the science of precision bred organisms, combined with the need for openness and transparency, has required a high level of scrutiny by scientific experts to ensure the framework supports the FSA’s mission of ‘food you can trust’, in which safety is a major component.
Power to make regulations that provide for enforcement measures in relation to failures to comply with requirements under Parts 2 and 3 of the Bill (paragraph 42)
Committee view
The Committee views the approach taken in clause 32(1)–which make provisions for ministerial regulation to determine whether the enforcement measures specified in that clause are to be put into place in relation to breaches of requirements under the Bill–“merits explanation; and unless the Minister can provide the House with a convincing justification for this approach, the power in clause 32(1) is inappropriate in its current form and should instead require regulations to be made to ensure that the enforcement measures in question are put into place.”
Government response
The purpose of the Bill is to facilitate the development and commercial use of these new technologies in England. The technologies are novel, the science behind them is developing rapidly, and these technologies have not been commercialised to any significant extent to date. It is intended that the obligations created by this Bill will be backed by a proportionate enforcement regime which will encourage compliance, enforceable by civil rather than criminal sanctions. The Government wants to ensure that the enforcement regime remains appropriate and proportionate for what is expected to be a rapidly evolving industry, and that the enforcement regime takes account of–and, where appropriate, harnesses–relevant scientific developments in this area.
It is intended that the GM Inspectorate will be responsible for ensuring compliance with the new legislative framework in relation to release and marketing of precision bred organisms (other than for food and feed use).
The GM Inspectorate will also continue to be responsible for the assessment of suspected unauthorised Genetically Modified Organism (GMO) releases. Developers found to have released a GMO without authorisation will be subject to sanctions under existing GM legislation.
The enforcement regime in relation to food and feed from PBOs will need to reflect the substantive regulatory framework for these products, which is discussed above.
Part 4 already contains mandatory provisions in relation to each type of enforcement power, including safeguards such as requirements for any regulations made under these powers to provide for review and appeal. Furthermore, regulations under these powers are subject to the affirmative procedure, providing Parliament with the opportunity to scrutinise the sanction regime.
We therefore consider that the provisions on enforcement in the Bill strike an appropriate balance between the need to respond to a rapidly evolving industry on one hand, and providing certainty and accountability on the other.
I would like to reiterate my thanks to the Committee for its report and I am confident we have improved the bill as a result of its scrutiny.
January 2023