474/2002 Sb.
DECREE
from day 1. November 2002,
implementing Act No. 281/2002, on certain measures
related to the prohibition of Bacteriological (Biological) and Toxin
weapons and amending the Trade Act
Change: 74/Sb.
State Office for nuclear safety, establishes, pursuant to section 22(1) of the 1 of the law
No 281/2002, on certain measures connected with the prohibition of
of Bacteriological (Biological) and Toxin Weapons and on change
the Trades Licensing Act, (hereinafter referred to as the "Act") for the implementation of paragraph 2 (a). (d)), and
(e)), section 9 and section 16 para. 6 of the Act:
§ 1
The subject of the edit
This Decree lays down the
and a list of high-risk biological) agents and toxins that have the
such features or capabilities that can be used as a weapon,
and with whom we may dispose of only the holder of the authorisation,
(b) a list of the risk of biological agents) and toxins, which can be
under the conditions laid down by law,
(c) the headings of the study programmes) Bachelor's, master's and
Doctoral type as one of the conditions for the fulfilment of the professional
eligibility,
(d)) for details on record keeping and information contained in the declarations.
§ 2
Lists of high-risk and high-risk biological agents and toxins
(1) the list of high risk biological agents and toxins is listed in
Annex No 1.
(2) the list of high-risk biological agents and toxins is given in annex
No. 2.
§ 3
Range of study programmes
One of the conditions of competence of persons for the issue of permits to
the management of high risk biological agents and toxins is
higher education ^ 1) obtained by studying in the Bachelor, master
or in doctoral programs or foreign higher education
Education recognised in ^ 2)
and) in the areas of medicine, veterinary medicine and in their
the respective fields of study,
(b)) in the areas of engineering and technology or natural sciences in
fields of study relating to the handling of biological agents and
toxins,
(c)) in the field of pharmacy or chemistry in their respective
fields of study, or
(d)) in the field of plant medicine or agriculture, and in their respective
fields of study.
Common provisions on record keeping
§ 4
A register of high-risk and high-risk biological agents and toxins
leading the designated person, which is recorded in the registration book, implementation
records in the records book. Registration book leads specifically for highly
risk biological agents, risk, high risk biological agents
toxins and risky toxins.
§ 5
Registration book
(1) Registration book consists of individual accounting sheets
must be bound and continuously numbered.
(2) the Registration book contains
and on the title page)
1. data relating to the identification of the legal or natural person under section 11 (1) 3
(a). a) or b) of the Act or pursuant to § 17 para. 2 (a). and) of the Act,
2. the date from which the records shall be made
3. the date of the last record
4. the name, address and signature of the statutory body,
5. name, address and signature of the person who it is intended for the keeping of registers,
(b)) on the first page for a list of registered biological agents or toxins;
This list contains the sequence number of the first page and putting the occurrence of
entries in the records book.
(3) the erroneous information is correct so that the original writing remains legible, and
each patch is signed by the person specified for record keeping, to
signature date the repair. connects
(4) if it runs out the number of pages allocated in the registration book for the
a specific item, it is possible in the same registration book for the same
biological agent or toxin of a new sequential pages and add to
This item list on the first page of records.
§ 6
Registration sheet
(1) Registration sheet contains
and the name and location of the device), in which the registered activities carried out,
(b)) page number in the registration book,
(c) biological agents or name) of the toxin,
d) serial number against a list of biological agents or toxins,
indicated on the first page of records,
(e) the registered quantity unit)
(f) the number and date of registration) and the additional particulars referred to in annex 3.
(2) Pattern an accounting worksheet is given in annex 3.
§ 7
Declaration of the high risk and the risk of biological agents and toxins and
about objects and devices in which they are treated by
(1) the declared data shall be transmitted on a form, a specimen of which is
given in annex 4.
(2) the claims are State Office for nuclear safety passed in
electronic form signed by a recognized electronic signature, if
the claim is not delivered via data boxes, or in
the documentary form with a signature of the statutory body and at the same time in electronic
the form.
