Decree No. 356 / 2004 Coll.
Decree on the monitoring of zoonoses and zoonotic agents and amending Decree No. 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans
Valid
Order
Effective from 12.06.2004
356
DECLARATION
of 1 June 2004
on the monitoring of zoonoses and zoonotic agents and amending Decree No. 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans
The Ministry of Agriculture provides pursuant to Section 78 of Act No. 166 / 1999 Coll., on Veterinary Care and on the amendment of certain related laws (Veterinary Act), as amended by Act No. 131 / 2003 Coll., ("the Act ') for the implementation of Sections 5 (3), 10 (3) (g), 48 (2) and 51a (3) of the Act:
MONITORING OF ZOONOSIS, ORIGINATOR OF ZOONOSIS AND RESIDENCE FOR ANTIMICROBIAL SUBSTANCES
Subject matter
(1) This decree, in accordance with the law of the European Communities (1), regulates:
(a) the system and method of collecting, evaluating and disseminating data relating to the occurrence of zoonoses and zoonotic agents;
(b) the system and method of collecting, evaluating and disseminating information on antimicrobial resistance related to zoonoses and zoonotic agents;
(c) epidemiological investigation of food outbreaks;
(d) exchange of information in relation to zoonoses and zoonotic agents.
(2) This decree is without prejudice to the provisions of specific legislation governing animal health and nutrition, animal protection, food hygiene, protection of public health against infectious diseases, health and safety at the workplace, genetic technology, transmissive spongiform encephalopathy and the management of high risk and risk biological agents.
Definition of terms
(1) For the purposes of this decree:
(a) zoonoses - diseases or infections which are naturally communicable directly or indirectly between animals and humans,
(b) the agent of zoonosis - virus, bacteria, fungus, parasite or other biological entity which may cause zoonosis;
(c) antimicrobial resistance - the ability of micro-organisms of certain species to survive or even grow in the presence of a given antimicrobial concentration which is generally sufficient to suppress or destroy micro-organisms of the same species;
(d) an outbreak of food disease - the occurrence of the same disease or infection, observed in the circumstances in two or more cases in humans, or a condition where the number of cases observed exceeds the expected number and these cases are bound or likely to be linked to the same food source;
(e) monitoring - a system of collection, evaluation and dissemination of data relating to the occurrence of zoonoses and zoonotic agents ("monitoring of zoonoses and zoonotic agents") and associated resistance to antimicrobial substances ("monitoring of antimicrobial resistance").
(2) If this decree uses the terms food, feed, danger and risk, this means their definition in the immediately binding regulation of the European Community.2)
General principles for monitoring zoonoses and zoonotic agents and for monitoring antimicrobial resistance
(1) The State Veterinary Administration, in accordance with Article 57 (1) of the Act, shall cooperate with the veterinary authorities of other official food surveillance bodies, (4) public health authorities, (5) or other bodies, organisations and bodies which perform or participate in certain tasks related to monitoring under this Decree; This cooperation is based on the free exchange of general information6) and the specific data subject to monitoring.
(2) In accordance with Article 48 (1) (o) (2) of the Act, the State Veterinary Administration shall inform the European Commission (hereinafter referred to as "the Commission") that it is a contact point for the Commission on matters covered by this Decree.
Monitoring of zoonoses and zoonotic agents
(1) Within the framework of the monitoring of zoonoses and zoonotic agents, established and comparable data are collected in a manner that allows identification, characterisation and risk assessment of zoonoses and zoonotic agents.
(2) Monitoring of zoonoses and zoonotic agents is carried out on those sections of the food chain in which zoonoses or zoonotic agents, i.e. at the level of primary production, as well as on other sections of the food chain, including food and feed, are most likely to occur. Monitoring of zoonoses and zoonotic agents includes zoonoses and zoonotic agents listed in Part A of Annex 1 to this Regulation and, if the epidemiological situation so requires, zoonoses and zoonotic agents listed in Part B of Annex 1 to this Regulation.
