Genetically Modified Organisms (Deliberate Release) Regulations, 2003

• Jurisdiction: Ireland
• Citation: IR SI 500/2003
• Year: 2003

ARRANGEMENT OF REGULATIONS
PART I
PRELIMINARY AND GENERAL
Article
1. Citation.
2. Commencement.
3. Interpretation.
4. Competent authority.
5. Obligations.
6. Savings.
7. Exclusions.
8. Calculation of time and payment of fees.
9. Register and public information.
10. Confidential information.
11. Transitional arrangements.
PART II
DELIBERATE RELEASE OF GENETICALLY MODIFIED ORGANISMS INTO THE ENVIRONMENT FOR PURPOSES OTHER THAN PLACING ON THE MARKET
12. Exclusions from this Part.
13. Duty to comply with this Part.
14. Notification of intent to make a deliberate release.
15. Advertisement of notification for consent to a deliberate release.
16. Representations in respect of matters comprehended by this Part.
17. Modification of notification or new information prior to the Agency's decision.
18. Duty of the Agency on foot of notification.
19. Power of the Agency to request further information.
20. Modification of deliberate release following grant of consent by the Agency.
21. Duty to inform the Agency of new information, etc.
22. Power of the Agency to modify, suspend or terminate consent.
23. Notification of decisions.
24. Post-release procedures.
PART III
PLACING ON THE MARKET OF PRODUCTS CONTAINING OR CONSISTING OF GENETICALLY MODIFIED ORGANISMS
CHAPTER 1
GENERAL PROVISIONS RELATING TO THIS PART
25. Exclusions from this Part.
26. Duty to comply with this Part.
27. Mandatory requirements in consents under this Part.
28. Power of the Agency to restrict or prohibit use or placing on market.
CHAPTER 2
PLACING ON THE MARKET FOR THE FIRST TIME
29. Duty to give notification and to advertise.
30. Information to be contained in a notification.
31. Modification of notification prior to the Agency's decision.
32. Duty of the Agency on foot of notification.
33. Decision on the notification.
34. Limitation on consent.
CHAPTER 3
RENEWAL OF CONSENT
35. Duty to comply with renewal requirements.
36. Submission of renewal notification.
37. Information to be contained in a renewal notification.
38. Duty of the Agency on foot of renewal notification.
39. Decision on the renewal notification.
40. Limitation on renewal of consent.
CHAPTER 4
POST APPROVAL
41. General.
42. Power of the Agency to adapt monitoring plan.
43. Duty to inform the Agency of new information.
44. Duty of the Agency on receipt of new information.
45. Decision on foot of new information.
PART IV
FEES AND CHARGES
46. Fee for notification of a proposed deliberate release.
47. Fee for notification of a proposed placing of a product on the market and renewal of consent.
48. Fee for representations.
49. Fee for amended notification in relation to a deliberate release.
50. Fee for amended notification of a proposed placing of a product on the market.
51. Refund of fee in case of certain repeat notifications.
52. Claim for refund to be in writing.
53. Discretionary power to refund or waive fee in certain limited circumstances.
54. Periodic charges for monitoring.
55. Agency investigations.
56. Recovery of costs or charges.
PART V
ENFORCEMENT AND REGULATION
57. Authorised persons.
58. Prosecution of offences.
59. High Court injunction.
60. Notice to take measures.
PART VI
GENETICALLY MODIFIED ORGANISMS ADVISORY COMMITTEE
61. Genetically Modified Organisms Advisory Committee.
62. Membership of Advisory Committee.
63. Term of appointment of members of Advisory Committee.
64. Appointment of person to chair meetings.
65. Regulation of procedure or business.
PART VII
MISCELLANEOUS
66. Testing, monitoring etc.
67. Reporting on functions under these Regulations.
68. Amendment of Genetically Modified Organisms (Contained Use) Regulations 2001.
69. Revocation and application of Genetically Modified Organisms Regulations 1994.
SCHEDULES
First Schedule: Techniques of genetic modification. Second Schedule: Principles for the environmental risk assessment. Third Schedule: Information required in notifications. Fourth Schedule: Additional information required in the case of notification for placing on the market of products containing or consisting of genetically modified organisms. Fifth Schedule: Guidelines for the assessment reports. Sixth Schedule: Monitoring plan.
S.I. No. 500 of 2003
GENETICALLY MODIFIED ORGANISMS (DELIBERATE RELEASE) REGULATIONS 2003
The Minister for the Environment, Heritage and Local Government, in exercise of the powers conferred on him by sections 6 and 111 (as amended by section 17 of the Protection (No. 27 of 2003)) of the Environmental Protection Agency Act 1992 (No. 7 of 1992), and for the purpose of giving effect to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 20011 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC2 , hereby makes the following Regulations.