§ 8
The effectiveness of the
This Decree shall enter into force on 1 January 2000. January 1, 2003.
Chair:
Ing. Drábová in r.
Č. 1
The list of high risk biological agents and toxins (section 2 (b), (d))
of the Act)
1. Human pathogens and zoonotic agents
1.1 Viruses
1. virus Andes;
2. Dengue virus;
3. the Ebola virus;
4. Hantaan virus;
5. Rift Valley fever virus (Rift Valley fever virus);
6. Chikungunya virus;
7. the virus of Japanese encephalitis (Japanese encephalitis virus);
8. Junin virus;
9. virus, Crimean-Congo hemorrhagic fever (Crimean-Congo
haemorrhagic fever virus);
10. the Lassa virus;
11. virus Lujo;
12. Lymphocytic choriomeningitidy virus;
13. Machupo virus;
14. Marburg virus;
15. monkey pox virus (Monkeypox virus);
16. the smallpox virus (Variola virus);
17. virus Sin Nombre;
18. virus Venezuelan equine encephalomyelitis (Venezuelan equine
encephalitis virus);
19. Eastern equine encephalitis virus (Eastern equine
encephalitis virus);
20. Western equine encephalitis virus, Western equine encephalitis (
virus);
21. yellow fever virus (Yellow fever virus);
1.2 the 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. shigatoxigenní strains of Escherichia coli (STEC) causing diarrhea,
hemorrhagic diarrhea and hemolytic uremic syndrome in humans;
Francisella tularensis 9;
10. Chlamydophila psittaci (Chlamydia psittaci);
11. Salmonella typhi (Salmonella enterica subsp. enterica serovar
Typhi);
Shigella dysenteriae Type 12 1;
13. Vibrio cholerae;
14. Yersinia pestis.
1.3 the Rickettsiae
1. Bartonella quintana (Rochalimea quintana, Rickettsia quintana);
2. Coxiella burnetii;
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 (African swine fever virus);
3. the virus of Aujeszky's disease (Porcine herpes virus (Aujeszky live's disease);
4. the influenza virus of poultry (Avian influenza virus), namely:
a. necharakterizovaný or
(b). defined as the virus with high pathogenicity, as follows:
1. type A viruses with an IVPI (intravenous pathogenicity index) in
6-week old chickens greater than 1.2 or
2. type A viruses H5 or H7 subtype for which nucleotide chain
have had multiple basic amino acids at the cleavage side hemoglutininu;
5. to bluetongue virus (Bluetongue virus);
6. classical swine fever virus (Classical swine fever virus);
7. small ruminants plague virus (Peste des petits ruminants virus);
8. rinderpest virus (Rinderpest virus);
9. sheep pox virus (Sheeppox virus);
10. goat pox virus (Goatpox virus);
11. virus Newcastle disease of poultry (Newcastle disease virus);
12. virus Nodular dermatitis cattle (Lumpy skin disease virus);
13. foot and mouth disease virus (Foot-and-mouth disease virus);
14. Teschen disease virus, contagious porcine paralysis (the town disease
virus)
15. swine vesicular disease virus (Swine vesicular disease virus);
16. vesicular stomatitis virus (Vesicular stomatitis virus);
17. the rabies virus (Lyssavirus);
2.2 Mycoplasma
1. Mycoplasma mycoides subsp. mycoides SC (small colony);
2. Mycoplasma capricolum subsp. capripneumoniae;
3. plant Pathogens
3.1 Viruses
1. potato Andean latent tymovir (Andean Potato latent virus);
2. the minimum vřetenovitosti in Potato tubers (Potato spindle tuber viroid);
3.2 Mushrooms
1. Cochliobolus miyabeanus (Helminthosporium oryzae);
2. Magnaporthe grisea (Pyricularia grisea, son of Pyricularia oryzae.);
3. Microcyclus ulei (SYN. Dothidella ulei);
4. Toxins and their subunits
1. the abrin;
2. aflatoxins;
3. whether or not (a neurotoxin cyanobakterií);
4. botulinum toxins;
5. bungarotoxin;
6. the toxins;
7. conotoxin;
8. choleratoxin;
9. microcystin (cyanginosin);
10. modecin;
11. ricin;
12. saxitoxin;
13. shiga toxin, shiga toxins 1 and 2 (for the verotoxin) and similar proteins
Shiga toxin, which inactivate Ribosomes;
14. tetrodotoxin;
15. Clostridium perfringens toxins;
16. Staphylococcus aureus toxins;
17. trichothecenové toxins;
18. viscumin;
19. volkensin.
