Decree No. 474 / 2002 Coll.
Decree implementing Act No. 281 / 2002 Coll., on certain measures related to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act
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Effective from 01.01.2003
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474
DECLARATION
of 1 November 2002
implementing Act No. 281 / 2002 Coll., on certain measures relating to the prohibition of bacteriological (biological) and toxin weapons and amending the Trade Act
According to Section 22 (1) of Act No. 281 / 2002 Coll., on certain measures relating to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act (hereinafter referred to as "the Act '), the State Office of Nuclear Safety provides for the implementation of Sections 2 (d) and (e), 9 and 16 (6) of the Act:
Subject matter
This decree provides
(a) a list of high-risk biological agents and toxins;
(b) a list of risk biological agents and toxins;
(c) a model for notification of the entry into, or exit from, the territory of the Czech Republic of high risk biological agents or toxins;
(d) a model for notification of the entry into, or exit from, the territory of the Czech Republic of hazardous biological agents or toxins;
(e) details of keeping records of high-risk biological agents and toxins, its retention time and the data contained in the declaration of high-risk biological agents and toxins;
(f) details of the keeping of records of risk biological agents and toxins, its retention time and the data contained in the declaration of risk biological agents and toxins;
(g) a model for the declaration of high risk biological agents and toxins;
(h) a model for the declaration of hazardous biological agents and toxins;
(i) a model form for the application for authorisation;
(j) a model for reporting the management of risk biological agents or toxins; and
(k) a model for the declaration of installation of new technical and technological laboratory and manufacturing equipment.
List of high risk and risk biological agents and toxins
(1) The list of high risk biological agents and toxins is set out in Annex 1.
(2) The list of risk biological agents and toxins is set out in Annex 2.
Common provisions on keeping records
(1) The records of high-risk and hazardous biological agents and toxins shall be kept by a person designated by the statutory authority, which is registered in the register, by making records in the register.
(2) The records of high-risk biological agents and toxins are kept separately from those of hazardous biological agents and toxins.
Registration book
(1) The record book consists of initial information, a list of registered biological agents or toxins and individual registers.
(2) The register must be kept in such a way that:
(a) the particulars registered in it cannot be removed or amended, except for the corrections referred to in paragraph 4;
(b) new data could not be entered by an unauthorised person;
(c) the individual records in the register have been numbered continuously; and
(d) it was possible to establish an overview of the actual status of changes to the register over a certain period of time.
(3) The ledger contains:
(a) introductory information,
1. details of the identification of a legal or natural person who, pursuant to Article 16 (1) or Article 17 (4) of the Act, is required to keep a register, within the scope of the business firm or name, seat and identification number of the legal person, if any, or the name, surname or surname, place of permanent residence or residence, if any, if any, and the place of business, if different from the place of permanent residence, identification number, if any, or the natural person's home number, if otherwise assigned,
2. the date on which the alerts are made;
3rd date of the last entry,
4. the name and, where applicable, the name, surname, place of permanent residence or residence, if any, if the person is not resident, and the signature of the statutory authority or its representative; and
5. the name and, where applicable, the name, surname, place of permanent residence or residence, if any, if the person does not have a permanent residence, and the signature of the person designated for keeping records;
(b) in the list of registered biological agents or toxins, a serial number and an indication of the number or extent of the numbers of all the entries in the register; and
(c) at least one separate record sheet for each individual biological agent or toxin included in the list of registered biological agents or toxins.
(4) Corrections to incorrect records in the register shall be made in such a way as to determine the contents of the original record. The corrected alert shall be dated and dated and in the name, where appropriate, of the name and surname of the person designated to carry out the alerts in the record book which has corrected the alert.
(5) Upon completion of the records in the register, the information referred to in paragraph 3 (a) (3) shall be completed and it shall be ensured that the individual registers or parts thereof remaining blank are discarded or prevented from adding any additional information to them.
Model of the record sheet
The model of the record sheet is set out in Annex 3 to this Decree.
Storage of the register
The closed register shall be kept by the authorisation holder or the person handling the risk biological agents or toxins for a period of 10 years from the date of its closure.
Declaration of high-risk and hazardous biological agents and toxins and workplaces where they are handled
(1) The declared data are to be transmitted on forms the model of which is set out in Annex 4.
(2) The declarations are transmitted to the Office of the State of Nuclear Security in electronic form signed by qualified electronic signature, unless the declaration is delivered via a data box or in paper form signed by the statutory authority and simultaneously in electronic form.
