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of 25 August 1999 (as of 23 November 1999)
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in accordance with Articles 29f paragraphs 2 and 3, 29g, 38 paragraph 3, 39
paragraph 1, 41 paragraph 2, 44 paragraph 3, 46 paragraphs 2 and 3, 48 paragraph 2
and 59b of the Federal Law relating to the Protection of the Environment of 7
October 19831 (LPE)
and Articles 29c paragraphs 2 and 3 and 29d of the Law on Epidemics of 18
December 19702,
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Purpose
The purpose of this Ordinance is to protect people and the environment, in particular
communities of animals and plants and their habitats, against harmful effects or
nuisances of the contained use of organisms. This Ordinance shall also contribute to
maintaining biological diversity and soil fertility.
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Scope
1
This Ordinance regulates the contained use of organisms, in particular genetically
modified or pathogenic organisms. Placing on the market of organisms in contained
systems is regulated by Articles 4, 13 and 14 only.
2
The use of organisms in the environment is regulated by the Ordinance on the
Release of Organisms into the Environment (RO) of 25 August 19993.
3
The protection of people and the environment against serious damage resulting
from major accidents involving microorganisms is regulated by the Ordinance on
Protection Against Major Accidents of 27 February 19914.
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Ecobalance protection
4
The protection of personnel working with microorganisms is regulated by the
Ordinance on Occupational Safety in Biotechnology (SAMV) of 25 August 19995.
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Definitions
For the purposes of this Ordinance:
a.
RUJDQLVP shall mean any cellular or noncellular biological entity able to
replicate or transfer genetic material, in particular animals, plants and
microorganisms; these include mixtures and objects that contain such
entities;
b.
PLFURRUJDQLVP shall mean any microbiological entity, in particular bacteria,
algae, fungi, protozoa, viruses and viroids; these include cell cultures,
parasites, prions and biologically active genetic material;
c.
JHQHWLFDOO\PRGLILHGRUJDQLVP shall mean any organism in which the genetic
material has been altered by methods of gene technology given in Appendix
1, in a way that does not occur under natural conditions by mating or natural
recombination;
d.
FRQWDLQHG XVH shall mean any containment measure using physical barriers
or a combination of physical and chemical or biological barriers to limit or
prevent contact between organisms and people or the environment;
e.
XVH shall mean any deliberate activity using organisms, in particular,
culturing, processing, multiplication, modification, detection, transport,
storage or disposal.
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Obligation to take due care
1
Anyone involved in the contained use of organisms must take all due care to
ensure that organisms, their metabolic and waste products do not endanger people
and the environment.
2
In particular, applicable regulations and the employer’s instructions and
recommendations must be observed.
5
2
SR Containment Ordinance
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Contained use obligation
1
Genetically modified or pathogenic organisms must be used in contained systems
except when they are used in the environment in accordance with the Ordinance on
the Release of Organisms into the Environment of 25 August 19996.
2
The Federal Department of the Environment, Transport, Energy and
Communications (DETEC) can stipulate that this Ordinance or individual provisions
therein apply to further organisms which could endanger the environment or,
indirectly, people by virtue of their properties, mode of application or scale of use.
In particular, it can stipulate:
a.
to which group these organisms shall be assigned;
b.
which safety measures and other requirements shall be observed in the use of
these organisms.
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Groups of organisms
1
Organisms shall be assigned to four groups, depending on the risk they present,
according to the current state of knowledge, i.e. their harmful properties, in
particular their pathogenicity to people, animals and plants, and the probability that
these properties will be effective.
2
The groups shall be described as:
a.
Group 1: organisms that present no risk or a negligible risk;
b.
Group 2: organisms that present a low risk;
c.
Group 3: organisms that present a moderate risk;
d.
Group 4: organisms that present a high risk.
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Classes of activity
1
Activities involving organisms in contained use shall be assigned to four classes
according to the risks they present to people and the environment.
2
6
The classes shall be described as:
a.
Class 1: activities with no risk or negligible risk;
b.
Class 2: activities with low risk;
c.
Class 3: activities with moderate risk;
d.
Class 4: activities with high risk.
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Risk assessment
1
Anyone involved in the contained use of genetically modified or pathogenic
organisms must assess in advance the possible damage to people and the
environment, as well as the extent of potential damage and the probability of its
occurrence (risk assessment). The damage to be considered includes in particular:
2
a.
diseases of people, animals and plants;
b.
nuisances or harmful effects resulting from the establishment or
dissemination of organisms in the environment;
c.
nuisances or harmful effects resulting from the natural transfer of genes to
other organisms.
The risk assessment shall include:
a.
assignment of the organism used to a group according to the lists referred to
in Article 22 or on the basis of an individual assessment using the criteria
given in Appendix 2.1;
b.
clarification of whether the combination of recipient organism and vector to
be used is included in the list of biological containment systems (Art. 22);
and
c.
assessment of the proposed activity according to the criteria given in
Appendix 2.3 and its assignment to a class.
3
The risk must be reassessed if the activity is significantly revised or if significant
new findings become available.
4
For activities that expose personnel to microorganisms, a risk assessment
according to this Ordinance may be combined with a risk assessment according to
Articles 5-7 of the Ordinance on Occupational Safety in Biotechnology of 25 August
19997.
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Recording, notification and authorisation obligation
1
Anyone using genetically modified or pathogenic organisms must record the
information stipulated by Appendix 3 and:
2
a.
store it or have it stored for five years after the activity ceases;
b.
present it to enforcement authorities upon their request.
Anyone using genetically modified organisms must:
a.
7
4
notify each first class 1activity;
SR Containment Ordinance
3
4
b.
notify each class 2 activity;
c.
obtain an authorisation for each class 3 or 4 activity .
Anyone using pathogenic organisms that are not genetically modified must:
a.
notify each first class 2 activity ;
b.
have each class 3 or 4 activity authorised; authorisation for the first activity
is sufficient if the activity consists of the analysis of clinical material
(medical-microbiological diagnostics) and is not associated with research.
