356/2004 Sb.
DECREE
from day 1. June 2004
Tracking (monitoring) of zoonoses and zoonotic agents and amending Decree No.
299/2003 Coll., on measures for the prevention and control of diseases and illnesses
transmissible from animals to man
The Ministry of agriculture lays down pursuant to § 78 of Act No. 167/1999 Coll., on the
veterinary care and amending certain related laws (health
Act), as amended by Act No. 131/2003 Coll. (hereinafter the "Act") to perform
§ 5 para. 3, section 10, paragraph 1. 3 (b). (g)), § 48 para. 2 and § 51a para. 3
the law:
PART THE FIRST
TRACKING (MONITORING) ZOONOSES, ZOONOTIC AGENTS AND RESISTANCE TO
ANTIMICROBIAL
§ 1
The subject of the edit
(1) this Ordinance in accordance with the law of the European Communities ^ 1)
modifies the
and system and method), collection, evaluation and dissemination of the data that is
related to the occurrence of zoonoses and zoonotic agents,
(b)) system and method of collection, evaluation and dissemination of information on
antimicrobial resistance, related to the adoption and
originators of zoonoses,
(c) epidemiological investigations of outbreaks of disease) from the food
(d)) the exchange of information in relation to specified zoonoses and specified zoonotic diseases.
(2) the provisions of this Decree shall not prejudice the provisions of the special legal
the rules governing animal health requirements on health and nutrition
animals, animal protection, food hygiene, protecting public health from
infectious diseases, health and safety in the workplace, genetic
transmissible spongiform encephalopathy, technology and management
high risk and hazardous biological agents.
§ 2
Definition of terms
(1) For the purposes of this Ordinance, means the
zoonosis-disease) or infections, which are naturally portable
directly or indirectly between animals and humans,
b) zoonotic virus, bacterium, fungus, parasite or other
biological entity that can cause a zoonosis,
c) resistance to antimicrobial-the ability of micro-organisms
of certain species to survive or even to grow in the presence of a given concentration of
antimicrobial agent, that is usually sufficient to inhibit or
the destruction of the microorganisms of the same kind,
(d) an outbreak of illness from food)-the incidence of the same disease or
infection, observed under given circumstances in two or more cases at the
the people or the State, when pursued by the number of cases exceeds the expected number of
and these cases are linked, or likely to be bound to the same
the food source,
e-tracking system) collection, evaluation and dissemination of data
relate to the occurrence of zoonoses and zoonotic agents (hereinafter referred to as "monitoring of zoonoses
and their agents ") and associated antimicrobial resistance
substances (hereinafter referred to as "monitoring antimicrobial resistance").
(2) If this Decree uses the terms food, animal feed, risk and
the risk, this means their definition in the immediately binding rules
Of the European communities. ^ 2)
§ 3
General principles of monitoring of zoonoses and zoonotic agents and monitoring
antimicrobial resistance
(1) the State Veterinary Administration in accordance with § 57 para. 1 of the law
cooperate with the authorities of the professional supervision of feedingstuffs, ^ 3) other bodies
State supervision over food, ^ 4) public health authorities, ^ 5)
button is clicked. with other authorities, organisations and institutions, which perform or
involved in the performance of certain tasks related to the monitoring referred to in
of this order; This cooperation is based on free exchange of General
^ 6) information and specific data that are subject to monitoring.
(2) the State Veterinary Administration in accordance with § 48 para. 1 (b). about point 2)
the Act shall inform the European Commission (hereinafter referred to as "the Commission") that is
the contact point for the Commission in matters governed by this Decree.
Monitoring of zoonoses and zoonotic agents
§ 4
(1) in the framework of the monitoring of zoonoses and zoonotic agents are collected
fixed and comparable data in a manner allowing the identification,
characteristics and evaluation of the hazards and risks in relation to the adoption of that directive, and
specified zoonoses.
(2) the Monitoring of zoonoses and zoonotic agents is done on those sections of the
the food chain, in which most easily can lead to the occurrence of zoonoses
or zoonotic agents, i.e.. at the level of primary production, as well as other
sections of the food chain, including in food and feed. Monitoring
zoonoses and zoonotic agents covers zoonoses and zoonotic agents referred to in
part A of annex 1 to this notice, and if required by the epidemiological
the situation also zoonoses and zoonotic agents listed in part B of annex 1 to the
This Decree.
