CONSULTATION ON ADMINISTRATION AND ENFORCEMENT OF EC REGULATION 1946/2003 ON THE TRANSBOUNDARY MOVEMENTS OF GENETICALLY MODIFIED ORGANISMS (GMOs) IN SCOTLAND
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Dear Sir / Madam
CONSULTATION ON ADMINISTRATION & ENFORCEMENT OF EC REGULATION 1946/2003 ON THE TRANSBOUNDARY MOVEMENTS OF GENETICALLY MODIFIED ORGANISMS (GMOs) IN SCOTLAND
I am writing to seek your comments on the enclosed draft Scottish Regulations which will provide for the domestic administration and enforcement of the EC Regulation 1946/2003 1 on the transboundary movement of genetically modified organisms ("the EC Regulation"). A copy of the EC Regulation is attached at Annex A.
Background
The Department for Environment Food and Rural Affairs (Defra) has conducted regular UK-wide consultations with stakeholders between 2001 and 2003, both before and during negotiations and on the EC Regulation itself. The EC Regulation entered into force on 5 November 2003 and is directly applicable in Scotland. The Executive is now required to establish domestic arrangements for the administration and enforcement of the EC Regulation in Scotland .
Purpose of consultation
As the EC Regulation is directly applicable, this consultation concerns the creation at national level of appropriate and proportionate offences and penalties for failure to comply with the EC Regulation's provisions, and the mechanisms for enforcing those provisions. A copy of the draft Scottish Regulations establishing these administration and enforcement provisions is attached at Annex B. It should be noted that the Executive does not have any flexibility in how the EC Regulation is implemented except in regard to its administration and enforcement in Scotland.
EC Regulation on Transboundary Movements (1946/2003) & the Cartagena Protocol
The EC Regulation aims to establish a common system of notification and information for transboundary movements of genetically modified organisms and implements the aspects of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity 2 that are not already covered by existing EC legislation. The Cartagena Protocol's overall objective is to contribute to ensuring an adequate level of protection in the field for the safe transfer, handling and use of genetically modified organisms. The Protocol is of particular benefit to developing countries without existing legislation on GMOs since it gives them the necessary information and means to decide, before accepting GMO imports, whether there may be adverse effects on the conservation and sustainable use of their particular habitats and wildlife.
The main practical obligation imposed by the EC Regulation is to require exporters of GMOs to deal directly with authorities in third countries. It will have no effect on the existing decision making process in relation to the release of GMOs in Scotland or elsewhere in the EU, which is already covered by EC Directive 2001/18 on deliberate release.
The EC Regulation extend to exports to third countries, formalities that are already compulsory for the same type of transactions within the EC. All sizes of business related to the international trade in products consisting of GMOs will be affected in the same way. A regulatory impact assessment is attached at Annex C.
Scope of proposed Scottish Regulations
Broadly speaking the main provisions of the draft implementing Regulations for Scotland on which we are now consulting are to:
- designate Scottish Ministers as the Competent Authority;
- make provision for powers of entry to enable enforcement;
- provide for criminal offences for breach of the requirements of the EC Regulation;
- set the penalties applicable to the offences and the timescales in which a prosecution can be brought (including details of what the penalties are); and
- provide specific defences.
A copy of the draft Regulations is attached at Annex B.
The United Kingdom is required under the EC Regulation to designate one national focal point to be responsible on its behalf for liaison with the Secretariat of the Biosafety Clearing-House based in the United Nations. NIEWS (the Northern Ireland, England, Wales and Scotland GM Unit), which assists the four UK Competent Authorities in administering deliberate release applications, will carry out this function on behalf of the UK. However, as responsibility for the transboundary movement of GMOs is devolved it is necessary to implement Scottish Regulations to provide a framework for the administration and enforcement of the EC Regulation for Scotland.
Key aspects of this consultation
The purpose of this written consultation is to seek stakeholders' views on the attached documents:
i) Regulatory Impact Assessment
A draft full Regulatory Impact Assessment (RIA), containing an assessment of the likely impact of the measures in terms of costs and benefits ( Annex C);
ii) Draft of the administration and enforcement Regulations for Scotland
Draft of domestic Regulations, setting out offences and penalties in relation to the new EC regulation on the transboundary movement of GMOs ( Annex B).
Key questions
We would particularly welcome your views on the following questions:
i) Draft full Regulatory Impact Assessment
a) Do you agree with the analysis of costs and benefits as presented in the RIA?
b) Are any significant areas of benefits and / or costs not covered in the RIA? Please submit any relevant supporting information.
ii) Draft administration and enforcement Regulations
a) Are the proposed offences appropriate in relation to the requirements of the Regulations?
b) Are the penalties created proportionate to the offences?
UK Co-ordination
11. The UK Department for Environment, Food and Rural Affairs, the National Assembly of Wales, and the Department of the Environment in Northern Ireland are conducting separate consultations in their areas and will be introducing their own Regulations covering those aspects of the EC Regulation for which they have legislative responsibility.