(3) Where the European Union institutions (hereinafter referred to as "the Union") are established in order to facilitate the collection and comparison of data, in particular those concerning the population or sub-population of animals, or the sections in the food chain to be included in the monitoring, the types and types of data collected, the definitions of the cases used, the sampling schemes used, the control methods used and the reporting frequency between local, regional and central authorities, including the methodological instructions thereto, shall be followed by these rules.
Where the institutions of the Union, taking into account the need for risk analysis or the determination of baseline values for zoonoses and zoonotic agents at Member State or Union level, and taking into account zoonoses and zoonotic agents referred to in the immediately binding European Community7) coordinated monitoring programmes, shall be carried out in accordance with Annex 3 to this Regulation.
Persons referred to in Article 22 (1) of the Act carrying out tests for the presence of zoonoses and zoonotic agents subject to monitoring pursuant to Article 4 (2),
(a) keep records of the results of the tests and keep such records for at least two years and the relevant isolates, which are the cultures of the disease or infection agents, for at least one year;
(b) communicate on request the results of the examination and provide the relevant isolates to the national veterinary surveillance authorities.
Antimicrobial resistance monitoring
(1) In the framework of the monitoring of antimicrobial resistance, comparable data on the occurrence of antimicrobial resistance in zoonotic agents and other agents are collected in accordance with the requirements set out in Annex 2 to this Regulation, if they pose a public health risk.
(2) Monitoring of resistance to antimicrobial substances complements the monitoring of human isolates carried out in accordance with the European Community Regulation. 8)
(3) Where Union institutions lay down detailed rules for the monitoring of resistance to antimicrobial substances, they shall comply with those rules.
Epidemiological investigation of food outbreaks
(1) Where the person referred to in Article 6 is required to provide the national veterinary surveillance authorities with information in accordance with the immediately binding provisions of the European Communities, 9) he shall keep the food in question or a sample thereof in accordance with Article 22 (1) (e) of the Act in such a way that they are not disqualified for their laboratory examination or for an outbreak of food diseases.
(2) State veterinary surveillance authorities are investigating outbreaks of food diseases in cooperation with public health authorities. 10) The investigation shall examine in particular the facts concerning the epidemiological profile, the potentially affected food and the causes of the disease or its agent. Where possible, the examination shall also include appropriate epidemiological and microbiological studies. Where the Union institutions lay down detailed rules for the implementation of epidemiological investigations into food outbreaks, they shall be implemented in accordance with those rules.
(3) In accordance with Section 48 (1) (o) (2) of the Act, the State Veterinary Administration shall submit to the Commission a summary report on the results of the examination carried out and on the data set out in Part E of Annex 4 thereto.
(4) The provisions of paragraphs 1 and 2 are without prejudice to the provisions of specific legislation relating to the health of products, early warning and warning systems for the prevention and control of infectious diseases in humans, food hygiene and general food requirements, (4) in particular those relating to measures and procedures leading to the withdrawal of food and feed from circulation.
Exchange of information
(1) The State Veterinary Administration shall, in accordance with Article 48 (1) (a) of the Act, evaluate the sources and trends of zoonoses, zoonotic agents and resistance to antimicrobial substances on the territory of the Czech Republic and in accordance with Article 48 (1) (o) (2) of the Act, shall report annually to the Commission by the end of May of the relevant calendar year the results of that evaluation and the data collected during the last year in accordance with Sections 4, 7 and 8.
(2) The requirements for the content of the report referred to in paragraph 1 are set out in Annex 4 to this Regulation. The report must also contain the information needed to assess the funds used in the implementation of the programmes referred to in Article 5 and to assess the results achieved, in accordance with the immediately binding European Communities Regulation (11).
(3) Where the Union institutions lay down detailed rules concerning the reporting referred to in paragraph 1, its content and its formats, they shall be implemented in accordance with those rules.
(4) In accordance with Section 48 (1) (o) (2) of the Act, the State Veterinary Administration provides the Commission with the results of the activities related to the implementation of those programmes where Union institutions provide for coordinated monitoring programmes.
