Contained use of Genetecally Modified Micro-organisms Act
Scope of application of Act
(1) This Act regulates the contained use of genetically
modified micro-organisms, with the purpose of safeguarding the employees’ health
and the environment.
(2) This Act
shall not be applied on use, preservation, storage or providing the harmlessness
of genetically modified micro-organisms released into the environment or
marketed that are regulated by the “Release of Genetically Modified Organisms
Into Environment Act” (RT I 1999, 10, 151; 2001, 23, 130).
Definitions used in Act
purposes of this Act:
“micro-organism” shall mean the microbiological forms of being, capable of
multiplying or transferring genetic factors, including viruses, viroids, as well
as cell cultures of animal and plant origin;
“genetically modified micro-organism” shall mean the micro-organism with genetic
material altered in a way that is not available in the nature (hereinafter GMMO);
modification” shall mean the activity where at least one method of modification
is used for the purposes of §3 of the “Release of Genetically Modified Organisms
Into Environment Act”;
use” shall mean the activity, during which micro-organisms are genetically
modified or GMMOs are cultivated, stored, made harmless or used in another
manner, by applying measures preventing the endangering of the health of
employees or the environment;
commission” shall mean the gene technology commission for the purposes of §5 of
the “Release of Genetically Modified Organisms Into Environment Act”;
6) “the user”
shall mean a natural person or a legal entity responsible for contained use of
shall mean a case where an accidental escape of contained GMMOs into working or
natural environment occurs during the contained use of GMMOs, endangering the
health of employees and the environment;
“submission of notice” shall mean the submission of documents containing
required information to the Labour Inspectorate.
CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS
Working with GMMOs shall occur only in contained conditions foreseen for
use of GMMOs shall commence only after submitting a notice to the Labour
Inspectorate and after receiving a written permission from the Labour
Inspectorate, except in cases where the law stipulates otherwise.
(3) The user
shall ensure the application of all necessary measures in order to avoid risks
to the employees’ health or to the environment due to contained use of GMMOs.
§ 4. Risk
analysis and its submission obligation
(1) The user shall conduct a risk analysis regarding the
contained use of GMMOs.
(2) In the course of risk analysis the user shall assess the
possibility of developing risk, risk elements and potential consequences of risk
as well as determine the containment class that shall ensure sufficient safety
to the employees’ health and the
in use of GMMOs.
(3) As a result of the risk analysis the user classifies
solid protection of people’s health and of the environment and the containment
shall be classified as follows:
1) class 1,
if the activity includes no risk;
2) class 2,
if the activity includes low risk;
3) class 3,
if the activity includes reasonable risk;
4) class 4,
if the activity includes high risk.
determining the class, upon doubts, the containment shall be classified as
higher-class containment and containment according to the higher class shall be
(5) The risk
analysis shall be based on the following:
assessment of the harmful impact, particularly that related to the
properties of the genetic material entered into recipient, the donor organism;
properties of the carrier of recombinant nucleic acid, i.e. the vector, and
properties of GMMO;
assessment of harmful impacts due to nature of work;
assessment of the severity of harmful impacts and likelihood of their
(6) The user
shall conduct a new risk analysis, if:
doubt or if there is solid evidence confirming that the conducted risk analysis
is no longer correct in light of new scientific and technical data;
doubt or if there is solid evidence confirming that the used containment is no
longer sufficient for ensuring safety or that the determined containment class
is no longer correct;
new GMMO is introduced or created.
(7) The risk
analysis shall be attached to notices mentioned in §6 and §7 of the Act and to
application for the permit mentioned in section 7(5) of the Act.
(8) The user
shall record the risk analysis, maintain it and submit the record to the Labour
Inspectorate at their request.
(9) The list
of data included in the risk analysis and the procedure for conducting the risk
analysis shall be established by the Regulation of the Minister of Social
Containment and other precautions
(1) The user
shall apply the general principles of contained use mentioned in section 2 and
the requirements established for the containment class, in order to ensure the
highest possible level of safety.
