| | english | español | français |
Go to record ID

  Home|Finding Information|Record details   Printer-friendly version

Second Regular National Report on the Implementation of the Cartagena Protocol on Biosafety
Record information and status
Record ID
102510
Status
Published
Date of creation
2011-10-13 15:34 UTC (andrew.bowers@cbd.int)
Date of last update
2011-11-11 19:43 UTC (andrew.bowers@cbd.int)
Date of publication
2011-11-11 19:43 UTC (andrew.bowers@cbd.int)

Origin of report
Country
  • Ireland
Contact officer for report
Coordinates
Dr. John O'Neill
Inspector
Dept. of Environment, Community and Local Government
Room 2.26, Custom House
Dublin 1
Ireland
Phone:+353 1 8882554
Fax:+323-1-8882994
Email:John.O'Neill@environ.ie
Consulted stakeholders
9. Organizations/stakeholders who were consulted or participated in the preparation of this report
Environmental Protection Agency

Department of Agriculture, Fisheries and Food, Food Safety Authority of Ireland
Submission
10. Date of submission
2011-09-30
11. Time period covered by this report
Start date
2007-10
Time period covered by this report
End date
2011-09
Party to the Cartagena Protocol on Biosafety
12. Is your country a Party to the Cartagena Protocol on Biosafety (CPB)?
  • Yes
Article 2 – General provisions
15. Has your country introduced the necessary legal, administrative and other measures for the implementation of the Protocol?
  • A domestic regulatory framework is fully in place
16. Which specific instruments are in place for the implementation of your national biosafety framework?
  • One or more national biosafety laws
  • One or more national biosafety regulations
  • Other laws, regulations or guidelines that indirectly apply to biosafety
17. Has your country established a mechanism for the budgetary allocations of funds for the operation of its national biosafety framework?
  • Yes
18. Does your country have permanent staff to administer functions directly related to the national biosafety framework?
  • Yes
19. If you answered Yes to question 18, how many permanent staff members are in place whose functions are directly related to the national biosafety framework?
  • Less than 5
20. Has your country’s biosafety framework / laws / regulations / guidelines been submitted to the Biosafety Clearing-House (BCH)?
  • Yes
21. Here you may provide further details on the implementation of Article 2 in your country:
EU legislation on genetically modified organisms (GMOs) has been in place since the early 1990s. Over the last decade, the EU has created a comprehensive legal framework for ensuring safety in the development, use and transfer of GMOs. The main legal measures include:

- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (transposed in Ireland by the Genetically Modified Organisms (Contained Use) Regulations 2001 to 2010)

- Directive 2001/18/EC of 12 March 2001 on the deliberate release into the environment of genetically modified organisms (transposed in Irish domestic law as the Genetically Modified Organisms (Deliberate Release) Regulations 2003)

-Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms covers exports of GMOs to third countries and unintentional movements of GMOs (transposed in Irish domestic law as the Genetically Modified Organisms (Transboundary Movement) Regulations 2004)

-Regulation (EC) No 1829/2003 of 22 September 2003 on genetically modified food and feed, covering the placing on the market of GMOs intended for food or feed and of food or feed products containing, consisting of or produced from GMOs.  Regulation (EC) No 1830/2003 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. (Transposed by the European Communities (Feedingstuffs) (Genetically Modified Feed) Regulations 2004)

-Regulation (EC) No 641/2004 of 6 April 2004 on detailed rules for the implementation of Regulation (EC) No 1829/2003 as regards the application for the authorisation of new genetically modified food and feed, the notification of existing products and adventitious or technically unavoidable presence of genetically modified material which has benefited from a favourable risk evaluation.

-Commission Regulation 619/2011 of 24 June 2011 laying down the methods of sampling and analysis for the official control of feed as regards presence of genetically modified material for which an authorisation procedure is pending or the authorisation of which has expired.
Article 5 – Pharmaceuticals
22. Does your country regulate the transboundary movement, handling and use of living modified organisms (LMOs) which are pharmaceuticals?
  • Yes
23. If you answered Yes to question 22, has this information been submitted to the BCH?
  • Yes
24. Here you may provide further details on the implementation of Article 5 in your country:
This is included under domestic ratification of EU Directive 2001/18/EC and Regulation 1946/2003 respectively.
Article 6 – Transit and Contained use
25. Does your country regulate the transit of LMOs?
  • Yes
26. Does your country regulate the contained use of LMOs?
  • Yes
27. If you answered Yes to questions 25 or 26, has this information been submitted to the BCH?
  • Yes
28. Here you may provide further details on the implementation of Article 6 in your country:
- Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (transposed in Ireland by the Genetically Modified Organisms (Contained Use) Regulations 2001 to 2010)