National reference laboratories
The State Veterinary Administration, in accordance with Section 48 (1) (e) of the Act, proposes to the Ministry of Agriculture the approval of national reference laboratories for the monitoring of zoonoses and zoonotic agents and for the monitoring of resistance to antimicrobial substances for each area for which the Union reference laboratory was designated. The State Veterinary Administration shall inform the Commission of the approved national reference laboratories in accordance with Section 48 (1) (o) (2) of the Act.
Transitional provision
The plan of measures for the detection of zoonoses and zoonotic agents and the monitoring plan for Salmonella in poultry flocks, adopted in accordance with Section 128 of Decree No 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans, and approved by the Commission, shall remain in force until the respective control programmes have been approved in accordance with the immediately binding Regulation of the European Communities. 12)
EFFECTIVE
This Decree shall take effect on 12 June 2004.
Minister:
Ing. Palas v. r.
Příloha č. 1
Annex No 1 to Decree No 356 / 2004 Coll.
MONITORATED ZOONOSIS AND ORIGIN OF ZOONOSIS
A. Zoonoses and zoonotic agents to be included in the monitoring
- brucellosis and its agents
- campylobacteriosis and its agents
- echinococcosis and its agents
- listeriosis and its agents
- salmonella and its agents
- Trichinella and its agents
- tuberculosis caused by Mycobacterium bovis
- Verotoxic Escherichia coli
B. List of zoonoses and zoonotic agents to be monitored according to the epidemiological situation
1. Viral Zoonoses
- Calicia virus
- hepatitis A virus
- influenza virus
- rabies
- viruses transmitted to arthropods
2. Bacterial Zoonoses
- disease and its agents
- botulism and its agents
- leptospirosis and its agents
- psitakosis and its agents
- tuberculosis except tuberculosis as referred to in point A
- vibriosis and its agents
- yersiniosis and its agents
3. Parasitic Zoonoses
- anisakiasis and its agents
- cryptosporidiosis and its agents
- cysticercosis and its agents
- toxoplasmosis and its agents
4. Other zoonoses and zoonotic agents
Příloha č. 2
Annex No 2 to Decree No 356 / 2004 Coll.
REQUIREMENTS FOR THE MONITORING OF REZISTENCE FOR ANTIMICROBIAL SUBSTANCES
A. General requirements
It shall be ensured that monitoring of antimicrobial resistance carried out in accordance with Section 7 provides at least the following information:
1. the animal species concerned by the monitoring;
2. the bacterial species and / or strain concerned by the monitoring;
3. the sampling system used in monitoring;
4. antimicrobials to be monitored;
5. the laboratory methodology used to detect resistance;
6. the laboratory methodology used to identify microbial isolates;
7. methods used for data collection.
B. Specific requirements
It shall be ensured that the monitoring of resistance to antimicrobial substances provides adequate information at least as regards the representative number of Salmonella spp., Campylobacter jejuni and Campylobacter coli derived from bovine, porcine, poultry and animal food derived from these species.
Příloha č. 3
Annex No. 3 to Decree No. 356 / 2004 Coll.
COORDINATED MONITORING PROGRAMMES
Where coordinated monitoring programmes referred to in Section 5 are set up, at least the following characteristics of the monitoring programme shall be defined:
- its purpose;
- its duration;
- geographical area or region;
- the zoonoses and zoonotic agents concerned;
- the type of samples taken and other data required;
- minimum sampling schemes;
- the type of laboratory testing methods;
- the tasks of the competent authorities;
- the appropriations to be allocated;
- the envisaged costs and the way in which they are financed;
- method and time of reporting of results.
Příloha č. 4
Annex No 4 to Decree No 356 / 2004 Coll.
REQUIREMENTS FOR STATEMENT OF DECLARATIONS
Reports submitted pursuant to § 9 shall contain at least the following information, the parts of which are: A to D refers to reports made in accordance with § 4 or § 7 and part E refers to reports made in accordance with § 8.
