Source: EURLEX
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# 52012SC0216

**COMMISSION STAFF WORKING DOCUMENT Details from individual Member States on their experience with Directive 2009/41/EC of the European Parliament and of the Council of May 2009 on the contained use of genetical modified micro-organisms (recast) for the period 2006 - 2009 Accompanying the document COMMISSION WORKING DOCUMENT Report on the experience of Member States with Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (recast) for the period 2006 – 2009**

  

1.         ANNEX I – DETAILS FROM INDIVIDUAL MEMBER STATE
THREE-YEAR REPORTS  3

1.1.      An overview of activities and installations  3

1.2.      Notification and approval system (and relevant
changes) 8

1.3.      Risk assessment and classification of contained
uses (including effectiveness of the risk assessment guidelines) 12

1.4.      Accidents  15

1.5.      Inspection and enforcement issues  18

1.6.      Problems with interpretation of the provisions  23

1.7.      Clinical trials using the provisions of the
Directive  25

1.8.      Public consultation and information  28

1.9.      Protection of confidential information  32

1.10.    Waste disposal 34

2.         ANNEX II – TABLE OF COMPETENT AUTHORITIES  40

COMMISSION STAFF WORKING DOCUMENT

Details from individual Member States on their experience
with Directive 2009/41/EC of the European Parliament
and of the Council of 6 May 2009 on the contained use of genetically modified
micro-organisms (recast) for the period 2006 – 2009

Annexes

1.           ANNEX I – DETAILS FROM INDIVIDUAL MEMBER STATE THREE-YEAR REPORTS

1.1.        An overview of activities
and installations

Austria

During the reporting period the two competent authorities, the
Ministry of Health or

the Ministry of Science and Research, acknowledged or authorised a
total of 491 activities involving genetically modified microorganisms
and other genetically modified organisms. In 129 cases these were first-time
activities in genetic engineering facilities.

Belgium

Since 1993, Belgium has fully implemented the Directive on the
contained use of genetically modified microorganisms (at that time: Directive 90/219/EEC)
in three regional decrees thereby. This means that, among the 750
notifications, 270 of them exclusively concerned non-GM pathogens and 310
notifications concerned GMMs and/or GMOs only. The rest of 130 notifications
concerned contained uses of both GMMs/GMOs and non-GM pathogens. 381
notifications of GMM and 117 notifications of GMM/GMO combined were registered
for the reporting period.

From 2006 to 2009, the subsequent use notifications represented 59%
which is a high increase compared to the previous 3 year reporting period, when
they represented only 31% of the total number. Since 2002, the Walloon decree
of 04/07/2002 regarding the contained use of GMOs and/or pathogens did not
distinguish anymore between first and subsequent contained uses. In
consequence, all notifications for this region were treated as new activities
(or first contained uses).

With respect to the type of exploitations, the large majority of
GMMs were used for fundamental research by university research laboratories
(70%). GMMs were handled in pharmaceutical companies (20%) for research
purposes or production of enzymes, vaccines and therapeutic molecules. Rarely,
GMMs were also used for teaching (2%) and diagnostics (5%).

Bulgaria

During the reporting period 2006-2009 neither installations nor activities
involving the contained use of GMM were approved in Bulgaria.

Czech Republic

Most institutions that had intended to use GMMs submitted their
notifications during the previous reporting period 2003 – 2006. Therefore, the
number of new subjects starting to use GMMs in the period 2006 – 2009 was
comparatively small. Prevailing notifications concerned new activities with
GMMs in previously notified premises and in consequence mostly amendments to
earlier notifications were submitted. The purpose of the 60 notified GMM activities
was almost entirely research and education.

During the reporting period, the competent authority from Czech Republic authorised 68 installations for research purposes, 8 for commercial uses and
9 for another purposes like laboratories for detection, transport and storage.
In this context 46 activities were approved for Class 1 and 39 for Class 2.

Cyprus

During the reporting period 2006-2009 no activities involving the
contained use of GMM were identified in Cyprus. No installations were notified.

Denmark

During the reporting period 694 installations for research and 63
installations for commercial purpose were approved. 664 activities were
classified as Class 1, 115 as Class 2 and 165 comprised GMO.

Estonia

During the reporting period 2006-2009 no activities involving the
contained use of GMMs were identified in Estonia. No installations were
notified.

Finland

During the reporting period 123 notifications of GMMs, GM animals
and GM plants were submitted, of which 115 were in respect of GMMs. Most notifications
concerned class 1 and class 2 contained use activities; one notification
included the use of Class 3 GMMs.

A further 6 notifications involved both GMM and GM plants while 2
involved GMM and GM animals. 90 installations for research purposes, 13
installations for commercial use and 5 installations for other purposes have
been notified over the period covered by this report.

France

During the reporting period 1167 activities were approved as
follows: 919 installations for research, 20 for commercial purposes and 228 for
gene therapy for GMM and GMO under contained use framework. The number of
activities approved under each class was not provided. Compared to the previous
reporting period 2003 - 2005, the overall number of notifications increased by
151.

Germany

In Germany 5408 installations for research and 129 for
commercial purposes were notified. The majority of activities concerned class 1
and 2 uses, with some notifications for class 3 uses and 3 for class 4 uses. In
terms of activities correlated with the above mentioned installations, 5813
activities were approved which belong to Class 1, 4722 to Class 2, 252 to Class
3, and 3 activities to Class 4.

1939 notifications were received (746 from Class 1, 1146 from Class
2,46 from Class 3 and 2 from Class 4).The number of notifications had decreased
as during the previous report period there were 2434 notifications. 28
notifications involved GMM in combination with GMO (10 for GM plants and 18 for
GM animals), all of them concerning class 2 uses.

Hungary

Compared to the previous period, when eight installations for the
contained use of Class 1 GMMs and GMOs were authorised for research purposes
and one authorisation was issued for the contained use of a Class 1 GMM for
commercial purposes, there was an increase in applications for contained use as
a result of growing research activities. 20 installations were approved for
research and 2 for commercial purpose. During the reporting period, the number
of class 1 activities approved increased from 1 to 13 and Class 2 activities
emerged at 10 notifications approved.

Ireland

During the reporting period 73 notifications for GMM were approved. 12
installations for research purposes and 7 installations for commercial uses were
notified over the period covered by this report. In terms of operations, 43
activities were notified for class 1, 30 activities for Class 2, and 36
activities involved GMO.

Latvia

No notifications for the contained use of the GMM were received by
the competent authority during the reporting period.

Lithuania

Two notifications relating to class 1 activities were submitted to
the Ministry of Environment during the reporting period. The activities were
for research purposes.

Luxembourg

Two notifications relating to class 1 activities were reported
during the reporting period. One notification was for GMM and GM plants.

Malta

No notifications for the contained use of the GMM were
received by the competent authority during the reporting period.

Netherlands

In the Netherlands, during the reporting period 195 institutes and
companies were actively involved in contained use activities with genetically
modified organisms. This contained use involved not only activities with
micro-organisms but also with genetically modified plants, animals, viruses
etc. In addition, most companies/institutes carried out activities with
combinations of GMOs, i.e. not exclusively with GMMs. 33 new installations were
forwarded notifications. In total 413 notifications and
2033 amendments on earlier notifications were received during the 2006-2009
period. In general more than one containment level was prescribed per
notification.

Poland

In Poland, 54 notifications for GMM were submitted. In comparison
with the previous reporting period, the number of installations and contained
use activities increased. 47 activities were classified as class 1, 6 as class 2,
and 1 as class 3. The majority of these activities took place in universities
or research institutions.

5 installations were approved, all for
research and development purposes.

Portugal

One installation for research comprising two activities for the
contained use of Class 1 and Class 2 GMM were notified and approved in Portugal during the reporting period 2006-2009. One activity was classified as Class 1
while the other was classified as Class 2. Four activities were approved for
GMO.

Romania

During the reporting period 2006-2009 no activities involving the
contained use of GMM were identified in Romania. No installations were
notified.

Slovakia

In Slovakia 42 notifications relating to Class 1 activities, 10
notifications for Class 2 as well as an overall of 52 activities for GMO were approved
during the reporting period. 49 installations for research purpose and 3
installations for commercial use were authorised.

Slovenia

In Slovenia 41 installations were approved for research activities
and 17 installations for commercial purpose, and one installation for
educational purpose. 45 activities were notified and approved, 41 being
assigned to Class 1 with the remainder in Class 2.

Spain

Spain approved 21 notifications, all of them
belonging to class 1 and 2.

During the reporting period 2006-2009, 50 installations were
notified for the contained use of GMMs and/or GMOs in Spain. Thirty five research and development related activities were notified and fifteen
for commercial purpose. Under the scope of the Spanish law on GMOs, all kind of
genetically modified organisms were included for contained use purposes as
well. Thus, during the reporting period Spain has received 15 notifications of
GM plants (all of them class 1) and 9 notifications of GM animals, and 26
notifications of GMM and in combination with another GMOs.

