GMO appeals guidance (in relation to regulation 31 of the 2014 Regulations)

• Introduction
• Before making an appeal
• The effect of making an appeal
• How to make an appeal
• Who can appeal?
• Once an appeal is received
• Appointed person
• The Appeal
• Hearing
• The Appointed Person's decision
• Annex

Introduction

Regulation 31(1) of the Genetically Modified Organisms (Contained Use) Regulations 2014 (SI No.1663) ("the 2014 Regulations") states that a complainant may appeal certain decisions made against them under the 2014 Regulations.

The decisions that may be appealed are set out in the 2014 Regulations. Under the 2014 Regulations the appeal is to be made to either the Secretary of State for Defra or the Secretary of State for Defra and the Scottish Ministers acting jointly ("the Appropriate Person") depending on which Competent Authority has taken the relevant decision.

This guidance is intended to assist the Appellant when lodging an appeal, the Appropriate Person when responding to an appeal and the Appointed Person when determining an appeal. The recommendations below should be followed as closely as possible.

For an explanation of any terms used in this guidance, please refer to the Annex at the end of this guidance. Any terms used that are not explained in the Annex to this guidance have the same meaning as in the 2014 Regulations.

Before making an appeal

Before making an appeal, prospective Appellants should be aware that in coming to the decision in question, a rigorous process will have been undertaken by the Competent Authority.  The regulations include a mechanism for HSE to request additional information from notifiers, in relation to notifications, sometimes involving multiple exchanges, to ensure that decisions are based on all relevant information. Where the decision is of a technical nature, HSE uses specialist inspectors (microbiologists and molecular biologists) to undertake technical assessments of notifications. Where further advice is required, HSE will seek expert opinion from the Scientific Advisory Committee for Genetic Modification (Contained Use).

Prospective Appellants are also advised and encouraged to try and resolve any difficulties or disagreements with the Competent Authority before commencing the appeals process. In practice, most difficulties and disagreements in relation to the Competent Authority's decision are resolved by engaging in a dialogue with the Competent Authority.

However, prospective Appellants should note that an appeal must be received by the Appropriate Person within the requisite time period, as detailed below. Preliminary discussions are not in themselves a full and formal review of the decision which is the subject of the appeal. The intention of any preliminary discussions is to reach timely and practical solution to issues raised.

There is no charge to the Appellant in making an appeal but the Appellant will have to pay their own costs, including those of any professional advisors who assist them (eg legal advice/representation).

Prospective Appellants should also be aware that if it is their intention to make a complaint against the Competent Authority, as opposed to appeal a decision of the Competent Authority under the 2014 Regulations, the appeals process under the 2014 Regulations and this guidance is not the correct forum for making such a complaint. Complaints should be directed to the relevant Competent Authority at the address set out for this purpose on the Health and Safety Executive website. 

The effect of making an appeal

The 2014 Regulations provide that where an appeal is brought under the 2014 Regulations, any decisions and requests for additional information made under the 2014 Regulations remain valid and any instructions given and notices issued under the 2014 Regulations are not suspended pending the final determination of the appeal. The 2014 Regulations also provide that the period of time between the date on which an appeal is lodged and the date on which an appeal is determined will not be taken into account in calculating the time periods referred to in the 2014 Regulations in relation to the notification of class 2, class 3 or class 4 contained use, or notifiable contained use involving large GMOs.  

How to make an appeal

The Appellant must submit a written notice of its appeal and supporting documents to the Appropriate Person.  This must be received within 21 days, starting from the date of the contested decision or notice.

The Appropriate Person will ensure that the appeal is not handled by anyone who was involved in making or advising on the original decision. Appropriate safeguards will be put in place to ensure that information and decisions relating to the handling of the appeal are not disclosed or discussed outside of those handling the appeal.

Where the Appropriate Person is the Secretary of State and the Scottish Ministers acting jointly the appeal should be sent to the Secretary of State who will notify the Scottish Ministers of receipt of the appeal.

The Appellant should submit their appeal to: [email protected]

The appeal process is primarily dealt with by electronic means and documents should be provided in electronic form wherever possible.   There may be some circumstances where the Appellant may not be able to submit all the necessary information electronically (eg security issues) in which case the Appellant should contact Defra ([email protected]) to discuss practical arrangements for submission of their appeal.