Responding to this consultation paper
We are inviting written responses to this consultation paper by Friday 22 April 2005. Please send your response to:
gmoteam@scotland.gsi.gov.uk; or to
GM Co-ordination Team
Scottish Executive
Mail point 14
Area 1-J South
Victoria Quay
Edinburgh
EH6 6QQ
If you have any queries contact Julie Simpson on 0131 477 7578.
We would be grateful if you could clearly indicate in your response which questions or parts of the consultation paper you are responding to (using the consultation questionnaire if appropriate) as this will aid our analysis of the responses received. Please also complete and enclose the attached respondee information form with your response.
Access to consultation responses
We will make all responses available to the public in the Scottish Executive Library, unless confidentiality is requested. All responses not marked confidential will be checked for any potentially defamatory material before being logged in the library or placed on the website.
For future engagement register with SEConsult
A new email alert system for SE consultations ( SEconsult) was launched in December 2003. http://www.scotland.gov.uk/consultations/ This system will allow stakeholder individuals and organisations to register and receive a weekly email containing details of all new SE consultations (including web links). SEconsult will complement, but in no way replace SE distribution lists, and is designed to allow stakeholders 'keep an eye' on all SE consultation activity, and therefore be alerted at the earliest opportunity to those of most interest. We encourage you to register as soon as possible.
The Scottish Executive Consultation Process
Consultation is an essential and important aspect of Scottish Executive working methods. Given the wide-ranging areas of work of the Scottish Executive, there are many varied types of consultation. However, in general Scottish Executive consultation exercises aim to provide opportunities for all those who wish to express their opinions on a proposed area of work to do so in ways which will inform and enhance that work.
While details of particular circumstances described in a response to a consultation exercise may usefully inform the policy process, consultation exercises cannot address individual concerns and comments, which should be directed to the relevant public body. Consultation exercises may involve seeking views in a number of different ways, such as public meetings, focus groups or questionnaire exercises.
Typically, Scottish Executive consultations involve a written paper inviting answers to specific questions or more general views about the material presented. Written papers are distributed to organisations and individuals with an interest in the area of consultation, and they are also placed on the Scottish Executive web site enabling a wider audience to access the paper and submit their responses. Copies of all the responses received to consultation exercises (except those where the individual or organisation requested confidentiality) are placed in the Scottish Executive library at Saughton House, Edinburgh (K Spur, Saughton House, Broomhouse Drive, Edinburgh, EH11 3XD, telephone 0131 244 4552).
The views and suggestions detailed in consultation responses are analysed and used as part of the decision making process. Depending on the nature of the consultation exercise the responses received may:
- indicate the need for policy development or review
- inform the development of a particular policy
- help decisions to be made between alternative policy proposals
- be used to finalise legislation before it is implemented
If you have any comments about how this consultation exercise has been conducted, please send them to the GM Co-ordination Team, at the addresses given above.
Yours faithfully
Alison Douglas
GM Co-ordination Team
List of Adressees
Aberdeen City Council
Aberdeenshire Council
Action Aid
Advanta Seeds Limited
Advisory Committee on Animal Feeding Stuffs
Advisory Committee on Genetic Modification
Advisory Committee on Novel Foods and Processes
Advisory Committee on Pesticides
Advisory Committee on Releases to the Environment
Advisory Committee on the Microbiological safety of Food
AGRICO UK LTD
Agricultural Engineers Association
Agricultural Industries Confederation
Angus Council
Animal Procedures Committee
Argonex Discovery Limited
ASDA Stores Ltd
Associated British Ports
Association of Bakery Ingredient Manufacturers (ABIM)
Association of British Insurers (ABI)
Association of Cereal Food Manufacturers Ltd
Association of Independent Crop Consultants
Association of the British Pharmaceutical Industry (ABPI)
Argyll & Bute Council
Argyll and Clyde NHS Board
Ayrshire and Arran NHS Board
Bayer CropScience Limited
Biodynamic Association
Bioindustry Association
Bioreliance Biotech Limited
Bioreliance Ltd
Biostrategy Associates Ltd.