Sweden

In Sweden approximately 530 involving the contained use of GMMs
activities were notified and carried out by 93 users. Two thirds of the users that had notified a GMM activity were
limited companies, having a small number of GMM activities. The majority of GMM
activities were registered at universities, institutes of technology and other
governmental research establishments. All GMM activities at containment levels
3 and 4 were at research establishments.

During the reporting period,
the Swedish Work Environment Authority approved for the first time a GMM
activity at containment level 4. In addition, there were 16 approvals in effect
for GMM activity at containment level 3. Approvals were normally granted for
three years, and sometimes for five years. Those
GMMs notified for the higher containment levels involve viruses, bacteria,
prions and human internal parasites.

There are 357 GMM activities notified at
containment level 1 in Sweden. At containment level 2, 154 GMM activities were
notified, involving a total of 540 different uses. The GMMs that occur most frequently in the uses notified at protection
level 2 were virus and cell cultures, followed by various human
pathogenic bacteria.

There were in total eight GMM activities with
contained use of GMMs in or on plants. Four users notified activities of
this type. Three of these were undertaken at containment level 2, and the
remainder at level 1.

A total of 52 activities
with contained use of GMMs in or on animals were notified by fifteen users. A
number of these were in the same animal cage installation, but those
responsible for the activity were based in different parts of the
organisations. Three
of the animal activities were at containment level 3, fifteen at containment
level 1, and the rest at level 2.

3 new installations for the contained use of plants and 7 new
installations for the contained use of animals were notified during the
reporting period.

The Swedish Board of
Agriculture decided on
extended approvals in 47 cases at 15 different installations involving
genetically modified animals. Three installations had approvals from the Swedish Board of Fisheries
for contained use of genetically modified fish.
All of these cases related to zebra fish. In one of the installations there was
also contained use of GMMs.

United Kingdom

Great Britain received 496 notifications mainly covering class 1 and
2. 42 notifications belonged to class 3, and 4 notifications to class 4. Northern
Ireland has received 14 notifications for GMMs, all belonging to class 1 and
class 2.

From 496 notifications, 355 were for research purposes and 141 for
commercial purposes. Information for the 14 Northern Ireland notifications were
not recorded in a way that made it possible to provide this information.

Regarding the installations, there were 746 approved premises (65%
for research, 30% for commercial purpose).

The number following numbers of activities were approved: 1193 for
class 2, 135 for class 3 and 10 for class 4.

During the reporting period, 5 notifications for GMM. In Great
Britain, activities involving GM animals or plants are only notifiable under
the Genetically Modified Organisms (Contained Use) Regulations if the activity
involves an increased risk to human health compared to the unmodified
animal/plant. Consequently, there are very few notifications for this type of
work. However, the requirement still applies to notify the Competent Authority
of the intention to work with any GMO at premises.

1.2.      Notification and approval system (and relevant changes)

Austria

The Ministry of Science and Research received notifications or
applications for authorisation for activities involving GMOs carried out
in university science faculties or federal scientific institutions under the
Minister for Science and Research; notifications or applications for
authorisation for all other activities involving GMOs were submitted to
the Ministry of Health.

There were no relevant changes with regard to administrative
practice since the last report in 2006. The operator of each genetic
engineering facility must appoint a person responsible for biological safety
and establish a Biological Safety Committee, with members which were not bound
by the operator's instructions in carrying out their tasks. For all activities
involving GMOs at Level 2 and above, the operator had to appoint a project
leader, who is responsible for planning, directing and supervising activity involving
GMOs.

Before beginning an activity involving GMOs, the operator had
to classify it and determine the safety measures required, taking into account
the risks associated with such activity. The biological safety committee had
the task of reviewing the operator's safety classification and proposed safety
measures, and publicising them internally if it agreed he or she agreed with
them. The operator had to notify activities involving GMOs to one of the
two competent authorities or apply for authorisation.

Belgium

The regulatory framework concerning the contained use of
GMMs is implemented and enforced in Belgium at the regional level. A
Cooperation agreement concerning biosafety was set up to ensure the
transposition and practical implementation of the Directive 2009/41/EC in a
harmonised way between the three regions at the administrative and scientific
level.

Bulgaria

No information provided.

Cyprus

No information provided.

Czech Republic

Czech legislation on contained requires a new notification in case a
new GMO is to be used. This rule applies to all classes of contained use.

No relevant changes since the previous
report.

Denmark

No relevant changes since the previous
report.

Estonia

No information provided.

Finland

No relevant changes since the previous
report.

France

No relevant changes since the previous
report.

Germany

No relevant changes since the previous
report.

Hungary

The Competent Authorities in Hungary are the Ministry of Agriculture
and Rural Development in case of agricultural/commercial notifications and the
National Institute of Pharmacy in case of clinical trial notifications. As part
of the authorisation procedure, the Genetic Engineering Advisory Board is
consulted. The Board is a 17‑member advisory body composed of
representatives of the Hungarian Academy of Sciences, the relevant government
ministries and civil society organisations in the field of environmental
protection, health, biotechnology and consumer protection. Environmental
concerns and impact on human public health are discussed with the eligible
experts of the Ministry of Environment and Water and the National Institute of
Pharmacy, respectively.

Ireland

The Competent Authority is the Environmental Protection Agency. The
Minister for the Environment Heritage and Local Government has overall
responsibility for policy matters in relation to the contained use of
GMMs/GMOs.

Latvia

The Ministry of Agriculture is the Competent Authority for Directive
2009/41/EC. The Food and Veterinary Service is the competent authority to issue
a permit for contained use of GMOs. On the other hand the State Labour
Inspectorate, in conformity with the regulatory enactments regarding labour
protection when coming into contact with biological substances, ensure the
supervision and control of such safety and labour protection measures which are
related to the contained use of GMOs.

Lithuania

The Ministry of Environment is the Competent Authority responsible
for implementation of the Council Directive 2009/41/EC. Notification and
approval systems are determined in the Order on Regulation on Contained Use of
Genetically Modified Micro-organisms.

Luxembourg

The Ministry of Health is the Competent Authority responsible for
Directive 2009/41/EC. Advice is obtained from different administrations
(Administration of Environment, Inspection Travail et Mines) and the
Inter-Ministerial Committee. Contained use facilities have to get an

Authorisation according to the legislation "Loi du 10 juin 1999
relative aux établissements classées".

Malta

The Malta Environment and Planning
Authority is the Competent Authority for Directive 2009/41/EC.

Netherlands

No relevant changes since the previous report.

Poland

The Ministry of the Environment is the Competent Authority
in Poland. After receipt and verification of the notification, the Ministry
forwards the notification to the Commission on GMOs for assessment by scientific
reviewers.

Portugal

The Competent Authority for Directive 2009/41/EC is the Portuguese
Environment Agency (previous Environment Institute), belonging to the Ministry
of Environment and Spatial Planning. Now according with national legislation
the final approval of a notification is granted by the Ministry of Environment,
after receiving a favourable opinion approval from the Ministry of Health.

Portugal is in the process of reviewing Decree Law n. 2/2001, which
is the law that transposes Directive 98/81/EC in order to have a broader
experts involvement and also to establish fees for notifications analysis, as
already foreseen in the GMO legislation.

Romania

Starting with July 2007 the National Environmental Protection Agency
(NEPA) is the Competent Authority
for contained use of genetically modified microorganisms. The Biosafety
Commission is the scientific authority with advisory role in the process of
decision making by the NEPA.

Slovakia

For contained use of GMMs, two national authorities are involved, the
Ministry of Environment of the Slovak Republic as the Competent Authority and
the Slovak Environmental Inspection.

Slovenia

The Ministry of Environment and
Spatial Planning of Slovenia (MESP), is the Competent Authority to decide upon registration of
the premises for contained use of GMOs and upon approvals for the work with
GMOs in containment.

The biosafety framework in Slovenia includes
also contained use of GMO and is covered by horizontal legislation based on
Management of Genetically Modified Organisms (MGMO) Act (OJ RS 23/2005 and
amended OJ RS 21/2010). The Act implements the provisions from Directive
2009/41/EC and includes also GM plants and animals.

Spain

The General Directorate for Sustainable Development of Rural
Affairs, Ministry of Environment, and Rural and Marine Affairs is the Competent
Authority for contained use activities carried out by Government Public
Research Institutes or for medical purposes (clinical trials, human and animal
medicines/vaccines, etc.), and the Autonomous Communities (Spanish regions) for
most of the activities carried out with GMOs.

Sweden

The
Swedish Work Environment Authority has commenced work on reviewing the Swedish National Board of Occupational Safety and Health’s
regulations on the contained use of genetically
modified organisms with a view to clarifying and simplifying the procedure for
notification of GMM activities. The Swedish Board of Agriculture modified its regulations on contained
use of genetically modified plants in order to simplify the rules.

