PowerPoint Presentation - Environmental Protection Agency

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.