A. At first, for each zoonosis and zoonotic agent, the following data should be described (later only changes are reported):
(a) monitoring systems (sampling strategy, sampling frequency, type of sample, case definition, diagnostic methods used);
(b) principles of procedure (tactics) for vaccination and other preventive actions;
(c) control mechanisms and any control programmes;
(d) measures in the case of positive findings or individual cases;
(e) an existing reporting system;
(f) history of disease and / or infection in the country.
B. Each year, the following data shall be described:
(a) the relevant susceptible animal population (together with the date to which the following figures relate):
- the number of herds or flocks,
- the total number of animals,
- and, where relevant, relevant production methods,
(b) number and general description of laboratories and institutions involved in monitoring.
C. The details and the following categories of data for each zoonosis and zoonotic agent, together with their effects, shall be described annually:
(a) changes in systems already described;
(b) changes in the methods previously described;
(c) results of investigations and results of further typing or other laboratory characterisation methods (reported separately for each category);
(d) national evaluation of the current situation, trends and sources of infection;
(e) relevance as zoonosis;
(f) the relevance of the results found in animals and foodstuffs for human cases as a source of human infection;
(g) recognised control strategies that could be used to prevent or minimise the transmission of zoonotic agents to the human population;
(h) if necessary, any specific action decided in a Member State or proposed by the Community as a whole on the basis of the current situation.
D. Reporting of test results:
The reports submitted indicate the number of epidemiological units (flocks, herds, samples, serial numbers) tested and the number of positive samples as defined in the case. If necessary, the results are presented in a way that shows the geographical range of zoonoses and zoonotic agents.
E. Data on an outbreak of food-derived disease:
(a) the total number of outbreaks during the year;
(b) the number of deaths and diseases in humans in these outbreaks;
(c) the agents of the outbreak, including, where possible, the serotype or other relevant description of the agents. If identification of the originator is not possible, the reason why it is;
(d) foodstuffs for which there is evidence of participation in the outbreak and other potential means of participation;
(e) identification of the place where the food was produced / bought / obtained / consumed;
(f) factors that have contributed to the outbreak, such as shortcomings in food hygiene.
1) Directive 2003 / 99 / EC of the European Parliament and of the Council of 17 November 2003 on the monitoring of zoonoses and zoonotic agents, amending Council Decision 90 / 424 / EEC and repealing Council Directive 92 / 117 / EEC.
2) Article 2 and 3 of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements 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 feedingstuffs, as amended by Act No. 244 / 2000 Coll., Act No. 147 / 2002 Coll., Act No. 320 / 2002 Coll. and Act No. 21 / 2004 Coll.
4) Act No. 110 / 1997 Coll., on Food and Tobacco Products and amending and supplementing certain related laws, as amended by Act No. 166 / 1999 Coll., Act No. 119 / 2000 Coll., Act No. 306 / 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 Coll.
5) Act No. 258 / 2000 Coll., on the Protection of Public Health and on the Amendment of Certain Related Acts, as amended by Act No. 254 / 2001 Coll., Act No. 274 / 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. 362 / 2003 Coll. and Act No. 167 / 2004 Coll.
6) Articles 9, 13, 21 (1) and (3) of Decree No. 329 / 2003 Coll., on the Information System of the State Veterinary Administration.
7) Annex I to Regulation (EC) No 2160 / 2003 of the European Parliament and of the Council of 17 November 2003 on the control of salmonella and certain other food-borne zoonotic agents.
8) Decision No 2119 / 98 / EC of the European Parliament and of the Council of 24 September 1998 establishing a network of epidemiological surveillance and control of communicable diseases in the Community.
9) Article 19 (3) of Regulation (EC) No 178 / 2002 of the European Parliament and of the Council.
10) Article 1 of Decision No 2119 / 98 / EC of the European Parliament and of the Council.
11) Article 3 (2) (b) of Regulation (EC) No 2160 / 2003 of the European Parliament and of the Council.
12) Article 5 of Regulation (EC) No 2160 / 2003 of the European Parliament and of the Council.
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Regulation Information
| Citation | Decree No 356 / 2004 Coll., on the monitoring of zoonoses and zoonotic agents and amending Decree No 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.06.2004 |
|---|---|
| Effective from | 12.06.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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