United Kingdom

In England and Wales, the Health and Safety Executive (HSE) and the
Secretary of State for Department for Environment, Food and Rural Affairs
(DEFRA) form the Competent Authority. The functions are delegated to HSE and
DEFRA officials.

In Scotland, the Competent Authority comprises Scottish Ministers
and HSE and similarly these functions are delegated to HSE and Scottish
Executive officials.

In Northern Ireland, the Competent Authority is the Health and
Safety Executive for Northern Ireland (HSENI) and the Department of the
Environment, acting jointly. The Biological Agents Unit (BAU) of HSE provides
technical support to HSENI, under an Agency Agreement.

1.3.        Risk
assessment and classification of contained uses (including effectiveness of the
risk assessment guidelines)

Austria

Activities involving GMOs are classified in four safety
levels and follow the four class system of Article 4 of Directive 2009/41/EC.

The reported activities involving GMOs related to activities
involving transgenic plants and animals (primarily Mus musculus)
were classified as level 1. Level 2 activities included cases where donor
organisms were bacteria (e.g. Staphylococcus ssp.), viruses (e.g.
influenza viruses A, B and C; polio virus vaccine
strains; adenovirus type 5; HIV-1) or cell lines from Homo sapiens.
Examples of level 3 are influenza virus A used to produce influenza virus
reassortants, and influenza virus A (H5N1) to produce wild type H5N1 strains using reverse genetics methods.

Belgium

In accordance with
the co-operation agreement concerning biosafety the Regional decrees classify
human and animal pathogens into three classes of risk and plant pathogens into
two classes of risk.

Bulgaria

No
information provided.

Czech Republic

The Competent Authority checks the risk assessment provided by the
notifier together with the resulting assignment of the containment level,
before or shortly after commencement of the activities, preventing in this way potential
errors in classification.

Cyprus

No information provided.

Denmark

No information provided.

Estonia

No information provided.

Finland

Despite existing guidelines, the classification of viruses and cell
cultures was difficult in some cases. A special problem was the classification
of pathogens that had been attenuated.

France

No information provided.

Germany

No changes since the last reporting
period.

Hungary

No changes since the last reporting
period.

Ireland

No new information.

Latvia

No new information.

Lithuania

The notification system is determined in the Order on
Regulation on Contained Use of Genetically Modified Micro-organisms.

Luxembourg

No information provided.

Malta

No information provided.

Netherlands

Standards for risk-assessment and classification of
organisms and activities are laid down in the Ministerial Regulation on
genetically modified organisms.

There are several classifications possible for the
containment level of activities: a) laboratory work ML-I (Safe Microbiological
Practice), ML-II, ML-III and MLIV; b) microorganisms in association with plants
in growth chambers: PCM-I, PCM-II, РСМ-Ш and
PCM-ĪV; c) microorganisms in association with plants: PKM-I, PKM-H,
PKM-III and PKM-IV; d) microorganisms in association with animals: DM-I, DM-II,
DM-III, DMIV, e) large scale productions MI-I, MI-II, MI-III and MI-IV. Lists
of safe hosts and safe vectors are provided by a Ministerial Decision.

Poland

No new information.

Portugal

No new information provided.

Romania

The EGO no. 44/2007 transposes Council
Directive No 98/81/EC.

Slovakia

No new information.

Slovenia

In Slovenia, the biosafety framework
which includes also contained use of GMO is covered by horizontal legislation
based on the Management of Genetically Modified Organisms (MGMO) Act (OJ RS
23/2005 and amended OJ RS 21/2010). The Act implements the provisions from
Directive 2009/41/EC and includes also GM plants and animals.

Spain

No new information provided. Under the scope of the
Spanish Law on GMOs, all kind of genetically modified organisms are included,
for contained use purposes as well.

Sweden

The forms for risk
assessment, notification and approval applications are subject to continual
review and improvement. The guidance on
contained use of GMMs on the Swedish
Work Environment Authority’s website will be reviewed in the near future.

United Kingdom

The Scientific Advisory Committee on Genetic Modification (Contained
Use) which provides technical and scientific advice to the Competent Authority
on all aspects of the human and environmental risks of the contained use of
genetically modified organisms (GMOs) held two open public meetings during this
reporting period.

1.4.        Accidents

No accidents
were reported by: Austria, Belgium, Cyprus, Portugal, Bulgaria, Germany, Romania,
Estonia, Lithuania, Latvia, Slovenia, Slovakia, Hungary, Sweden, Republic
Czech, Denmark, France, Germany, Malta, Poland, and Spain.

Finland

During the
report period there was one accident with consequences and several accidental
needle pricks without consequences (in the latter cases operators were advised
of proper working practices during inspections). In case of the accident with
consequences, an operator had received an E. coli strain with Staphylococcus
aureus enterotoxin gene from another research group and taken it into use
based on the records provided. The strain was supposed to contain partial
enterotoxin gene and the operator incorrectly assumed it to be a class 1 GMM.
When lysing the bacteria with pressure, a small amount of bacterial suspension
burst onto the worker’s face. No safety or protective clothing were used, and
the worker encountered some health problems. It was later discovered that the
GM E. coli strain contained an operational enterotoxin gene. The
operator failed to report the accident to the authorities in due course, and it
was later discovered during an inspection. As the strain originated from
another Member State laboratory, the Finnish supervisory authority informed the
respective supervisory authorities on the accident.

Ireland

One accident was
reported to the Competent Authority during the reporting period. The user was
carrying out a procedure involving the aspiration of supernatant from a
trypsinised, genetically modified lentivirus-infected HeLa cell culture (Class
2 GMM) previously rendered inactive after fixing with Para formaldehyde. During
the aspiration procedure, the glass end of the Pasteur pipette (attached to the
aspirator) broke, piercing the latex glove worn by the user and penetrating the
skin of the hand. Subsequently, the use of glass Pasteur pipettes during the
course of the procedure was stopped. Prior to the accident occurring, the cells
containing the viral vector had undergone a series of steps that would, in the
opinion of the researchers, significantly reduce the infectivity of the virus.

Netherlands

Nine incidents
were reported. The Dutch authorities concluded in each of these cases that the
incidents did not result in harm to people or the environment. In the first
incident 1800 liters of GM bacteria were released in the sewage system. Based
on the risk assessment, it involved an E. coli strain that most likely
could not have survived in the sewer (biological restriction). In the second
incident during construction work the airflow was disrupted in a high
containment level GMO laboratory in which work on an unmodified SARS-virus had
just ended. Although the chances of contamination were small, people that might
have been exposed were followed clinically. No health problems were detected.
In the third incident during a blood extraction procedure in an animal
experiment involving GM malaria, a puncture incident took place. Research
showed that the pathogen was no longer present in the animal at the time of the
incident. In the fourth incident GMO waste had been mixed with conventional
company waste. The complete batch of waste was incinerated under supervision. In
the fifth incident there was a fire in a laboratory with GM animal cell lines. In
the sixth incident GM E. coli was disposed in a sink in a school. It
involved a weakened E. coli strain where survival in the sewer was
unlikely (biological restriction), based on the risk assessment. In the seventh
incident, an unintended release of approximately ten litres occurred from a
fermenter with GM yeast. Based on a risk assessment, it was unlikely that this
yeast survived the water purification system of the company. In the eighth
incident 100 litres of a bacteria suspension was accidentally released in the
sewers. This involved a weakened E. coli strain, which was being used
for vaccine production. Based on a risk assessment, survival in the sewer was
unlikely. In the ninth incident a flooding of an ML-III laboratory was
registered. At the moment of the incident no activities with GMO's were taking
place, but activities involving wild-type pathogenic viruses and bacteria. Approximately
100 liters of water got into the sewers. Based on a risk assessment, it was
concluded that even if all this water was contaminated with pathogens it would
have been highly unlikely that they could have survived in the sewers.

United Kingdom

Seven accidents
were reported to the Competent Authority during the reporting period. All
accidents involve GMM belonging to class 2.

The first
accident involved the transfer of the seed bacterial culture (E.coli
HMS174(DE3) genetically modified to express Neisseria meningitidis surface
proteins) from a flask into the fermenter using a peristaltic pump. The pump
was activated while the clamp closing the transfer tubing was still in place.
Consequently, the tubing separated from the pump, resulting in the spill.
Following the incident, the company’s standard operating procedure was adapted
to highlight the clamp removal stage.