-Regulation (EC) No 1946/2003 of 15 July 2003 on transboundary movements of genetically modified organisms covers exports of GMOs to third countries and unintentional movements of GMOs (transposed in Irish domestic law as the Genetically Modified Organisms (Transboundary Movement) Regulations 2004)
Articles 7 to 10 – Advance Informed Agreement (AIA) and intentional introduction of LMOs into the environment
29. Has your country adopted law(s) / regulations / administrative measures for the operation of the AIA procedure of the Protocol?
  • Yes
30. Has your country adopted a domestic regulatory framework consistent with the Protocol regarding the transboundary movement of LMOs for intentional introduction into the environment?
  • Yes
31. Has your country established a mechanism for taking decisions regarding first intentional transboundary movements of LMOs for intentional introduction into the environment?
  • Yes
32. If you answered Yes to question 31, does the mechanism also apply to cases of intentional introduction of LMOs into the environment that were not subject to transboundary movement?
  • Yes
33. Has your country established a mechanism for monitoring potential effects of LMOs that are released into the environment?
  • Yes
34. Does your country have the capacity to detect and identify LMOs?
  • Yes
35. Has your country established legal requirements for exporters under its jurisdiction to notify in writing the competent national authority of the Party of import prior to the intentional transboundary movement of an LMO that falls within the scope of the AIA procedure?
  • Yes
36. Has your country established legal requirements for the accuracy of information contained in the notification?
  • Yes
37. Has your country ever received an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
38. Has your country ever taken a decision on an application / notification regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • No
41. In the current reporting period, how many applications/notifications has your country received regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
42. In the current reporting period, how many decisions has your country taken regarding intentional transboundary movements of LMOs for intentional introduction into the environment?
  • None
Article 11 – Procedure for living modified organisms intended for direct use as food or feed, or for processing (LMOs-FFP)
51. Has your country adopted specific law(s) or regulation(s) for decision-making regarding domestic use, including placing on the market, of LMOs-FFP?
  • Yes
52. Has your country established legal requirements for the accuracy of information to be provided by the applicant?
  • Yes
53. Has your country established a mechanism to ensure that decisions regarding LMOs-FFP that may be subject to transboundary movement will be communicated to the Parties through the BCH?
  • Yes
54. Has your country established a mechanism for taking decisions on the import of LMOs-FFP?
  • No
55. Has your country declared through the BCH that in the absence of a regulatory framework its decisions prior to the first import of an LMO-FFP will be taken according to Article 11.6 of the Cartagena Protocol on Biosafety?
  • No
56. Has your country indicated its needs for financial and technical assistance and capacity building in respect of LMOs-FFP?
  • No
57. Has your country ever taken a decision on LMOs-FFP (either on import or domestic use)?
  • No
63. Here you may provide further details on the implementation of Article 11 in your country, including measures in case of lack of scientific certainty on potential adverse effects of LMOs-FFP:
The EU has developed a comprehensive legal framework on GMOs, which also addresses the import of GMOs intended for direct use for food or feed, or for processing. The EU has declared with reference to Article 14.4 of the Cartagena Protocol that it relies on its existing legislative framework for intentional movements of GMOs within the EU and for imports of GMOs into the EU.