The Appellant's notice of appeal should be accompanied by:

• A copy of any decision or notice which is the subject matter of the appeal
• A statement of the grounds of appeal, including detailed reasons as to why the decision is not accepted and which points are in dispute
• Copies of relevant correspondence between the Appellant and Competent Authority
• Any other documents the Appellant deems necessary to their appeal
• Details of any documents the Appellant requires from the Competent Authority to assist their appeal
• An indication of whether the Appellant wishes the appeal to be in the form of a hearing or on the basis of written representations (see below)
• Details of Appellant's name, address and relevant contact details

Who can appeal?

The ability to make an appeal is restricted to Persons Responsible for the Contained Use under the 2014 Regulations. Third parties not subject to the decision are not eligible to appeal under the 2014 Regulations.

Once an appeal is received

The Appropriate Person will email the Appellant within 5 working days of receiving the Appellant's notice of appeal to acknowledge that their appeal has been received and forwarded to the Competent Authority.

Within 21 days of receiving the Appellant's notice of appeal, the Competent Authority should provide a written response to the appeal, stating whether it contests the disputed decision and if so, commenting on the reasons given for opposing the appeal. The Appellant then has 7 days to comment on the Competent Authority's reasons for upholding the decision or notice.

If contesting the decision or notice, the Competent Authority should also provide the Appellant with any documents on which it intends to rely.  The Competent Authority should also aim to comply with any reasonable requests for documents as set out in the Appellant's notice of appeal.

The Competent Authority may decide, as a result of receiving the appeal, to withdraw the decision or notice that is the subject matter of the appeal rather than defend the appeal.  They may make this decision at any time during the course of the appeal process.

Withdrawing the appeal

The Appellant may withdraw its appeal at any time by writing to the Appropriate Person, or if appointed, the Appointed Person.  If the Appellant withdraws its appeal it cannot bring a fresh appeal in relation to the disputed decision.

Appeals made out of time

The Appropriate Person has discretion to accept an appeal given to it outside of the 21 day period where it is satisfied that it was not reasonably practicable for the Appellant to submit his appeal on time. The Appropriate Person will inform the Appellant in writing whether or not the submission of the appeal has been accepted, and will give reasons for this decision to the Appellant.

Appointed person

The Appropriate Person has discretion whether to delegate the function of determining the appeal to an Appointed Person.  The Appropriate Person will consider whether the appeal is one that can be dealt with by the Appropriate Person or one that requires an Appointed Person.  In most cases it is expected that the Appropriate Person will appoint an Appointed Person.  The appointment will be made as soon as possible after the Competent Authority has indicated its intention to oppose the appeal. 

The Appointed Person will normally be someone with a legal background and from outside Government. If the appeal raises technical and scientific issues, the Appropriate Person may consider it necessary to appoint a technical or scientific expert from outside Government to act as Appointed Person, or a technical or scientific expert and someone with a legal background to determine the appeal.

The Appointed Person should ideally have relevant experience in dealing with appeals in general and appeals of a similar nature as brought by the Appellant. The Appointed Person must also be able to commit to completing the appeal process and delivering the required decision no later than three months from the date of the Appellant bringing their appeal.

The Appointed Person must be independent and retain their independence for the duration of their appointment. The Appointed Person must confirm that they have no conflict of interest which prevents them from considering the Appellant's case.  If there is a conflict of interest or if there is a concern that there may be a conflict, the Appointed Person should make a declaration accordingly and seek advice on whether to decline to act, or step down if the conflict does not come to light until later in the appeal process.

The Appeal

Unless otherwise stated in the 2014 Regulations or indicated in this guidance, the procedure and form of the appeal (including the submission of any further written representations by the parties) will be under the control and discretion of the Appointed Person.

Once the Appointed Person has been appointed, the Appointed Person will ensure that the appeals process is reasonable, transparent, accessible, independent and impartial, and operate according to principles of natural justice. The Appellant and Competent Authority are entitled to be heard at any hearing. The Appellant and Competent Authority may, if they wish to do so, be represented by legal advisers. Anything which a party wishes to be considered should be seen by the other party.

Before the Appointed Person makes their decision on the appeal, the Appointed Person must consider all of the evidence. The Appointed Person can ask for further information from the parties, if they think it is necessary. The Appointed Person will determine the appeal on the basis of whether the Competent Authority's decision was reasonable in all the circumstances.

The Appointed Person may uphold or quash the decision.   The Appointed Person may also include directions to give effect to their determination, for example, they may give directions about the actions the Competent Authority must take before re-considering the decision. 