Model form for application for authorisation
The model of the application form for authorisation to handle high-risk biological agents or toxins is set out in Annex 5 to this Decree.
Model for the data transmitted
(1) The model of notification of the entry into, or leaving the territory of the Czech Republic of high-risk biological agents or toxins and of risk biological agents or toxins is set out in Annex 6 to this Decree.
(2) The model for reporting the management of risk biological agents or toxins is set out in Annex 7 to this Regulation.
(3) The model for the declaration of installation of new technical and technological laboratory and manufacturing equipment is set out in Annex 8 to this Decree.
Efficacy
This Decree shall take effect on 1 January 2003.
President:
Ing. Drábová v. r.
Příloha č. 1
Annex No 1 to Decree No 474 / 2002 Coll.
List of high-risk biological agents and toxins
[Paragraph 6 (4) of the Law]
I. Human and animal pathogens
I.I Viruses
1. African horse sickness virus (African horse sickness virus);
2. African Swine Fever virus;
3. Andes virus;
4. Aujeszky's disease virus (Suid herpesvirus 1, Pseudorabies virus);
5. Ebola virus: all Ebolavirus viruses;
6. Hantaan virus;
7. Rift Valley fever virus (Rift Valley fever virus);
8. Chikungunya virus;
9. Japanese encephalitis virus (Japanese encephalitis virus);
10. Junin virus;
11. bluetongue virus;
12. classical swine fever virus;
13. Crimean-Congo haemorrhagic fever virus (Crimean-Congo haemorrhagic fever virus);
14. Lassa virus;
15. Lujo virus;
16. lymphocytic choriomeningitis virus;
17. Machupo virus;
18. Marburg virus: all Marburgvirus viruses;
19. Peste des petits Ruminants virus;
20. rinderpest virus;
21. Goat pox virus (Goatpox virus);
22. sheep pox virus (Sheeppox virus);
23. Newcastle disease virus (Newcastle disease virus);
24. lumpy skin disease virus;
25. monkey pox virus (Monkeypox virus);
26. smallpox virus (Variola virus);
27. avian influenza virus (Avian influenza virus) - a virus defined as a high pathogenicity virus;
28. Sin Nombre virus;
29. foot-and-mouth disease virus;
30. Teschen disease virus (Porcine Tescovirus);
3. Venezuelan equine encephalomyelitis virus (Venezuela equine encephalitis virus);
32. swine vesicular disease virus (Swine vesicular disease virus);
33. vesicular stomatitis virus (Vesicular stomatitis virus);
34. Eastern equine encephalomyelitis virus (Eastern equine encephalitis virus);
35. rabies virus (Lyssavirus rabies) and other Lyssavirus members;
36. Western equine encephalomyelitis virus (Western equine encephalitis virus);
37. Yellow fever virus (Yellow fever virus);
38th Middle East coronavirus causing respiratory syndrome (MERS-CoV);
39. coronavirus causing severe acute respiratory syndrome (SARS-CoV);
The 40th reconstructed influenza virus from 1918.
I.II Bacteria
1. Bacillus anthracis;
2. Brucella abortus;
3. Brucella melitensis;
4. Brucella suis;
5. Burkholderia mallei (Pseudomonas mallei);
6. Burkholderia pseudomallei (Pseudomonas pseudomallei);
7. Clostridium argentinense (formerly known as Clostridium botulinum type G), strains producing botulinum neurotoxin;
8. Clostridium baratii, strains producing botulinum neurotoxin;
9. Clostridium botulinum;
10. Clostridium butyricum, strains producing botulinum neurotoxin;
11. Coxiella burnetii;
12. Escherichia coli producing shiga toxin (STEC) serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin serogroups;
13. Francisco tularensis;
14. Chlamydia psittaci (Chlamydophila psittaci);
15. Mycoplasma capricolum subsp. capripneumoniae (strain F38);
16. Mycoplasma mycoides subsp. mycoides SC (small columns);
17. Rickettsia prowazekii;
18. Salmonella typhi (Salmonella enterica subsp. enterica serovar Typhi);
19. Shigella dysenteriae;
20. Vibrio cholerae;
21. Yersinia pestis.
II. Plant pathogens
II.I Viruses
1. potato andean latent tymovirus (Andean potato latent virus);
2. potato spindle tuber viroid (Potato spindle tube viroid).