A first activity means:
a.
the first such activity in a particular installation;
b.
each activity in which the risk to people and the environment has
significantly changed compared with an already notified activity, in
particular when an organism with significantly different properties is used.
5
A notified activity may be commenced immediately, except when it is a first class 2
activity. Such an activity may be commenced only if the competent authority
(Art. 16):
a.
raises no objection within 45 days of the notification; or
b.
has previously declared that no objection exists.
6
Notifications and authorisation applications must be submitted to the Federal
Coordination Centre for Biotechnology (Art. 15) with the required number of
copies; these must contain the information stipulated by Appendix 3. For public
information purposes, an additional copy must be submitted which contains at least
the information required by Article 24 paragraph 5.
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Safety measures
1
Anyone involved in the contained use of genetically modified or pathogenic
organisms must apply the general safety measures for protecting people and the
environment stipulated by Appendix 4, as well as the additional safety measures
required for the type of installation and the class of activity.
2
Individual safety measures listed in Appendix 4 may be altered, substituted or
omitted if:
a.
it can be demonstrated for a particular activity that the protection of people
and the environment is nevertheless ensured; and
b.
the competent authority has approved the exception.
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Liability guarantee
1
Anyone carrying out contained use activities of classes 3 or 4 must guarantee
liability of up to 20 million Swiss francs (Art. 59a LPE).
5
2
Ecobalance protection
Guarantee of liability may be provided:
a.
by taking out a liability insurance with an insurance company authorised to
operate in Switzerland;
b.
by providing equivalent security.
3
The Federal Government, its public corporations and institutions and the cantons
shall be exempt from this liability guarantee.
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Commencement, suspension and cessation of the guarantee
1
Anyone guaranteeing liability must notify the competent office designated by the
canton in which the contained use is carried out of the commencement, suspension
and cessation of the guarantee.
2
Suspension and cessation of the guarantee shall come into effect 60 days after
receipt of the notification by the competent office designated by the canton,
provided no substitute guarantee has been brought.
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Informing the purchaser
Anyone placing on the market genetically modified, pathogenic or other potentially
harmful organisms in contained systems under Article 5, must inform the purchaser:
a.
of the properties of the organisms;
b.
whether the organisms are genetically modified;
c.
that the use of the organisms is subject to containment.
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Transport
1
Anyone transporting genetically modified or pathogenic microorganisms must
observe applicable, national and international transport regulations regarding
labelling and packaging.
2
These transport regulations apply by analogy to the transport of genetically
modified or pathogenic organisms, in particular genetically modified animals and
plants, and plant-pathogenic microorganisms.
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Federal Coordination Centre for Biotechnology
1
The Federal Government shall administer a Coordination Centre for Biotechnology
within the Swiss Agency for the Environment, Forests and Landscape (SAEFL).
2
6
The Coordination Centre shall have the following administrative duties:
Containment Ordinance
a.
it shall receive notifications and authorisation applications under Articles 9
and 10, as well as notifications according to the Ordinance on Occupational
Safety in Biotechnology (SAMV) of 25 August 19998;
b.
it shall check whether the notifications and authorisation applications are
complete and shall request any missing information;
c.
it shall forward complete notifications and authorisation applications to the
Federal Office of Public Health (FOPH), to SAEFL, to the Swiss National
Accident Insurance Organisation (SUVA), to the Swiss Expert Committee
for Biosafety (SECB), to the designated office of the Canton in which the
contained use will occur and, if requested, to the State Secretariat for
Economic Affairs (seco); in addition, it shall forward notifications and
authorisation applications of activities involving animal- or plant-pathogenic
organisms to the Federal Veterinary Office (FVO) and the Federal Office of
Agriculture (SFOA) and notifications and authorisation applications of
activities involving animals and plants to the Swiss Ethics Committee on
Non-human Gene Technology (ECNH) for their consideration;
d.
it shall announce receipt of notifications and authorisation applications in
the Federal Law Gazette and make the notifications and authorisation
applications public so long as they are not confidential;
e.
it shall monitor progress in processing the notifications and authorisation
applications received;
f.
it shall communicate the decisions of the competent authority for
notifications and authorisation applications to the applicant, to FOPH, to
SAEFL, to SUVA, to SECB, to ECNH, to the designated office of the
canton in which the contained use will occur and, where necessary, to FVO,
SFOA and seco;
g.
it shall maintain a register of all notified and authorised activities and
compile the results of enquiries covered by Article 23; the records shall not
contain confidential information, shall be available to the public and may be
published in whole or in part;
h.
it shall be the information office for enquiries about:
1. the course and state of notification and authorisation procedures,
2. forms, guidelines and international standards, as well as contact
addresses within the federal administration,
3. lists of classified organisms and biological containment systems.
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Competent authorities
Decisions relating to activities requiring notification or authorisation shall be taken
by:
a.
8
FOPH in agreement with SAEFL, when the risk is primarily to people;
SR 7
Ecobalance protection
b.
SAEFL in agreement with FOPH and SFOA, for activities involving plantpathogenic organisms;
c.
SAEFL in agreement with FOPH, for all other activities.
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Notification procedure
1
The competent authorities shall examine whether the risk assessment has been
carried out correctly and in particular, whether the proposed activity has been
assigned to the correct class, taking into account statements expressed by FVO,
SFOA and the designated office of the canton in which the contained use will occur.
In particular, the SECB shall be consulted where necessary.
2
If examination of the risk assessment requires the submission of further
information, the 45-day waiting period before commencement of the activity shall be
extended accordingly.
3
The competent authority may prohibit an activity if there is reason to believe that
the risk assessment has not been carried out correctly and, in particular, if the
proposed activity has not been assigned to the correct class. The competent authority
shall communicate its decision to the Federal Coordination Centre for
Biotechnology.
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Authorisation procedure
1
The competent authorities shall examine whether the risk assessment has been
correctly carried out and, in particular, whether the proposed activity has been
assigned to the correct class, taking into account statements received, in particular,
those from SECB, FVO, SFOA and the designated office of the canton in which the
contained use will occur.
