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
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
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
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
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
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’
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
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.
Techniques not considered to result in GeneticModification 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.
Techniques yielding organisms that are excluded fromthe 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
Techniques yielding organisms that are excluded fromthe 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.
What we don’t want… SARS, China 2004 Foot & Mouth, Pirbright 2007 Smallpox accident, 2000
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
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
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
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
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
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
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
Notification to the Agency – Fees Class 1 Class 2 Class 3 Class 4Notification of a first time use of a premises for €250 €1,250 €3,000 €15,000a contained use under article 16Notification of a Class 2 contained use under n/a €625 n/a n/aarticle 18Notification of a Class 3 / 4 contained use n/a n/a €1,500 €7,500under article 19 Eight Schedule, Table B of GMO (Contained Use) Regulations, S.I. No 73 of 2001
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
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
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
Confidential Information – Article 9 Certain information Request in writing Separate documentation Memo to the Director Approval letter to notifier
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
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
Enforcement – Annual Reporting 31st March each year Forms available on www.epa.ie GMMs (Class 2 & Class 3 GMMs only) GM Plants GM Animals
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
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...,
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
Part B Release – Clinical TrialNotifier 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)
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
To conclude….The overriding concern of the EPA is to ensure the use ofGMOs does not have an adverse effect on human health orthe environment.