5. Genetic elements and genetically modified organisms
5.1 Genetic elements that contain nucleic acid sequences
associated with pathogenicity of organisms specified in points 1-3.
5.2 Genetic elements that contain nucleic acid sequences
coding for any of the toxins mentioned in point 4, or coding for the subunits
the toxins mentioned in point 4.
5.3. the genetically modified organisms, that contain sequence
nucleic acids associated with pathogenicity of organisms specified in
points 1-3.
5.4. the genetically modified organisms, that contain sequence
nucleic acid coding for any of the toxins mentioned in point 4, or
coding for the subunits of the toxins mentioned in point 4.
5.5 chemically synthesized De novo genetic material and artificially created
organisms that contain nucleic acid sequences associated with the
the pathogenicity of organisms specified in points 1-3.
5.6 chemically synthesized De novo genetic material and artificially created
organisms that contain nucleic acid sequences coding for any of the
of the toxins mentioned in point 4, or coding for the subunits of the toxins mentioned
in point 4.
Notes:
1) micro-organisms referred to in point 1.2 of the 9. in particular, the tribes
serogroups 26, O91, O103, O45, O104, O111, O145, O121, O113, O157 and
other shiga toxins, producing or carrying genes coding for their
the production. The designation "shigatoxigenní strains of Escherichia coli (STEC)" is
equivalent to indicate "tribes or Enterohaemorrhagic Escherichia coli (VTEC)".
2) rules for dealing with toxins do not apply to control botulinum toxins
(section 4.4). or conotoxiny (section 4.7.) contained in medicinal products
registered under the law on pharmaceuticals.
3) Genetic elements include, among others, chromosomes, genomes,
plasmids, transposons, and vectors, both genetically modified and
unmodified.
Nucleic acid sequences associated with pathogenicity of organisms
referred to in points 1-3 represent any sequence specific to the
any of the above micro-organisms, that:
and) as such, or through their transcription or
of products represents a significant risk to the health of the people,
animals or plants, or
b) is known by the micro-organism, or any other
the organism into which it may be inserted or otherwise integrated, increases
its ability to cause serious damage to the health of people, animals or
plants.
4) for micro-organisms referred to in point 1.2 of the 9 "genetic elements, and
genetically modified organisms "referred to in section 5 apply only to
nucleic acid sequences that encode the shiga toxins (for the verotoxin) and
proteins similar to the shiga toxin, which inactivate Ribosomes, or their
the subunits.
Č. 2
The list of high-risk biological agents and toxins (section 2 (b), (e)) of the Act)
I. Viruses
1. virus Australian encephalitis (Murray Valley encephalitis virus);
2. virus Dobrava-Belgrade;
3. virus encephalitis St. Louis (St. Louis encephalitis virus);
4. Flexal virus;
5. the Guanarito virus;
6. Hendra virus (Equine morbilli virus);
7. virus fever Kyasanurského forest (Kyasanur forest disease virus);
8. the Chapare virus;
9. Choclo virus;
10. virus, tick-borne encephalitis virus, the virus of the Russian spring-summer encephalitis virus
(Tick-borne encephalitis virus, the Russian Spring-Summer encephalitis
virus);
11. Laguna Negra virus;
12. Nipah virus;
13. Oropouche virus;
14. Omsk hemorrhagic fever virus (Omsk hemorrhagic fever virus);
15. Powassan virus;
16. Puumala virus;
17. Rocio virus;
18. Sabiá virus;
19. the Seoul virus;
20. vrtivky virus (Louping ill virus);
21. West Nile virus (West Nile virus).
Ii. The Bacteria
1. Clostridium perfringens epsilon toxin-producing strains;
2. Clostridium tetani;
3. Legionella pneumophila;
4. Mycobacterium bovis (except BCG strain);
5. Mycobacterium tuberculosis (multidrug-resistant strains);
Xanthomonas albilineans; 6.