It is important to note that decisions taken for placing on the market of LMOs-FFP are taken for the whole European territory and not at individual MS level.
Article 12 – Review of decision
64. Has your country established a mechanism for the review and change of a decision regarding an intentional transboundary movement of LMOs?
  • Yes
65. Has your country ever received a request for a review of a decision?
  • No
66. Has your country ever reviewed / changed a decision regarding an intentional transboundary movement of LMOs?
  • No
67. In the current reporting period, how many decisions were reviewed and/or changed regarding an intentional transboundary movement of an LMO?
  • None
Article 13 – Simplified procedure
72. Has your country established a system for the application of the simplified procedure regarding an intentional transboundary movement of LMOs?
  • No
73. Has your country ever applied the simplified procedure?
  • No
75. In the current reporting period, how many LMOs has your country applied the simplified procedure to?
  • None
76. Here you may provide further details on the implementation of Article 13 in your country:
Ireland has not made use of the simplified procedure for imports of LMOs as specified in Article 13.
Article 14 – Bilateral, regional and multilateral agreements and arrangements
77. Has your country entered into any bilateral, regional or multilateral agreements or arrangements?
  • No
Article 15 – Risk assessment
81. Has your country established a mechanism for conducting risk assessments prior to taking decisions regarding LMOs?
  • Yes
82. If you answered Yes to question 81, does this mechanism include procedures for identifying experts to conduct the risk assessments?
  • Yes
83. Has your country established guidelines for how to conduct risk assessments prior to taking decisions regarding LMOs?
  • Yes
84. Has your country acquired the necessary domestic capacity to conduct risk assessment?
  • Yes
85. Has your country established a mechanism for training national experts to conduct risk assessments?
  • Yes
86. Has your country ever conducted a risk assessment of an LMO for intentional introduction into the environment?
  • No
87. Has your country ever conducted a risk assessment of an LMO intended for direct use as food or feed, or for processing?
  • No
88. If your country has taken decision(s) on LMOs for intentional introduction into the environment or on domestic use of LMOs-FFP, were risk assessments conducted for all decisions taken?
  • Not applicable
89. Has your country submitted summary reports of the risk assessments to the BCH?
  • Not applicable
91. Has your country ever required the exporter to conduct the risk assessment(s)?
  • Not applicable
92. Has your country ever required the notifier to bear the cost of the risk assessment(s) of LMOs?
  • Not applicable
93. Here you may provide further details on the implementation of Article 15 in your country:
The EU domestic legal framework, based on a prior risk assessment before authorisation is given, is applicable. The notification provided by the company intending to market a GMO must include a full risk assessment of the risks to human and animal health and to the environment, which is assessed by the European Food Safety Authority (EFSA), with an active involvement of Member States, notably as regards the authorisation of GMOs for cultivation, where they carry out the initial risk assessment.
Article 16 – Risk management
94. Has your country established and maintained appropriate and operational mechanisms, measures and strategies to regulate, manage and control risks identified in risk assessments for:
94.1) LMOs for intentional introduction into the environment?
  • Yes
94.2) LMOs intended for direct use as food or feed, or for processing?
  • Yes
95. Has your country established and maintained appropriate measures to prevent unintentional transboundary movements of LMOs?
  • Yes
96. Has your country taken measures to ensure that any LMO, whether imported or locally developed, undergoes an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use?
  • Yes
97. Has your country cooperated with other Parties with a view to identifying LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
98. Has your country cooperated with other Parties with a view to taking measures regarding the treatment of LMOs or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity?
  • Yes
99. Here you may provide further details on the implementation of Article 16 in your country, including any details regarding risk management strategies, also in case of lack of scientific certainty on potential adverse effects of LMOs:
The European legislative framework provides that environmental risk assessment described should be conducted with a view to identifying if there is a need for risk management and if so, the most appropriate methods to be used as well as a risk management strategy to be defined. In cases of limited data availability appropriate risk management has to be considered to prevent adverse effects on human health and the environment.
Article 17 – Unintentional transboundary movements and emergency measures
100. Has your country made available to the BCH the relevant details setting out its point of contact for the purposes of receiving notifications under Article 17?
  • Yes
101. Has your country established a mechanism for addressing emergency measures in case of unintentional transboundary movements of LMOs that are likely to have significant adverse effect on biological diversity?
  • Yes
102. Has your country implemented emergency measures in response to information about releases that led, or may have led, to unintentional transboundary movements of LMOs?
  • No
103. In the current reporting period, how many times has your country received information concerning occurrences that led, or may have led, to unintentional transboundary movement(s) of one or more LMOs to or from territories under its jurisdiction?
  • Never
Article 18 – Handling, transport, packaging and identification
108. Has your country taken measures to require that LMOs that are subject to transboundary movement are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards?
  • Yes
109. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is not known through means such as identity preservation systems, they may contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
110. Has your country taken measures to require that documentation accompanying LMOs-FFP clearly identifies that, in cases where the identity of the LMOs is known through means such as identity preservation systems, they contain living modified organisms and are not intended for intentional introduction into the environment, as well as a contact point for further information?
  • Yes
111. Has your country taken measures to require that documentation accompanying LMOs that are destined for contained use clearly identifies them as living modified organisms and specifies any requirements for the safe handling, storage, transport and use, the contact point for further information, including the name and address of the individual and institution to whom the LMO are consigned?
  • Yes
112. Has your country taken measures to require that documentation accompanying LMOs that are intended for intentional introduction into the environment of the Party of import, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter?
  • Yes
113. Does your country have the capacity to enforce the requirements of identification and documentation of LMOs?
  • Yes
114. Has your country established procedures for the sampling and detection of LMOs?
  • Yes
115. Here you may provide further details on the implementation of Article 18 in your country:
Article 118 requirements are implemented in EU legislation.
Article 19 – Competent National Authorities and National Focal Points
116. Has your country designated one national focal point for the Cartagena Protocol to be responsible for liaison with the Secretariat?
  • Yes
117. Has your country designated one national focal point for the Biosafety Clearing-House to liaise with the Secretariat regarding issues of relevance to the development and implementation of the BCH?
  • Yes
118. Has your country designated one or more competent national authorities, which are responsible for performing the administrative functions required by the Cartagena Protocol on Biosafety and are authorized to act on your country’s behalf with respect to those functions?