Hearing

Appeals can be dealt with on the basis of either written submissions or a hearing.  The decision as to whether the appeal will be on the basis of written submissions or a hearing is at the discretion of the Appointed Person who should take into account the nature and circumstances of the appeal and consult with the Appellant and Competent Authority. Although the written submissions procedure is usually the quickest, simplest and most cost effective way of deciding an appeal, a hearing may be appropriate where there are complex issues or disputed questions of fact or law. 

If the appeal is to be decided by a hearing, in determining the procedure and form of the hearing, the Appointed Person will take into account the preferences of the Appellant and Competent Authority. The Appellant or Competent Authority may apply, at any time leading up to the hearing, to the Appointed Person for further procedural directions.

As soon as reasonably practicable after it has been decided that an appeal will be conducted by way of hearing, and after consultation with the Appellant and the Competent Authority, the Appointed Person will notify the Appellant and the Competent Authority of the time, date and location of the hearing. The Appointed Person may vary the time and place of a hearing and is only required to give such notice as appears to be reasonable in the circumstances. The hearing should take place within 28 days of the latest of either the appointment of the Appointed Person or receipt of the Competent Authority's response to the Appellant's notice of appeal, or where this is not practicable, as soon as possible after that time.

The hearing can take place where all parties are present in person or by either teleconference or video conference. The hearing will be informal and held in private. The Appellant and Competent Authority will notify the Appointed Person as to who it wants to have as representations on their behalf. This should be limited to as few people as possible who can provide further information or explanation of issues in dispute and is subject to the discretion of the Appointed Person.

Failure by a party to attend a hearing or be represented at a hearing will not prevent the Appointed Person from proceeding in the absence of that party. If either of the parties at a hearing has any concerns or questions about the procedures, they must be raised with the Appointed Person either before the hearing or at the time of the hearing rather than after the hearing.

The Appointed Person's decision

Any decision of the Appointed Person should be issued as promptly as possible, having regard to the circumstances of the case.  The Appointed Person should aim to issue the draft decision within 21 days of the hearing or 28 days of the appointment of the Appointed Person if decided on the basis of written submissions. If the Appointed Person is unable to send out the decision within the above timescale, it will contact the parties to advise when the draft decision will be sent.  However, the Appellant should, normally, be informed of the Appointed Person's draft decision within 3 months of the appointment of the Appointed Person

The Appellant and the Competent Authority will have an opportunity to make factual written comments (eg to correct misunderstandings) to the Appointed Person on a draft of the Appointed Person's decision. The comments are to be copied to all parties, and the Appointed Person is to consider them before finalising their decision.  This process should not take more than 28 days unless there are good reasons for departing from this timescale.

The Appointed Person will ensure that their decision is easily comprehensible so that the parties can understand the basis on which the decision was made. The decision must contain a summary of relevant factors that were raised by the parties and considered by the Appointed Person. The decision must give clear reasons for the Appointed Person's decision, including how, and why, any issues of fact or law were decided by the Appointed Person.

The final decision must be submitted to the Appropriate Person, the Appellant and the Competent Authority at the same time.

The final decision is confidential between the Appropriate Person, the Appointed Person, the Appellant and the Competent Authority. If a copy is requested by a third party, or either the Appellant or Competent Authority request that the decision be published, this will be considered by the Appropriate Person, who will take into account the views of the parties in deciding whether any material should be published and if any part of it should be kept confidential.

There is no separate right of appeal against the Appointed Person's decision. The decision may be challenged through an application for a judicial review.  An Appellant considering bringing a judicial review is advised to obtain legal advice at the earliest opportunity.

Annex

• "the Appellant" means the Persons Responsible for the Contained Use who is appealing the decision of the Competent Authority
• "the Appointed Person" means the person or persons appointed by the Appropriate Person to determine the appeal
• "the Appropriate Person" means the Secretary of State for Defra for a decision relating to contained use or premises in England and Wales or both the Secretary of State for Defra and the Scottish Ministers acting jointly for a decision relating to contained use or premises in Scotland
• "the Competent Authority" means the Health and Safety Executive and Secretary of State for Defra for England and Wales or the Health and Safety Executive and Scottish Ministers for Scotland or both together as joint competent authority in some circumstances
• "Persons Responsible for the Contained Use" means:
  1. a person who has the authority to determine whether a particular contained use takes place, or
  2. a person who has control of the planning or conduct (or both) of that contained use,
  3. and there may be more than one person responsible for the same contained use.