Decree No. 74 / 2013 Coll.
Decree amending 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
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Effective from 01.05.2013
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01.05.2013
25.03.2013
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74
DECLARATION
of 8 March 2013
amending 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 amending the Trade Code
According to Section 22 (1) of 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, the State Office of Nuclear Safety provides for the implementation of Sections 2 (d) and (e), Sections 9 and 16 (6) of the Act:
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, is amended as follows:
1. in Paragraph 3 (b):
"(b) in the fields of technical sciences and technology or natural sciences in the field of study concerning the management of biological agents and toxins,"
2. In Article 3 (c), the words "or toxicology 'shall be inserted after the words" pharmacy'.
3. In Article 3 (d), the words "or agriculture 'shall be inserted after the words" plant health' and the words "its' shall be replaced by the words" theirs'.
4. In the first sentence of Paragraph 4, the words "designated staff member 'are replaced by" designated person', the words "who 'are replaced by the words" who' and the words "registered 'are replaced by the words" registered'.
5. in Article 5 (2) (a) (5), the word "staff member" shall be replaced by the word "person," the word "who" shall be replaced by "who" and the word "designated" shall be replaced by "designated."
6. Paragraph 5 (3) reads as follows:
"(3) The incorrect data shall be corrected in such a way that the original entry remains legible and each repair shall be signed by the person responsible for keeping the register, who shall attach the date of the repair to the signature. ';
7. Paragraph 7 (2) reads as follows:
"(2) The declarations shall be transmitted to the Office of the State for Nuclear Safety in electronic form signed by a recognised electronic signature, unless the declaration is delivered via a data box or in paper form with the signature of the statutory authority and simultaneously in electronic form. ';
8. Annex 1 shall read as follows:
"Annex No 1 to Decree No 474 / 2002 Coll.
List of high-risk biological agents and toxins (§ 2 (d) of the Act)
1. Human pathogens and zoonotic agents
1.1 Viruses
1. Andes virus;
2. Dengue virus;
3. Ebola virus;
4. Hantaan virus;
5. Rift Valley fever virus (Rift Valley fever virus);
6. Chikungunya virus;
7. Japanese encephalitis virus (Japanese encephalitis virus);
8. Junin virus;
9. Crimean-Congo haemorrhagic fever virus (Crimean-Congo haemorrhagic fever virus);
10. Lassa virus;
11. Lujo virus;
12. lymphocytic choriomeningitis virus;
13. Machupo virus;
14. Marburg virus;
15. monkey pox virus (Monkeypox virus);
16. smallpox virus (Variola virus);
17. Sin Nombre virus;
18. Venezuelan equine encephalomyelitis virus (Venezuela equine encephalitis virus);
19. Eastern equine encephalomyelitis virus;
20th Western equine encephalomyelitis virus (Western equine encephalitis virus);
Yellow fever virus (Yellow fever virus).
1.2. 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 botulinum;
8. Escherichia coli - shigatoxigenic strains (STEC) causing diarrhoea, haemorrhagic diarrhoea and haemolytic-uremic syndrome in humans;
9. Francisco tularensis;
10. Chlamydophila psittaci (Chlamydia psittaci);
11. Salmonella typhi (Salmonella enterica subsp. enterica serovar Typhi);
12. Shigella dysenteriae Type 1;
13. Vibrio cholerae;
14. Yersinia pestis.
1.3. Rickettsia
1. Bartonella quintana (Rochalimea quintana, Rickettsia quintana);
2. Coxiella burnetia;
3. Rickettsia prowazekii;
4. Rickettsia rickettsii.
2. Animal pathogens
2.1 Viruses
1. African horse sickness virus (African horse sickness virus);
2. African Swine Fever virus;
3. Aujeszky's disease virus (Porcine herpes virus (Aujeszky's disease);
4. poultry influenza virus (Avian influenza virus), as follows:
b.
a.