PART I PRELIMINARY AND GENERAL
	Citation	1. These Regulations may be cited as the Genetically Modified Organisms (Deliberate Release) Regulations 2003.
	Commencement	2. These Regulations shall come into operation on 1 November 2003.
	Interpretation	3. (1) In these Regulations, unless the context otherwise requires—
“the Act” means the Environmental Protection Agency Act 1992 ;
“the Agency” means the Environmental Protection Agency established under section 19 of the Act;
“competent authority” has the meaning assigned to it in article 4;
“deliberate release” means any intentional introduction into the environment of a genetically modified organism or a combination of genetically modified organisms for which no specific containment measures are used to limit their contact with, and to provide a high level of safety for, the general population and the environment, and cognate words and expressions shall be construed accordingly;
“the Directive” means Directive 2001 18 EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC:
“environmental risk assessment” means an evaluation, carried out in accordance with the Second Schedule, of risk to human health or the environment, whether direct or indirect, immediate or delayed, which the deliberate release or the placing on the market of a genetically modified organism may pose;
“genetically modified organism” means an organism, other than a human being, in which the genetic material has been altered in a way that does not occur naturally by mating or natural recombination, or by a combination of both;
“the Minister” means the Minister for the Environment, Heritage and Local Government;
“notification” means the submission of required information to the competent authority;
“notifier” means any legal or natural person submitting a notification or, where the context so requires, any legal or natural person responsible for a deliberate release or for a placing on the market, or for meeting any other requirement of these Regulations in relation to a deliberate release or a placing on the market;
“organism” has the meaning given to it in section 111 of the Act and includes any biological entity capable of replication or of transferring genetic material;
“placing on the market” means any transaction in which a genetically modified organism is supplied or made available to a third party, whether in return for payment or otherwise, but does not include—
(a) supplying or making a genetically modified organism available for use in an activity to which the Genetically Modified Organisms (Contained Use Regulations 2001 apply.
(b) supplying or making a genetically modified organism, other than a genetically modified organism to which the Genetically Modified Organisms (Contained Use) Regulations 2001 apply, available for use exclusively in an activity in respect of which appropriate stringent, containment measures, based on the principles of containment established in the said Regulations, are used for the purposes of limiting contact with, and to provide a high level of safety for, the general population and the environment.
(c) supplying or making a genetically modified organism available for use exclusively in a deliberate release to be carried out in compliance with Part II.
and cognate words and expressions shall be construed accordingly;
“product” means a preparation consisting of, or containing, a genetically modified organism or a combination of genetically modified organisms, which is placed on the market.
(2) In these Regulations, a reference to a genetically modified organism shall, where it arises, be construed as including a reference to a combination of genetically modified organisms.
(3) (a) Within the terms of the definition of a “genetically modified organism” as set out in sub-article (1), for the purposes of these Regulations genetic modification occurs at least through the use of the techniques listed in Part I of the First Schedule.
(b) For the purposes of these Regulations, the techniques listed in Part II of the First Schedule are not considered to result in genetic modification.
(4) (a) In these Regulations, any reference to a Schedule, Part, Chapter or article which is not otherwise identified is a reference to a Schedule, Part, Chapter or article of these Regulations.
(b) In these Regulations, any reference to a sub-article, paragraph or subparagraph which is not otherwise identified is a reference to the sub-article, paragraph or subparagraph of the provision in which the reference occurs.
	Competent authority	4. The Agency shall be the competent authority for the purposes of these Regulations.

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