Dr Tom McLoughlin
Senior Inspector
Office of Climate Change, Licensing
& Resource Use
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
Regulation of GMOs in Contained Use facilities in Ireland by the 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.
152
52
0
0
49
8
Class 1
Class 2
Class 3
Class 4
GMO
Deliberate Release
Register of GMO users in Ireland
–
October 2007
•
261 registered users
•
78% contained use consents (Class 1 & 2)
58%
20%
Elements of Risk Assessment
1.
Provisional allocation to Class 1, 2, 3 or 4 as per
DIRECTIVE 2000/54/EC
–
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
GMP (Good Microbiological Practices)
GOSH (Good Occupational Safety and Hygiene)
Training
,
Containment equipment
& Special Installation
Design.
Advice
-
Biological Safety Committees, BSO
Containment Measures
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
GMM notification
First time use of a premises
Subsequent contained use
Class 1, 2, 3 & 4.
Class 2, 3 & 4.
+
GMM Notification requirements
First time use of the premises
Subsequent contained use
Class 1
•
Information under Part A of 5
th
Schedule
•
Risk Assessment
•
Fee
€
250
Class 2
•
Information under Part A of 5
th
Schedule
•
Fee
€
1,250
•
Information under Part B, 5
th
Schedule
•
Risk Assessment
•
Fee
€
625
Class 3
•
Information under Part A of 5
th
Schedule
•
Fee
€
3,000
•
Information under Part C, 5
th
Schedule
•
Risk Assessment
•
Fee
€
1,500
•
Public notice
Class 4
•
Information under Part A of 5
th
Schedule
•
Fee
€
15,000
•
Information under Part C, 5
th
Schedule
•
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
Information required for a Class 2 contained use
-
Article 18
Date of submission of the notification
-
Article 16
Names of persons
-
supervision & safety & information
-
training &
qualifications
Recipient, donor &/or parental micro
-
organism(s) used & the host
-
vector
Source(s) & intended function(s) of the genetic material
-
used in
modification
Identity & characteristics of the GMM
Purpose of contained use
-
expected results
Approximate culture volumes
-
used
Description of containment measures, information about waste
Management
-
wastes generated
–
treatment, final form & destination
A summary of the RA
-
Article 13
Information
-
CA to evaluate any emergency response plans
-
Article 30.
Relevant fee
-
8
th
Schedule
GMO Notification Requirements
Notification of Contained Use for a GMO (GM
plants/animals) must contain
•
Risk Assessment (Article 36(2), Part II of 7
th
Schedule)
•
Information set out in Part I of 7
th
Schedule
•
Fees
–
no requirement
•
Activity may commence 45 days after submission of
notification
•
The EPA is not required to issue consent
•
Annual reporting applies
•
Guidelines
Enforcement
Under
Article 26
of the CU Regulations the EPA can issue
a consent with or without conditions or refuse consent.
Enforcement
-
Article 56
–
‘
The Agency shall carry out,
cause to be carried out or arrange for such monitoring,
inspections ….’
To ensure
-
users comply
–
conditions
-
licence
To ensure
-
risks to human health & environment
-
managed properly
-
promote high standard of biological
safety
Allay public concerns
Regulator of GM technology
-
3
rd
level; biopharma industry
Site Inspection
What we look for (use a checklist that was agreed at the European
Enforcement Project CU)
General Information re the premises
Containment measures in place
Restricted access
Biohazard signs
Procedures / RA
Training / training records
Class of MSC /date of last validation
Personal protective measures
GMP / GOSH
Handwashing facilities
Segregation of write up area
General observations
Site Inspection
continued
GMM Storage
Location /in lab?/ elsewhere? / inventory
Waste Inactivation
Location of autoclave relative to lab
Last date of validation
Procedure for decontamination of
Solid waste
Liquid waste
Sharps
Procedure for treatment of spillages
Decontaminating agents
Procedure for reporting of accidents / incidents
Are GMOs/GMMs used for teaching purposes?
Enforcement actions
Site inspection is followed up with
Site inspection report
Letter of non
-
compliance to registered user, where applicable, for
example,
Annual reporting
Where user has relocated activity and has not informed the Agency
SOPs
Non
-
notified activity
BSC
-
management structure
Prosecution of Offences
HC injunction
Notice to Take Measures
Duties & Power of the EPA
•
Review of contained use activities
•
Enforce Regulations
-
site inspections, compliance
with consent conditions
•
EPA
-
require modification, suspension or termination
•
Report
-
Minister
-
performance of functions
•
Inform the EU Commission of accidents
•
Notice to take measures
•
Prosecution of offences
•
High Court Injunction
Cartegena Protocol
UN legislation to protect biodiversity
–
EU Regulation
Covers all LMO’s transboundary movement outside the
EU
Reguirements for Contained Use:
Exporters need to provide documentation:
Labelling
-
that it contains or consists of a GMO
Unique code, if available
RA relating to the safe handling, storage and transport
Contacts for further information
Help and Guidance
www.epa.ie
-
under ‘What we do/Licensing and
Permitting/GMOs’
Licensing process explained
Contained Use of GMMs and GMOs,
Risk assessment
-
examples
Who should apply
-
procedures
Annual reporting guidance
Legislation
Future Trends
Move to use replicating viral vectors with altered
tropism/tissue specificity/ immune evasion
Increasing development of viral chimeras
Reverse genetics of multi
-
segmented ds RNA
viruses (e.g., Blue
-
tongue, Rotavirus)
Biopharming
-
to produce human medicines?
Drivers for change
-
e.g., SARs, Influenza H5N1,
Climate Change
-
Blue tongue
Concluding remarks
The overriding concern of the EPA in the
implementation of the GMO Contained Use
Regulations is to ensure that their use does not
have an adverse effect on human health or the
environment.
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