The second
accident involved genetically modified Mycobacterium tuberculosis. The
accident occurred when the shaking platform of the middle one of three
stacked Infors Multitron 2 incubators appeared to shake much faster than the
speed it had been set to. ).The overspeed caused some of the secondary
containers to come out of their clamps and some broke. Some of the primary
containers containing GM Mycobacterium tuberculosis cultures were also
thrown out of their secondary containers and into the body of the incubator.
Eight of these primary containers had broken. The user
had the faulty circuit board replaced. However, in case another overspeed incident
occurred they had changed their procedures. In order to further reduce the possibility of overspeed incidents,
Infors UK (the distributors) developed further overspeed prevention software,
which was to be installed on all existing machines in the UK, free of charge.

The third
accident involved waste liquid from work with samples
containing live but highly attenuated genetically modified H5N1 influenza virus
and also contained small amounts of thiomersal, a mercury containing
preservative. The estimated maximum titre of the virus
present in the liquid waste which was spilled was approximately
1 × 105 EID50/ ml. All microbiology staff was
retrained in the use of the peristaltic pump. The operating procedure was
changed.

The fourth
accident involved egg waste from the pandemic influenza vaccine facility
containing genetically modified pandemic vaccine influenza virus The pandemic
influenza vaccine facility pumps waste fluid into an intermediate bulk
container (IBC) waste vessel or diverts it to the stand-by unit. A blockage
occurred in the steel pipe work, causing a rupture at a flexible rubber elbow
joint. The cause of the blockage is unknown. The spillage went into the waste
tank area in an external building. Some of the spilled material reached the
outside of the building but did not enter any drains. The pandemic influenza
production run ended 3 days after the accident and there were no plans to use
this waste system again due to a move to a new facility with a different waste
handling system.

The fifth
accident involved a 4th year postgraduate student who was injecting
pigs subcutaneously with a genetically modified mutant of Actinobacillus
pleuropneumoniae (App). A pig kicked out and struck his hand (right)
holding the syringe. This caused the needle to pierce the skin of the
non-injection hand (left). A small amount of App entered the nail bed of his
left thumb causing a severe reaction which ultimately resulted in
hospitalisation and surgery with antibiotic treatment. It is estimated that the
postgraduate student was exposed to approximately 1 µl
(≈ 1 × 107 CFU) of App. The incident involved a
severe reaction to a pathogen that had not previously been known to cause this.
The College amended the risk assessment to highlight the potential consequences
of subcutaneous exposure when working with this pathogen.

The sixth
accident involved a GM vaccinia virus construct. A researcher suffered a
needlestick injury very superficial while inoculation a mouse with a GM
vaccinia virus construct. Consequently a very small volume (not more than
10μl) could have penetrated the individual’s skin. Particular training was
performed to ensure employees were aware that needles should never be
re-sheathed and that the needle and syringe should be safely stored between inoculations.

The seventh
accident involved GM parasite Leishmania
mexicana. A University researcher was using a 25 gauge needle attached
to a 5ml syringe to lyse 2.5ml culture of mouse cells infected with a
genetically modified (GM) version of the parasite Leishmania mexicana.
The procedure was undertaken on ice on the open bench. The force of pressure
caused the needle to disengage from the syringe which resulted in the
researcher being sprayed on the forehead with a small amount of the culture
containing the GM parasites. No health effects were registered. The University
changed its procedures to minimise the likelihood of disengagement of needle
from the syringe.

1.5.        Inspection and enforcement issues

Austria

During the reporting period, both competent authorities carried out
checks scheduled and unannounced random on activities involving GMOs in
closed systems. These included checks on closed systems for Levels 1 to 3, with
different applications (small-scale basic research, food testing and large-scale
production) being inspected. These checks provided no grounds for administrative
measures.

Belgium

During the period 2006-2009, inspections were organized in the three
regions by different inspectorates on a regular basis and concerned contained
uses with GMOs as well as pathogens. In the Flemish Region inspections were
done by 2 inspection bodies, the Flemish Agency for Care and Health of the
Flemish Community and the Environmental Inspection Department of the Flemish
Competent Authority, respectively concerning Public Health and Environment. Exchange
of information with other European inspectorates was achieved by participation
in the activities of the European network of inspectors (EEP: European
Enforcement Project on contained use and deliberate release of GMOs) since
2005. One of the actual concerns of inspection is
sampling of pathogens and GMOs as a means to control the adequacy of
containment and work practices. For this purpose the Flemish Environmental
Inspection ordered a study on the methodology for sampling and analysis of GMOs
and pathogens and in parallel the Flemish Health Inspection asked for a study
on sampling inside the facility with the aim to help in discern situations
where sampling could be necessary and to provide an answer on the relevance and
univocal interpretation of the sampling method.

The enforcement actions taken were the following: a) if
inspection reveals shortcomings in the application of containment measures the
user is summoned to comply with the conditions of the authorization within a
limited period of time: an exhortation is drawn up. b) If the notifier does not
comply with exhortation within the required timeframe an official report of infringement
is written. c) when the shortcomings represent a serious risk or when there is
no environmental permit or authorization, an official report of infringement is
written.

The most recurrent problems encountered were: no regular
supervision and control of the biosafety equipment, no validation of the used
waste inactivation methods, insufficient training and lack of biosafety
procedures, and incomplete registration of used and stored micro-organisms.
Also, still a few installations did not posses the requested environmental
licence or authorization for the concerned activities. The Inspectorates are
also responsible for the control of the storage and transportation of hazardous
medical waste. As this is often related to contained use, inspections on
storage and transportation of hazardous medical waste were also done during routine
contained use inspections. Concerning this issue, non- compliances with the
Flemish regulations were often found.

Bulgaria

No procedure yet defined for the inspection of contained use and in
consequence there were no actions that were taken during the reporting period.

Czech Republic

Czech Environmental Inspectorate
co-operates with other state supervision bodies carries out inspections for
contained use of GMOs, in accordance with the yearly schedule based on the
information from the Ministry of Environment and other authorities. Inspections
are targeted on compliance with the requirements for the contained space,
documentation, waste treatment, transport of GMOs, equipment of the premises,
training of the personnel etc. In total, 77 inspections were carried out in
contained use premises within the reported period, some of the facilities were
inspected repeatedly. About 75 % of all authorised subjects were inspected
during these 3 years.

No serious breach of the rules was
identified within the reported 3 years period. Most frequent deficiencies found
by the Inspection were missing updates or parts of the documentation and in one
case some of the specific requirements for containment level were not met.
These imperfections in most cases did not lead to infringement of the law nor
to any risk to the environment. Six remedial measures and one fine were imposed
during the reported period.

Cyprus

The
Department of Labour Inspection during the reporting
period has carried out inspections in various premises
in order to verify whether GMMs are used. No premise within the scope of the Directive
was identified in Cyprus up to now. About 20 Labour Inspectors were partially
involved under the instructions of a specialised Labour Inspection Officer.

Denmark

Inspections were always performed upon notification of new premises
or changes of already classified location. There were 7 inspectors in Denmark
who spent part of their working hours with inspection. The frequent errors
were: the information submitted to support risk assessment was not sufficient,
the notification of the location but not also of the activities etc. Companies did
not always remember to give the information that a location is no longer being
used for work with GMMs.

When a company had not notified e.g. a research project they were
given an order with short notice to get the matter settled. Sometimes companies
were given advice on how to make things right. If the problem is more serious
companies may be given an order with notice to get the matter settled.

Estonia

No information provided.

Finland

The National Supervisory Authority for Welfare and Health, Finland
(Valvira) was in charge with inspection. The inspection procedure was based on
risk, so that class 3 uses were inspected more often (at least every second
year) than class 1 or 2 uses (at least every 5 years /4 years respectively). During
the reporting period 201 inspections were performed by two full-time inspectors
(54 % of valid notifications). Approximately 500-800 orders of correcting
measures were delivered (about 1 to 6 corrective measures / inspection, no
further statistics available).

France

In May 2008 the Office for the Inspection of Contained Use
Installations and Activities was created. Since, the proceedings initiated for
control had been especially directed to a file review of application for
accreditation. During
the period May 2008 to late 2009, two major structures were visited, one
private and one public structure. One part time inspector (biologist at CNRS) was available for
control activities. The problems most frequently encountered in
the sites visit were related to the application for decommissioning group of
GMOs, the handling large volumes of lentiviral vector, the procedures for
inactivation of liquid and solid waste.

Germany

After the notification of the consent the competent authorities
regularly carried out the inspections on the premises. They checked the record
of activities and in individual cases, took samples if needed. The inspection
carried out during the reporting period revealed some negative points such us
deficiencies concerning safety equipment, incomplete record keeping of genetic
experiments, wrong or missing notes, detection of GMOs outside of the primary
containment, e.g. in centrifuges. During the reporting period about 1600
enforcement actions were taken such as administrative offences, administrative
fine, and written complaints, ordered tests of cell lines, administrative
defences, and prohibition of genetic engineering operations. The users took
different measures to minimise the occurrence of the problems, i.e. nomination
of a dedicated person for dealing with legal and safety requirements and
keeping in touch with competent authorities, training of biosafety officers and
of project leaders etc.