  • Yes, one
120. Has your country made available the required information referred in questions 116-119 to the BCH?
  • Yes, all information
122. Has your country established adequate institutional capacity to enable the competent national authority(ies) to perform the administrative functions required by the Cartagena Protocol on Biosafety?
  • Yes
Article 20 – Information Sharing and the Biosafety Clearing-House (BCH)
124. Please provide an overview of the status of the information provided by your country to the BCH by specifying for each category of information whether it is available and whether it has been submitted to the BCH.
124.a) Existing national legislation, regulations and guidelines for implementing the Protocol, as well as information required by Parties for the advance informed agreement procedure (Article 20, paragraph 3 (a))
  • Information available and in the BCH
124.b) National laws, regulations and guidelines applicable to the import of LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 5)
  • Information available and in the BCH
124.c) Bilateral, multilateral and regional agreements and arrangements (Articles 14, paragraph 2 and 20, paragraph 3 (b))
  • Information not available
124.d) Contact details for competent national authorities (Article 19, paragraphs 2 and 3), national focal points (Article 19, paragraphs 1 and 3), and emergency contacts (Article 17, paragraph 3 (e))
  • Information available and in the BCH
124.e) Reports submitted by the Parties on the operation of the Protocol (Article 20, paragraph 3 (e))
  • Information available and in the BCH
124.f) Decisions by a Party on regulating the transit of specific living modified organisms (LMOs) (Article 6, paragraph 1)
  • Information available and in the BCH
124.g) Occurrence of unintentional transboundary movements that are likely to have significant adverse effects on biological diversity (Article 17, paragraph 1)
  • Information not available
124.h) Illegal transboundary movements of LMOs (Article 25, paragraph 3)
  • Information not available
124.i) Final decisions regarding the importation or release of LMOs (i.e. approval or prohibition, any conditions, requests for further information, extensions granted, reasons for decision) (Articles 10, paragraph 3 and 20, paragraph 3(d))
  • Information available and in the BCH
124.j) Information on the application of domestic regulations to specific imports of LMOs (Article 14, paragraph 4)
  • Information available and in the BCH
124.k) Final decisions regarding the domestic use of LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing (Article 11, paragraph 1)
  • Information available and in the BCH
124.l) Final decisions regarding the import of LMOs intended for direct use as food or feed, or for processing that are taken under domestic regulatory frameworks (Article 11, paragraph 4) or in accordance with annex III (Article 11, paragraph 6) (requirement of Article 20, paragraph 3(d))
  • Information available and in the BCH
124.m) Declarations regarding the framework to be used for LMOs intended for direct use as food or feed, or for processing (Article 11, paragraph 6)
  • Information available and in the BCH
124.n) Review and change of decisions regarding intentional transboundary movements of LMOs (Article 12, paragraph 1)
  • Information not available
124.o) LMOs granted exemption status by each Party (Article 13, paragraph 1)
  • Information not available
124.p) Cases where intentional transboundary movement may take place at the same time as the movement is notified to the Party of import (Article 13, paragraph 1)
  • Information not available
124.q) Summaries of risk assessments or environmental reviews of LMOs generated by regulatory processes and relevant information regarding products thereof (Article 20, paragraph 3 (c))
  • Information available and in the BCH
125. Has your country established a mechanism for strengthening the capacity of the BCH National Focal Point to perform its administrative functions?
  • Yes
126. Has your country established a mechanism for the coordination among the BCH National Focal Point, the Cartagena Protocol focal point, and the competent national authority(ies) for making information available to the BCH?
  • Yes
127. Does your country use the information available in the BCH in its decision making processes on LMOs?
  • Yes, always
128. Has your country experienced difficulties accessing or using the BCH?
  • No
130. Is the information submitted by your country to the BCH complete and up-to date?
  • Yes
Article 21 – Confidential information
132. Has your country established procedures to protect confidential information received under the Protocol?
  • Yes
133. Does your country allow the notifier to identify information that is to be treated as confidential?
  • Yes, always
Article 22 – Capacity-building
135. Has your country received external support or benefited from collaborative activities with other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • No
137. Has your country provided support to other Parties in the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
138. If you answered Yes to question 137, how were these resources made available?
  • Bilateral channels
139. Is your country eligible to receive funding from the Global Environment Facility (GEF)?
  • No
143. During the current reporting period, has your country undertaken activities for the development and/or strengthening of human resources and institutional capacities in biosafety?
  • Yes
144. If you answered Yes to question 143, in which of the following areas were these activities undertaken?
  • Institutional capacity
  • Human resources capacity development and training
  • Risk assessment and other scientific and technical expertise
  • Information exchange and data management including participation in the Biosafety Clearing-House
  • Measures to address unintentional and/or illegal transboundary movements of LMOs
145. During the current reporting period, has your country carried out a capacity-building needs assessment?
  • No
146. Does your country still have capacity-building needs?
  • No
148. Has your country developed a capacity-building strategy or action plan?
  • No
149. Has your country submitted the details of national biosafety experts to the Roster of Experts in the BCH?
  • No
150. Here you may provide further details on the implementation of Article 22 in your country, including further details about your experience in accessing GEF funds:
The EU and its Member States have contributed to capacity building initiatives in the field of biosafety for the effective implementation of the Protocol in developing country Parties as well as in Parties with economies in transition.
Article 23 – Public awareness and participation
151. Has your country established a strategy or put in place legislation for promoting and facilitating public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes, to some extent
152. Has your country established a biosafety website?
  • Yes
153. Has your country established a mechanism to ensure public access to information on living modified organisms that may be imported?
  • Yes
154. Has your country established a mechanism to consult the public in the decision-making process regarding LMOs?
  • Yes
155. Has your country established a mechanism to make available to the public the results of decisions taken on LMOs?
  • Yes
156. Has your country taken any initiative to inform its public about the means of public access to the Biosafety Clearing-House?
  • Yes
157. In the current reporting period, has your country promoted and facilitated public awareness, education and participation concerning the safe transfer, handling and use of LMOs?
  • Yes
158. If you answered Yes to question 157, has your country cooperated with other States and international bodies?
  • Yes
159. In the current reporting period, how many times has your country consulted the public in the decision-making process regarding LMOs and made the results of such decisions available to the public?
  • None
160. Here you may provide further details on the implementation of Article 23 in your country:
Public participation is mandatory in accordance with national legislation and the Community Regulatory framework.