2
The competent authority shall issue a permit for a first activity no later than 90
days as a rule, and for a subsequent activity no later than 45 days, after examination
of the application begins. An authorisation shall be valid for five years.
3
If examination of the risk assessment requires the submission of further
information, the periods shall be extended accordingly.
4
The competent authority shall communicate its decision to the Federal
Coordination Centre for Biotechnology.
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1
Authorisations for the alteration, substitution or omission of
particular safety measures
The competent authority shall issue a permit for the proposed divergence from
particular safety measures, under the conditions required by Article 10 paragraph 2,
no later than 90 days as a rule after examination of the application begins. The
authority shall take into account statements received, in particular, those from
SUVA, SECB and the designated office of the canton in which the contained use
will occur.
8
Containment Ordinance
2
If examination of the application requires the submission of further information,
the period shall be extended accordingly.
3
The competent authority shall communicate its decision to the Federal
Coordination Centre for Biotechnology.
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1
The cantonal authorities shall monitor observance of the obligation to take due
care, the contained use obligation and the safety measures.
2
Further they shall monitor by spot checks whether:
a.
the records required by Article 9 paragraph 1 have been properly kept and
preserved;
b.
the descriptions of the organisms to be used and the activity given in a
notification or an authorisation application accurately describe the organisms
actually used and the activity being carried out;
c.
a significant change in the proposed activity has been made such that the risk
assessment must be repeated (Art. 8 para. 3);
d.
the required liability is guaranteed.
3
If the monitoring requires samples, detection methods or materials as evidence,
they shall be provided to the cantonal authorities without charge.
4
If the results of monitoring give cause for complaint, the cantonal authorities shall
stipulate the measures to be undertaken and inform the Federal Coordination Centre
for Biotechnology.
5
If there is cause to suspect that an activity which was only recorded is actually
notifiable or requires authorisation, the cantonal authorities shall report this to the
Federal Coordination Centre for Biotechnology.
6
The cantonal authorities coordinate as far as possible the monitoring based on
these and other regulations.
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Responsibility for monitoring transport of genetically modified or pathogenic
organisms as well as for stipulating appropriate measures shall be in accordance with
the applicable transport regulations.
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Ecobalance protection
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Lists of classified organisms and biological containment systems
1
SAEFL, in agreement with FOPH, seco, FVO, SFOA and SUVA and after
consulting SECB, shall maintain a publicly available list in which:
2
a.
organisms are assigned to four groups according to the criteria given in
Appendix 2.1; and
b.
biological containment systems are given that meet the specifications listed
in Appendix 2.2.
It shall take into account existing lists, in particular those of the European Union.
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Inquiries
1
SAEFL may carry out inquiries into activities involving the contained use of
genetically modified and pathogenic organisms, in particular about the nature,
number and duration of these activities.
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Confidentiality
1
The authorities responsible for the enforcement of this ordinance shall treat
information as confidential for which there are grounds for confidentiality. They
shall classify this information as such when forwarding it to other authorities.
2
In particular, the protection of business and production secrets are grounds for
confidentiality.
3
Anyone submitting documents to the authorities must:
a.
indicate information which is confidential; and
b.
give the grounds for confidentiality.
4
An authority which does not wish to accede to a request for confidentiality shall
investigate whether the grounds given for confidentiality are justifiable. If their
assessment differs from the proposal of the persons supplying the information, the
authorities, after consultation with the notifier, shall inform the notifier by order
which information they do not find worthy of protection.
5
The following information shall in no case be confidential:
10
a.
the names of those responsible for carrying out the activity and for
monitoring of biosafety;
b.
the address of the institution and its installation (site of the activity);
c.
the type of installation, safety measures and waste disposal measures;
d.
a general description of the organisms and their properties;
e.
a general description of the activity, in particular the purpose and the
approximate scale (e.g. culture volume);
Containment Ordinance
f.
a summary of the risk assessment;
g.
the class of the activity.
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Obligation
1
Anyone using the services of the Federal Coordination Centre for Biotechnology,
SAEFL or FOPH or instigating the issue of orders from SAEFL or FOPH must pay a
fee. Expenses shall be charged separately.
2
Where several persons share a service, they are jointly liable to the fee.
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Scale of fees
1
DETEC in agreement with the Federal Department of Home Affairs shall set fees
for the following services:
2
a.
examination of notifications and authorisation applications under Article 9
paragraphs 2 and 3;
b.
examination of authorisation applications under Article 10 paragraph 2.
It shall set the fee:
a.
per hour for services without a set fee;
b.
per page for written work.
3
The fee for examination of repeated applications may be up to 50 percent of the set
fee.
4
Services without a set fee will be charged according to time invested.
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Expenses
Expenses shall mean the additional costs arising during provision of individual
services, in particular:
9
a.
honoraria according to the Ordinance of 12 December 19969 on the
Remuneration of Members of Extraparliamentary Commissions;
b.
costs arising from hearings, scientific investigations, special tests or the
procurement of documents;
c.
international postage and telephone charges;
d.
travel and transport costs;
e.
costs of tasks delegated to third parties by the Federal Coordination Centre
for Biotechnology, FOPH or SAEFL.
SR 11
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1
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Settlement
Payment shall be due:
a.
30 days after issue of an invoice to the party liable;
b.
with the final ruling in case of dispute.
The period allowed for payment shall be 30 days after the due date.
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1
SAEFL may issue guidelines on the enforcement of this ordinance if required, in
particular with respect to risk assessment and safety measures and their quality
assurance, after consulting FOPH, seco, SUVA, SECB and the cantonal authorities.
2
SAEFL, jointly with FOPH, shall ensure that training and further education events
are organised periodically for people who carry out tasks according to this
ordinance.
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Transitional provisions
1
Notifiable activities involving genetically modified or pathogenic organisms and
those requiring authorisation may be carried out without notification or
authorisation until 31 October 2000.