(2) The user
1) keep the
exposure of working and natural environment to GMMOs at the lowest possible
avoiding risk, apply technical common precautions and if necessary, supply
employees with personal safety means, including protective clothing;
the working order of safety equipment and carry out maintenance and inspection
thereof on a regular basis;
necessary, test the existence of live GMMOs outside containment;
training of employees;
necessary, form a commission for solving safety related matters;
manuals ensuring the employees’ safety and supervise their implementation;
8) install a
warning sign “Biohazard” and other relevant safety signs to the door and visible
location inside of the room or complex of rooms used for containment, pursuant
to established procedure;
eating, drinking, storing of products and use of cosmetics in the working
personnel with washing premises equipped with showers and ensure the
availability of antiseptic skin cleansing products;
disinfecting means necessary for making GMMOs harmless and enable the carrying
out of disinfecting procedures;
safe storing of GMMO wastes, contaminated laboratory equipment and materials
until the above is made harmless;
to the containment class special requirements are established for contained use
of GMMOs, if they are handled in laboratory conditions, in greenhouse or if
animals are used.
(4) Requirements to containment classes and special
requirements mentioned in section 3 shall be established by a Regulation of the
Minister of Social Affairs.
(5) The user may combine the required containment upon the
consent of the Labour Inspectorate.
Initial contained use
initial introduction of rooms or complex of rooms for contained use of GMMOs the
user shall submit to the Labour Inspectorate the “Initial Notice”.
(1) Contained use of class 1
may be commenced after forwarding of the “Initial Notice”, provided all
requirements are met and the Labour Inspectorate has no objections.
contained use of class 2, the user shall submit to the Labour Inspectorate the
“Class 2 Notice”. Contained use of class 2 may commence 45 days after
submission of the notice, provided the Labour Inspectorate has no objections.
Upon a written agreement with the Labour Inspectorate work can be commenced
(3) In the
event that the user has previously submitted a notice regarding the contained
use of class 2 or higher and the Labour Inspectorate has no objections, the use
or creation of GMMOs requiring class 2 containment may thereafter be commenced
immediately after submission of the Class 2 Notice, provided all requirements
For initial use of class 3 and 4, i.e. the containment belonging to risk class,
as well as for creation or use of every new GMMO requiring containment of class
3 or 4, the user shall submit to the Labour Inspectorate the “Risk Class Notice”
and apply for a permit from the Labour Inspectorate.
use of class 3 and 4 may not be commenced prior to receiving a written permit
from the Labour Inspectorate.
The form and submission procedure of notices mentioned in §6 and sections 7(2)
and 7(4) and list of data included in the said notices shall be established by a
Regulation of the Minister of Social Affairs.
Review of the notice
(1) Upon receipt of the notice the Labour Inspectorate shall:
the accuracy of data included in the notice and the compliance of the notice
with requirements stipulated by this Act and legal acts established based on
the notice to the commission for assessment;
necessary, submit inquiries to public offices and scientific institutions.
(2) Upon receipt of the Notice the commission shall:
the containment included in the notice and other precautions, as well as the
risk that may arise out of the desired GMMO to people’s health and to the
up a written evaluation of the notice, which shall include a justified proposal
for either allowing the contained use or refusal thereof and shall forward them
to the Labour Inspectorate;
submit proposals to the Labour Inspectorate for allowing the contained use
together with additional measures preventing risk;
submit other proposals to the Labour Inspectorate for ensuring the safety of
employees and the environment.
Labour Inspectorate shall have the right to:
request further information from the party submitting the notice,
including additional justifications on determining the containment class;
request re-evaluation of the determined class and changing of
commission may, if necessary, make proposals to the Labour Inspectorate:
receiving additional information from the party submitting the notice;
changing the containment included in the notice.
Review of application for permit
(1) Labour Inspectorate shall issue a permit for contained
use of GMMOs.
