Genetically modified organisms: Primary or delegated legislation?

The Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022 come into force on Monday 11 April (SI 2022/No. 347) (‘GMO SI’). This Statutory Instrument (SI) surfaces at least two fundamental questions about the current delegated legislation system – questions that we are grappling with in our ongoing Delegated Legislation Review:

• Is there a clear boundary that can be drawn between what should be in primary legislation and what should be in delegated legislation?

• If parliamentarians and/or the public are concerned about an SI, what can they do about it?

The GMO SI will change the legal requirements on businesses or individuals who wish to release, for non-marketing purposes, plants with genetic modifications that “could have occurred naturally”. Currently, there is a legal requirement to submit a risk assessment and seek the Secretary of State’s consent before releasing such plants. However, the GMO SI removes this: the only requirement will be that a notice must be given to the Secretary of State and published.

The GMO SI was made mainly using powers in the Environmental Protection Act 1990.

The legal changes made by the GMO SI have attracted significant public interest: a large number of responses were received to the Government’s public consultation on the matter.

The House of Lords Secondary Legislation Scrutiny Committee (SLSC) published a highly critical report that drew the SI to the special attention of the House on the ground that it is “politically or legally important and gives rise to issues of public policy likely to be of interest to the House”. The SLSC highlighted three key concerns:

• The Government stated that the SI is the first step in a wider reform programme in the area of genetic technologies and gene editing. However, the SI’s Explanatory Memorandum did not provide any further information on the Government’s plans for wider reform.

• The SI does not include criteria to assess whether genetic modifications of a relevant plant

  “could have occurred naturally”. When asked what scientific and regulatory criteria will be used to assess this, the Government responded that guidance is in the process of being developed.

• The difference in regulatory approach in different parts of the UK raised concerns about what the new rules in England will mean for collaboration between researchers in different parts of the UK.

The primary legislative process allows greater parliamentary scrutiny than existing procedures for delegated legislation. However, it is unrealistic and undesirable for all law to be made by primary legislation. There is a trade-off to be made between depth and speed of scrutiny. This trade-off should take into consideration the content of the law being enacted.

However, there is no hard-edged line that clearly demarcates the boundary between what should be in primary and what should be in delegated legislation.

Indeed, both the House of Lords Delegated Powers and Regulatory Reform Committee (DPRRC) and the House of Lords Constitution Committee have previously concluded that it is not possible to prescribe “a list of criteria which would give precision to the test of appropriateness” for the use of delegated legislation, or to cater for the variety of circumstances in which delegation of legislative power is sought.

Despite this, over the years, certain guiding principles have emerged that inform the debate about where the boundary between primary and delegated legislation should lie.

Sources such as Constitution Committee reports, the (recently updated) Cabinet Office ‘Guide to Making Legislation’ and the DPRRC’s ‘Guidance for Departments’ emphasise that matters that are “the essence of the bill” and “principal aspects of policy” ought to be in primary legislation, with only its detailed implementation left to delegated legislation.

The DPRRC and Constitution Committee have highlighted that certain subject matter - such as the components of criminal offences, the creation of statutory bodies, and the imposition of taxes - should not normally be dealt with using delegated legislation. Certain broad criteria have also been suggested to identify when the use of delegated legislation is appropriate, such as to deal with matters concerning the technical implementation of a policy, which cannot be known at the point when the primary legislation is being passed, or to deal with matters which it is anticipated may change in future, such as uprating for inflation.

While such guiding principles are a useful starting-point, at least two conundrums persist:

• Matters that are ‘operational’ or ‘technical’ in nature can still have significant policy implications and impact on people’s lives. Many areas of law are now highly technical, and thus many important policy decisions will inevitably be at least partly technical in nature.

• A power delegated for a particular purpose or in a particular context may allow other unanticipated changes to be made years or even decades later. Such changes can be difficult to predict in advance. For example, when the then-Environmental Protection Bill was making its way through Parliament, the UK was still a member of the EU – membership that entailed regulatory constraints in the area of genetic technologies and gene editing.

Once legislative power has been delegated, the opportunity for parliamentarians to formally influence the content of the resulting delegated legislation is limited. This applies even to SIs - like the GMO SI - which are laid before Parliament as draft SIs, before the Minister has signed them into law. By the time any SI is laid before Parliament, the horse has already bolted. Unlike a Bill, an SI cannot be amended by Parliament, and SIs are seldom rejected. For Parliament, the only option is to vote an SI down in its entirety.

For the vast majority of SIs, Parliament has no formal mechanisms short of outright rejection to oblige the Government to think again about an SI.

Parliament also has limited tools available to press the Government for further explanation of its policy. In the case of the GMO SI, the SLSC raised the important issue of the lack of additional material explaining how the changes made by the SI would operate in practice - in particular, guidance over how key terms would be interpreted and information about the wider context of reforms.

In the House of Commons, the problem is compounded because the House does not have a dedicated Select Committee - akin to the SLSC in the Lords - that scrutinises and reports on the policy enacted in SIs. While the Joint Committee on Statutory Instruments (JCSI) reports to both Houses, its remit is to report only on the technical qualities of SIs, rather than their policy.

Assuming that the SLSC has already reported on the SI in question, there is naturally nothing stopping MPs from utilising SLSC reports in debates, as was done in the Delegated Legislation Committee debate on the GMO SI. However, as a House of Lords Select Committee, the SLSC does not necessarily report in line with the arrangement of Commons business, and, understandably, may not be attuned to the needs of MPs when conducting its scrutiny of SIs.