7. Xanthomonas campestris pv. citri including strains referred to as
Xanthomonas campestris pv. citri types A, B, C, D, E, or otherwise
classified as Xanthomonas citri, Xanthomonas campestris pv.
aurantifolia or Xanthomonas campestris pv. Citrumelo;
8. Yersinia pseudotuberculosis.
Iii. Fungi
1. Coccidioides immitis;
2. Coccidioides posadasii;
Colletotrichum coffeanum 3 var. Virulans (Colletotrichum kahawae);
4. Puccinia graminis (SYN. Puccinia graminis f. SP. tritici);
5. Puccinia striiformis (SYN. Puccinia glumarum).
IV. The toxins and their subunits
1. Tetanotoxin.
The genetic elements in., and genetically modified organisms
1. Genetic elements that contain nucleic acid sequences
associated with pathogenicity of organisms specified in sections I-III.
2. Genetic elements that contain nucleic acid sequences
coding for any of the toxins mentioned in point IV, or coding for the subunits
the toxins mentioned in point IV.
3. genetically modified organisms that contain nucleic sequences
acids associated with pathogenicity of organisms specified in sections I-III.
4. genetically modified organisms that contain nucleic sequences
acid sequences coding for any of the toxins mentioned in point IV, or coding
the subunits of the toxins mentioned in point IV.
5. chemically synthesized De novo genetic material and artificially created
organisms that contain nucleic acid sequences associated with the
the pathogenicity of organisms specified in sections I-III.
6. chemically synthesized De novo genetic material and artificially created
organisms that contain nucleic acid sequences coding for any of the
of the toxins mentioned in point IV, or coding for the subunits of the toxins mentioned
in point IV.
Notes:
Genetic elements include, among others, chromosomes, genomes, plasmids,
Transposons and vectors, both genetically modified and
unmodified.
Nucleic acid sequences associated with pathogenicity of organisms
referred to in points (I)-(III) represent any sequence specific to the
any of the above micro-organisms, that:
and) as such, or through their transcription or
of products represents a significant risk to the health of the people,
animals or plants, or
b) is known by the micro-organism, or any other
the organism into which it may be inserted or otherwise integrated, increases
its ability to cause serious damage to the health of people, animals or
plants. ".
Č. 3
Registration sheet
The name and location of the facility....................................... number: ... ... ... ... ... ....
(in which the operations are performed by registered) (records)
The name of the biological agents (toxin)................................ Serial number:.................
(according to the first party records)
The unit logged a lot ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ....
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The number of the date of reception of the supplier-consumer Stock Picking the type and number of the signature of the Note
record registration (number) (number) (number) (name, address, identification number) of the document (available in the recipient
sheet, picking list ...)