(3) if the authorities of the European Union (hereinafter referred to as "the Union") in order to facilitate the
data collection and benchmarking established detailed rules
monitoring, in particular the rules relating to the population or subpopulations
animals, or segments in the food chain, which has monitoring
include, kinds and types of data collected, the definition of cases,
used sampling schemes, used control methods and
the frequency of reporting between local, regional and central authorities, including
methodical instructions to them, proceed according to the following rules.
§ 5
Where the institutions of the Union in view of the need for risk analysis or determination of
the default values related to zoonoses and zoonotic agents at the level of
the Member State or the Union, and taking into account the specified zoonoses and specified zoonotic diseases
referred to in the provisions of the European communities immediately binding ^ 7)
coordinated monitoring programmes, shall be treated in accordance with the annex
No. 3 to this notice.
§ 6
The persons referred to in section 22 para. 1 of the law, carrying out examinations on
the presence of zoonoses and zoonotic agents subject to monitoring under section 4
paragraph. 2,
and) maintain records of the results of the test and shall keep these records for the
for at least two years, and the respective isolates, which means the culture
zoonotic disease or infection, for a period of at least one year,
(b) shall communicate on request) the test results and provide the respective isolates
the authorities of the State veterinary supervision.
§ 7
Monitoring of antimicrobial resistance
(1) in the framework of monitoring antimicrobial resistance in
accordance with the requirements set out in annex 2 to this Decree
gather comparable data on the occurrence of antimicrobial resistance
substances of zoonotic agents. other agents if they represent
threat to public health.
(2) the Monitoring of antimicrobial resistance the following
the monitoring of human isolates conducted in accordance with the European
community. ^ 8)
(3) where the institutions of the Union, the detailed rules for the monitoring of resistance
against antimicrobial, proceed in accordance with these rules.
§ 8
Epidemiological investigation of outbreaks of food-borne disease
(1) If a person referred to in paragraph 6 of the obligation to provide the authorities of the State
surveillance information in accordance with the immediately binding
Regulation of the European communities, ^ 9) is kept in accordance with section 22 paragraph 1. 1
(a). e) of the Act in question or the food sample in such a way
that is not depreciated for their examination in the laboratory or examination
outbreaks of food-borne disease.
(2) the authorities of the State are investigating an outbreak of disease surveillance of the
food in collaboration with the public health authorities. ^ 10)
The investigation will determine in particular the matters relating to the
the epidemiological profile, the foodstuffs potentially affected and account
causes of the occurrence of the disease coming or his agent. If it is
possible, the examination also includes the corresponding epidemiological and
Microbiological studies. If the institutions of the Union shall establish detailed rules for the
epidemiological investigation of outbreaks of food-borne disease, the procedure is
in accordance with these rules.
(3) the State Veterinary Administration in accordance with § 48 para. 1 (b). about point 2)
the Act shall send the Commission a summary report on the results of the executed
examination and about the information listed in part E of annex 4 to this notice.
(4) the provisions of paragraphs 1 and 2 are without prejudice to the provisions of the Special
legislation relating to health products,
early warning and alert systems in the area of the surge
Prevention and control of infectious diseases in humans, food hygiene and
General foods, ^ 4) and especially those that relate to the
measures and procedures leading to the withdrawal of food and feed.
§ 9
The exchange of information
(1) the State Veterinary Administration in accordance with § 48 para. 1 (b). and) Act
evaluates the sources and trends of zoonoses, zoonotic agents and resistance to
antimicrobial in the Czech Republic and in accordance with section 48
paragraph. 1 (b). of paragraph 2 of the law) shall send the Commission each year before the end of the
in May of the calendar year reporting on the results of this
reviews and information gathered in the course of the past year in accordance with the
§ 4, 7 and 8.
(2) the requirements for the content of the reports referred to in paragraph 1 are listed in annex
No 4 to this notice. Reports shall also in accordance with the immediately
binding by a regulation of the European communities ^ 11) contain the data needed
for an assessment of the resources used for the implementation of the programmes referred to in §
5 and for the assessment of the results achieved.
(3) if the authorities of the Union provides for the detailed rules concerning the information referred to in
paragraph 1, of its contents and formats, it shall proceed in accordance with the following
the rules.
(4) if the authorities of the Union provides for coordinated monitoring programmes,
provides State Veterinary Administration in accordance with § 48 para. 1 (b). about)
point 2 of the Act to the Commission the results of the activities related to the implementation of these
programs.
§ 10
National reference laboratories
The State Veterinary Administration in accordance with § 48 para. 1 (b). e) of the Act
the Ministry of agriculture is proposing approval of the national reference
laboratories in the field of the monitoring of zoonoses and zoonotic agents and monitoring
antimicrobial resistance, for each area, for
the Union reference laboratory was established. The State Veterinary Administration
in accordance with § 48 para. 1 (b). of paragraph 2 of the law) shall inform the Commission of the
the approved national reference laboratories.