Hungary

The authority regularly monitored the contained use
activities, but no irregular activities were identified. The audits were
conducted once a year and the compliance with Good Laboratory Practices was
checked every two years.

Ireland

The CA is responsible for both the licensing and the
inspection/enforcement of contained use activities. There were three inspectors
available to carry out inspections. On balance the CA aimed to inspect all
contained use activities once every three years. In carrying out inspections,
inspectors used the checklist for contained use inspections devised by the
European Enforcement Project.

Few aspects to be improved: users already actively engaged in the
contained use of GMO/ GMMs without having first obtained the authorisation to
do so, lack of knowledge regarding the consent conditions issued in respect of
the contained use activity. Adequate training was provided by the CA. In
specific cases it was recommended to have a Biological Safety Committee and a
Biological Safety Officer. All site inspection activities were followed up with
a letter to the user making recommendations in an effort to strengthen and
harmonise containment measures.

Latvia

No comments due to lack of activities.

Lithuania

According to the Order on Regulation on Contained Use of Genetically
Modified Micro-organisms, the Ministry of Environment inspects and examined the
containment and other applied safety measures, at least every 3 years for Class
1 uses, every 2 years for Class 2, and every year for Class 3 and Class 4 uses.
One specialised inspector is available for inspections under Directive
2009/41/EC.

The major objective for inspection was to confirm the effectiveness
of the containment level and to evaluate the compliance with relevant approved
conditions concerning the protection of the environment and human health.

The administrative penalties according to the Administrative Law
Offence Code can be imposed on users, who carry out activities related to GMMs
without or when the relevant requirements are not fulfilled. Approvals can be
suspended or revoked where deficiencies with safety measures are discovered.

Luxembourg

Before planned contained use activities are started, inspections are
held on a consultative basis with the applicant.

Malta

No facilities
to be inspected.

Netherlands

No information provided.

Poland

Three authorities carried out inspections of contained use
installations. The State Labour Inspection is in charge of the safety and
hygiene of work; they inspect the labelling of facilities, the safety measures
and the equipment used. The State Sanitary Inspection controls biological
factors, whereas the Environmental Protection Inspection is in charge of the
control of wastes from contained use activities. These three authorities can
carry out inspections on their own initiative or upon request of the Ministry
of Environment. During the reporting period 71 inspections have been carried
out. Frequently detected offences were the following: lack of an emergency plan
and the lack of entrance signage in laboratories where GMO activities are
carried out. There were 10 enforcement actions taken during the reporting
period.

Portugal

The Portuguese Environmental and Spatial Planning General
Inspectorate (IGAOT) is responsible for the inspection. During the reporting
period there were no site inspections. There is one inspector, not specialised,
who was involved with the OGM/MGM issues, among other issues not related with
Biotechnology.

Romania

The National Environmental Guard (NEG) is a specialized control and
inspection body under the co-ordination of the Ministry of Environment and
Forests. The Directorate for Control of Biodiversity, Biosafety and Protected
Areas in NEG is responsible for control and inspection activities in biosafety.
Seven specialised inspectors were available for inspections under Directive
2009/41/EC.

Slovakia

During the reporting period 469 inspections were done with three
specialised inspectors, which could impose fines for procedural offences. The
most frequently encountered problems were related to the first time use of the
premises and the lack of notifications. 15 enforcement actions were
taken during the reporting period.

Slovenia

Slovenia had two specialised inspectors for GMOs. Each
inspector was available for 10% of full working time for inspections under
Directive 2009/41/EC and GM plants and GM animals. During the reporting period
there were only minor infringements regarding the documentation management
(e.g. emergency action plans were not sent to the local authorities as
required, yearly reports were not sent to the ministry etc.). In this context
11 written warnings were issued. The Competent Authority organised 2 workshops which
focused on the preparation of the dossier and on risk assessment for potential
notifiers.

Spain

Inspectors were from the Spanish Biosafety Committee and from the competent
region. All installations were inspected. The problems most frequently
encountered were: deficiencies in Good Laboratory Practices (GLP) and
inadequate equipment, as well as the lack of internal Biosafety Committees at
the premises of the user. The system was improved following a dialogue between
the users and officials from the Biotechnology Unit before supplying the final
notifications to the Competent Authority.

Sweden

Activities are inspected by Swedish Work Environment Authority (SWEA). Inspections
were undertaken for various purposes: checking the information provided in the
notification or regular inspection of premises. Inspection activity was at a
relatively low level over the last two years. During the period inspections
generally were triggered by notifications or approval applications.

United Kingdom

Great Britain had 13 Specialist Inspectors and 4 Principal Specialist
Inspectors (managers). The inspection programme was a risk-based programme.
Higher risk laboratories received more frequent inspections, for instances
sites working at Class 2 were visited approximately every 5 years, sites
working at Class 3 approximately every 3 years and sites working at Class 4
approximately every 1 year.

During the reporting period, 246 inspections were carried out on all
sites working with GMMs in contained use.

Inspectors used a range of enforcement tools to ensure that users of
GMM complied with the legislation such as: providing written advice and
requesting improvements in certain areas; issuing of statutory Improvement
Notices, requiring notifiers to remedy contraventions of the legislation within
an agreed time period; issuing Prohibition Notices requiring the immediate
cessation of work where it is considered by the inspector that it poses an
imminent risk to human health; withdrawal or variation of consent to carry out
GM work; and prosecution. Two enforcement actions were taken and involved the
variation/suspension of consent to carry out GM activities until the problems
were rectified. Note that this figure reflected formal enforcement specifically
taken under the Regulations that implement Directive 2009/41/EC. Enforcement
action had been taken under other health and safety legislation at premises
that may have been carrying out GM activities.

In 2010, the implementation of a new rating system for all sites was
started. This was be based on a rating for the inherent hazard (e.g.
classification, complexity, scale and nature of the work) and a rating for the
safety performance (e.g. safety management, maintenance, training/competence
found during an inspection). The combined rating will be used to determine how
often a site is revisited.

The most frequently encountered issues were related with: waste
transport/storage/inactivation; insufficient/inappropriate risk
assessment/standard operating procedures/local rules; poor laboratory
equipment/fabric; and training/competence.

1.6.        Problems
with interpretation of the provisions

Belgium, Czech
Republic, Hungary and the Netherlands encountered problems in
assessing whether new techniques of genetic
modification fall within the scope of Directive 2009/41/EC.

Also Belgium encountered problems related to
clinical trials in humans submitted under the provisions of the Directive
2001/18/EC, part B, which also require in some instances an authorization based
upon the contained use decrees (Directive 2009/41/EC), causing a double
authorisation regime. In Belgium the term subsequent contained use caused
problems for notifiers who had difficulties in determining what modifications
of their activities constituted a subsequent contained use, i. e. whether the
use of other genetically modified or pathogenic microorganisms or other
techniques still fall under the scope of the authorized contained use activity
or not.

Czech Republic encountered problems with
new techniques for genetic modification, e. g. whether animals used for testing
DNA vaccines could be considered genetically modified organisms as defined in
the Directive. Problems also emerged regarding clinical trials.

For Denmark the increased number of class 1 notifications
represented the greatest burden.

Finland reported some problems with the
definition of a GMO as well as with the classification
of pathogenic organisms in cases where their pathogenicity has been attenuated.
Finland saw the need for guidance on the notification procedures concerning
clinical treatments of patients.

France encountered administrative
problems when implementing the 45 days deadline in which the Competent
Authority should examine the notification. The deadline was too short.

Germany encountered problems with the interpretation
of Annex IV of the Directive 2009/41/EC and suggested a more precise wording of
standards. The Directive would not specify acceptance criteria for technical
demands (for example the term air tight). Germany also noted difficulties with
the verification of the identity of GMO and with the detection of contamination
of the working environment with GMO.

Hungary also encountered problems with a
potential "overlap" between Directive 2009/41/EC and Directive
2001/18/EC in regard to gene therapy.

In Ireland the high number of site inspections and subsequent
enforcement activities represented the greatest duty on the Competent
Authority's resources. Ireland argued for a simplification procedure in as far
as organisms falling into class I could be exempted from the scope of the
Directive (Part C of Annex II) if they had a proven and well established
history of safe use.

Luxembourg proposes annual reporting of
all authorized contained use activities by the authorization holder.

Malta recommended holding an EU training
workshop dealing with what is required according to the Directive 2009/41/EC in
order to have a co-ordinated approach in the whole EU.

The Netherlands calls for
a common interpretation on the scope of directives 2009/41/EC and 2001/18/EC
with respect to applicable legislation for gene therapy studies and trial
notification.

Poland also encountered problems with
clinical trials and potential "overlapping" between Directive 2009/41/EC
or Directive 2001/18/EC as well as difficulties in classification of activities
involving plant and animal cells (GMM vs GM plants or animals).

