1. Implementation of the GMO legislation in
Ireland - the role of the EPA
Office of Climate, Licensing & Resource Use
Environmental Protection Agency
Johnstown Castle Estate
Wexford

2. Introduction
 Legislation  Waste Inactivation
 Definitions  Deliberate Release
 Risk Assessments  Clinical Trials
 Classification  Useful Links
 Containment Measures
 Enforcement & Site Inspections and
Annual Reporting
 Notifications, Confidential Information

3. EPA’s Role in Regulating GMOs in Ireland
 Implement the Regulations
 Contained Use – laboratories & industry
 Deliberate Release into the environment
 Research & Development Purposes - field trials, clinical trials
 Placing GMO products on the market
 European Food Safety Authority
 European Medicines Agency
 Transboundary movement of GMOs

4. Regulating GMOs in Ireland
 Government responsible for policy
 Minister for the Environment, Community & Local Government
 Contained Use (CU) and Deliberate Release (DR) into environment of GMOs
 Dept of Health & Children
 Food safety aspects (FSAI)
 Dept of Agriculture, Food & the Marine
 Seed for cultivation
 Animal feed
 Co-existence
 Use of Plant Protection Products on GM plants

5. Legislation
 Contained Use Directive 2009/41/EC on the
contained use of Genetically Modified Micro-
Organisms (GMMs)
 Genetically Modified Organisms (Contained Use)
Regulations, S.I. 73 of 2001
 Amended by S.I. No. 442/2010 — Genetically Modified
Organisms (Contained Use) (Amendment) Regulations
2010
 http://www.irishstatutebook.ie/statutory.html

6. Legislation contd.
 EU Directive 2001/18/EC on the deliberate release of GMOs
into the environment
 Genetically Modified Organisms (Deliberate Release
Regulations), S.I. 500 of 2003
 Genetically Modified Organisms (Transboundary Movement
Regulations), S.I. 54 of 2004

7. Definitions
 A Genetically Modified Organism (GMO) / Genetically
Modified Micro-organism (GMM) is defined as:
“...an organism/micro-organism... 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
 An organism (any biological entity) and a micro-organism
(any micro-biological entity, cellular or non-cellular) must be
capable of replication or of transferring genetic material

8. Definitions contd.
 Contained Use
‘any activity in which micro-organisms are genetically modified or
in which such micro-organisms are cultured, stored,
transported, destroyed, disposed of or used in any other
way and for which specific containment and other protective
measures are used to limit their contact with the general public
and the environment’

9. Definitions contd.
 User
‘any legal or natural person responsible for a contained use or for
giving notification of, or for meeting any other requirements in
relation to, a proposed contained use’
 Article 5 of the Regulations - Obligations

10. Techniques of Genetic Modification
 Part I of the First Schedule of S.I. No 73 of 2001
Techniques of Genetic modification referred to in article 3(3)(a) are inter
alia
 Recombinant nucleic acid techniques involving the formation of new
combinations of genetic material by the insertion of nucleic acid molecules
produced by whatever means outside an organism, into any virus, bacterial
plasmid or other vector system and their incorporation into a host organism in
which they do not naturally occur but in which they are capable of continued
propagation.
 Techniques involving the direct introduction into an organism of heritable
material prepared outside the organism including micro-injection, macro-
injection and micro-encapsulation.
 Cell fusion or hybridisation techniques where live cells with new combinations
of heritable genetic material are formed through the fusion of two or more cells
by means of methods that do not occur naturally.

11. Techniques not considered to result in Genetic
Modification
 Part II of the First Schedule of S.I. No 73 of 2001
Techniques referred to in article 3(3)(b) which are not considered to
result in genetic modification, provided they do not involve the use of
recombinant-nucleic acid molecules or genetically modified organisms
made by techniques or methods other than techniques or methods
excluded under articles 11(1) and 33(1) and set out in the Second
Schedule:
 in vitro fertilisation;
 natural processes such as: conjugation, transduction, transformation;
 polyploidy induction.

