Genetically Modified Organisms Regulations, 1994

• Jurisdiction: Ireland
• Year: 1994
• Citation: IR SI 345/1994

S.I. No. 345 of 1994.
GENETICALLY MODIFIED ORGANISMS REGULATIONS, 1994.
ARRANGEMENT OF REGULATIONS
PART I
PRELIMINARY AND GENERAL
Article
1. Citation.
2. Commencement.
3. Interpretation.
4. Competent authority.
5. Obligations, etc.
6. Savings.
7. Calculation of time.
8. Register.
9. Confidential information.
10. Transitional arrangements.
PART II
CONTAINED USE
11. Exclusions.
12. Duty to comply with this Part.
13. General duty to conduct assessment of risks.
14. Record of existing uses.
15. Principles to be applied by users.
16. Notification of first-time use of an installation for the contained use of genertically modified organisms.
17. Contained use of Group I genetically modified micro-organisms.
18. Contained use of Group II genetically modified micro-organisms.
19. Effect of notifications.
20. Duty of the Agency under this Part.
21. Power of the Agency to request further information or modifications.
22. Power of the Agency to grant or refuse consent.
23. Duty of user to inform the Agency of new information etc.
24. Review of contained uses.
25. Accident procedures.
26. Consultation concerning emergency plans.
27. Informing the Commission of the European Communities.
PART III
DELIBERATE RELEASE INTO THE ENVIRONMENT FOR PURPOSES OTHER THAN FOR PLACING ON THE MARKET
28. Exclusions.
29. Prohibition of a deliberate release in the absence of consent.
30. Notification of intent to make a deliberate release.
31. Advertisement of notification for consent to a deliberate release.
32. Modification of notifications.
33. Duty of the Agency under this Part.
34. Power of the Agency to modify consent.
35. Duty to inform Agency of new information, etc.
36. Post release procedures.
37. Notification of decision.
38. Waiver or modification.
PART IV
PLACING ON THE MARKET OF PRODUCTS CONTAINING GENETICALLY MODIFIED ORGANISMS
39. Consent to market products.
40. Power of the Agency to prohibit placing on the market.
41. Information to be contained in a notification.
42. Duty of the Agency under this Part.
PART V
FEES AND CHARGES
43. Fee for notification of a first time use of an installation.
44. Fee for notification of a Group I contained use.
45. Fee for notification of a Group II contained use.
46. Fee for an amended notification of a contained use.
47. Fee for notification of a deliberate release.
48. Fee for notification of the placing of a product on the market.
49. Refund of fee in case of certain repeat notifications.
50. Claim for refund to be in writing.
51. Discretionary power to refund or waive fee in certain limited circumstances.
52. Periodic charges for monitoring.
53. Agency investigations.
54. Recovery of costs or charges.
PART VI
ADVISORY COMMITTEE ON GENETICALLY MODIFIED ORGANISMS
55. Advisory Committee.
56. Membership of Advisory Committee.
57. Term of appointment of members of Advisory Committee.
58. Appointment of person to chair meetings.
59. Regulation of procedure or business.
PART VII
ENFORCEMENT AND REGULATION
60. Authorised persons.
61. Prosecution of offences.
62. High Court injunction.
63. Notice to take measures.
PART VIII
MONITORING AND REPORTING
64. Monitoring.
65. Reporting on functions under these Regulations.
SCHEDULES
First Schedule: Techniques of genetic modification. Second Schedule: Classification of genetically modified micro-organisms. Third Schedule: Safety assessment parameters to be taken into account as far as they are relevant. Fourth Schedule: Containment measures for micro-organisms in Group II. Fifth Schedule: Information required in the notification of a first time use of an installation, and/or a contained use. Sixth Schedule: Information to be supplied to the Commission of the European Communities by the Agency where an accident has occurred. Seventh Schedule: Information required in the notification of intent to make a deliberate release. Eighth Schedule: Additional information required in the case of notification for placing on the market. Ninth Schedule: Summary notification information format for releases of genetically modified organisms. Tenth Schedule: Summary notification information format for products containing genetically modified organisms. Eleventh Schedule: Fees.