2
Installations which were subject to the Ordinance on Protection Against Major
Accidents of 27 February 199110 (as of 31 October 1999) prior to the present
ordinance coming into force may carry out activities using genetically modified or
pathogenic microorganisms until 31 October 2002, without:
a.
resort to the safety measures required by Article 10 so long as the safety
measures laid down in the Ordinance on Protection Against Major Accidents
(as of 31 October 1999) are observed;
b.
guarantee of liability.
3
Activities involving all other genetically modified organisms of classes 1 and 2
may be carried out until 31 October 2001 without resort to the safety measures
required by Article 10 so long as the safety measures contained in the guidelines of
18 September 199511 by the Swiss Interdisciplinary Committee for Biosafety in
Research and Technology are observed.
4
Activities involving all other not genetically modified, pathogenic organisms
assigned to class 2 and initiated prior to the coming into force of the Ordinance on
10
11
12
SR Available from: SAEFL, 3003 Bern
Containment Ordinance
the Contained Use of Organisms may be carried out until 31 October 2001 without
resort to the safety measures required by Article 10.
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Entry into force
This Ordinance shall enter into force on 1 November 1999.
13
Ecobalance protection
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(Art. 3c)
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1
Methods of gene technology include, in particular:
a.
recombinant nucleic acid techniques, in which nucleic acid molecules
synthesised outside the organism are inserted into viruses, bacterial plasmids
or other vector systems to produce novel combinations of genetic material,
which are then transferred to a recipient (host) organism in which they
would not naturally occur but are capable of continued propagation;
b.
techniques in which genetic material produced outside the organism is
inserted directly into an organism, in particular by microinjection,
macroinjection and microencapsulation, electroporation or on
microprojectiles;
c.
cell fusion or hybridisation techniques in which cells with novel
combinations of genetic material are produced by the fusion of two or more
cells through processes that do not occur under natural conditions.
2
Self-cloning of pathogenic organisms shall be regarded as a method of gene
technology. This consists of the removal of nucleic acid sequences from one cell of
an organism and the complete or partial insertion of this nucleic acid or a synthetic
equivalent (possibly after a previous enzymatic or mechanical treatment) into cells
of the same species or cells which are closely related phylogenetically and which can
exchange genetic material by natural physiological processes.
3
Self-cloning of non-pathogenic organisms and the following methods shall not be
regarded as methods of gene technology, so long as they are not used in association
with recombinant nucleic acid molecules or genetically modified organisms:
14
a.
mutagenesis
b.
cell and protoplast fusion of prokaryotic microorganisms that exchange
genetic material by natural physiological processes;
c.
cell and protoplast fusion of eukaryotic cells, including the production of
hybridoma cell lines and the fusion of plant cells;
d.
in vitro fertilisation;
e.
natural processes such as conjugation, transduction and transformation;
f.
changes in ploidy level, including aneuploidy and the elimination of
chromosomes.
Containment Ordinance
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(Art. 6, 8 para. 2a und 22 para. 1a)
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1
The assignment of organisms to a group shall be based in particular on the
following criteria:
a.
pathogenicity and lethality;
b.
virulence or attenuation;
c.
mode of infection, effective infection dose and the infection route;
d.
production of noncellular components such as toxins and allergens;
e.
the reproductive cycle and survival structures;
f.
host range;
g.
the degree of natural or acquired immunity of the host;
h.
pattern of resistance or sensitivity to antibiotics and other specific agents;
i.
availability of appropriate prophylaxis and therapy;
j.
the presence of oncogenic nucleic acid sequences;
k.
the shedding of viruses in the case of cell lines;
l.
parasitic properties.
2
If it is unclear to which of two groups an organism belongs, it shall be assigned to
the higher group.
3
Plants and animals, with the reservation expressed in Article 5 paragraph 2, shall
belong to group 1.
15
Ecobalance protection
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(Art. 22 para. 1b)
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1
A combination of host and vector shall be recognised as a biological containment
system if the host organism and the vector meet the following conditions.
2
3
The host organism:
a.
must be characterised scientifically and classified taxonomically;
b.
must require conditions for its replication that never or seldom occur outside
the contained system;
c.
must not be pathogenic or display properties that might endanger people and
the environment in another way;
d.
must show no or negligible horizontal gene exchange with animal- or plantassociated organisms.
The vector:
16
a.
must have genetic material which has been extensively characterised;
b.
must have a very high host specificity;
c.
must, especially in the case of vectors for bacteria and fungi, have no
transfer system, a low rate of cotransfer and low mobilisation;
d.
must, in the case of viral vectors for eukaryotic cells, show no independent
infectivity and only a low transfer rate by endogenous helper viruses;
e.
must, in the case of viral vectors, be unable to regain infectivity or
replication ability through recombination.
Containment Ordinance
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(Art. 8 para. 2c)
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1
Where an activity involves only naturally occurring organisms which will not
become genetically modified, the class of the activity shall as a rule correspond to
the group of the organism. Where several organisms from different groups are
involved, the class of the activity shall correspond to the group of the organism
presenting the highest risk.
2
The class of the activity may deviate from the group of the organism involved
based in particular on the following criteria:
3
a.
nature, extent and purpose of the activity;
b.
potential for survival, replication and dissemination of the organism in the
environment, in particular selective advantage and the formation of
structures for survival or dormancy;
c.
interaction with other organisms in the environment or involvement in
biogeochemical processes.
The following activities shall as a rule be assigned to class 1:
a.
analyses of samples of soil, water, air and foodstuffs unless these activities
are associated with an enhanced risk to people and the environment;
b.
activities using certain strains of group 2 organisms as long as available
experimental data or long-term experience have shown them to be as safe as
group 1 organisms;
c.
activities using not genetically modified organisms which are pathogenic for
plants, fungi or lichens, if they meet the conditions given in Appendix 2 of
the Ordinance on the Release of Organisms into the Environment (RO) of 25
August 199912.
4
Analyses of clinical material (medical-microbiological diagnostics) shall as a rule
be assigned to class 2. If pathogenic organisms of group 3 are cultured for diagnostic
purposes and this is associated with an enhanced risk to people and the environment,
the activity shall be assigned to class 3. Activities involving group 4 organisms are
in all cases to be assigned to class 4.