12. Techniques yielding organisms that are excluded from
the legislation
 Second Schedule of S.I. No 73 of 2001
Techniques or methods of genetic modification yielding organisms
excluded from the requirements of these Regulations, provided
they do not involve the use of recombinant-nucleic acid molecules or
genetically modified organisms other than those produced by one or
more of the techniques or methods listed below:
 mutagenesis,
 cell fusion (including protoplast fusion) of prokaryotic species that
exchange genetic material by known physiological processes,
 cell fusion (including protoplast fusion) of cells of any eukaryotic
species, including production of hybridomas and plant cell fusions, or

13. Techniques yielding organisms that are excluded from
the legislation (continued)
 self-cloning consisting of the removal of nucleic acid sequences from
a cell of an organism which may or may not be followed by reinsertion
of all or part of that nucleic acid (or a synthetic equivalent) with or
without prior enzymic or mechanical steps, into cells of the same
species or into cells of phylogenetically closely related species which
can exchange genetic material by natural physiological processes
where the resulting organism is unlikely to cause disease to humans,
animals or plants.
For the purposes of these Regulations, self-cloning may include the
use of recombinant vectors with an extended history of safe use in the
particular organisms.

14. What we don’t want…
SARS, China
2004
Foot & Mouth, Pirbright
2007
Smallpox accident, 2000

15. Classification of GMMs
 Activities classified into 1 of 4 classes (Class 1, 2, 3, or 4)
 Class 1 - activities of no or negligible risk, Containment Level 1
(CL1) is appropriate
 Class 2 - activities of low risk, CL2
 Class 3 - activities of moderate risk, CL3
 Class 4 - activities of high risk, CL4
 Level of containment required for the GMM
corresponds directly to the risk

16. Environmental Risk Assessment
 Cornerstone of EU GM legislation
 Identify and evaluate any potential adverse effects, direct or
indirect on human health and the environment
 Potentially harmful effects:
 disease to humans incl. allergenic/toxic effects;
 disease to animals or plants;
Adverse effects due to the:
 impossibility of treating a disease or providing effective prophylaxis;
 establishment of micro-organisms in the environment;
 natural transfer of inserted genetic material to other organisms.
 Article 13 - General duty to conduct risk assessment
 Guidance notes - Commission decision 2000/608/EC

17. Elements of the Risk Assessment
 Provisional allocation to Class 1, 2, 3 or 4 (Biological agents at
work, Directive 2000/54/EC)
 Identification of potentially harmful effects associated with the:
 donor micro-organism
 recipient micro-organism
 genetic insert
 vector
 resulting GMM
 Identification of the level of risk associated with the GMM/GMO
 Assign appropriate containment level
 Review and reconsideration of overall assessment

18. Containment Measures
 Training & Awareness
 Containment equipment / PPE
 Fourth Schedule of the Regulations
 General principles of Good Microbiological Practice (GMP) and Good
Occupational Safety and Hygiene (GOSH)
 Tables of containment measures

19. Containment Measures – GMMs in a Laboratory

20. Biological Safety Committee
 Biological Safety Committee
 Statutory requirement
 3 – 5 members
 Review CU applications
 Provide advice on RA
 Biological Safety Officer
 BSC member
 GMM/GMO users informed of legislative requirements
Point of contact for EPA
 EPA guidelines for establishment of BSC

21. Notification to the Agency
 Risk Assessment
 Part A or B or C of 5th Schedule of Regulations -
GMMs
 7th Schedule of Regulations - GMOs
 Pay the relevant fee for the class of GMM
 No fee for GMOs

22. Notification to the Agency – Part A 5th Schedule
(GMMs)
 Name of User
 Training & Qualifications
 Biological Committees or sub-committees
 Address & General Description of the premises
 A description of the nature of the work
 The class of the contained use
 Information on waste management
 Risk Assessment