The Irish Environmental Protection Agency maintains information on its web page that provides the public with up-to-date information on the legislative framework for GMOs, applications for Part B GM crop authorisations (small scale field trials for research and development purposes), decisions taken by the Competent Authority on Part B releases, risk assessment aspects and guidelines on the Contained use and  Deliberate release of GMOs. Please refer to the following EPA web page for further details:

http://www.epa.ie/whatwedo/licensing/gmo/
Article 24 – Non-Parties
161. Has your country entered into any bilateral, regional, or multilateral agreement with non-Parties regarding transboundary movements of LMOs?
  • No
162. Has your country ever imported LMOs from a non-Party?
  • No
163. Has your country ever exported LMOs to a non-Party?
  • No
166. If your country is not a Party to the Cartagena Protocol, has it contributed information to the BCH on LMOs released in, or moved into, or out of, areas within its national jurisdiction?
  • Not applicable
167. Here you may provide further details on the implementation of Article 24 in your country:
As regards imports of LMOs, the EU applies its domestic legislative framework to all imports of LMOs, whether these originate from parties or non-parties to the Protocol.

As regards exports of LMOs, notification requirements of the exporter to the competent authority of the Party of import established by Regulation (EC) No 1946/2003 apply regardless of whether the country of import is a Party or a non-Party to the Protocol.
Article 25 – Illegal transboundary movements
168. Has your country adopted domestic measures aimed at preventing and/or penalizing transboundary movements of LMOs carried out in contravention of its domestic measures to implement this Protocol?
  • Yes
169. Has your country established a strategy for detecting illegal transboundary movements of LMOs?
  • Yes
170. In the current reporting period, how many times has your country received information concerning cases of illegal transboundary movements of an LMO to or from territories under its jurisdiction?
  • Never
175. Here you may provide further details on the implementation of Article 25 in your country:
European legislation contains explicit obligations on Member States to lay down rules on penalties applicable to infringements of the provisions of European regulations. Appropriate domestic measures are in place  in conjunction with a range of European legislation including the Genetically Modified Organisms (Transboundary Movement) Regulations 2004
Article 26 – Socio-economic considerations
176. If your country has taken a decision on import, has it ever taken into account socio-economic considerations arising from the impact of the LMO on the conservation and sustainable use of biological diversity?
  • Not applicable
177. Has your country cooperated with other Parties on research and information exchange on any socio-economic impacts of LMOs?
  • Yes, to a limited extent
178. Here you may provide further details on the implementation of Article 26 in your country:
Socio-economic considerations are relevant at Member State level in considering co-existence between conventional, organic and GM crops.

The Commission has recently issued a report on the socio-economic implications of GMO cultivation, based on the contributions of the Member State, including Ireland, and in line with Article 31 of Directive 2001/18/EC. However, Irish experience with GMO commercial cultivation in Europe is limited
Article 27 – Liability and Redress
179. Has your country signed the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress?
  • Yes
180. Has your country initiated steps towards ratification, acceptance or approval of the Nagoya-Kuala Lumpur Supplementary Protocol?
  • Yes
181. Here you may provide further details on any activities undertaken in your country towards the implementation of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress:
Ireland has undertaken steps and procedures towards a prompt ratification of the Supplementary Protocol, signing in May 2011.
Article 33 – Monitoring and reporting
182. Has your country submitted the previous national reports (Interim and First National Reports)?
  • Yes
183. If your country did not submit previous reports, indicate the main challenges that hindered the submission
  • Not applicable
Other information
184. Please use this field to provide any other information on issues related to national implementation of the Protocol, including any obstacles or impediments encountered.
Re: Q. 14 - Ratified in November 2003                                           

Re: Q. 138 - Regional channels as well

No further comments 
Comments on reporting format
185. Please use this field to provide any other information on difficulties that you have encountered in filling in this report.
No further comments 
Survey on indicators of the Strategic Plan (2014)
In decision BS-VI/15, Parties requested the Executive Secretary to conduct a dedicated survey to gather information corresponding to indicators in the Strategic Plan that could not be obtained from the second national reports or through other existing mechanisms.