1. type A viruses having an IVPI (intravenous pathogenicity index) in six-week chickens greater than 1,2; or
2. Viruses of type A of subtype H5 or H7 in which nucleotide chains show multiple amino acids on the cleavage side of haemoglutinin;
5. bluetongue virus;
6. classical swine fever virus;
7. peste des petits Ruminants virus;
8. rinderpest virus;
9. sheep pox (Sheeppox virus);
10. goat pox virus (Goatpox virus);
11. Newcastle disease virus (Newcastle disease virus);
12. lumpy skin disease virus;
13. foot-and-mouth disease virus;
14. Teschen disease virus, porcine polio (Teschen disease virus)
15. swine vesicular disease virus (Swine vesicular disease virus);
16. vesicular stomatitis virus (Vesicular stomatitis virus);
17. rabies virus (Lyssavirus).
2.2 Mycoplasma
1. Mycoplasma mycoides subsp. mycoides SC (small columns);
2. Mycoplasma capricolum subsp. capripneumoniae.
3. Plant pathogens
3.1 Viruses
1. potato andean latent tymovirus (Andean potato latent virus);
2. potato spindle tuber viroid (Potato spindle tube viroid).
3.2. Mushrooms
1. Cochliobolus miyabeanus (Helminthosporium oryzae);
2. Magnaporthe grisea (Pyricularia grisea, son. Pyricularia oryzae);
3. Microcyclus ulei (son. Dothidella ulei).
4. Toxins and their subunits
1. Abrin;
2. aflatoxins;
3. atoxin (neurotoxin of cyanobacterium);
4. botulinum toxins;
5. bungarotoxin;
6. ciguatoxin;
7. conotoxin;
8. choleratoxin;
9. microcystine (cyanginosine);
10. moxacin;
11.ricin;
12. saxitoxin;
13. shiga toxin, shiga toxins 1 and 2 (verotoxins) and shiga toxin-like proteins inactivating ribosomes;
14. tetrodotoxin;
15. Clostridium perfringens toxins;
16. Staphylococcus aureus toxins;
17. trichothecene toxins;
18. viscumin;
19th volkensin.
5. Genetic elements and genetically modified organisms
5.1 Genetic elements containing nucleic acid sequences related to the pathogenicity of the organisms referred to in 1-3.
5.2 Genetic elements containing nucleic acid sequences coding for any of the toxins listed in point 4 or coding sub-units of toxins listed in point 4.
5.3 Genetically modified organisms containing nucleic acid sequences related to the pathogenicity of the organisms referred to in points 1-3.
5.4 Genetically modified organisms containing nucleic acid sequences coding for any of the toxins referred to in point 4 or coding subunits of toxins referred to in point 4.
5.5 De novo chemically synthesised genetic material and artificial organisms containing nucleic acid sequences related to the pathogenicity of the organisms referred to in points 1-3.
5.6 De novo chemically synthesized genetic material and artificial organisms containing nucleic acid sequences coding for any of the toxins referred to in point 4 or coding subunits of toxins referred to in point 4.
Notes:
1) The micro-organisms referred to in point 1.2 9 include in particular strains of serogroups O26, O45, O91, O103, O104, O111, O113, O121, O145, O157 and others producing shiga toxins or bearing genes coding their production. The designation "shigatoxigenic strains of Escherichia coli (STEC) 'is equivalent to that of" verotoxigenic strains of Escherichia coli (VTEC)'.
2) The rules on the treatment of toxins do not apply to botulinum toxins (point 4.4.) or conotoxins (point 4.7.) contained in medicinal products authorised under the Drug Act.
3) Genetic elements include among other chromosomes, genomes, plasmids, transposons and vectors, both genetically modified and unmodified.
A sequence of nucleic acids related to the pathogenicity of the organisms referred to in points 1-3 constitutes any sequence specific to any of the above micro-organisms which:
(a) as such, or through its transcription or translation products, presents a significant risk to the health of persons, animals or plants; or
(b) is known to increase the ability of the micro-organism or any other organism in which it may be inserted or otherwise integrated to cause serious harm to human, animal or plant health.