23. Notification to the Agency – Fees
Class 1 Class 2 Class 3 Class 4
Notification of a first time use of a premises for €250 €1,250 €3,000 €15,000
a contained use under article 16
Notification of a Class 2 contained use under n/a €625 n/a n/a
article 18
Notification of a Class 3 / 4 contained use n/a n/a €1,500 €7,500
under article 19
Eight Schedule, Table B of GMO (Contained Use)
Regulations, S.I. No 73 of 2001

24. Notification to the Agency – 7th Schedule (GMOs)
 Risk Assessment – Article 36 & Part II of the Seventh
Schedule
 Issues related to the disposal of waste and effluent
 Information as set out under Part I of the 7th Schedule
Source: Dr TJ Higgins, CSIRO, Australia

25. Notification Process
 Agency receives valid application
 Register entry sent to user for agreement /approval
 Request for further information - Article 25
 Article 26 - Power to grant or refuse consent and to impose conditions
 Inspector’s Report and draft Consent Conditions sent to OCLR Director for
approval
 Timelines: Agency must issue a decision within:
 Class 1/2/GMO – 45 days for first time use
 Class 2 – 10 days for subsequent use
 Class 3/4 - 90 days for first time use
 Class 3/4 – 45 days for subsequent use

26. Notification Process - Register of Users –
Article 8
 Name and address of notifier
 Location of the Contained Use
 Description & Purpose of each GMO/GMM
 Date of receipt of a record, notification
 Date of request/receipt of further information
 Date & nature of the decision

27. Confidential Information – Article 9
 Certain information
 Request in writing
 Separate documentation
 Memo to the Director
 Approval letter to notifier

28. Confidential Information
 What cannot be held as confidential:
 Name and address of user
 Location of contained use
 Purpose of the contained use
 General characteristics of the GMM/GMO
 Class of CU and level of containment
 Harmful effects on humans or the environment

29. Enforcement
 To ensure compliance with legislation and consent conditions
 Risks to human health & environment - managed properly
 Promote high standard of biological safety
 2008 – 17 centres inspected – multiple users
 2009 – 14 centres inspected – multiple users
 2010 – 17 centres inspected – including TCD
 checklist for contained use inspections devised by the
European Enforcement Project

30. Enforcement – Annual Reporting
 31st March each year
 Forms available on www.epa.ie
 GMMs (Class 2 & Class 3 GMMs
only)
 GM Plants
 GM Animals

31. Enforcement - Site Inspection Follow Up
 Site inspection report
 Letter of non-compliance to registered user (if required)
 Annual reporting
 Where user has relocated activity and has not informed the Agency
 SOPs
 Non-notified activity
 BSC - management structure
 Prosecution of Offences - Article 53
 High Court injunction - Article 54
 Notice to Take Measures - Article 55

32. Deliberate Release of GMOs
‘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...,

33. Deliberate Release – EPA Remit Clinical Trials
 The patient receiving the treatment insofar as they are part
of the general population and the wider environment
 The potential risk of the GMM moving from the patient to the
general population and the consequences of such a risk
 The potential environmental concerns from the use of GMMs
 Involvement of other Agencies
 IMB – risks treatment might pose to the patient
 HSA – worker protection

34. Part B Release – Clinical Trial
Notifier submits EPA acknowledges Notifier publishes notice
application receipt of notification
Summary Notification
Information Format (SNIF)
•Commission
•Competent Authorities
GMO Register
Representations Compliance?
(public & competent authorities)
Further information request
EPA Board Decision
(90 days)

35. So what to do if proposing to use GMOs?
 Using GMMs/GMOs?
 Conduct a Risk Assessment – consult with
BSO/BSC
 Submit Notification/Fee to the EPA
 Consent Conditions
 Annual Report (31st March)
 Inspection by the EPA

36. To conclude….
The overriding concern of the EPA is to ensure the use of
GMOs does not have an adverse effect on human health or
the environment.

37. Useful Links
 www.epa.ie
 www.environ.ie
 www.irishstatutebook.ie
 www.gmoinfo.ie
 http://ec.europa.eu/environment/index_en.htm