The answers to the survey are displayed below.
When did your national biosafety framework become operational?
indicator 1.1.1
  • 2001 or earlier
Here you may provide further details
Biosafety work forms part of wider national work programmes (for example in environmental licensing, monitoring, and enforcement work). A specific national figure, attributable to Biosafety work only , is not available.
Survey 4. How many biosafety short-term training programmes and/or academic courses are offered annually in your country?
indicator 1.2.3
  • 5 per year or more
Here you may provide further details
At national level, the Irish Environmental Protection Agency (competent authority for the purposes of the Cartagena Protocol) provides presentations on the GM regulatory regime/biosafety requirements at colleges/universities and for the benefit of students, GM users and potential GM users.  In terms of academic courses, biosafety forms part of the curriculum on many science courses.
Survey 5. Does your country have in place a functional national mechanism for coordinating biosafety capacity-building initiatives?
indicator 1.2.4
  • Yes
Here you may provide further details
Capacity-building initiatives are coordinated amongst the relevant Government Departments and Agencies with a role in GM/biotechnology policy, GM assessment and monitoring and GMO detection methods.  An inter-Agency group meets on a regular basis to facilitate such coordination.
Survey 6. How much additional funding (in the equivalent of US dollars) has your country mobilized in the last four years to support implementation of the Biosafety Protocol, beyond the regular national budgetary allocation?
indicator 1.2.5
  • 100,000 USD or more
Survey 7. Does your country have predictable and reliable funding for building capacity for the effective implementation of the Protocol?
indicator 1.2.6
  • Yes
Here you may provide further details
As with question 6, funding is available to support relevant work.
Survey 8. How many LMO-related collaborative bilateral/multilateral arrangements has your country established with other Parties/non-Parties?
indicator 1.2.8
  • 10 or more
Here you may provide further details
Please refer to EU answer to this question.
Survey 9. Has your country adopted or used any guidance documents for the purpose of conducting risk assessment and/or risk management?
indicator 1.3.1.1
Survey 9.a) Risk assessment
  • Yes
Survey 9.b) Risk management
  • Yes
Here you may provide further details
The European Food Safety Authority has published scientific guidance documents on risk assessment. These are used by the national competent authority. http://www.efsa.europa.eu/en/gmo/gmoguidance.htm  Guidance documentation on this issue is also available on the Environmental Protection Agency website. http://epa.ie/pubs/advice/gmo/  http://epa.ie/licensing/gmo/contained/risk/  http://epa.ie/pubs/advice/gmo/gmms/Exampleriskassessmentclass1gmm.pdf  http://epa.ie/pubs/advice/gmo/Guidelines_Containment3.pdf
Survey 10. Has your country adopted or used any guidance documents for the purpose of evaluating risk assessment reports submitted by notifiers?
indicator 1.3.1.2
  • Yes
Here you may provide further details
The guidance documents referred to in question 9 are used by the Irish Environmental Protection Agency.
Survey 11. Has your country adopted any common approaches to risk assessment with other countries?
indicator 1.3.2
  • Yes
Here you may provide further details
Ireland participates in discussions under the Codex Alimentarius and the Organisation for Economic Co-operation and Development (OECD).
Survey 12. Has your country ever conducted a risk assessment of an LMO?
indicator 1.3.3
  • Yes
Here you may provide further details
The EU domestic legal framework, based on a prior risk assessment before authorisation is given, is applicable. For example, the notification provided by the company intending to market a GMO must include a full risk assessment of the risks to human and animal health and to the environment, which is then assessed by the European Food Safety Authority (EFSA), with an active involvement of Member States including Ireland, notably as regards the authorisation of GMOs for cultivation, where they carry out the initial risk assessment.  In a domestic context, the competent authority has evaluated the risk assessment plans in respect of a field trial, a clinical trial and a veterinary trial in the last two years. Information on these evaluations is available on the Agency website.   http://epa.ie/licensing/gmo/
Survey 13. Does your country have the capacity to identify, assess and/or monitor living modified organisms or specific traits that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health?
indicator 1.4.2
Survey 13.a) Identify
  • Yes
Survey 13.b) Assess
  • Yes
Survey 13.c) Monitor
  • Yes
Here you may provide further details
This is provided for under Irish transposition of the EU domestic legal framework, as set out under Q3.   Ireland has the necessary infrastructure to identify, assess and/or monitor LMOs.
Survey 14. Does your country have available any guidance for the purpose of ensuring the safe handling, transport, and packaging of living modified organisms?
indicator 1.6.4
  • Yes
Here you may provide further details
The EU legal framework on GMOs addresses the issues of handling, transport and packaging.   Existing EU legislation contains appropriate rules on the safe transport, handling and packaging of GMOs. These rules are contained in:  - Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road (last amended by Commission Directive 2003/28/EC); and   - Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by rail (last amended by Commission Directive 2003/29/EC).
Survey 15. Does your country have any specific approaches or requirements that facilitate how socio-economic considerations should be taken into account in LMO decision making?
indicator 1.7.2
  • Yes
Here you may provide further details
At present, this is not relevant in the context of the EU legislative process.  Ireland has participated in work at European level to consider how such considerations could be included in legislative procedure in the future.  In April 2011, the EU Commission issued a report ( http://ec.europa.eu/food/food/biotechnology/reports_studies/index_en.htm) on the socio-economic implications of GMO cultivation, based on the contributions of the Member States and in line with Article 31 of Directive 2001/18/EC and the conclusions of the Environment Council of December 2008. Ireland conducted a national public consultation on socio-economic implications as part of the information gathering required to compile the national response.  http://ec.europa.eu/food/food/biotechnology/reports_studies/docs/Ireland_impact_report_en.pdf  Nationally, relevant information on the ex-post socio-economic impacts of GMO cultivation is rather limited, particularly as Ireland does not currently have any commercial cultivation of GM crops.  The Commission has set up a technical working group (the "European GMO Socio-Economics Bureau" - ESEB) composed of experts from the Member States. The ESEB started its work in January 2013 and Ireland will participate in this work  The mission of the ESEB is to organise and facilitate the exchange of technical and scientific information regarding the socio-economic implications of the cultivation and use of GMOs between Member States and the Commission. On the basis of this process, the ESEB will develop Reference Documents that will enable a science-based assessment of these impacts in the Member States and across the EU.
Survey 16. How many peer-reviewed published materials has your country used for the purpose of elaborating or determining national actions with regard to socio-economic considerations?
indicator 1.7.1
  • None
Here you may provide further details
N/A.
Survey 17. What is your country's experience, if any, in taking socio-economic considerations into account in LMO decision making?
indicator 1.7.3
N/A.
