Regulation of GMOs in Contained Use facilities in Ireland by the EPA Regulations ➢ S.I. No 73 of 2001 (Contained Use of GMOs) transposes Directive 98/81/EC amending Directive 90/219/EEC-Contained use of GMM. ➢ S.I. No 54 of 2004 (Transboundary Movement)-Reg. 1946/03 Dr Tom McLoughlin Senior Inspector Office of Climate Change, Licensing & Resource Use EPA
Aims and Objectives Government Policy Definitions Interpretations Legislation Obligations on the GMO user Classification of GMM Risk Assessment Requirements for GMM/GMO Notifications Biological Safety Committee/BSO Cartegena Protocol Enforcement by the EPA Duties and Power of the Agency Future Trends
Definitions Micro-organism means ‘ any microbiological entity, cellular or non cellular, capable of replication or of transferring genetic material, including viruses, viroids, animal and plant cells in culture’ Genetically Modified Micro-organisms-GMM • bacteria, • viruses, • fungi, • plant & animal cells, 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 or natural recombination.
Definitions Genetically Modified Organisms means any 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 e.g. plants & animals GMOs inclusive of Genetically Modified Micro- organisms (GMMs).
Definitions Contained use ‘any activity in which organisms are genetically modified or in which such 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'. Containment measures/barriers can be physical, biological or chemical or a combination of these.
Contained Use (CU) Directive 98/81/EC amending 90/219/ECC Objectives of Directive: Preventive action be taken - protect the environment & human health CU of GMMs - classified in relation to the risks - present for human health & environment Classification - based on RA Containment and other protective measures – correspond - classification of CU Adopt appropriate measures for the disposal of waste - from CU of GMM
GMO (Contained Use) Regulations, 2001-S.I. No. 73 of 2001 (60 Articles + 8 Schedules) Part I - General Part II - Contained use of GMMs Part III - Contained use of GMOs Part IV - Fees & charges Part V - Enforcement & regulation Part VI - Advisory Committee on GMOs, Monitoring & Reporting etc.
Obligations Article 5- A user or any other person carrying out an activity involving a contained use shall ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment. Article 13 -Before commencing a Contained Use- RA must be carried out – human health and the environment-which may be associated with such use.
What we don’t want… “ Probe after Scots student ’ s smallpox accident ” The Sunday Post 17th December 2000 “SARS spreads in China: Investigation launched into lab safety.” 27 April 2004 Nature Science Update 'Pirbright link' to farm outbreak
What is Regulated/Not Regulated? ➢ Techniques of Genetic Modification - cloning vectors - plasmids & viruses-direct introduction - micro- injection, macro-injection and micro-encapsulation- cell fusion ➢ Techniques which are not considered to be GMO - In vitro fertilisation-conjugation, transduction, transformation, mutagenesis, cell fusion, self cloning ➢ Oct 2007 - Working Group to be set at EU level up to look at ‘newer’ techniques of GE to ascertain if they should be included or excluded from the remitt of EU Directives-CU/DR? ➢ Exemption of safe organisms - Annex II, Part B?
Classification of GMM based on Risk Assessment • 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 • Classification is based on Risk Assessment (Art. 13) • Appropriate level of containment required to control risk to human health and the environment.
Register of GMO users in Ireland – October 2007 • 261 registered users • 78% contained use consents (Class 1 & 2) 8 49 0 0 58% 20% 152 52 Class 1 Class 2 Class 3 Class 4 GMO Deliberate Release
Elements of Risk Assessment Provisional allocation to Class 1, 2, 3 or 4 as per DIRECTIVE 2000/54/EC – 1. Biological agents at work 2. Identification of potentially harmful effects associated with: ➢ Recipient Micro-organism ➢ Genetic insert ➢ Vector ➢ Donor micro-organism ➢ Resulting GMM 3. Assessment of potentially harmful effects occurring 4. Assign appropriate containment level (CL 1, 2, 3 or 4) and other protective measures to control risk 5. Review and confirm classification in light of completed assessment
Containment Levels and Measures (4 th Sched) Table 1A – minimum requirement for contained use of a GMM in a laboratory Table 1B – in addition to Table 1A contained use of a GMM in plant growth facilities Table 1C – in addition to Table 1A contained use of a GMM in animal units Table II – minimum requirements for GMM in facilities other than those covered by tables 1A, 1B or 1C
Containment Measures GMP (Good Microbiological Practices) GOSH (Good Occupational Safety and Hygiene) Training , Containment equipment & Special Installation Design. Advice - Biological Safety Committees, BSO
GMP & GOSH Keep workplace & environmental exposure - GMM - lowest practicable level; Exercise engineering control measures - source & supplement - protective clothing & equipment; Test & maintain control measures/equipment; Test for presence of GMM outside-primary physical containment; Provide training of personnel; Establish biological safety committees/subcomm. Formulate & implement local codes of practice- safety of personnel, display biohazard signs;
GMP & GOSH-cont. Provide washing & decontamination facilities - personnel; Adequate records; written SOP’s to ensure safety; Effective disinfectants - disinfection procedures - spillage of GMMs; Safe storage - contaminated laboratory equipment & materials Prohibit eating, drinking, smoking, application of cosmetics or storage of food for human consumption -work area; prohibit mouth pipetting.
GMM Notification Requirements • Art. 16 states that a premises shall not be used for the first time unless • a notification has been submitted by user to EPA • a consent for such use has been granted by EPA • compliance with consent conditions
GMM Notification Requirements Class 1, 2, 3 & 4. First time use of a premises + GMM notification Subsequent contained use Class 2, 3 & 4.
GMM Notification requirements First time use of the premises Subsequent contained use • Information under Part A of 5 th Schedule Class 1 • Risk Assessment •Fee €250 • Information under Part A of 5 th Schedule • Information under Part B, 5 th Schedule Class 2 •Fee €1,250 • Risk Assessment •Fee €625 • Information under Part A of 5 th Schedule • Information under Part C, 5 th Schedule Class 3 •Fee €3,000 • Risk Assessment •Fee €1,500 • Public notice • Information under Part A of 5 th Schedule • Information under Part C, 5 th Schedule Class 4 •Fee €15,000 • Risk Assessment •Fee €7,500 • Public notice
GMM Notification Requirements Timeframe for decisions First time use of a premises • Class 1/2 - 45 days • Class 3/4 - 90 days Subsequent use of a premises • Class 2 – 10 days • Class 3/4 - Notifier may not proceed without the EPA’s prior approval and the EPA must revert within 45 days. Clock Stoppage
GMM Notification Requirements Consents (Article 26) EPA will • issue consent with or without conditions, or, • refuse consent Fees (8 th Schedule) Receipt of fees validates notification Refund/waiver of up to 50% of fees payable (Article 48)
GMM Notification Requirements Annual Reporting User is required to carry out and maintain Risk Assessments (RAs) and to submit to EPA with annual report.
INFORMATION REQUIRED -NOTIFICATION FOR FIRST TIME USE OF PREMISES FOR CONTAINED USE - ARTICLE 16 ✓ Name of user, persons responsible for supervision & safety ✓ Training & qualifications of persons - supervision & safety ✓ Details - biological committees/subcommittees ✓ Address & general description of premises ✓ Description of the nature of the work ✓ Class of the contained use ✓ Class 1 GMM - a summary of RA - Article 13 ✓ Information on waste management ✓ Relevant fee - 8 th Schedule
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