(4) For micro-organisms referred to in point 1.2 9, "genetic elements and genetically modified organisms" referred to in point 5 shall apply only to nucleic acid sequences that encode shiga toxins (verotoxins) and shiga-like proteins that inactivate ribosomes or their subunits. "
9. Annex 2 shall read as follows:
"Annex No 2 to Decree No 474 / 2002 Coll.
List of risk biological agents and toxins (Section 2 (e) of the Act)
I. Viruses
1. Australian encephalitis virus (Murray Valley Encephalitis virus);
2. Dobrava-Belgrade virus;
3. St. Louis encephalitis virus (St. Louis Encephalitis virus);
4. Flexal virus;
5. Guanarito virus;
6. Hendra virus (Equine morbilli virus);
7. Kyasanur forest fever virus (Kyasanur forest disease virus);
8. Chapare virus;
9. Choclo virus;
10. tick encephalitis virus, Russian jaro-summer encephalitis virus (Tick-borne encephalitis virus, Russian Spring-Summer encephalitis virus);
11. Laguna Negra virus;
12. Nipah virus;
13. Oropouche virus;
14. Omsk haemorrhagic fever virus;
15. Powassan virus;
16. Puumala virus;
17. Rocio virus;
18. Sabia virus;
19. Seoul virus;
20. Louping ill virus;
21 West Nile Fever virus.
II. Bacteria
1. Clostridium perfringens - strains producing epsilon toxin;
2. Clostridium tetani;
3. Legionella pneumophila;
4. Mycobacterium bovis (except BCG strain);
5. Mycobacterium tuberculosis (multi-resistant strains);
6. Xanthomonas albilineans;
7. Xanthomonas campestris pv. citri including strains known as Xanthomonas campestris pv. citri type A, B, C, D, E or otherwise classified as Xanthomonas citri, Xanthomonas campestris pv. aurantifolia or Xanthomonas campestris pv. Citrumelo;
8. Yersinia pseudo-tuberculosis.
III. Fungi
1. Coccidioides immitis;
2. Coccidioides posadasii;
3. Colletetrichum coffeanum var. Virulans (Colletetrichum kahawae);
4. Puccinia graminis (son. Puccinia graminis F. sp. tritici);
5. Puccinia striiformis (son. Puccinia glumarum).
IV. Toxins and their subunits
1. Tetanotoxin.
V. Genetic elements and genetically modified organisms
1. Genetic elements which contain nucleic acid sequences related to pathogenicity of organisms referred to in points I-III.
2. Genetic elements containing nucleic acid sequences coding for any of the toxins listed in point IV or coding sub-units of toxins listed in point IV.
3. Genetically modified organisms containing nucleic acid sequences related to the pathogenicity of the organisms referred to in points I-III.
4. Genetically modified organisms containing nucleic acid sequences coding for any of the toxins referred to in point IV or coding subunits of toxins referred to in point IV.
5. De novo chemically synthesized genetic material and artificial organisms containing nucleic acid sequences related to the pathogenicity of the organisms referred to in points I-III.
6. De novo chemically synthesized genetic material and artificial organisms containing nucleic acid sequences coding for any of the toxins referred to in point IV or coding subunits of toxins referred to in point IV.
Notes:
Genetic elements include among other chromosomes, genomes, plasmids, transposons and vectors, both genetically modified and unmodified.
The nucleic acid sequences related to the pathogenicity of the organisms referred to in points I-III constitute any sequence specific to any of the above micro-organisms which:
(a) as such, or through its transcription or translation products, presents a significant risk to the health of persons, animals or plants; or
(b) is known to increase the ability of the micro-organism or any other organism in which it may be inserted or otherwise integrated to cause serious harm to human, animal or plant health. ";
Efficacy
This Decree shall take effect on 1 May 2013.
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Regulation Information
| Citation | Decree No. 74 / 2013 Coll., amending 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 | 25.03.2013 |
|---|---|
| Effective from | 01.05.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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