Survey 18. Does your country have the capacity to take appropriate measures in the event that an LMO is unintentionally released?
indicator 1.8.3
  • Yes
Here you may provide further details
Specific capacities include information channels among Member States of the European Union allowing for rapid dissemination of the information in case of unintentional release of a GMO, expertise of the European Union Reference Laboratory for GM Food Feed and detection capacities in the Member States.    Article 50 of Regulation 178/2002 on the general principles of food law set up a Rapid Alert System for Food  and Feed which is a means of allowing rapid dissemination of the information in case of unintentional release of a GMOs.    Article 14 of Regulation 1946/2003 provides for measures to prevent unintentional transboundary movement of GMOs and appropriate responses, including emergency measures.    Regulation (CE) N° 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules was adopted by the European Parliament and the Council on 29 April 2004.   In this context, it is also worth noting that Ireland has ratified the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress.
Survey 19. How many people in your country have been trained in risk assessment, monitoring, management and control of LMOs?
indicator 2.2.3
Survey 19.a) Risk assessment
  • One or more
Survey 19.b) Monitoring
  • One or more
Survey 19.c) Management / Control
  • One or more
Here you may provide further details
The competent authority has a number of qualified inspectors, as does the Department of the Environment, Department of Agriculture, Food Safety Authority, Department of Health and Health Service Executive.  The Joint Research Centre of the European Union organized general training courses on detection of GMOs in food and feed samples as well as ad-hoc training courses for National Reference Laboratories under Regulation (EC) 882/2004.  One analyst from Public Analyst Laboratory Cork has been trained on the detection of GMOs by the Joint Research Centre (JRC) of the European Union.
Survey 20. Does your country have the infrastructure (e.g. laboratory facilities) for monitoring or managing LMOs?
indicator 2.2.4
  • Yes
Here you may provide further details
At the EU level, the EU Reference Laboratory for GM Food Feed (EU-RL GMFF) is responsible for the scientific assessment and validation of detection methods for GM Food and Feed as part of the EU authorisation procedure and the coordination of the National Reference Laboratories for GMO in the 27 Member States. The EU-RL GMFF is supported by ENGL, the European Network of GMO Laboratories, and hosted by the Joint Research Centre (JRC) of the European Commission (http://gmo-crl.jrc.ec.europa.eu/default.htm)  At present Ireland also utilises National Reference Laboratories located in the United Kingdom. The Department of Agriculture, Food and the Marine (DAFM) in Ireland are beginning to set up their laboratory for GMO detection and plan to begin GMO testing later this year. This laboratory is intended to take over NRL duties.    Cork Public Analyst laboratory (Cork PAL) is currently the only lab carrying out GMO testing in Ireland. The laboratory is concerned with testing foodstuffs. The lab has accreditation for the detection of a number of GMO events which will be expanded in the coming months to include 5 more maize events. Data is being gathered  to achieve accreditation status in feed stuffs.  Work is closely linked to the advice of the JRC, and uses the validated methods published from the JRC.
Survey 21. Is your country using training material and/or technical guidance for training in risk assessment and risk management of LMOs?
indicator 2.2.5
  • Yes
Here you may provide further details
The Joint Research Centre of the European Union uses both training materials and guidance when organizing training courses on detection of GMOs. These documents are publicly available on the following webpages: http://gmo-crl.jrc.ec.europa.eu/guidancedocs.htm and http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/documentation.htm.   The Cork Public Analyst laboratory uses the guidance documentation published from the Joint Research Centre. The methods used at the laboratory are the methods published by the JRC. These methods are available in the compendium of reference methods for GMO analysis. The methods published are solely used for the detection of a GMO.  The Department of Agriculture, Food and the Marine laboratory will also use the compendium to detect GMOs.
Survey 22. Are the available training materials and technical guidance on risk assessment and risk management of LMOs sufficient and effective?
indicator 2.2.6
Survey 22.a) Sufficient
  • Yes
Survey 22.b) Effective
  • Yes
Survey 23. How many customs officers in your country have received training in the identification of LMOs?
indicator 2.3.1
  • One or more
Here you may provide further details
Department of Agriculture inspectors collect samples of feed materials at the ports for testing for the presence of GMOs. The sampling process is similar to that used to identify other non-uniformly distributed substances 'undesirable substances' such as salmonella and aflatoxins.
Survey 24. How many laboratory personnel in your country have received training in detection of LMOs?
indicator 2.3.1
  • 10 or more
Here you may provide further details
As set out under Q19, one analyst from Public Analyst Laboratory -Cork has been trained on the detection of GMOs by the Joint Research Centre (JRC) of the European Union.
Survey 25. Does your country have reliable access to laboratory facilities for the detection of LMOs?
indicator 2.3.2
  • Yes
Here you may provide further details
See Q20.  At present there are 2 laboratories carrying out GMO testing:  The Cork Public Analyst Laboratory currently tests foodstuffs for GMOs, but is also beginning to test feed samples.   The Department of Agriculture, Food and the Marine, Backweston, is the second laboratory which will be carrying out GMO testing in the near future. The laboratory is fully equipped to carry out both qualitative and quantitative testing. This laboratory plans to become the NRL in the coming years.  Ireland also has reliable access to external facilities.
Survey 26. How many laboratories in your country are certified for LMO detection?
indicator 2.3.3
  • One or more
Here you may provide further details
See Q 25 answer.
Survey 27. How many of the certified laboratories in the previous question are operational?
indicator 2.3.4
  • One or more
Here you may provide further details
See Q25 answer.
Survey 28. Has your country received any financial and/or technical assistance for capacity-building in the area of liability and redress relating to living modified organisms?
indicator 2.4.1
  • No
Here you may provide further details
N/A
Survey 29. Does your country have administrative or legal instrument that provide for response measures for damage to biodiversity resulting from living modified organisms?
indicator 2.4.2
  • Yes
Here you may provide further details
In the European Union, the provisions of the Cartagena Protocol on Biosafety are covered by the European legislation on Biosafety. The liability provisions of the Nagoya-Kuala Lumpur Supplementary Protocol are covered by the Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004, on environmental liability with regard to the prevention and remedying of environmental damage  which Ireland has transposed through the European Communities (Environmental Liability) Regulations 2008 (SI 547 of 2008).  Ireland has also ratified the Nagoya-Kuala Lumpur Supplementary Protocol.
Survey 30. Has your country informed the public about existing modalities for public participation in the decision-making process regarding living modified organisms?
indicator 2.5.2
  • Yes
Here you may provide further details
