On The Monitoring Of Zoonoses And Zoonotic Agents

Original Language Title: o sledování zoonóz a původců zoonóz

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=58096&nr=356~2F2004~20Sb.&ft=txt

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.