12
SR 17
Ecobalance protection
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1
Where organisms are genetically modified or where genetically modified
organisms are used, the risk of the activity shall be assessed in particular on the basis
of the following components:
2
a.
donor and recipient organism;
b.
genetic material introduced (inserts);
c.
vector or vector-recipient system;
d.
genetically modified organism.
In particular, the following criteria shall be taken into account:
a.
nature, extent and purpose of the activity;
b.
function of the genetic modification;
c.
degree of purity and characterisation of the genetic material used for
recombination;
d.
for vectors: the host specificity, presence of a transfer system, mobilisation
potential, independence of infectivity;
e.
stability and expression of the recombinant genetic material;
f.
mobilisation potential of the recombinant genetic material;
g.
selection pressure for the recombinant genetic material;
h.
techniques for detecting, identifying and monitoring recombinant genetic
material;
i.
geographic spread, interaction with other organisms or involvement in
biogeochemical processes resulting from the genetic modification;
j.
known or assumed spread of the recombinant genetic material in the
environment through sexual reproduction or horizontal gene transfer;
k.
potential for survival, replication and dissemination of the genetically
modified organism in the environment, in particular the formation of
structures for survival or dormancy;
l.
potential for regeneration of eukaryotic cells to higher organisms.
3
An activity shall be assigned to class 1 when there is no or a negligible risk to
people and the environment, in particular when:
18
a.
donor and recipient organisms belong to group 1 or are strains of organisms
from higher groups as long as available experimental data or long-term
experience have shown them to be as safe as group 1 organisms;
b.
vectors are considered safe on the basis of long-term experience or are an
accepted part of a biological containment system;
c.
the genetically modified organism fulfils the specifications of a group 1
organism and does not itself yield organisms of a higher group; and
Containment Ordinance
d.
the recipient organisms are not eukaryotic cells with the potential to
regenerate spontaneously to higher organisms.
4
An activity shall be assigned to class 2 if the risk to people and the environment is
low, in particular if:
a.
donor and recipient organisms belong to group 2;
b.
viral vectors are transferable horizontally;
c.
the genetically modified organism fulfils the specifications of a group 2
organism;
d.
the genetically modified organism itself does not yield organisms of a higher
group;
e.
escape of the organism from the contained system would lead to an effect on
people and the environment which is reversible and restricted in both
duration and area.
5
An activity shall be assigned to class 3 if the risk to people and the environment is
moderate, in particular if:
a.
donor and recipient organisms belong to group 3;
b.
the genetically modified organism fulfils the specifications of a group 3
organism;
c.
the genetically modified organism itself does not yield organisms of group 4;
d.
escape of the organism from the contained system would lead to an effect on
people and the environment which is irreversible but restricted in area.
6
An activity shall be assigned to class 4 if the risk to people and the environment is
high, in particular if:
a.
group 4 organisms, in particular intact viruses or defective viruses of group 4
in the presence of helper viruses, are used;
b.
the genetically modified organism fulfils the specifications of a group 4
organism;
c.
escape of the organism from the contained system would lead to an
irreversible effect on people and the environment;
d.
escape of the organism from the contained system could lead to an epidemic
with serious consequences for people, animals or plants.
19
Ecobalance protection
$SSHQGL[
(Art. 9)
,QIRUPDWLRQUHTXLUHGLQWKHUHFRUGLQJDQGQRWLILFDWLRQRI
DFWLYLWLHVDQGIRUDXWKRULVDWLRQDSSOLFDWLRQV
1RWH
The documentation must clearly show which information is to be treated as
confidential. Justification for the requested confidentiality must be given (Art. 24).
,QIRUPDWLRQIRUFODVVDFWLYLWLHV
5HVSRQVLEOHSHUVRQV
a.
Name(s) and qualification(s) of the person(s) responsible for the activity;
b.
name(s) and qualification(s) of the person(s) responsible for biosafety.
,QVWLWXWLRQDQGLQVWDOODWLRQ
a.
Address of the institution and the installation (site of activity);
b.
type of installation;
c.
safety measures;
d.
types of waste and their disposal.
20
$FWLYLW\
a.
Identity and properties of the donor and recipient organisms and the genetic
material;
b.
description of the activity, including the purpose and the approximate scale;
c.
expected duration of the activity.
Containment Ordinance
5LVNDVVHVVPHQW
a.
A comprehensible record of the risk assessment as required by Article 813;
b.
the class of activity.
,QIRUPDWLRQIRUFODVVDFWLYLWLHV
5HVSRQVLEOHSHUVRQV
a.
Name(s) and qualification(s) of the person(s) responsible for the activity;
b.
name(s) and qualification(s) of the person(s) responsible for biosafety.
,QVWLWXWLRQDQGLQVWDOODWLRQ
a.
Address of the institution and the installation (site of activity);
b.
type of installation;
c.
safety measures;
d.
types of waste and their disposal.
$FWLYLW\
a.
Identity, properties and source of the organisms and the genetic material;
b.
for genetically modified organisms: the proposed recipient or donor
organism and, if applicable, the host-vector system;
c.
description of the activity, including its purpose and the results expected;
d.
approximate liquid culture volume;
e.
expected duration of the activity.
13
14
5LVNDVVHVVPHQW
a.
A comprehensible record of the risk assessment as required by Article 814;
b.
the class of activity.
A summary of the risk assessment is sufficient in the case of a notification.
A summary of the risk assessment is sufficient in the case of a notification.
21
,QIRUPDWLRQIRUFODVVDQGDFWLYLWLHV
5HVSRQVLEOHSHUVRQV
a.
Name(s) and qualification(s) of the person(s) responsible for the activity;
b.
name(s) and qualification(s) of the person(s) responsible for biosafety.
,QVWLWXWLRQDQGLQVWDOODWLRQ
a.
Address of the institution and the installation (site of activity);
b.
type of installation;
c.
safety measures;
d.
types of waste and their disposal;
e.
confirmation of the liability guarantee.
$FWLYLW\
a.