Before a GMO can be approved for commercial cultivation, the Commission consults the public on the risk assessment done by the European Food Safety Agency (EFSA).   In accordance with Article 15 of the GMO Regulations S.I. No 500 of 2003, applicants proposing to carry out a Deliberate Release of GMOs in Ireland for purposes other than placing on the market, are required to advertise this intent. The advertisement also invites the public to make representations to the EPA in relation to the proposed deliberate release.    http://www.epa.ie/pubs/advice/gmo/Public%20Representations.pdf
Survey 31. If you answered yes to the previous question, please indicate the modalities used to inform the public?
indicator 2.5.2
  • http://gmoinfo.jrc.ec.europa.eu/gmc_browse.aspx
Survey 32. If you indicated multiple modalities for public participation in the question above, which one was most used?
indicator 2.5.2
  • National website
Survey 33. How many academic institutions in your country are offering biosafety education and training courses and programmes?
indicator 2.7.1
  • 10 or more
Here you may provide further details
See response to Q4.   At national level, the Irish Environmental Protection Agency (competent authority for the purposes of the Cartagena Protocol) provides presentations on the GM regulatory regime/biosafety requirements at colleges/universities and for the benefit of students, GM users and potential GM users.  In terms of academic courses, biosafety forms part of the curriculum on many science courses. The major third level institutions have Biosafety Officers and Biosafety Committees.  At the EU level, the JRC (EU Reference Laboratory for GM Food Feed (EU-RL GMFF), responsible for the scientific assessment and validation of detection methods for GMOs and the coordination of the National Reference Laboratories for GMO in the 27 Member States, organizes workshops and trainings courses on GMO detection and analysis (see  http://gmo-crl.jrc.ec.europa.eu/capacitybuilding/default.htm).
Survey 34. How many biosafety training materials and/or online modules are available in your country?
indicator 2.7.2
  • One or more
Here you may provide further details
The EPA has online guides on legislation and reporting requirements.   IT Carlow has recently prepared the following online guide:  http://www.ndlr.ie/articulate/itcarlow/working-with-GMOs/player.html  For details at EU Member States level, please refer to the Member States national survey reports.
Survey 35. Does your country have in place a monitoring and/or an enforcement system?
indicator 3.1.6
Survey 35.a) Monitoring system
  • Yes
Survey 35.b) Enforcement system
  • Yes
Here you may provide further details
Yes. Again this is in place under transposition of the EU framework as set out in answer to Q3.
Survey 36. Please indicate the number of regional, national and international events organized in relation to biosafety (e.g. seminars, workshops, press conferences, educational events, etc.,) in the last 2 years.
indicator 4.3.1
  • One or more
Here you may provide further details
The most recent such event was a 2 day conference on GM Technology organised by the Environmental Protection Agency. The theme of the Conference was "Regulation and Use of GMO Technology in Ireland", with specific modules on Regulation of GMO Technology, Technology Communication and Risk Management.  http://www.epa.ie/pubs/conferencesandevents/EPA%20GMO%20Programme%20B2%20(3).pdf
Survey 37. Please indicate the number of biosafety related publications that has been made available in your country in the last year.
indicator 4.3.2
  • One or more
Here you may provide further details
Documentation on two applications made during 2013 is available on the EPA website.  http://www.epa.ie/licensing/gmo/vettrial/  http://www.epa.ie/licensing/gmo/haeb/
Survey 38. If biosafety related publications were made available (see question above), please indicate which modalities were preferred.
indicator 4.3.2
  • BCH Central Portal
Survey 39. How many collaborative initiatives (including joint activities) on the Cartagena Protocol and other Conventions and processes has your government established in the last 4 years?
indicator 5.2.1
  • One or more
Survey 40. Does your country have any awareness and outreach programmes on biosafety?
indicator 5.3.1
  • Yes
Here you may provide further details
• Ireland participates in various EU coordinated projects which have awareness and outreach remit. These include:"Better Training for Safer Food" is a training programme on food and feed safety, animal health and animal welfare, and plant health, including analysis of GMOs. The courses are delivered in EU and non-EU countries, targeting the staff of competent authorities dealing with official controls from EU and select non-EU countries.  • EU research programmes on the biosafety of GMOs, which include a module on communication, e.g. AMIGA (Assessing and Monitoring the Impacts of Genetically modified plants (GMPs) on Agro-ecosystems, http://www.amigaproject.eu/project/overview/),   Teagasc, the Irish Agriculture and Food Development Authority undertaking national land-use research, teaching and advisory activities, participates as an AMIGA partner.  http://www.amigaproject.eu/partners/teagasc/    More information on Teagasc and its activities within the framework of the AMIGA project are available on the Teagasc website.  (Material provided under Q42 is also relevant in this context.  http://www.teagasc.ie/news/proposed_gm_potato_research.asp  At national level, the EPA has a statutory role in coordinating environmental research. The EPA's  STRIVE research programme has a strong focus on policy and has been driven by national regulations and European Directives. The EPA supports the principle that ideas and knowledge derived from publicly-funded research should be made available and accessible for public use, interrogation and scrutiny, as widely, rapidly and effectively as practicable.
Survey 42. Has your country designed and/or implemented an outreach/communication strategy on biosafety?
indicator 5.3.2
  • Yes
Here you may provide further details
Information on GMO related-issues including relevant legislation, guidance documentation, information on previous consultation processes, assessment reports are all available on the EPA website.   http://www.epa.ie/licensing/gmo/  The Department of Environment, Community and Local Government and the Department of Agriculture, Food and the Marine also host relevant information on the respective websites;  http://environ.ie/en/GMO    http://www.agriculture.gov.ie/agri-foodindustry/feedingstuffs/geneticallymodifiedfeeds  As mentioned under Q15 ,the Department of the Environment, Community and Local Government carried out a public consultation process on the Socio-economic Implications of the placing on the market of GMOs for cultivation in 2010. A summary of responses received issued in 2011.  In July 2012, the EPA granted a licence to Teagasc, the Irish agriculture and food development authority, to begin field trials of a GM potato. A public consultation was carried out. However the Agency also facilitated a separate "#gmpotato Community of Inquiry project" which was carried out by Dublin City University researchers.  http://www.gm-potato.com/  The intention was to;  • facilitate public debate and dialogue between stakeholders involved in both the proposal of, and resistance to, the GM potato, as well as the wider public.  • allow a process of dialogue that will inform policy and regulation on genetically modified organisms and future farming practice in Ireland.  • use the latest in communication research and practice in deliberative, democratic processes enabling public response to controversial technologies  Teagasc has also hosted visits to the site, open-days, and information seminars to explain the rationale behind the field trial.
Survey 43. Please indicate the number of educational materials on biosafety that are available and accessible to the public.
indicator 5.3.4
  • 10 or more
Here you may provide further details
The relevant Agencies and Departments host relevant information materials on respective websites. Links provided under Q42 apply.