Implementation of the GMO legislation in Ireland - the role of the EPA

Office of Climate, Licensing & Resource UseEnvironmental Protection AgencyJohnstown Castle EstateWexford

Introduction

n Legislationn Definitionsn Risk Assessmentsn Classificationn Containment Measuresn Enforcement & Site Inspections and

Annual Reportingn Notifications, Confidential Information

n Waste Inactivationn Deliberate Releasen Clinical Trialsn Useful Links

EPA’s Role in Regulating GMOs in Ireland

Implement the Regulations

Contained Use – laboratories & industry

Deliberate Release into the environmentn Research & Development Purposes - field trials, clinical trialsn Placing GMO products on the market

n European Food Safety Authorityn European Medicines Agency

Transboundary movement of GMOs

Regulating GMOs in Ireland

n Government responsible for policyn Minister for the Environment, Community & Local Governmentn Contained Use (CU) and Deliberate Release (DR) into environment of GMOs

n Dept of Health & Childrenn Food safety aspects (FSAI)

n Dept of Agriculture, Food & the Marinen Seed for cultivationn Animal feedn Co-existencen Use of Plant Protection Products on GM plants

Legislation

n Contained Use Directive 2009/41/EC on the contained use of Genetically Modified Micro-Organisms (GMMs)

n Genetically Modified Organisms (Contained Use) Regulations, S.I. 73 of 2001n Amended by S.I. No. 442/2010 — Genetically Modified

Organisms (Contained Use) (Amendment) Regulations 2010

n http://www.irishstatutebook.ie/statutory.html

Legislation contd.

n EU Directive 2001/18/EC on the deliberate release of GMOs into the environment

n Genetically Modified Organisms (Deliberate Release Regulations), S.I. 500 of 2003

n Genetically Modified Organisms (Transboundary Movement Regulations), S.I. 54 of 2004

Definitions

n 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

n 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.

n 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.

n 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’

n Article 5 of the Regulations - Obligations

Techniques of Genetic Modification

n 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 n 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.

n Techniques involving the direct introduction into an organism of heritable material prepared outside the organism including micro-injection, macro-injection and micro-encapsulation.

n 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 Genetic Modification

n 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:

n in vitro fertilisation;

n natural processes such as: conjugation, transduction, transformation;

n polyploidy induction.

Techniques yielding organisms that are excluded from the legislation

n 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:

n    mutagenesis,

n cell fusion (including protoplast fusion) of prokaryotic species that exchange genetic material by known physiological processes,

n    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 from the legislation (continued)

n  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

n Level of containment required for the GMM corresponds directly to the risk

Environmental Risk Assessment

n Cornerstone of EU GM legislationn Identify and evaluate any potential adverse effects, direct or

indirect on human health and the environmentn Potentially harmful effects:

n disease to humans incl. allergenic/toxic effects;n disease to animals or plants;Adverse effects due to the: n impossibility of treating a disease or providing effective prophylaxis;n establishment of micro-organisms in the environment; n natural transfer of inserted genetic material to other organisms.

n Article 13 - General duty to conduct risk assessmentn 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

n Training & Awareness

n Containment equipment / PPE

n Fourth Schedule of the Regulationsn General principles of Good Microbiological Practice (GMP) and Good

Occupational Safety and Hygiene (GOSH)n Tables of containment measures

Containment Measures – GMMs in a Laboratory

Biological Safety Committee

n Biological Safety Committeen Statutory requirementn 3 – 5 membersn Review CU applicationsn Provide advice on RA

n Biological Safety Officer n BSC membern GMM/GMO users informed of legislative requirementsPoint of contact for EPA

n 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)

n Name of Usern Training & Qualificationsn Biological Committees or sub-committeesn Address & General Description of the premisesn A description of the nature of the workn The class of the contained usen Information on waste managementn Risk Assessment

Notification to the Agency – Fees

Class 1 Class 2 Class 3 Class 4Notification of a first time use of a premises for a contained use under article 16

€250 €1,250 €3,000 €15,000

Notification of a Class 2 contained use under article 18

n/a €625 n/a n/a

Notification of a Class 3 / 4 contained use under article 19

n/a n/a €1,500 €7,500

Eight Schedule, Table B of GMO (Contained Use) Regulations, S.I. No 73 of 2001

Notification to the Agency – 7th Schedule (GMOs)

n Risk Assessment – Article 36 & Part II of the Seventh Schedule

n Issues related to the disposal of waste and effluent

n Information as set out under Part I of the 7th Schedule

Source: Dr TJ Higgins, CSIRO, Australia

Notification Processn Agency receives valid application

n Register entry sent to user for agreement /approval

n Request for further information - Article 25

n Article 26 - Power to grant or refuse consent and to impose conditions

n Inspector’s Report and draft Consent Conditions sent to OCLR Director for approval

n Timelines: Agency must issue a decision within:n Class 1/2/GMO – 45 days for first time usen Class 2 – 10 days for subsequent use n Class 3/4 - 90 days for first time usen 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

n Certain information

n Request in writing

n Separate documentation

n Memo to the Director

n Approval letter to notifier

Confidential Information

n What cannot be held as confidential:

n Name and address of usern Location of contained usen Purpose of the contained usen General characteristics of the GMM/GMOn Class of CU and level of containmentn 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

n checklist for contained use inspections devised by the European Enforcement Project

Enforcement – Annual Reporting

n 31st March each year

n Forms available on www.epa.ien GMMs (Class 2 & Class 3 GMMs

only)n GM Plantsn 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

n The patient receiving the treatment insofar as they are part of the general population and the wider environment

n The potential risk of the GMM moving from the patient to the general population and the consequences of such a risk

n The potential environmental concerns from the use of GMMs

n Involvement of other Agencies n IMB – risks treatment might pose to the patientn HSA – worker protection

Part B Release – Clinical Trial

Notifier submits application

EPA acknowledgesreceipt of notification

Compliance?GMO Register

Representations(public & competent authorities)

Further information request

EPA Board Decision(90 days)

Notifier publishes notice

Summary Notification Information Format (SNIF)

• Commission• Competent Authorities

So what to do if proposing to use GMOs?

n Using GMMs/GMOs?

n Conduct a Risk Assessment – consult with BSO/BSC

n Submit Notification/Fee to the EPA

n Consent Conditions

n Annual Report (31st March)

n Inspection by the EPA

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.

Useful Links

n www.epa.ien www.environ.ien www.irishstatutebook.ien www.gmoinfo.ien http://ec.europa.eu/environment/index_en.htm