Lack of Guidance on Regulatory Change on use of Genetically Modified Plants is Unsatisfactory: Lords Committee

The instrument, laid by the Department for Environment, Food and Rural Affairs (Defra), proposes to remove the legal requirement for obtaining the Secretary of State’s consent, completing a risk assessment and conducting a public consultation before releasing plants with genetic modifications, which could have occurred naturally or been produced by traditional breeding, into the environment for non-marketing purposes.

The new regulations apply only to England. Under the proposals only the notification of the Secretary of State and publication of said notice would be required before the seed or plant material is placed into the ground to germinate or grow. The notice can be given by email to Defra and will be published. Defra says that the change will enable the bioscience sector to test the benefits and safety of relevant new products “without the burden of unnecessary regulatory processes”.

The report sets out several concerns in relation to this change of policy, including;

• A lack of detail in the Explanatory Memorandum about plans for wider reform of the rules for Genetically Modified Organisms (GMOs). Defra states that the changes are being made as the first step of a wider reform programme which seeks to maximise the potential of genetic technologies and gene editing. However, the Committee noted that there were no details of the Government’s wider reform plan in the explanatory material provided.
• A lack of clarity regarding the criteria that will be used to assess whether a plant is a qualifying higher plant. The draft Regulations include a definition of the “qualifying higher plants” which would be subject to the new rules, but they do not set out any scientific or regulatory criteria to assess whether a genetic modification or change in a plant could have occurred naturally or could have been produced through traditional breeding methods. Concerns over the use of terms such as “occurred naturally” were raised during a public consultation and in submissions the Committee received, showing a high level of uncertainty about how the new category of “qualifying higher plant” would be assessed and by whom. Defra told the Committee that the Advisory Committee on Releases to the Environment (ACRE) were in the process of developing guidance for developers and researchers to assist in assessing whether genetic modifications were of a type that could have occurred naturally or through traditional breeding techniques. The Committee’s report expresses regret that the guidance is yet to be published despite Defra being aware of the concerns raised at consultation stage. The report urges the Department to ensure that the guidance is published in good time before the new rules come into effect and that this guidance is communicated effectively, to provide clarity to researchers and those who have concerns about the new policy. In addition, the report suggests the House should ask the Minister why the guidance was not made available to Parliament so it could be considered alongside the draft Regulations.
• A lack of safeguards or containment measures. Under the proposals, while there is a requirement to notify the Secretary of State before any qualifying higher plants are released into the environment, there are no provisions for the notification to include information as to the location or scale of the release. There is also no requirement for the notification to include details about any containment measures that have been taken to prevent any potential adverse effects on commercial crops in the area that might occur once GMOs are released into the environment. This is an area of particular concern to organic farmers. Defra told the Committee that on the basis of the scientific advice provided by ACRE, it did not believe that field trials involving qualifying higher plants would lead to any more risk of environmental or economic damage than traditionally bred plants, and that safeguards or containment measures were the responsibility of whoever was developing or releasing the GMO into the environment. The Committee concludes that given the public interest in the new rules and the fact they rely on self-declaration to be effective, Defra should consider conducting and publishing an evaluation of the practical application of the new rules and of any environmental or economic damage, to inform the wider reforms that the Government intend to take forward in this area.
• Given that the new rules only apply to England the Committee was concerned how this may affect collaboration between researchers in different parts of the UK. The Committee remained unconvinced by Defra’s assertion that the regulatory difference with both Wales and Scotland (neither of which will be introducing these changes) will not cause any issues for researchers or developers.

Lord Hodgson of Astley Abbotts, Chair of the Secondary Legislation Scrutiny Committee said;

“This instrument proposes a significant change in policy and regulation which might have been more suitably dealt with by primary legislation to allow thorough and robust scrutiny by Parliament rather than under secondary legislation, an issue we explored in detail in our report – Government by Diktat: A call to return power to Parliament.

“Since Defra has told us that the intention is for the changes proposed by this instrument to be the first step of a wider reform programme the House might have found it helpful for their scrutiny to have been given some detail of the future direction of travel the government proposes to follow in this important area.

“The proposals are of significant public interest, as indicated by critical submissions sent to the Committee and the significant number of responses to the consultation Defra conducted. With guidance on the new rules still under development, the draft Regulations raise questions about their practical implementation including how qualifying higher plants will be assessed, the reliance on self-declaration and the absence of prescribed safeguards and containment measures. Given that the issues surrounding genetically modified organisms are both complex and controversial Defra surely should have anticipated that there would be considerable public interest in this instrument. Accordingly it seems astonishing that the guidance on these new rules has not been made available for scrutiny alongside the regulation.

“We have asked the House to consider exploring these issues with the Minister.”