Identity, properties and source of the organisms and the genetic material;
b.
for genetically modified organisms: the proposed recipient or donor
organism and, if applicable, the host-vector system;
c.
description of the activity, including its purpose and the results expected;
d.
approximate liquid culture volume;
e.
expected duration of the activity.
22
Ecobalance protection
5LVNDVVHVVPHQW
a.
A comprehensible record of the risk assessment as required by Article 8;
b.
the class of activity.
Containment Ordinance
,QIRUPDWLRQUHTXLUHGIRUWKHDQDO\VLVRIFOLQLFDOPDWHULDO
PHGLFDOPLFURELRORJLFDOGLDJQRVWLFV
5HVSRQVLEOHSHUVRQV
a.
Name(s) and qualification(s) of the person(s) responsible for the activity;
b.
name(s) and qualification(s) of the person(s) responsible for biosafety.
,QVWLWXWLRQDQGLQVWDOODWLRQ
a.
Address of the institution and the installation (site of activity);
b.
type of installation;
c.
safety measures;
d.
types of waste and their disposal;
e.
confirmation of the liability guarantee for class 3 and 4 activities.
1DPHGHVFULSWLRQDQGJURXSRIWKHRUJDQLVPVWREH
DQDO\VHG
$FWLYLW\
a.
Description of the analytical methods to be used in case of group 3 or 4
organisms;
b.
justification for the assignement of the activity to a class.
23
Ecobalance protection
$SSHQGL[
(Art. 10)
6DIHW\PHDVXUHV
*HQHUDOVDIHW\PHDVXUHV
The following safety measures apply to all types of activity:
a.
compliance with the installation’s biosafety concept and the associated
instructions and codes of behaviour;
b.
employment of at least one person to monitor biosafety, who has sufficient
knowledge of both technical and safety matters to be able to carry out the
assignment;
c.
employment of sufficient personnel adequately trained in safety matters;
d.
compliance with the principles of good microbiological practice as given in
Appendix 3 section 1 paragraph 1 of the Ordinance on Occupational Safety
in Biotechnology (SAMV) of 25 August 199915, including the provision of
washing and decontamination facilities for personnel;
e.
adequate control and servicing of the monitoring systems and equipment;
f.
as necessary, testing for the presence of viable representatives of the applied
organism outside of the primary physical barriers;
g.
use of appropriate storage facilities for apparatus and materials which may
be contaminated;
h.
provision of effective disinfectant agents and methods in case of
contamination.
$GGLWLRQDOVDIHW\PHDVXUHV
1
In addition to the general safety measures, measures of safety levels 1-4
appropriate to the type of installation and class of activity are to be applied:
a.
as given in Table 1 for activities in research and development laboratories;
b.
as given in Table 2 for activities in growth rooms and greenhouses;
c.
as given in Table 3 for activities in animal units;
d.
as given in Table 4 for activities in production plants.
2
Each safety measure must be at the level of the latest developments in safety
technology.
15
24
SR Containment Ordinance
7DEHOOH
$GGLWLRQDOVDIHW\PHDVXUHVIRUDFWLYLWLHVLQUHVHDUFKDQGGHYHORSPHQW
ODERUDWRULHVDQGIRUWKHDQDO\VLVRIFOLQLFDOPDWHULDO
/HJHQGH
+ means that the measure is required,
– means that the measure is not required.
6DIHW\PHDVXUH
6DIHW\OHYHO
1
2
3
4
+
+
+
+
+
+
+
+
+
+
No.
%XLOGLQJ
1
2
–
–
–
–
3
4
Separate work area 16
Work area sealable to allow
fumigation
Biohazard warning sign
Restricted entry to the work area
–
–
+
+
5
Entry to work area via airlock 18
–
–
17
17
6
7
8
16
17
18
19
20
Observation window or other means
of observing the work area
–
Work area under air pressure negative
to atmosphere
–
Air supply to the work area and the
exhaust to pass through a HEPA
filter 19
–
–
+
+
17
–
+
+
17
–
+
+
17
(exhaust)
(supply and
exhaust)20
in a separate building or separated from other areas in the same building
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
Airlock: entry must be through a room separated from the controlled laboratory area. The
clean side of the lock must be separated from the other side by facilities for changing
clothing and showering and preferably by a lockable door.
HEPA = high efficiency particulate air
Further measures are required for the exhaust air when viruses are used which are not
retained by the HEPA filter.
25
Ecobalance protection
6DIHW\PHDVXUH
6DIHW\OHYHO
1
Nr.
(TXLSHPHQW
9
Surfaces resistant to acids, alkalis,
solvents and disinfectants
10
11
2
3
4
+
+
+
+
(bench)
(bench)
(bench and
floor)
(bench, floor,
ceiling and
walls and
floor)
Working area with complete,
independent equipment
–
–
+
+
Biological safety cabinet
–
21
+
+
+
21
12
13
Measures against aerosol formation
and dissemination
Autoclave
14
Shower facility
15
Special clothing for the work area
–
+
+
+
(minimise
aerosols)
(prevent
aerosols)
(prevent
aerosols)
+
+
+
+
(available)
(in building)
–
–
(in
(pass-through
laboratory)22 autoclave in
laboratory)
+
21
+
:RUNLQJSURFHGXUHV
16
Gloves
+
+
+
+
(laboratory
clothing)
(laboratory
clothing)
(suitable
preotective
clothing and,
if necessary,
shoes)
(complete
change of
clothing and
shoes before
entering and
leaving )
+
+
+
+
+
+
+
–
23
17
18
Regular disinfection of the work place
Inactivation of microorganisms in the
effluent of sinks, pipes and showers
–
–
+
–
19
Inactivation of microorganisms in
contaminated material and waste, and
on contaminated equipment
–
+
21
22
23
26
21
+
+
(harmless
disposal)
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
or outside the laboratory in the controlled area using validated procedures, that enable the
secure transfer of contaminated material to an autoclave outside the laboratory, and
guarantee the appropriate safety level
required when skin contact with the organisms is unavoidable
Containment Ordinance
7DEOH
$GGLWLRQDOVDIHW\PHDVXUHVIRUDFWLYLWLHVLQJURZWKURRPVDQGJUHHQKRXVHV
A growth room or a greenhouse is here understood to be a building with walls, roof
and floor built and used primarily for cultivating plants in a controlled and protected
environment.