§ 11
Transitional provision
The plan of measures for the detection of zoonoses and zoonotic agents and monitoring plan
salmonella in flocks of poultry, adopted in accordance with section 128 of Decree No.
299/2003 Coll., on measures for the prevention and control of diseases and illnesses
transmissible from animals to humans, and approved by the Commission shall remain in
force until the approval of the respective control programmes based on
directly binding regulation of the European communities. ^ 12)
PART TWO
Amendment of the Decree on measures for the prevention and control of diseases and illnesses
transmissible from animals to man
§ 12
Decree No. 299/2003 Coll., on measures for the prevention and control of
diseases and diseases transmissible from animals to humans, is amended as follows:
1. In paragraph 1 (b). and) the words "and diseases transmissible from animals to man
(hereinafter referred to as "zoonosis") ' shall be deleted.
2. In paragraph 1 (b). (b)), the words "and zoonoses" are deleted.
3. In paragraph 2, points (g) and (h))) shall be deleted.
4. in part two, title XII, including the title and the annexes No 20 to 22
repealed.
PART THREE
The EFFECTIVENESS of the
section 13 of the
This Decree shall enter into force on 12 March 2005. June 2004.
Minister:
Ing. Palas in r.
Č. 1
ZOONOSES AND ZOONOTIC AGENTS TO BE MONITORED
A. zoonoses and zoonotic agents to be included in the monitoring
-brucellosis and agents thereof
-campylobakterióza and agents thereof
-echinococcosis and agents thereof
-Listeriosis and agents thereof
-salmonellosis and agents thereof
-be infested with trichinae and agents thereof
-tuberculosis due to Mycobacterium bovis
-verotoxigenic Escherichia coli
B. list of zoonoses and zoonotic agents to be monitored according to the
the epidemiological situation
1. Viral zoonoses
-virus Calicia
-hepatitis A virus
-influenza virus
-rabies
-viruses by arthropods
2. Bacterial zoonoses
-borreliosis and agents thereof
-botulism and agents
-leptospirosis and agents thereof
-psittacosis and agents thereof
-In addition to tuberculosis tuberculosis referred to in point A
-vibrióza and agents thereof
-yersinióza and agents thereof
3. Parasitic zoonoses
-anisakiáza and agents thereof
-Cryptosporidiosis and agents thereof
-cysticercosis and agents thereof
-toxoplasmosis and agents thereof
4. Other zoonoses and zoonotic agents
Č. 2
REQUIREMENTS FOR THE MONITORING OF ANTIMICROBIAL RESISTANCE
A. General requirements
It must be ensured that the monitoring of antimicrobial resistance
substances carried out pursuant to § 7 provides at least the following information:
1. the animal species in which the monitoring applies;
2. bacterial species and/or strain to which the monitoring applies;
3. the sampling system, which is used in monitoring;
4. antimicrobials, which the monitoring applies;
5. Laboratory methodology used for the detection of resistance;
6. Laboratory methodology used for the identification of microbial
isolates;
7. the methods used for data collection.
B. specific requirements
It must be ensured that the monitoring of antimicrobial resistance
the additives provide adequate information, at least as regards the
a representative number of isolates of Salmonella spp., Campylobacter jejuni, and
Campylobacter coli derived from bovine animals, pigs, poultry and food
of animal origin obtained from these species.
Č. 3
COORDINATED MONITORING PROGRAMMES
If they are established coordinated monitoring programmes referred to in paragraph 5, it shall
be defined at least the following characteristics of the monitoring program:
-its purpose;
-its duration;
-the geographical area or region;
-What are the zoonoses and zoonotic agents concerned;
-the type of samples to be taken and the other required information;
-minimum sampling schemes;
-the type of laboratory diagnostic methods;
-the tasks of the competent authorities;
-resources to be allocated;
-the estimated costs and how to finance them;
-the method and time of reporting the results.
Č. 4
REQUIREMENTS FOR THE CONTENTS OF THE REPORT
Reports submitted under section 9 shall contain at least the following
information, and part A to D apply to reports carried out in
accordance with section 4 or section 7 and part E applies to a message carried out in
accordance with § 8.