Slovenia suggested
that inclusion of safe organisms in Part C of the Annex II of Directive
2009/41/EC could contribute to a reduction of the number and size of the
notifications.

Spain has encountered difficulties to
obtain feedback from the users of centres and institutions working with
GMMs/GMOs in order to comply with the obligations derived from the contained
use directive. According to the Spanish Competent Authority there were still
some facilities which did no have notified installations or activities with
GMM/GMOs. Spain suggested to have harmonised Guidelines at EU level regarding:
a) clinical trials in order to clarify whether they have to be carried out
under the scope of Directive 2009/41/EC or/and the 2001/18 /EC (or both, “case
by case”); b) interpretation of Article 3 (2) of Directive 2009/41/EC (on
transport).

Sweden considered that the yearly
reports and three year report requested under Directive 2009/41 are sometimes
redundant in terms of information provided.

The United Kingdom considered the work with viral
vectors was at the low end of the risk spectrum, but because of the high number
of notifications, took a disproportionate amount of time to review. The
Competent Authorities from the United Kingdom suggested that the requirement to
notify class 2 activities could be changed so that there is only a requirement
to notify the first class 2 activity at premises. Subsequent class 2 activities
could be carried-out, following approval by an internal committee, without the
need to notify the Competent Authority. The Competent Authority could then commit
more resources to the assessment of more hazardous work (including reviewing
notifications) and to inspections of all classes of premises.

1.7.        Clinical
trials under the provisions of the Directive

Austria

Pursuant to the Austrian Genetic Engineering Law,
clinical trials for the purpose of somatic gene therapy in humans are not
subject to the legal requirements governing activities involving GMMs in
a closed system. However, such trials only receive an authorisation from the
Ministry of Health if various conditions under the legislation governing
medicinal products are met, and if the somatic gene therapy causes no changes
to the germ line and no harmful release of GMOs into the environment is to be
expected.

Belgium

During the reporting period, two clinical trials were
carried out and one more trial was authorised but withdrawn by the applicant
before start.

Bulgaria

No clinical trials were notified to the
Competent Authority during the period 2006-2009.

Czech Republic

Only one clinical trial with CEREPROTM was carried out (notified in 2005). No other notification was
submitted during the period. According to Czech Act on GMOs, the hospital
participating in a clinical study and the company providing the product to be
tested have to submit separate notifications, which constituted a considerable
administrative burden.

Cyprus

The Department of Labour Inspection is not aware of any clinical
trials with GMMs that take place in Cyprus.

Denmark

One clinical trial was notified.

Estonia

No clinical trials were notified.

Finland

No clinical trials were notified.

France

228 clinical trials were carried out in France between 2006 and
2009.

Germany

14 clinical trials were carried out in Germany between 2006 and
2009.

Hungary

No clinical trials were notified.

Ireland

No clinical trials were notified.

Latvia

No clinical trials were notified.

Lithuania

No information given.

Luxembourg

No clinical trials were notified.

Malta

No clinical trials were notified.

Netherlands

Clinical trials were handled under Directive 2001/18/EC.

Poland

Six clinical trials with GMM were authorised. Clinical trials with
GMM require decisions of the Minister of Health, the Ethical Committees and the
Minister of the Environment.

Portugal

No clinical trials were notified.

Romania

No clinical trials were notified.

Slovakia

No clinical trials were notified.

Slovenia

No clinical trials were notified.

Spain

Clinical trials with GMMs were assessed case by case and most of
them are dealt as Part B notifications (Directive 2001/18/CE). Notifications of
clinical trials increased since the last report but all of them were considered
as deliberate releases.

Sweden

The Swedish Work
Environment Authority and the Swedish Medical Products Agency reached the
conclusion that clinical trials with GMMs on humans should be regarded as
deliberate releases, as in Sweden it is required that there is physical
containment of GMOs as well as biological containment. The Swedish Medical Products Agency deals with applications for clinical trials in accordance with Part B of Directive 2001/18/EC on the deliberate release into the environment of genetically modified
organisms. The procedure has also been incorporated into the Swedish Medical
Products Agency’s regulations and general advice is given on deliberate
release into the environment of medicinal products that contain or consist of
genetically modified organisms.

The United Kingdom

The regulations which implement Directive 2009/41/EC allow clinical
trials to be undertaken as contained use activities. The Competent Authority
does not collect this information. The vast majority of clinical trials were
from class 1 as such, would not individually require notification to the
Competent Authority (apart from first use of the premises for work with GMMs).
Any class 2 clinical trial activities is included in the total number of class
2 activity notifications, and the information is not recorded in a way that
readily allows retrieval of the number of this type of activity.

1.8.        Public
consultation and information

In Austria public information on the significance of
genetic engineering and biotechnology was provided by the genetic
engineering-related web pages of the Ministry of Health (www.gentechnik.gv.at)
and the Ministry of Science and Research (www.bmwf.gv.at). There were no public
consultations concerning activities involving GMMs as no
applications for level 3 (large-scale) or level 4 were submitted. In addition,
contact with operators carrying out activities involving GMMs or with
petitioners was largely in electronic form.

In Belgium, public consultation was performed,
when relevant, through the general procedures established under the regional
environmental laws. The procedures for public consultation aim at providing
general information to the neighbourhood regarding the contained use of GMOs
and/or pathogens. In the Flemish and Brussels Capital Regions, this information
is given via a "public dossier", which is a short summary of the full
notification drafted by the user and containing generally understandable information
without any reference to confidential information. A similar procedure of public
consultation was established in the Walloon Region for the environmental releases.
The consultation also gives the public the possibility to express comments,
observations or objections regarding the contained uses. The competent
authorities take these comments, observations or objections into account when
drafting their final decision. All decisions were made publicly available for a
time-limited period. Appeals against decisions may be submitted to the
Competent Authority within that period. In the Flemish and the Brussels Capital
Region, the public was only consulted for environmental permit demands. Public
information is provided primarily in two ways. Firstly, general information (in
French and/or in Dutch) focusing on legal and administrative aspects can be
found on the websites of the three regional competent authorities (Brussels Capital Region: http://www.ibgebim.be; Flemish
Region: http://www.lne.be; Walloon Region: http://environnement.wallonie.be/. Secondly, scientific and technical information (in
English, Dutch and French) is provided through the "Belgian Biosafety
Server" (http://www.biosafety.be), a website maintained by the SBB.

During the reporting period, there was no public
reaction received in response to consultations

and or information made publicly available under Directive
2009/41/EC.

In Bulgaria during the reporting period no public
consultation was carried out. A
public register of the premises for contained use of GMOs was established and
maintained in an electronic form at the Ministry of Environment and Water. The
public register was part of the information system in the framework of the
Biosafety Clearing House.

In Czech Republic the public was informed in general by different
means: yearly public meetings of Competent Authorities' advisory body,
seminars, publications etc. No public consultation on any specific contained
use notification was conducted during the period.

The Competent Authority keeps updated the register of subjects
authorised for contained use (“Register of Users”) on its website www.mzp.cz.
The Register contained the name and address of the user, the specification of
GMOs, the purpose of the use and its classification.
Summaries of emergency plans are published as well.

Information in English was made available at Czech Biosafety
Clearing House webpage www.mzp.cz/biosafety including the legislation,
notification formats and guidance document on the clinical trials
notifications.

No specific reactions were received. The overall public attitude to
biotechnology research and to the use of GMM in the health sector was positive
in Czech Republic.

In Cyprus no public consultation were
carried out.

In Denmark all notifications were registered in a common
database shared by the Danish Working Environment Authority and the Danish
Environment Protection Agency. Other authorities can get access to this
database when needed. The public can apply for access following the rules laid
down in the Law concerning Access to Public Records. Before the Environment
Protection Agency makes a decision about an application for production, the
application is presented to the local authorities and if necessary other
parties of interest. All of the approved notifications for production were
published in a national and a local newspaper. When the approval was published complaint
against the decision could be filed to the Environmental Appeal Board within a
four week period.

Estonia
did not provide any information about public consultation.

In Finland there was no public
consultation in connection with contained use activities.

In France there was no public
consultation in connection with contained use activities.

The Central Committee on Biological Safety from Germany
published annual reports concerning on-going activities as well as general
recommendations and the list of classified microorganisms. All the data was
available on BVL homepage.

In Hungary the notification of an activity has to include a
short, easily understandable summary of the risk assessment for public
information purposes, which can be consulted at the Secretariat of the Gene
Technology Advisory Board. The Biotechnology Advisory Board ensures that civil
society organizations are involved in the authorisation procedure. The Registry
Office appointed by the Competent Authority offers information concerning
contained use.

