Contained use of Genetecally Modified Micro-organisms Act

 Chapter 1
GENERAL PROVISIONS

 § 1. 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).

§ 2. Definitions used in Act
For the purposes of this Act:
1) “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;
2) “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);
3) “genetic 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”;
4) “contained 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;
5) “the 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 GMMOs;
7) “accident” 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;
8) “submission of notice” shall mean the submission of documents containing required information to the Labour Inspectorate.

Chapter 2
CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS

§ 3. General provisions
(1)               Working with GMMOs shall occur only in contained conditions foreseen for that purpose.
(2) Contained 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 environment 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.
(4) In determining the class, upon doubts, the containment shall be classified as higher-class containment and containment according to the higher class shall be applied.
(5) The risk analysis shall be based on the following:
1)      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;
2)      assessment of harmful impacts due to nature of work;
3)      assessment of the severity of harmful impacts and likelihood of their realisation.
(6) The user shall conduct a new risk analysis, if:
1)  in 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;
2)  in 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;
3)  a 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 Affairs.

§ 5. 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 shall:
1) keep the exposure of working and natural environment to GMMOs at the lowest possible level;
2) for avoiding risk, apply technical common precautions and if necessary, supply employees with personal safety means, including protective clothing;
3) maintain the working order of safety equipment and carry out maintenance and inspection thereof on a regular basis;
4) if necessary, test the existence of live GMMOs outside containment;
5) ensure training of employees;
6) if necessary, form a commission for solving safety related matters;
7) prepare 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;
9) prohibit eating, drinking, storing of products and use of cosmetics in the working environment;
10) prohibit oral dosing;
11) provide personnel with washing premises equipped with showers and ensure the availability of antiseptic skin cleansing products;
12) provide disinfecting means necessary for making GMMOs harmless and enable the carrying out of disinfecting procedures;
13) ensure safe storing of GMMO wastes, contaminated laboratory equipment and materials until the above is made harmless;
(3) According 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.

§ 6. Initial contained use

Prior to initial introduction of rooms or complex of rooms for contained use of GMMOs the user shall submit to the Labour Inspectorate the “Initial Notice”.
§ 7. Contained use

(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.
(2) For 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 earlier.
(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 are met.
(4) 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.  
(5) Contained use of class 3 and 4 may not be commenced prior to receiving a written permit from the Labour Inspectorate.     
(6) 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. 

§ 8. Review of the notice

(1) Upon receipt of the notice the Labour Inspectorate shall:
1)  examine 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 this Act;
2)  forward the notice to the commission for assessment;
3)  if necessary, submit inquiries to public offices and scientific institutions.
(2) Upon receipt of the Notice the commission shall:
1)  evaluate 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 environment;
2)  draw 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;
3)  possibly submit proposals to the Labour Inspectorate for allowing the contained use together with additional measures preventing risk;
4)  possibly submit other proposals to the Labour Inspectorate for ensuring the safety of employees and the environment. 
(3) The Labour Inspectorate shall have the right to:
1)      request further information from the party submitting the notice, including additional justifications on determining the containment class;
2)      request re-evaluation of the determined class and changing of containment;
(4) The commission may, if necessary, make proposals to the Labour Inspectorate:
1)  for receiving additional information from the party submitting the notice;
2)  for changing the containment included in the notice.
§ 9. Review of application for permit
(1) Labour Inspectorate shall issue a permit for contained use of GMMOs.
(2) Labour 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 refusal thereof.
(3) The 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.
(4) The 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:
1)      awaits further information from the user;
2)      examines the implementation of changing the required containment;
3)      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. 
(7) The 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 Affairs.

§ 10.  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 writing;
2) 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:
1)      place and circumstances of the accident;
2)  list and quantities of GMMOs related to the accident;      
3) other information enabling to determine the possible impact of the accident to the employees’ health, to population and to the environment;
4) applied and applicable measures.
(3) Upon receipt of information mentioned in section 2, the Labour Inspectorate shall:
1)      examine that all necessary emergency measures are applied;
2)      gather information necessary for complete analysis of the accident;
3)      provide advice in order to avoid similar accidents in the future.
(4) The Labour Inspectorate shall ensure that all accidents are investigated and that the results of investigations are documented and stored for a period of 55 years.
(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.

§ 11. Notification
(1) The user shall notify the Labour Inspectorate of the following:
1)      new data on used GMMOs that change the containment class;
2)      intent to use GMMOs differently from that indicated in the notice of contained use.
(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.
(3) The 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).

 Chapter 3

DATA ON CONTAINED USE OF GENETICALLY MODIFIED MICRO-ORGANISMS

§ 12. Storing of data
The documentation related to contained use of GMMOs shall be stored in the Labour Inspectorate as a public office database of genetically modified micro-organisms.
§ 13. Confidentiality of information
(1)   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.
(2)   Based on assessment of the commission the Labour Inspectorate shall decide, which data are kept confidential and shall notify the user of their decision.
(3)   The following information shall not be treated as confidential:
1)      name and address of the party submitting the notice;
2)      general description of GMMO and the location of contained use;
3)      containment class and measures for ensuring the containment;
4)      assessment on the potential effects on people’s health and on the environment upon unauthorised escape of GMMOs from containment.
(4)   The Labour Inspectorate and the commission shall not disclose confidential information to third parties.
(5)   The Labour Inspectorate and the commission shall protect the intellectual property rights of the party submitting the notice in regards to information in their possession.
(6)    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.
 
Chapter 4
SUPERVISION AND LIABILITY

§ 14. Supervision
(1) 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.
(2) The 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.
§ 15. Liability
(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 Act.
(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: 
1) for violation of requirements for contained use of GMMOs – a monetary fine is imposed in a maximum amount of EEK 250 000;
2) for submitting incorrect data in the notice – a monetary fine is imposed in a maximum amount of EEK 50 000.
§ 16. Drawing up a protocol on violation of administrative law
(1) For 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.
(2) The 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 up;
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;
5) time, place and description of the violation of administrative law;
6) reference to provision in the Act that was violated;
7) reference 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 their rights;
9) other materials proving the violation of administrative law, such as results of examination or analysis, witness testimonies or other materials necessary for resolving the matter.
(3) The 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
 (1) 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.
(2) For 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.

Chapter 5
IMPLEMENTING PROVISIONS
 
§ 18. Amendment of the “Release of Genetically Modified Organisms Into Environment Act”
The following 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 modified micro-organisms.”
§ 19. 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.