Inspectorate, considering the opinion of the commission and proposals, shall
evaluate the containment and other precautions included in the notice, as well
as the potential risk to the employees’ health and the environment due to the
requested GMMO, and shall adopt a decision regarding issuing of permit or
Labour Inspectorate shall, prior to issuing a permit to the user, examine the
compliance of containment with that presented in the application, in order to
ensure that the requirements set forth for the containment class are met, that
the extraordinary measures plan mentioned in section 10(1) is prepared and that
respective precautions are applied.
Labour Inspectorate shall issue the permit or refuse from issuing the permit and
inform the user of this in writing not later than within 45 days after receiving
the “Risk Class Notice”, provided the permit for class 3 or 4 contained use of
the given rooms has previously been granted and all requirements for contained
use are met. In all other cases the decision is made within a period of up to 90
days after receipt of the notice.
(5) The terms
mentioned in section 4 may be extended, if the Labour Inspectorate:
awaits further information from the user;
examines the implementation of changing the required containment;
carries out public poll or consultation.
(6) The party
carrying out class 2 contained use of GMMOs may request the Labour Inspectorate
to issue a permit in case the user for some reason develops a need for the
permit. Decision regarding the issuing of permit shall be made not later than
within 45 days.
permit shall not be issued if the containment and other precautions fail to
ensure the protection of the employees’ health and the environment from the
influence of GMMOs. Upon refusal to issue a permit the Labour Inspectorate shall
submit a written justification to the applicant.
(8) Form of the permit, list of
information submitted for applying for the permit and the procedure of applying
for the permit shall be established by a Regulation of the Minister of Social
Precautions and accident
(1) The user
shall ensure that prior to contained use of GMMOs:
1) a plan of
extraordinary measures for protecting the employees and the environment upon
accidents is prepared and local rescue services are notified of such plan in
establishments and enterprises potentially endangered by an accident are
informed of the used precautions and of the correct conduct in case of an
emergency. Such information shall be updated as necessary.
(2) In case
of an accident the user shall immediately forward the following data to the
Labour Inspectorate by telephone, email or facsimile:
place and circumstances of the accident;
2) list and
quantities of GMMOs related to the accident;
information enabling to determine the possible impact of the accident to the
employees’ health, to population and to the environment;
and applicable measures.
receipt of information mentioned in section 2, the Labour Inspectorate shall:
examine that all necessary emergency measures are applied;
gather information necessary for complete analysis of the accident;
provide advice in order to avoid similar accidents in the future.
Labour Inspectorate shall ensure that all accidents are investigated and that
the results of investigations are documented and stored for a period of 55
(5) In the
event that the party handling the contained use of GMMOs fails to arrange the
elimination of contamination resulting from unauthorised escape of GMMOs into
the natural environment, the Environmental Inspectorate shall arrange for it at
the expense of the user that caused the contamination.
(1) The user shall notify the Labour Inspectorate of the
new data on used GMMOs that change the containment class;
intent to use GMMOs differently from that indicated in the notice of
(2) In cases
mentioned in section 1 the user shall submit a new notice to the Labour
Inspectorate and harmonise the contained use with new requirements.
In the event
that a change occurs in class 3 or 4 contained use, the work is to be stopped
until a new permit is received.
Labour Inspectorate shall, if necessary, notify the public of the contained use
of GMMOs, pursuant to procedure provided for by the “Public Information Act” (RT
I 2000, 92, 597).
DATA ON CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS
Storing of data
documentation related to contained use of GMMOs shall be stored in the Labour
Inspectorate as a public office database of genetically modified
Confidentiality of information
In the notice, the user shall indicate, the disclosure of which
information may harm the interests of the user and should therefore be treated
as confidential. The request for confidentiality shall be justified.
Based on assessment of the commission the Labour Inspectorate shall
decide, which data are kept confidential and shall notify the user of their
The following information shall not be treated as confidential:
name and address of the party submitting the notice;
general description of GMMO and the location of contained use;
containment class and measures for ensuring the containment;
assessment on the potential effects on people’s health and on the
environment upon unauthorised escape of GMMOs from containment.
The Labour Inspectorate and the commission shall not disclose
confidential information to third parties.