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1 2 3 4 5 6 7 8 9
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Č. 4
Declaration of high risk biological agents and toxinů1 and about objects
and the devices in which they are treated by
Form 1-Basic declarations form
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Business name or the name of the legal entity
people:
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Registered office:
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Identification number (if assigned):
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Natural person
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Name and surname:
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Social security number (if assigned, otherwise
date of birth):
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Country of citizenship:
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Stay:
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Responsible representative of the
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Name and surname:
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Social security number (if assigned, otherwise
date of birth):
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Country of citizenship:
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Stay:
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The statutory body or its members
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Name and surname:
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Social security number (if assigned, otherwise
date of birth):
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Country of citizenship:
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Stay:
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Name and surname:
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Social security number (if assigned, otherwise
date of birth):
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Country of citizenship:
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Stay:
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1) cross out what is not applicable
Form 2-type and quantity of high risk or risk
biological agents or toxins
The list of high risk (or risk) biological agents or
the toxins that are in your organization is being made (or will be handled)
The name of the
The amount, which is handling (loading)
The purpose of the
The treatment of
The final destination
The name of the
The amount, which is handling (loading)
The purpose of the
The treatment of
The final destination
The name of the
The amount, which is handling (loading)
The purpose of the
The treatment of
The final destination
The name of the
The amount, which is handling (loading)
The purpose of the
The treatment of
The final destination
The name of the
The amount, which is handling (loading)
The purpose of the
The treatment of
The final destination
The name of the
The amount, which is handling (loading)
The purpose of the
The treatment of
The final destination
Form 3-Device, in which the declared activities carried out
1. The name of the device---------------------------
2. The trade name or name---------------------------
legal/natural persons
---------------------------
---------------------------
3. the location (address) of the devices---------------------------
---------------------------
---------------------------
---------------------------
4. source (e) financing of waste management, including an indication of the declared,
whether it is fully or partially funded by the U.S. Department of Defense
---------------------------------------------------------------
5. Number of units with the device, the level of technical security BL4
inside the machine with indication of their area (m2)
---------------------------------------------------------------
6. in the absence of the unit with the device, the level of technical
Security BL4, indicate the highest level of protection
---------------------------------------------------------------
7. scope and general description of the waste, including the type (s)
micro-organisms or toxins
---------------------------------------------------------------
---------------------------------------------------------------
---------------------------------------------------------------
8. the type of device (Research Centre, laboratory, manufacturing
the unit...) ...................
9. the list of equipment referred to in paragraph 2 (a). (f)) and n) Act No. 281/2002 Coll.:
a) Chambers designed for aerosol challenge testing with
micro-organisms or toxins
static No/Yes-their overall volume......... m3
dynamic No/Yes-their overall volume......... m3
explosive No/Yes-their overall volume......... m3
Fermenters capable of cultivation of b) pathogenic micro-organisms,
viruses or toxins without leakage of aerosols with a total
capacity of 100 litres or more yes/no
specify the volume of the largest fermenter................ m3
Note: fermenters include bioreactors, chemostaty and
continuous flow fermentation systems
c) Centrifugal separators and decanters capable of continuous or
polokontinuálního operation without leakage of aerosols, which have
flow rate exceeding 100 litres per hour and are
capable of in-situ sterilisation in a closed state Yes/No
(d)): spray Dryer yes/no
drum yes/no
the main purpose of their usage:................................
............................................................
e) equipment for drying Steam Sterilizable frost with
the condenser capacity greater than 10 kg of ice in 24 hours and
less than 1000 kg of ice in 24 hours yes/no
f) equipment for cross (tangential) filtration capable
continuous flow separation without leakage of aerosols, which has
area of 5 m2 or larger, and is capable of in situ sterilization
YES/NO
g) Anaerobic Chamber yes/no
h) devices designed for micro-encapsulation (mikrozapouzdřování)
of living organisms, their products or components, including
toxins or biological material yes/no
I) equipment for destruction (upset) cells, including
ultrasonic devices, capable of continuous operation without
the release of aerosols with a capacity of more than 10 liters per hour
YES/NO
j) equipment used in molecular biology
device for nucleic acid sequence processing: Yes/No
Automatic synthesis of nucleic acid yes/no
sequential processing of peptides yes/no
Automatic synthesis of peptides, yes/no
to design or Chamber) used for the breeding of insects yes/no
The total volume of these chambers........... m3
l) Autoclaves designed to Sterilise infectious material with
the internal contents from 0.5 m3 yes/no
m), Mixační (mixed) incubators with a total capacity of the container
greater than 5 litres yes/no
n) input and output air via aerosol filter (HEPA)
YES/NO
about Protective clothing or pressure) self-contained breathing apparatus
used for purposes other than fire-yes/no
Form 3.1-Device, in which the declared activities carried out
Declaration of installations for the manufacture of vaccines
1. the name of the device:
2. The location (address) of the device:
3. a general description of the type of diseases covered:
Form 4-the purpose of the management of high risk or risk
biological agents or toxins
National biological defence programme of research and development
Is your organization involved in the national programme for the defence
biological research and development on the territory of the Czech Republic or anywhere
under its jurisdiction or control? The activity of such a program would
include prophylaxis, studies and pathogenitě and virulence, diagnostic
technology, aerobiologii, detection, treatment, toxinologii, physical
protection, decontamination and other related research.