.H\
+ means that the measure is required,
– means that the measure is not required.
6DIHW\PHDVXUHV
6DIHW\OHYHO
1
2
3
4
Nr.
%XLOGLQJ
1
Solid construction with a waterproof
roof and self-closing, lockable doors
Separate work area 24
Work area sealable to allow
fumigation
Biohazard warning sign
Restricted entry to the work area
Entry to work area via a separate
room with two lockable doors
–
+
+
+
–
–
–
–
+
+
+
+
–
–
–
+
+
+
+
+
+
+
+
+
25
25
Observation window or other means
of observing the work area
–
Work area under air pressure negative
to atmosphere
–
Air supply to the work area and the
exhaust to pass through a HEPA
filter 26
–
2
3
4
5
6
7
8
9
24
25
26
27
–
25
+
+
25
–
+
(minimise
escape of
organisms)
25
+
–
+
+
(minimise
escape of
organisms)
25
(supply and
exhaust) 27
(exhaust)
in a separate building or separated from other areas in the same building
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
HEPA = high efficiency particulate air
Further measures are required for the exhaust air when viruses are used which are not
retained by the HEPA filter.
27
Ecobalance protection
6DIHW\PHDVXUHV
6DIHW\OHYHO
1
Nr.
(TXLSPHQW
10
Surfaces resistant to acids, alkalis,
solvents and disinfectants
11
12
13
14
15
2
3
4
+
+
+
+
(bench)
(bench)
(bench and
floor)
(bench, floor,
ceiling and
walls)
Working area with complete,
independent equipment
–
–
+
+
Biological safety cabinet for work
with microorganisms
–
Measures against aerosol formation
and dissemination
–
Autoclave
Shower facility
28
+
+
+
28
+
+
+
(minimise
aerosols)
(prevent
aerosols)
(prevent
aerosols)
+
+
+
+
(available)
(in building)
–
–
(in
(pass-through
laboratory)29 autoclave in
laboratory)
+
+
28
:RUNLQJSURFHGXUHV
16
Special clothing for the work area
17
Gloves
+
+
+
+
(laboratory
clothing)
(laboratory
clothing)
(suitable
preotective
clothing and,
if necessary,
shoes)
(complete
change of
clothing and
shoes before
entering and
leaving)
+
+
+
–
30
18
19
Regular disinfection of the work place
Contaminated waste water
20
Inactivation of microorganisms in the
effluent of sinks, pipes and showers
28
29
30
28
–
–
+
+
+
+
+
+
(minimise)
(minimise)
(prevent)
(prevent)
–
–
+
+
28
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
or outside the laboratory in the controlled area using validated procedures, that enable the
secure transfer of contaminated material to an autoclave outside the laboratory, and
guarantee the appropriate safety level
required when skin contact with the organisms is unavoidable
Containment Ordinance
6DIHW\PHDVXUHV
6DIHW\OHYHO
1
2
3
4
-
+
+
+
Nr.
:RUNLQJSURFHGXUHV
21
Inactivation of microorganisms in
contaminated material and waste, and
on contaminated equipment
(harmless
disposal)
Escape of organisms during transport
between different work areas
+
+
+
+
(minimise)
(minimise)
(prevent)
(prevent)
+
+
+
+
22
23
Measures against pests and vermin
7DEOH
$GGLWLRQDOVDIHW\PHDVXUHVIRUDFWLYLWLHVLQDQLPDOXQLWV
Animal unit is understood here to mean a building or a work area within a building
which houses animal rooms and laboratories as well as ancillary rooms and
equipment, such as changing rooms, showers, autoclaves and feed-storage rooms.
.H\
+ means that the measure is required,
– means that the measure is not required.
6DIH\PHDVXUH
6DIHW\OHYHO
1
2
3
4
Nr.
%XLOGLQJ
1
Isolation of animal unit
+
+
+
+
2
Animal rooms separated by lockable
doors 31
+
+
+
+
3
Animals rooms with easily cleanable
floors and walls
4
5
6
31
32
+
+
+
+
(floor)
(floor)
(floor and
walls)
(floor and
walls)
Work area sealable to allow
fumigation
–
–
+
+
Biohazard warning sign
Restricted entry to the work area
–
–
32
+
+
+
+
+
+
Rooms in which breeding or experimental animals are normally kept
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
29
Ecobalance protection
6DIH\PHDVXUH
Nr.
7
6DIHW\OHYHO
1
2
–
–
3
4
+
+
%XLOGLQJ
Entry to work area via airlock 33
32
8
9
10
Observation window or other means
of observing the work area
–
Work area under air pressure negative
to atmosphere
–
Air supply to the work area and the
exhaust to pass through a HEPA
filter 34
–
–
+
+
32
–
+
(minimise
escape of
organisms)
32
+
–
+
+
(minimise
escape of
organisms)
35
(supply and
exhaust) 36
(exhaust)
(TXLSHPHQW
11
12
13
14
15
16
33
34
35
36
37
30
Working surfaces resistant to acids,
alkalis, solvents and disinfectants
+
+
(bench)
(bench)
Working area with complete,
independent equipment
–
–
Biological safety cabinet for work
with microorganisms
–
Cages, stalls or containers, suitable
for keeping animals, which are easy to
decontaminate (e.g. cages made of
waterproof material)
Filter on isolation chambers or
isolation rooms37
Measure against aerosol formation
and dissemination
+
+
(bench and (bench, floor,
floor)
ceiling and
walls)
+
+
35
+
+
+
+
+
35
+
(cleanable)
–
+
(sterilisable) (sterilisable) (sterilisable)
+
+
+
35
–
+
+
+
(minimise
aerosls)
(prevent
aerosls)
(prevent
aerosols)
Airlock = entry must be through a room separated from the controlled laboratory area.
The clean side of the lock must be separated from the other side by facilities for changing
clothing and showering and preferably by a lockable door.