Biotechnology and Biological Sciences Research Council (BBSRC)
Biovation Ltd
Borders NHS Board
Brewers and Licensed Retailers Association
British Chambers of Commerce
British Crop Protection Council
British Ecological Society
British Industrial Biological Research Association
British Institute of Agricultural Consultants
British Medical Association
British Potato Council
British Retail Consortium
British Society of Plant Breeders
British Trust of Ornithology Scotland
Cancer Research UK
CBI Scotland
Central Scotland Countryside Trust
Centre for Ecology and Hydrology
Centre for Human Ecology
Centre for Reproductive Biology
Christian Aid
Church of Scotland
Clackmannanshire Council
Comhairle nan Eilean Siar
Commercial Farmers Group
COSLA
CRC The Beatson Institute for cancer research
Crofters Commission
CropGen
Crop Protection Association
Crusade Laboratories LTD
CXR Bioscience Limited
Cyclacel Limited
Cypex Limited
Dumfries and Galloway Council
Dumfries and Galloway NHS board
Duncan Guthrie Institute of Medical Genetics
Dundee City Council
East Ayrshire Council
East Dunbartonshire Council
East Lothian Council
East Renfrewshire Council
Edinburgh Council
Excell Biotech Limited
Expression Bio Systems Limited
Falkirk College of Further Education
Falkirk Council
Farming and Wildlife Advisory Group (Scotland)
Federation of Small Businesses
Fife Council
Fife NHS Board
Fisheries Research Services Marine Laboratory
Forth Valley NHS Board
Forum of Private Business (Scotland) Ltd
Friends on the Earth
Genewatch UK
Glasgow Caledonian University
Glasgow City Council
Grain and Feed Traders Association (GAFTA)
Grampian NHS Board
Greater Glasgow NHS Board
Green Alliance
Greenpeace
Hannah Research Institute
Haptogen Limited
Healthcare Environmental Services Limited
Heriot-Watt University
Highland Council
Highland Health Board NHS Board
Highlands and Islands Enterprise
Highlands and Islands Organic Association
Home Grown Cereals Authority
Institute for Public Policy and Research (IPPR)
Initiative for Scottish Insects
Institute of Animal Health
Institute of Biomedical and Life Science Glasgow
Institute of Cell and Molecular Biology
Institute of Directors Scotland
Institute of Food Science and Technology (Scottish Branch)
Institute of Grocery Distribution
Institute of Science in Society
Inverclyde Council
Inveresk Research International
Invitrogen Limited
John Muir Trust
Lanarkshire NHS Board
Local Government Association
Lothian NHS Board
Lothian University Hospitals NHS trust.
Macaulay Institute
Malt Distillers Association of Scotland
Maize Growers Association
Manufacturing, Science and Finance Union
Medical Research Council
Midlothian Council
Monsanto UK Ltd
Moray Beekeepers
Moray Council
Moredun Research Institute
MRC Human Genetics Unit
MRC Protein Phosphorylation Unit
MRC technology Centre Scotland
Munlochy GM Vigil
National Association of Seed Potato Merchants
National Collections of Industrial and Marine Bacteria Limited
National Consumer Council
National Consumer Federation
National Farmers Union of Scotland
National Sheep Asssociation
Natural Environment Research Council (NERC)
Napier University
Neuropa Limited
North Ayrshire Council
North Glasgow University Hospitals NHS Trust
North Lanarkshire Council
Nuffield Council on Bioethics
Oatridge College
Organon Laboratories Limited
Orkney Islands Council
Orkney NHS Board
Oxfam UK
Perth & Kinross Council
Quintiles Scotland Limited
Renfrewshire Council
RICS Scotland
Roslin Institute
Rowett Research Institute
Royal Botanic Garden Edinburgh
Royal Commission on Environmental Pollution
Royal Society of Edinburgh
RSBP Scotland
SCIMAC
Scotch Whisky Association
Scottish Agricultural College
Scottish Agricultural Organisation Society
Scottish Agricultural Science Agency
Scottish Association for Marine Science
Scottish Association of Master Bakers
Scottish Beefarmers Association
Scottish Beekeepers Association
Scottish Biomedical Foundation Limited
Scottish Borders Council
Scottish Centre for Infection and Environmental Health
Scottish Chamber of Commerce
Scottish Civic Forum
Scottish Consumer Council
Scottish Corn Trade Association Ltd
Scottish Council for Development & Industry
Scottish Council For National Parks
Scottish Crofters' Union
Scottish Crofting Foundation
Scottish Crop Research Institute
Scottish Dairy Association
Scottish Development International
Scottish Ecological Protection Agency
Scottish Enterprise
Scottish Enviornment Link
Scottish Food and Drink Federation
Scottish Food Quality Certification
Scottish Green party
Scottish Grocer's Federation
Scottish Landowners' Federation
Scottish National Blood Transfusion Service
Scottish Natural Herritage
Scottish Organic Producers Association
Scottish Potato Trade Association
Scottish Retail Consortium
Scottish Rural Property and Business Association
Scottish Seed and Nursery Trade Association
Scottish Trade Union Congress
Scottish Wholesale Association
Scottish Wildlife Trust
Scottish Women's Rural Institutes
Serological Limited
Shetland Islands Council
Shetland NHS Board
Simply Organics
Soil Association Scotland
South Ayrshire Council
South Lanarkshire Council
Stem Cell Sciences (UK) Limited
Stirling Council
Syngenta Ltd.
Tayside NHS Board
The BioIndustry Association
The Five Year Freeze Campaign
The National Trust for Scotland
The Wellcome Trust
Trades Union Congress (TUC)
University of Aberdeen
University of Abertay
University of Dundee
University of Edinburgh
University of Glasgow
University of Paisley
University of St Andrews
University of Stirling
University of Strathclyde
UKREP
UK Agricultural Supply Trade Association
UK Oilseeds Producers Ltd
UK Xenotransplantation Interim Regulatory Authority
Viragen Limited
West Dunbartonshire Council
Western Isles NHS Board
West Lothian Council