The Labour Inspectorate and the commission shall protect the intellectual
property rights of the party submitting the notice in regards to information in
In the event that the party submitting the notice shall withdraw the
notice for any reason, the Labour Inspectorate and the commission shall ensure
the confidentiality of information included in the notice.
SUPERVISION AND LIABILITY
Supervision over implementation of the requirements of the Act and legal acts
established based on the Act shall be carried out by the Labour Inspectorate and
other state supervision offices within the scope of their competence.
Labour Inspectorate may require the user to change the use conditions of GMMOs
or to seize or end the contained use of GMMOs, if they receive information that
the contained use or other precautions do not meet the established requirements
or if in their opinion the employee’s health or the environment is jeopardised.
(1) A natural
person shall bear disciplinary, administrative, criminal or civil liability for
violating the requirements of this Act and legal acts established based on this
(2) A legal
entity shall bear administrative liability for violating the requirements of
this Act and legal acts established based on this Act to the following extent:
violation of requirements for contained use of GMMOs – a monetary fine is
imposed in a maximum amount of EEK 250 000;
submitting incorrect data in the notice – a monetary fine is imposed in a
maximum amount of EEK 50 000.
Drawing up a protocol on violation of administrative law
violation of administrative law as stipulated in section 15(2) of this Act a
protocol may be drawn up by authorised officials of state supervision offices
mentioned in section 14(1) of this Act.
protocol on violation of administrative law shall indicate:
1) time and
place of drawing up the protocol;
2) name and
address of the supervision office, in the name of which the protocol is drawn
3) first and
last name and position of the person that prepared the protocol;
4) name and
address of the legal entity that committed a violation of the administrative
law, and the first and last name and position of their representative;
place and description of the violation of administrative law;
to provision in the Act that was violated;
to provision in the Act that stipulates the liability;
8) note by
the party that violated the administrative law in that they have been explained
materials proving the violation of administrative law, such as results of
examination or analysis, witness testimonies or other materials necessary for
resolving the matter.
protocol on violation of administrative law shall be signed by the official that
prepared the protocol and by the representative of the party that committed the
violation of administrative law. In the event that the party that violated the
administrative law refuses to sign the protocol or provide an explanation, the
person preparing the protocol shall make a respective note in the protocol.
§ 17. Proceeding the case of
violation of administrative law
Proceeding the case of legal entity’s violation of administrative law, including
imposing or disputing the penalty and execution of decision of administrative
penalty, shall occur pursuant to procedure provided for in the Administrative
Law Violations Code (RT 1992, 29, 396; RT I 1999, 41, 496; 45, certificate; 58,
608; 60, 616; 87, 792; 92, 825; 95, 843; 2000, 10, 58; 25, 141; 28, 167; 29,
169; 40, 247; 49, 301 and 305; 51, 321; 54, 346, 348 and 351; 55, 361; 58, 376;
84, 533; 86, 544 and 548; 89, 578; 95, 609 and 613; 2001, 3, 5; 17, 76; 18, 87)
considering the differences provided for by this Act.
violation of administrative law a legal entity may be imposed a penalty within
six months after the day the protocol on violation of administrative law was
drawn up, however, not later than one year after drawing up of the protocol.
(3) In the
event that a natural person committed the violation of administrative law
mentioned in this Act, by acting on behalf of or in the interests of a legal
entity, the penalty in the case of violating administrative law may be applied
to the natural person and the legal entity at the same time.
Amendment of the “Release of Genetically Modified Organisms Into Environment
amendments shall be made in §5 of the “Release of Genetically Modified Organisms
Into Environment Act” (RT I 1999, 10, 151, 2001, 23, 130):
1) article 6
shall be inserted to section 2:
“6) to advise
the Labour Inspectorate in matters involving contained use of genetically
Entry into force of Act
(1) The existing persons
carrying out contained use of GMMOs shall submit to the Labour Inspectorate a
notice according to the containment class not later than 6 months after this Act
has entered into force.
(2) This Act
shall enter into force on January 1 2002.