Yes No
If YES, fill in the form 4.1, which describes the program.
Form No. 4.1-purpose of the management of high risk or risk
biological agents or toxins
The program of the national biological defence research and development
Description
1. State the objectives and funding of the program, and summarize the main research and
development activities carried out in the framework of the program. The addressed area should
include: prophylaxis, studies on pathogenicity and virulence, diagnostic
technology, aerobiologii, detection, treatment, toxicity, physical protection,
decontamination and other related research.
2. Give the total funding of the programme and its source.
3. aspects of the program Are carried out according to the contract with industry,
academic institutions or other devices outside the
the Ministry of defence?
Yes/No
4. If Yes, what proportion of the total funding of the programme is published in
These kontrahovaných or other devices?
5. Summarize the objectives and research programme, performed by contractors or
in other devices with finances identified under paragraph 4.
6. Please specify the schema of the organizational structure of the programme and relationships in administration
messages (including individual facilities participating in the programme).
7. To declare, in accordance with the form # 4.2 of every individual device,
both Government and non-governmental, which has a significant share of its resources designed
for national defense research and development program, on the territory of the
servicing the State or anywhere under its jurisdiction or control.
Form 4.2-the purpose of the management of high risk or risk
biological agents or toxins
The program of the national biological defence research and development
Device in which the declared activity is performed by:
Fill out the form for each individual device in accordance with point 7 in
form No. 4.1.
In a partitioned devices only provide the following information on the proportion of
the program of the defense research and development.
1. What is the name of the device?
2. Where it is located (including address and geographic location)?
3. the Surface area of the laboratory according to standards of technical security:
BL2................... (m2)
BL3................... (m2)
BL4................... (m2)
The total surface area of laboratories..................... (m2)
4. the organizational structure of each individual device.
(i) the total number of personnel......................
(ii) Division of personnel:
vojenský ......................
civilní ......................
(iii) Division of personnel by categories:
vědci ......................
inženýři ......................
technici ......................
Administrative and auxiliary
personál ......................
(iv) an overview of the scientific disciplines
representing the qualifications
scientific/engineering
employees.
(v) work in an external device
staff? If Yes,
Please indicate the approximate number of.
(vi) what (what) is (are) the source (e)
the financing of work carried out
on the device, including
whether the activity is fully or
in part financed by the
The Department of Defense?
(vii) what is the amount of funding for
the following program
area:
výzkum ......................
vývoj ......................
testing and evaluation ......................
(viii) describe briefly the publication
management policy:
(ix) provide a list of publicly
accessible documents and reports
arising from the work under the
the previous 12 months.
(Indicate the authors, titles, and
full links-reference).
5. describe briefly the activities for defence purposes to be carried out in
device. Please indicate the type (s) of micro-organisms, including viruses and prions
or studied toxins, as well as the types of biological aerosols
studied in the environment.
Form 5-publications and publication of results and the use of
knowledge of research
1. the list of the most important publications that were issued in the course of the
of the year
2. the list of the latest events (conferences, seminars) throughout the year
Form No. 6-contact list
1. The planned international conferences, symposia, seminars and other similar
Exchange forum
For each of the individual events should be listed with the following information:
-the name of the Conference etc. ......................
-organizing organization, etc. ......................
- doba ......................
- místo ......................
-the main theme of the Conference, etc. ......................
......................
......................
-conditions for participation ... ... ... ... ... ... ....
......................
-point of contact for further information
registration, etc. ......................
......................
......................
2. information on other occasions
.................................................................
................................................................
1) section 44 of the Act No. 111/1998 Coll., on universities and amending and supplementing
other laws (the law on universities).
2) § 89 and 90 of Act No. 111/1998 Coll.