S.I. No. 345 of 1994.
GENETICALLY MODIFIED ORGANISMS REGULATIONS, 1994.
In exercise of the powers conferred on the Minister for the Environment by sections 6 and 111 on the Environmental Protection Agency Act, 1992 (No. 7 of 1992), which said powers are delegated to me by the Environment (Delegation of Ministerial Functions) Order, 1993 ( S.I. No. 127 of 1993 ), I, JOHN BROWNE, Minister of State at the Department of the Environment, hereby make the following Regulations.
PART I PRELIMINARY AND GENERAL
	1 Citation.	1. These Regulations may be cited as the Genetically Modified Organisms Regulations, 1994.
	2 Commencement.	2. The Regulations shall come into operation on the 1st day of January, 1995.
	3 Interpretation.	3. (1) In these Regulations, unless the context otherwise requires—
"accident" means any incident involving a significant and unintended release of genetically modified organisms in the course of their contained use which could present an immediate or delayed hazard to human health or the environment;
"the Act" means the Environmental Protection Agency Act, 1992 ;
"the Agency" means the Environmental Protection Agency established under section 19 of the Act;
"confidential information" includes information the disclosure of which might harm the competitive position of the notifier or the intellectual property rights relating to any data received;
"competent authority" has the meaning assigned to it in article 4;
"contained use" means any operation in which organisms are genetically modified or in which such genetically modified organisms are cultured, stored, used, transported, destroyed or disposed of and for which physical barriers, or a combination of physical barriers, together with chemical and/or biological barriers, are used to limit their contact with the general population and the environment;
"deliberate release" means any intentional introduction into the environment of a genetically modified organism or a combination of genetically modified organisms without provisions for containment such as physical barriers or a combination of physical barriers together with chemical and/or biological barriers used to limit their contact with the general population and the environment, and cognate words and expressions shall be construed accordingly;
"first time use of an installation" means the first time use of an installation for an operation involving the contained use of a genetically modified organism;
"Group I genetically modified micro-organisms" means genetically modified micro-organisms which satisfy such of the criteria of Part I of the Second Schedule as are applicable in the particular case in accordance with the guidelines set out in Part II of that Schedule. For Type A operations, where any of the criteria in Part I of the Second Schedule may not be applicable in determining the classification of a particular genetically modified micro-organism, the matter shall be referred to the Agency, which shall, as far as possible, determine the classification having regard to the relevant criteria and the guidelines set out in Part II of that Schedule;
"Group II genetically modified micro-organisms" means genetically modified micro-organisms other than those in Group I;
"genetically modified micro-organism" means any microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material in which the genetic material has been altered in a way that does not occur naturally by mating and/or by natural recombination;
"Type A operation" means any activity involving genetically modified micro-organisms for the purposes of teaching, research or development, or for non-industrial or non-commercial purposes on a scale at which the practices and conditions of the activity relative to the culture, volume and numbers of organisms are such that—
( a ) the system used to keep the organisms under containment reflects good microbiological practice and good occupational safety and hygiene, and
( b ) it is practicable to render the organisms inactive by standard laboratory decontamination techniques;
"Type B operation" means any activity involving the genetic modification of micro-organisms other a Type A operation;
"higher plant" has the meaning assigned to it in the Seventh Schedule;
"notifier" means a person or body who submits a notification or a record to the competent authority under these Regulations;
"organism" has the meaning assigned 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 supplying or making available to third parties, 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;
"use" means the deliberate release of a product which has been placed on the market;
"user" shall mean any legal or natural person responsible for the contained use of a genetically modified organism, or a person carrying out a use as defined above, whichever is appropriate.
(2) ( a ) Within the terms of the definition of "genetically modified organism" as set out in section 111 of the Act, and "genetically modified micro-organism" as set out in subarticle (1), genetic modification occurs at least through...