II.II Fungi
1. Bipolaris oryzae (Cochliobolus miyabeanus, Helminthosporium oryzae);
2. Magnaporthe oryzae (Pyricularia oryzae);
3. Pseudocercospora ulei (Microcyclus ulei, Dothidella ulei).
III. Toxins and their subunits
1. Abrin;
2. aflatoxins;
3. botulinum toxins;
4. brevetoxins;
5. conotoxins;
6. gonybuxins;
7. microcysteins (cyanginosines);
8. Modeccin;
9. Nodularies;
10. palytoxin;
11.ricin;
12. saxitoxin and neosaxitoxin;
13. shiga toxin, shiga toxins 1 and 2 (verotoxins) and shiga toxin-like proteins inactivating ribosomes;
14. Staphylococcus aureus enterotoxins, haemolysin alpha toxin, and toxin toxic shock syndrome (formerly known as Staphylococcus enterotoxin F);
15. Tetrodotoxin;
16. clostridium perfringens (alpha, beta 1, beta 2, epsilon and iota) toxins;
17. trichothecene toxins;
18. viscumin (Viscum Album Lectin 1);
19th volkensin.
IV. Genetic elements and genetically modified organisms
Any genetically modified organism that contains, or genetic element that encodes, any of the following:
IV.I any gene, genes, translational product or translational products specific to any virus referred to in I.I and II.I;
b.
a. In itself or through its transcription or translation products, it presents a significant hazard to human, animal or plant health; or
b. Could lend or increase pathogenicity; or
IV.III any of the toxins referred to in point III or any subunit of toxins referred to in point III;
Additional information:
(1) The micro-organisms with high pathogenicity referred to in point I.I 27 include:
(a) type A viruses having an IVPI (intravenous pathogenicity index) in six-week-old chicks exceeding 1,2; and
(b) virus type A, subtype H5 or H7 with gene sequences that encode multiple base amino acids in the haemagglutinin cleavage area, as with other highly pathogenic avian influenza viruses (HPAI), indicating that haemagglutinin may be broken by host cell protease.
2) Between micro-organisms referred to in point I.II. 12. Escherichia coli producing Shiga Toxin (STEC) is mainly composed of enterohaemorrhagic E. coli (EHEC), verotoxin producing E. coli (VTEC) or verocytoxine producing E. coli (VTEC).
3) The rules on the treatment of toxins do not apply to botulinum toxins (point III. 3.) or conotoxins (point III. 5.) contained in medicinal products authorised under the Drug Act.
4) Genetically modified organisms include organisms whose nucleic acid chains have been created or modified by deliberate molecular manipulation.
5) Genetic elements include chromosomes, genomes, plasmids, transposons, vectors and inactivated organisms containing renewable nucleic acid fragments, whether genetically modified or not, or chemically synthesized in whole or in part. For the purposes of the control of genetic elements, nucleic acids from an inactivated organism, virus or sample shall be considered as renewable if inactivation and preparation of the material is intended to facilitate or facilitate the isolation, purification, amplification, detection or identification of nucleic acids.
6) Lending or increasing pathogenicity is defined as a situation where the insertion or inclusion of a nucleic acid sequence or sequences is likely to allow or increase the capacity of the recipient organism to be used to cause a disease or death intentionally. It may include in particular changes: virulence, transportability, stability, infection patterns, host spectrum, reproducibility, ability to escape or suppress host immunity, resistance to medical countermeasures or detection.
7) For micro-organisms referred to in point I.II 12, the "genetic elements and genetically modified organisms" referred to in point IV shall apply only to nucleic acid sequences that encode shiga toxins (verotoxins) or their subunits.
Příloha č. 2
Annex No 2 to Decree No 474 / 2002 Coll.
List of risk biological agents and toxins
[Paragraph 17 (5) of the Law]
I. Human and animal pathogens
I.I Viruses
1. Australian encephalitis virus (Murray Valley Encephalitis virus);
2. Dobrava-Belgrade virus;
3. St. Louis encephalitis virus (St. Louis Encephalitis virus);
4. Guanarito virus;
5. Hendra virus (Equine morbilli virus);
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Regulation Information
| Citation | Decree No. 474 / 2002 Coll., implementing Act No. 281 / 2002 Coll., on certain measures relating to the prohibition of bacteriological (biological) and toxin weapons and on the amendment of the Trade Act |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 20.11.2002 |
|---|---|
| Effective from | 01.01.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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