A. initially, it should be for each zoonosis and zoonotic agent concerned to describe
the following details (later reports only the changes):
(a) monitoring systems (sampling strategies, frequency of sampling
samples, kind of specimen, case definition, diagnostic methods used);
(b) principles of the procedure (tactics) vaccination and other preventive actions;
(c) the control mechanisms and possible control programmes;
(d) the measures in the case of positive findings or single cases;
(e) the existing reporting system;
(f) history of the disease and/or infection in the country.
B. describe each year the following data:
(a) relevant susceptible animal population (together with the date on which the
subject to the following figures):
-number of herds or flocks,
-the total number of animals,
-and, where applicable, the methods of production,
(b) the number and general description of the laboratories and institutions involved in the
monitoring.
C. describe the details of each year and for the following categories of data
each zoonosis and zoonotic agent concerned and with their effects:
(a) changes in the systems already described;
(b) changes in previously described methods;
(c) the results of the investigation and the results of further typing or other method
characterisation in laboratories (for each category reported on separately);
(d) national evaluation of the current situation, trends and sources of infection;
(e) relevance as zoonotic disease;
(f) the relevance of the results observed in animals and foodstuffs for cases
in humans as the source of infection of people;
(g) control strategies recognised that could be used to prevent
or minimize the transmission of zoonotic agents on human population;
(h) if necessary, any specific action that was
decided in the Member State or the community that was designed as a
of the whole on the basis of the current situation.
(D) Reporting the results of the tests:.
Given number of epidemiological reports state
units (flocks, herds, samples, serial number) and the number of positive
the samples according to the case definition. If necessary, the results are
presented in a way that shows the geographical scope of zoonoses and
zoonotic agents.
(E) data on the outbreak of the disease. the origin of the foods:
(a) the total number of outbreaks during the year;
(b) the number of human deaths and disease among people in these outbreaks;
(c) the originator of the outbreak, including, where possible, serotype or other
definitive description of the agents. If it is not possible, the identification of a
the reason why this is so;
(d) the food for which it is the proven participation in outbreak and more
potential means of participation;
(e) the identification of the place where the food is produced/purchased/
acquired/consumed;
(f) the factors that contributed to the occurrence of outbreaks, such as deficiencies in
hygiene in food processing.
1) directive of the European Parliament and of the Council 2003/99/EC of 17 May 1999.
November 2003 on the monitoring of zoonoses and zoonotic agents, amending decision
90/424/EEC and repealing Council Directive 92/117/EEC.
2) Article. 2 and 3 of the European Parliament and Council Regulation (EC) No 178/2002 of
28 June 1999. January 2002 laying down the General principles and requirements of
of food law, establishing the European food safety authority and
laying down procedures in matters of food safety.
3) Act No. 91/1996 Coll., on feedstuffs, as amended by Act No. 247/2000 Coll.,
Act No. 147/2002 Coll., Act No. 320/2002 Coll. and Act No. 21/2004 Sb.
4) Act No. 110/1997 Coll. on foodstuffs and tobacco products and
amendments to some related laws, as amended by Act No.
166/1999 Coll., Act No. 121/2000 Coll., Act No. 308/2000 Coll., Act No.
146/2002 Coll., Act No. 131/2003 Coll., Act No. 274/2003 Coll., Act No.
94/2004 Coll. and Act No. 316/2004 Sb.
5) Act No. 258/2000 Coll., on the protection of public health and amending
some related laws, as amended by Act No. 254/2001 Coll., Act
No. 276/2001 Coll., Act No. 13/2002 Coll., Act No. 76/2002 Coll., Act
No. 86/2002 Coll., Act No. 120/2002 Coll., Act No. 320/2002 Coll., Act
No 274/2003 Coll., Act No. 356/2003 Coll., Act No. 361/2003 Coll. and
Act No. 167/2004 Sb.
6) § 9, 13, § 21, art. 1 and 3 of Decree No. 329/2003 Coll. on information
of the State Veterinary Administration.
7) Annex I to the regulation of the European Parliament and of the Council (EC) No 2160/2003 of the
17 May. November 2003 on the control of salmonella and some other agents
zoonoses present in the food chain.
8) European Parliament and Council Decision No 2119/98/EC of 24 July 2003.
September 1998 setting up a network for the epidemiological surveillance and control of communicable
diseases in the community.
9) Article. 19 para. 3 European Parliament and Council Regulation (EC) No.
178/2002.
10) Article. 1 European Parliament and Council decision No 2119/98/EC.
11) Article. 3 (2). 2 (a). b) European Parliament and Council Regulation (EC)
No 2160/2003.
12) Article. 5 European Parliament and Council Regulation (EC) No 2160/2003.