HEPA = high efficiency particulate air
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
Further measures are required for the exhaust air when viruses are used which are not
retained by the HEPA filter.
Isolation chamber = transparent container in which animals can be kept inside or outside
a cage; isolation rooms may be necessary for larger animals
Containment Ordinance
6DIH\PHDVXUH
6DIHW\OHYHO
1
Nr.
(TXLSHPHQW
17
Autoclave
18
Shower facility
2
+
+
(available)
(in building)
–
–
3
4
+
+
(in
(pass-through
laboratory)38 autoclace in
in laboratory)
+
+
35
:RUNLQJSURFHGXUHV
19
20
Special clothing for the work area
Gloves
+
+
(laboratory
clothing)
(laboratory
clothing)
–
+
+
+
(suitable
(complete
protective
change of
clothing and, clothing and
if necessary, shoes before
shoes)
entering and
leaving)
+
+
+
+
+
+
39
21
22
Regular disinfection of the work place
Inactivation of microorganisms in the
effluent of sinks, pipes and showers
–
–
+
–
23
Inactivation of microorganisms in
contaminated material and waste, and
on contaminated equipment
–
+
38
39
40
40
+
+
(harmless
disposal)
or outside the laboratory in the controlled area using validated procedures, that enable the
secure transfer of contaminated material to an autoclave outside the laboratory, and
guarantee the appropriate safety level
required when skin contact with the organisms is unavoidable
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
31
Ecobalance protection
7DEOH
$GGLWLRQDOVDIHW\PHDVXUHVIRUDFWLYLWLHVLQSURGXFWLRQSODQWV
.H\
+ means that the measure is required,
– means that the measure is not required.
6DIHW\PHDVXUH
6DIHW\OHYHO
1
2
3
4
+
+
+
+
+
+
42
42
+
+
–
+
+
+
Nr.
%XLOGLQJ
1
2
Separate work area 41
Work area sealable to allow
fumigation
–
–
3
4
5
Biohazard warning sign
Restricted entry to the work area
Entry to work area via airlock 43
–
–
–
+
+
+
42
6
7
8
Observation window or other means
of observing the work area
–
Work area under air pressure negative
to atmosphere
–
Air supply to the work area and the
exhaust to pass through a HEPA
filter 44
–
–
+
+
42
–
+
+
42
–
+
+
(exhaust)
(exhaust and
supply)45
+
42
(supply)
9
41
42
43
44
45
32
Microorganisms must be held in a
primary closed system that physically
separates the process from the rest of
the work area
–
+
+
+
in a separate building or separated from other areas in the same building
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
Airlock = entry must be through a room separated from the controlled laboratory area.
The clean side of the lock must be separated from the other side by facilities for changing
clothes and showering and preferably by a lockable door.
HEPA = high efficiency particulate air
Further measures are required for the exhaust air when viruses are used which are not
retained by the HEPA filter.
Containment Ordinance
6DIHW\PHDVXUH
6DIHW\OHYHO
1
Nr.
%XLOGLQJ
10
The primary closed system must be
located within the controlled working
area
The working area must be so
constructed that spillage of the total
contents of the primary closed system
is contained
Monitoring of exhaust gases from the
primary closed system
11
12
13
Ventilation of the working area
should reduce contamination to a
minimum
–
2
3
4
+
+
+
+
+
46
+
–
–
+
+
+
+
(minimise
escape of
organisms)
(prevent
escape of
organisms)
(prevent
escape of
organisms)
+
+
+
46
46
(TXLSHPHQW
14
15
16
Surfaces resistant to acids, alkalis,
solvents and disinfectants
+
+
+
+
(bench)
(bench)
(bench and
floor)
(bench, floor,
ceiling and
walls)
Working area with complete,
independent equipment
–
–
+
+
Biological safety cabinet
–
46
+
+
+
46
17
18
19
46
47
Measures against aerosol formation
and dissemination
Autoclave
Seal requirements
–
+46
+
+
(minimise
aerosols)
(prevent
aerosols)
(prevent
aerosols)
+
+
+
+
(available)
(in building)
–
(in
(pass-throug
laboratory) 47 autoclave in
laboratory)
+
+
+
(minimise
escape of
organisms)
(prevent
escape of
organisms)
(prevent
escape of
organisms)
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
or outside the laboratory in the controlled area using validated procedures, that enable the
secure transfer of contaminated material to an autoclave outside the laboratory, and
guarantee the appropriate safety level
33
Ecobalance protection
6DIHW\PHDVXUH
6DIHW\OHYHO
1
Nr.
:RUNLQJSURFHGXUH
20
Special clothing for the work area
21
Shower on leaving the work area
2
3
4
+
+
+
+
(laboratory
clothing)
(laboratory
clothing)
(suitable
protective
clothing and,
if necessary,
shoes)
(complete
change of
clothing and
shoes before
entering and
leaving)
–
–
+
+
48
22
Gloves
–
+
+
+
+
+
+
+
+
+
(minimise
escape of
organisms)
(prevent
escape of
organisms)
(prevent
escape of
organisms)
–
+
+
+
–
–
+
+
49
23
24
25
26
27
48
49
34
Regular disinfection of the work place
Prevention of aerosols when taking
samples or when adding or removing
material from the primary closed
system
Inactivation of large volumes of
culture medium prior to its removal
from the primary closed system
Inactivation of microorganisms in the
effluent of sinks, pipes and showers
Inactivation of microorganisms in
contaminated material and waste, and
on contaminated equipment,
including the process solution before
the final delivery
–
–
48
–
+
+
(harmless
disposal)
These measures may be altered, substituted or omitted with the permission of the
competent authority (Art. 19).
required when skin contact with the organisms is unavoidable
+
Containment Ordinance
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1. Ordinance of 1 October 198850 on Environmental Impact Assessment
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2. Ordinance on Protection Against Major Accidents of 27 February 199151
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SR . The change given below is inserted in the mentioned ordinance mentioned.
SR . The changes given below are inserted in the ordinance mentioned.
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Ecobalance protection