PowerPoint Presentation - Environmental Protection Agency

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14 Δεκ 2012 (πριν από 4 χρόνια και 6 μήνες)

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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.