In Ireland the Competent Authority notifies the public of class
3 and 4 activities in accordance with national Regulation 73/2001. Based on the
same regulation the public consultation may be carried out at the discretion of
the Competent Authority for class 2 contained use activities. No public
consultations relating to class 3 and 4 contained use activities were carried
out during the reporting period since no class 3/4 applications were received.
With regard to applications for class 2 activities, the Competent Authority did
not deem it necessary to consult the public on any of the applications
received. The GMO Register listing GMO users is made available for public
viewing at the headquarters of the Competent Authority. Considerable technical
guidance relating to the contained use of GMMs/ GMOs is published on the
Competent Authority’s website (www.epa.ie). No public consultations were
carried out during the reporting period. The Competent Authority received no
public reaction or comment in response to the GMO Register or its guidance.

In Latvia no public consultation
took place because no notifications were submitted.

In Lithuania according to the Order on Regulation on Public
Information and Participation in Authorization of Consent for Use of GMOs, the
Ministry of Environment has to organize use, storage and availability of
information about GMOs to the public through the national GMO database. This
database is available at the following address: http://gmo.am.lt and has a
dedicated section for the direct public opinion presentation. Notification and
information on contained use of GMMs are presented in this database.

In Luxembourg, public consultation is performed through the
general procedures established under environmental law "Loi du 10 juin
1999 relative aux établissements classes. According to the law "Loi
du 13 janvier 1997 relative aux contrôle de l'utilisation et de la
dissemination des organismes génétiquement modifiés", a public
consultation is performed for first time moderate or high risk activities.

In Malta the Competent Authority published and disseminated a
leaflet on contained use, which explained the legislation requirements and
timeframes. It also organised a one day public awareness on this issue.

In the Netherlands in the case of a large scale production
the dossier was made public by means of an advertisement in a national
newspaper in order to give the public the opportunity to make objections before
the license was issued. All other dossiers were made public after the license
was issued. This was done by publishing the name of the notifier, title of the
project and the issuing date of the licence on the Internet. In addition
anybody could request to look into a specific dossier at the GMO office and the
public concerned can object to an issued licence. No objections were received
during the reporting period.

In Poland public consultation is a part of the approval procedure
for all classes of notifications under the Polish law on public information.
The provisions for public participation in the decision making process require
public access to the notification while restricting public access to
confidential information. General information on contained use activities in
Poland was provided on the web site http://gmo.mos.gov.pl.

In Portugal, although the legislation foresees the option
that the Competent Authority could promote consultation procedures when it
considers appropriate, no consultation procedures were carried out for the
notifications presented in the current period.

In Romania the national legislation transposing Directive
2009/41/EC includes provisions regarding public consultation and public
information in the decision making process regarding the contained use of GMMs.
The approval procedure is public. The National Environmental Protection Agency
publishes notifications on the website www.anpm.ro. Within 10 days from the acceptance
of the notification and within 30 days from the display, the public has the
possibility to comment.

In accordance with national legislation for the contained use
classes 3 and 4, the National Environmental Protection Agency (NEPA) should
held public debates and report to the authorities involved in the notification
procedure. The public information at the national level is made available to
the public in collaboration with local environmental protection agencies that
are subordinated to the National Environmental Protection Agency.

All risk assessments submitted by the notifiers and the summary of
all decisions taken by the competent authority are published on the NEPA
website: www.anpm.ro and, if necessary, public debates are held during
the authorization procedure for contained use of genetically modified
microorganisms.

In Slovakia all the information are publicly available on the
websites www.enviro.gov.sk and www.gmo.sk. Also during the reporting period 8
events were organized (workshops and seminars) for the general public, consumer
associations, school teachers, environmental inspectors, researches and
scientists.

Slovenia
did not provide any data regarding public consultation.

In Sweden there were no changes
since the last reporting period.

In the United Kingdom the Competent Authority maintains a
public register of information on all notifications concerning contained use
(with the exception of those withheld for reasons of national security). This register
contains information on premises and individual activities, including the nature of the work to be carried out, the
purpose of individual activities and the characteristics of the GMOs involved.
The register can be found at

http://www.hse.gov.uk/biosafety/gmo/publicregister.htm.

Additional information is provided by The
Scientific Advisory Committee on Genetic Modification (Contained Use). This
committee provides technical and scientific advice to the Competent Authority
on all aspects of the human and environmental risks of the contained use of
genetically modified organisms (GMOs). It held two open public meetings during
this reporting period.

1.9.        Protection
of confidential information

Austria

The operator may indicate in the application or notification
submitted to the authority those data to be treated as confidential. In such a
case, the authority decides which data are to be recognised as confidential in
accordance with § 105 of the Genetic Engineering Law and may therefore not be
made accessible to the public during the consultation process.

Belgium

As the elaboration of a public as well as a technical
dossier is often a burden for the notifier, the competent authorities are
willing to accept only one (technical) dossier. The Brussels Capital Region
considers the possibility of a new single form with confidential information in
an annex, if necessary. In the Flemish and Brussels Capital Regions, the
information for public is given via a "public dossier" which is a
short summary of the full notification drafted by the user and containing
information written in every day language and without any reference to
confidential information.

Bulgaria

No information provided.

Czech Republic

No information provided.

Cyprus

No information provided.

Denmark

No information provided.

Estonia

No information provided.

Finland

No information provided.

France

No information provided.

Germany

No information provided.

Hungary

Notifications are published on the internet. The notification of an
activity has to include a short, easily understandable summary of the risk
assessment for public information purposes, which can be consulted at the
Secretariat of the Gene Technology Advisory Board.

Ireland

Confidential information was submitted in connection with three
Class 1 GMM applications received during the reporting period. All requests to
keep information confidential were considered by the CA in the context of
Article 18 of Directive 2009/41/EC and implementing Regulations. The
information submitted and proposed as confidential was deemed by the notifier to
be commercially sensitive and provided it did not impede the provision of an
adequate description of the GMM on the GMO Register, the CA agreed that it
should be treated and held as confidential.

Latvia

No comments due to lack of activities.

Lithuania

According to the Order on Regulation on Public Information and
Participation in Authorization of Consent for Use of GMOs the Ministry of
Environment has to organize use, storage and availability of information about
GMOs to the public through the national GMOs database (Internet address: http://gmo.am.lt),
undamaging the rights of confidential and intellectual information.
Notification and information on contained use of GMMs are presented in this
database.

Luxembourg

No information provided.

Malta

No information provided.

Netherlands

When a notifier claims confidentiality it has to be made
clear on what basis the risk assessment has been carried out. A general
description of the confidential parts has to be submitted in order to give the
public insight into the entire risk assessment. All confidential parts of
notifications have to be submitted in confidential annexes. Only authorised
personnel have access to the rooms where the dossiers are handled and stored.

Poland

No information provided.

Portugal

No information provided.

Romania

No information provided.

Slovakia

No information provided.

Slovenia

No information provided.

Spain

No information provided.

Sweden

No
changes since submission of the 2003-2006 report.

United Kingdom

No information provided.

1.10.    Waste disposal

Austria

GMMs of class 2 to 4 which are capable of proliferating under
ambient conditions must be inactivated prior to disposal. Inactivation of GMOs
was mainly carried out using validated thermal (autoclaving) or chemical (e.g.
sodium hypochlorite) processes. Most inactivated GMO waste was thermally
treated. The planned disposal of waste and waste water must be considered
during the safety classification of the specific activity involving
GMOs.

Belgium

In the Belgian Regional decrees implementing Directive
2009/41/EC, there is an explicit legal

requirement to inactivate all types of GMOs, class 1
included, by appropriate and validated means prior to disposal as waste. Inactivation
can either be done on site, or after transport in biohazard containers to a
waste processing company. In each region, these requirements are completed by
specific regulations on waste originating from medical care and dangerous waste
in general, including waste from animal experiments, imposing rules for
storage, for incineration and for collection by an approved company. Transport
of waste material follows the UN recommendations of dangerous goods.

Bulgaria

Bulgarian legislation requires that all kind of waste must be
inactivated and disposed in an appropriate manner. The details regarding inactivation
and disposal are given in the application under a specific point of information
for waste management.There were
no waste treatment facilities in Bulgaria which are authorised to inactivate
waste arising from GM installations.

Czech Republic

There were no special waste facilities, GMMs were inactivated at the
premises where they had been used and the resulting waste was treated together
with other hazardous waste from the premises (laboratories, hospitals etc.).

For the GMMs (class 1 and 2) which have been authorised in Czech
Republic the waste was inactivated and disposed of in the same way and by the
same means as infectious waste containing pathogenic micro-organisms (by
chemical disinfectants, autoclaving etc.). Likewise, GM laboratory animals and
animals inoculated with GMMs were disposed of as other infectious animals. GM
plants were either autoclaved or in large volumes chopped, the seeds ground and
the resulting material composted.

Cyprus

No data available.

