ORDER OF THE GOVERNMENT OF THE REPUBLIC OF MOLDOVA

of September 25, 2003 No. 1153

About approval of the Regulations on issue of permissions to the types of activity connected with testing, production, use and realization of genetically modified organisms

The government DECIDES:

Approve Regulations on issue of permissions to the types of activity connected with testing, production, use and realization of genetically modified organisms it (is applied).

Approved by the Order of the Government of the Republic of Moldova of September 25, 2003 No. 1153

Regulations on issue of permissions to the types of activity connected with testing, production, use and realization of genetically modified organisms

I. General provision

1. The regulations on issue of permissions to the types of activity connected with testing, production, use and realization of genetically modified organisms are developed according to provisions of Item of 1 part (4) article 43 of the Law on biological safety N 755-XV of December 21, 2001 and provides issue of permissions to the types of activity connected with testing, production, use and realization of genetically modified organisms in case of application of methods of modern biotechnology and derivative products from them.

2. Permission is the official document representing to its owner the right to perform during the established period certain type of activity on condition of obligatory observance of the conditions provided in it.

3. Permission is issued according to the procedure, provided by the Law on biological safety, this provision and special conditions given in the appendices which are integral part of this provision.

4. Issue of permissions to the types of activity regulated by this provision is performed by the National commission on biological safety (further - the National commission).

5. Ceased to be valid

6. Conditions of this provision extend to the types of activity specified in part (1) article 2 of the Law on biological safety.

7. Actions of this provision do not extend to the organisms received by traditional methods of genetical intransmutations as that: mutagenesis, cellular merge, including vegetable and bacterial protoplasts, self-cloning (provided that they require use of molecules of rekonbinirovanny nucleic acids), refined products, including the pharmaceutical medicines intended for the person and for use in veterinary science on activities for transportations, irrespective of the vehicle, and also transaction on sale and import/export which are regulated by other regulations.

II. Issue of permission

A. Use in the closed systems of genetically modified microorganisms/organisms

8. In case of issue of permissions to types of activity on use in the closed systems of microorganisms and other genetically modified organisms it must be kept in mind that:

a) genetical intransmutations arise when using methods of recombination of nucleic acids, genetical intransmutation of organisms with use of different vectorial systems, cellular merge or direct injection of nucleic acids in cages and organellas, and also other methods of modern biotechnology;

b) as the methods which are not leading to genetical intransmutations are considered: fertilization of in vitro, polyploidization, conjugation, transduction, transformation or any other natural process provided that molecules recombined DNA or genetically modified organisms will not be used.

9. Before receipt of permission the user shall make use assessment in the closed systems from the point of view of risk for human health and the environment using minimum of estimative elements and the procedure established in appendix N 1, parts A and B for the purpose of reference of use in the isolated conditions to one of four classes of risk listed in part (1) article 3 of the Law on biological safety.

10. Reference to one of four classes of risk will allow to determine procedure for distribution of measures for isolation according to the appendix N 2 to this provision.

11. In case there are doubts concerning the used class, the toughened security measures are taken.

12. When evaluating according to Item 9 of this provision it is necessary to consider especially the aspects concerning waste disposal with acceptance, as necessary, of security measures for the purpose of health protection of people and the environment.

13. Users shall record the estimates provided in Item 9, and to provide them to the National commission as part of the notification according to provisions of subitems c), d), e) Item 16 of this provision or according to its requirement.

14. Except as specified, provided in appendix N Item 1 2, other measures resolving application, the user shall apply the general principles, the corresponding isolation and other security measures stated in the specified annex, the supporting workplaces and the environment is able, the least subjected to impact from genetically modified microorganisms/organisms.

15. Assessment, and also level of isolation and other measures for protection shall be reviewed periodically or as required if:

a) the applied measures for isolation became inadequate or earlier established risk class for use in the closed systems changed; or

b) there are instructions on the fact that assessment does not correspond to new knowledge in the field of science or the equipment any more.

16. For receipt of permission economic agents submit the National commission the following documents:

a) the statement in which are specified:

legal entities - the name and form of business, legal address (location) and fiscal code;

physical persons - name and surname, these identity certificates or passports (series, number, registration) and fiscal code;

types of activity for which permission is requested.

b) the operating plan of use in the closed systems where inefficiency of measures for isolation can create serious danger with the immediate or remote effects to human health or the environment out of the location of installation. Such operating plan is not developed if the applicant provided already developed similar plan recognized by the European Union;

c) if installations in the closed systems are applied to use for the first time, the user shall provide the notification containing, at least, the following information: surnames of the user and persons responsible for supervision and safety, their specialty and qualification, the description of installation, use class in the closed systems. Only for use in the closed systems carried to 1 class the summary of assessment and waste management is represented. After the notification subsequent use in the closed systems carried to 1 class can be performed without additional notices;

d) for the first, and also subsequent uses in the closed systems belonging to the 2nd class which should be performed in the installations declared according to subitem provisions c) of this Item the user represents the notification containing information on microorganisms receptors, donors or initial on the used vectorial system and its characteristic, the purpose of use and the expected results, the description of methods of isolation and security measures, including waste management, risks assessment summary, information necessary for competent authority for assessment of response prompt actions in case of emergency situations according to subitem b provisions) this Item;

e) for the first, and also subsequent uses in the closed systems belonging to the 3 or 4 class of risk which should be performed in the declared installations according to requirements of the subitem c) of this Item the user represents the notification containing information provided in the subitem d), and also information on specific risks which can arise the description of the plan and preventive measures on safety, the prevention and isolation;

f) assessment is provided as the notification component provided in subitems c) d), e) this Item, or upon the demand of the National commission.

17. In case of need the National commission has the right:

a) demand from the user the additional information, change the proposed measures of use or modify risk class. At the same time the commission can dispose about prohibition of the beginning of use or suspend the begun activities for use before issue of permission based on in addition acquired information or based on the changed use conditions;

b) in case of violation of the requirements provided in permission to limit the term of permission to activities in the closed systems or to establish special conditions for use.

B. Deliberate entering into the environment of genetically modified organisms

18. For permission of the activities connected with deliberate entering into the environment of genetically modified organisms it must be kept in mind that:

a) genetically modified organisms arise when using the methods specified in the subitem and) Item 8 of this provision;

b) the methods which are not leading to genetical intransmutations are provided in the subitem b) Item 8 of this provision.

19. Issue of the permissions to deliberate entering into the environment of genetically modified organisms got by the methods described in Item 7 of this provision is not provided.

20. For receipt of permission economic agents submit the National commission the following documents:

a) the statement which contents are provided in the subitem and) Item 16 of this provision;

b) the notification containing:

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