Denmark

There were no authorised waste treatment facilities in Denmark. The users
inactivated their GMO-waste themselves. For class 1 the treatment of the waste
was based on the risk assessment in each specific case. For class 2 the waste
had to be inactivated with validated methods before final discharge. For class
3 the waste had to be inactivated before final discharge with validated
chemical or physical methods. For class 4 only a validated physical
inactivation is sufficient.

Estonia

No data available.

Finland

Any viable organism in the waste must be inactivated. GM-vertebrates
were incinerated or buried. Most GM-plants were autoclaved, but there was a
list of recommended methods for different species and their tissues, depending
on whether the specific plant tissue is capable of reproduction. One waste
treatment facility in Finland, which had a long experience of GM-waste
inactivation, was used to treat class 1 and 2 GMO waste. However, most of the
GMO operators inactivated their GMO-waste themselves.

France

No data available.

Germany

There were two facilities in Germany authorised to inactivate waste
containing GMMs, in North Rhine Westphalia and in Hamburg. Both facilities were
authorised to accept waste containing Class 1 GMMs. The transfer of waste was
organised by the operator.

Hungary

Waste from biotechnological activities was treated under the
national legislation concerning dangerous waste.

The waste treatment facilities in Hungary authorized for such
activities did not only treat GMO waste. The activity of inactivating waste
arising from GM installations required a special registration procedure. The
transfer from the installation to the waste treatment facility was done under
controlled conditions and specifying the route of transfer.

Ireland

The Competent Authority stipulated in consent
conditions issued to the GMO user that all waste had to be inactivated by
validated means. Waste arising from Class 2, 3 or 4 GMM activities had to be
inactivated on site using validated procedures (autoclaving or chemical
inactivation in the case of liquid waste). The only exception to this would be
where GM and/or non-GM animals had been inoculated with class 1 or class 2
GMMs. In the case of animals inoculated with Class 1/2 GMMs, the remains were
transported off site to waste treatment facilities authorised for the
inactivation of Class 1/2 GMMs, under the national legislation implementing
Directive 2009/41/EC. The inactivation of large animals (where heat penetration
in a laboratory sized autoclave would not be feasible) inoculated with Class
1/2 GMMs, or any sized animal inoculated with Class 3/4 GMMs, had not arisen
and such a decision would be made on a case-by-case basis. GM Plant waste was
inactivated by autoclaving or off-site incineration.

There were two facilities in Ireland authorised to inactivate waste
containing GMMs. Transportation was arranged by the waste treatment company.

Latvia

No information available.

Lithuania

According to the Order on Regulation on Contained Use of Genetically
Modified Microorganisms, the notifier has to provide information concerning the
waste management, including the amount and type of waste, the methods of
inactivation and the final form of the waste and destination. In all cases, all
types of GMMs had to be inactivated prior to disposal. Waste was mainly
inactivated through thermal or chemical means.

Luxembourg

Waste inactivation is by autoclaving or by using chemicals.

Malta

The requirement for inactivation for
Class 1 GMMs was through autoclaving.

Netherlands

A Ministerial Decision provides that all waste has to be
inactivated by validated means. Waste storage must comply with the rules as
laid down in an annex to the Ministerial Order. In general waste disposal and
inactivation was performed in-house. If this was not possible, the waste had to
be transported to dedicated waste facilities.

Poland

The notifier must provide information about the
foreseen quantity of aerosols and contaminated sewages resulting from the
contaminated use activity. Information about storage and inactivation methods
must be provided. All waste must be inactivated prior to disposal if is not
guaranteed that no harmful effects will occur otherwise. In case of class 3 and
4 activities, the water from sinks, showers, glass houses and animal houses
must be inactivated as well.

Portugal

In all cases, including activities at risk class 1, effluents,
residues and wastes must be inactivated prior to disposal .There were several
companies dedicated to inactivate biological waste, who operate mainly with
hospital contaminated residues, and also with GM biological waste.

Romania

In Romania, Emergency Government Ordinance 44/2007, as amended by
Law 3/2008, regulates the necessary measures on waste management. These
requirements are completed by regulations on waste from medical activities.
Emergency Government Ordinance 44/2007 as amended by Law 3/2008, requires users
of contained use of genetically modified micro-organisms to have equipment to
autoclave and inactivate waste from such activities.

Slovakia

In Slovakia, the holder of waste, who treated per year in total more
than 100 kilos, or carrier, that transports annually more than 100 kilos of
hazardous waste, shall have a waste management plan and approval from the
Competent Authority. The applicant has to declare the amount of waste material
to be produce and how the inactivation is performed. The carrier is obliged to
inactivate the waste arising from GMO installations at the place before he can transport
waste to a specialized facility. The transfer of waste from the GM installation
to the authorised waste facility is organised according to the Treaty on
International Railway Transport (COTIF) and the European Treaty on International
Road Transport of Dangerous Goods (ADR).

Slovenia

In Slovenia according to the Regulation on
risk assessment of work with genetically modified organisms in contained uses (OJ
RS 45/2004) and the Decree of waste
management (OJ RS
34/2008), the notification should submit a detailed plan for
waste treatment, inactivation procedures and final disposal of the wastes and
waste waters. The waste disposal procedure outlined in the risk assessment must
be taken into consideration by the Scientific Committee before the premises for
contained use of GMOs are registered or approved for work with GMOs. Several
waste incineration facilities were registered in Slovenia.

Spain

The treatment facilities for the waste inactivation need
authorisation from the Spanish Regional Competent Authorities. Usually
autoclaves and chemical treatments were used for GMMs, and incineration for GM
plants and animals. After waste treatment, the resulted waste was collected by certified
companies. The transfer of waste from the GM installation to the authorised
waste facility is the responsibility of the users.

Sweden

No change since the second report in
2006.

United Kingdom

In the UK the regulations that transpose Directive 2009/41/EC
require that all waste, including waste from Class 1 activities, is
“inactivated by validated means” prior to discharge/disposal. The Competent
Authority has, in consultation with stakeholders, produced guidance on this
subject. There are currently 9 registered sites authorised to inactivate waste,
three at class 1 and six at class 2. It is the waste producer’s responsibility,
in all cases, to ensure that the waste is inactivated or correctly packaged in
approved containers and labelled appropriately.

2.         ANNEX II – TABLE OF COMPETENT AUTHORITIES

Member States || Competent Authority || Other authorities involved

Austria || Federal Ministry of Education, Science and Culture (work at universities and scientific institutions) Federal Ministry of Health and Women (remaining activities) ||

Belgium || Competent authorities in the three regions (Brussels Capital, Flemish Region, Walloon Region) || SBB (Section Biosécurité et Biotechnologie) as federal advisory body

Czech Republic || Ministry of the Environment || Czech Commission for the use of GMOs and genetic products (opinion), Ministry of Agriculture and Ministry of Health (may make comments or raise objections)

Cyprus || Department of Labour Inspection (Ministry of Labour and Social Insurance) || Licensing Technical Committee (advice)

Denmark || Forest and Nature Agency (under the Environment Ministry) and Working Environment Authority (under the Employment Ministry) in collaboration ||

Estonia || Labour Inspectorate ||

Finland || Board for Gene Technology ||

France || Ministry of Research || Commission de genie génétique (Genetic Engineering Commission)

Germany || Länder authorities Competent federal authority: BVL (Federal Office for Consumer Protection and Food Safety) || Zentrale Kommission für die biologische Sicherheit (ZKBS, expert advisory body) (makes statements on classification)

Hungary || Genetic Engineering Authority (Ministry of Agriculture and Rural Development) || Genetic Engineering Advisory Board (consulted)

Ireland || Environmental Protection Agency (EPA) ||

Italy || Ministry of Health || Biotechnology Committee (positive opinion required)

Latvia || Food and Veterinary Service (Ministry of Agriculture) ||

Lithuania || Ministry of the Environment || Steering Committee on GMOs (political advisory body), Ministry of Agriculture, Ministry of Health, State Food and Veterinary Service (opinions)

Luxemburg || Ministry of Health ||

Malta || Malta Environment and Planning Authority (MEPA) || Biosafety Coordinating Committee (assessment)

Netherlands || Ministry of Housing, Spatial Planning and the Environment ||

Poland || Ministry of the Environment || Commission on GMOs (assessment)

Portugal || Institute for the Environment (Ministry of Environment, Spatial Planning and Regional Development) ||

Slovakia || Ministry of the Environment || Commission for Biological Safety (expert advisory body) (recommendation)

Slovenia || Ministry of the Environment and Spatial Planning || Scientific Committee for Work with GMOs in Containment (assistance)

Spain || Autonomous Communities Interministerial Council on Genetically Modified Organisms (activities representing a risk for human health, research programs) || National Commission on Biosafety (CNB) (evaluation, inspection, favourable or unfavourable report)

Sweden || Swedish Work Environment Authority (SWEA) ||

United Kingdom || Health and Safety Executive (HSE) ||

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