Decree No. 316 / 2007 Coll.
Decree amending Decree No. 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans, as amended
Valid
Order
Effective from 01.01.2008
Text versions:
01.01.2008
11.12.2007
316
DECLARATION
of 3 December 2007
amending Decree No 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans, as amended
The Ministry of Agriculture provides pursuant to § 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., Act No. 316 / 2004 Coll. and Act No. 48 / 2006 Coll., ("the Act ') for the implementation of Article 10 (3) (e) and (g) of the Act:
Decree No. 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans, as amended by Decree No. 356 / 2004 Coll., Decree No. 389 / 2004 Coll., Decree No. 214 / 2005 Coll. and Decree No. 36 / 2007 Coll., are amended as follows:
1. In footnote 1, the words "Commission Directive 92 / 119 / EEC of 17.12.1992 introducing general Community measures for the control of certain animal diseases as well as specific measures in relation to swine vesicular disease 'are inserted after the words" Commission Directive 2007 / 10 / EC of 21.2.2007 amending Annex II to Council Directive 92 / 119 / EEC as regards measures to be taken within the protection zone following an outbreak of swine vesicular disease'.
2. in Article 27 (1) (f):
"(f) meat originating from pigs referred to in (e) (1)
1. must not be the subject of intra-Union or international trade and must bear the health mark laid down by the rules on animal health requirements for livestock products4),
2. must be obtained, cut, transported and stored separately from meat intended for intra-Union trade or international trade and must not be used for the manufacture of meat products intended for intra-Union trade or international trade unless it has undergone a treatment in accordance with the animal health requirements Regulation (4). ';
3. In Article 27, the following paragraph 5 is added:
"(5) Where the prohibitions referred to in point (e) of paragraph 1 are in force for more than 30 days because of the occurrence of other cases of disease and where animal welfare problems arise as a result, the competent authority may authorise the transport of animals from a holding situated in the protection zone, at the reasoned request of the owner and if the official veterinarian has verified the status of the animals. Paragraph 1 (e) shall apply mutatis mutandis. ';
4. In Paragraph 143, the current text becomes paragraph 1 and the following paragraph 2 is added:
"(2) The results of tuberculination shall be evaluated in accordance with Annex 20 to this Regulation. ';
5. Annex 20 shall read as follows:
"Annex No 20 to Decree No 299 / 2003 Coll.
Tuberculosis
1. IDENTIFICATION OF THE ORIGIN
The presence of Mycobacterium bovis (M. bovis), a bovine tuberculosis agent, in clinical and autopsy samples can be demonstrated by dye coating testing or immunoperoxidase techniques and confirmed by culture of the micro-organism on the primary isolation soil.
The autopsy material for the confirmation of M. bovis should be collected from pathomorphologically altered lymph nodes and parenchymatous organs such as lungs, liver, spleen, etc. If the animal does not show pathomorphologic changes, samples to be tested and cultured should be taken from the opultaneous lymph nodes, from the lymph nodes to the trachnico-trachnico-trachea, interpulmonary, superficial grooves, i.e. dwindling, lymph nodes to the lower jaw and some circular lymph nodes and liver.
The determination of isolated mycobacteria can usually be performed by the determination of culture and biochemical properties. The polymerase chain reaction (PCR) can also be used to detect the M. tuberculosis complex. DNA analysis methods may be faster and more reliable than biochemical methods for distinguishing M. bovis from other members of the M. tuberculosis complex. Genetic traces allow the distinction between different strains of M. bovis and the description of patterns of origin, transmission and extension of M. bovis.
The methods and soil used, their standardisation and evaluation of the results shall comply with the OIE Manual of Standards of Investigation and Vaccines, fourth edition, 2000, Chapter 2.3.3 (bovine tuberculosis).
2. INTRADERMAL TUBERCULINATION
Tuberculin purified protein derivative ("tuberculin PDD '), bovine or aviary, which meets the standards set out in paragraph 2.1, shall be used for officially determined intradermal tuberculination, in accordance with the procedures referred to in paragraph 2.2.
2.1. Standards for bovine and avian tuberculin
2.1.1. Definitions
Tuberculin PPD, bovine or aviary, is a preparation obtained from heat-treated growth and degradation products of Mycobacterium bovis or Mycobacterium avium (as appropriate) which is capable of detecting a late allergic reaction in an animal sensitised to micro-organisms of the same species.
2.1.2. Production
It is obtained from water-soluble fractions prepared by heating in free-flowing steam and then filtered by cultures of M. bovis or M. avium (as appropriate) grown in liquid synthetic soil. The active fraction of filtration, consisting mainly of protein, is isolated by precipitation, washed and dissolved again. An antimicrobial preservative may be added that does not cause false positive reactions such as phenol. The final sterile preparation, free from mycobacteria, is aseptically transferred to sterile containers of damage-resistant glass which are then sealed to prevent contamination. The product can be lyophilised.
2.1.3. Product test
Injections are given in series of successive intradermal dilution at different sites to appropriately sensitised guinea pigs, each weighing at least 250 g. After 24 to 28 hours, oedema reactions occur with reddening of the skin, whether or not with or without necrosis at the injection site. The magnitude and intensity of reactions are different by dose. Unsensitised guinea pigs show no reactions to similar applications.
2.1.4 Testing
2.1.4.1 pH: pH is 6,5 to 7,5.
2.1.4.2 Phenol: If the preparation contains phenol, its concentration is not higher than 5 g / l.
2.1.4.3 Sensitising effect: a group of three guinea pigs shall be used which has not been treated with any material to distort the results of the examination. Three times at intervals of five days, intradermal injection is given to each guinea pig a dose of the test preparation corresponding to 500 MJ at 0.1 mL. 15 to 21 days after the third injection is given the same dose, i.e. 500 MJ, intradermal administration to these animals and a control group of three guinea pigs of the same weight, which had not previously received an injection of tuberculin. Within 24 to 28 hours of the last application, the reactions of these two groups should not differ significantly.
2.1.4.4 Toxicity: two guinea pigs, each weighing at least 250 g, have not been given any material to distort the test results. Under the skin, 0,5 ml of the test preparation is administered to each guinea pig. Animals shall be monitored for seven days. No abnormal effects should occur during the follow-up period.
2.1.4.5 Sterility: matches the sterility test prescribed in the monograph on Vaccines for Veterinary Use, 4th edition of the European Pharmacopoeia 2002.
2.1.5. Efficacy
The efficacy of tuberculin PPD, bovine or aviary is determined by comparing the reactions of sensitised guinea pigs following intradermal injections of a series of solutions of the tested preparation with those resulting from the administration of known concentrations of the reference preparation of tuberculin PPD, bovine or aviary (as appropriate), calibrated in international units.
For efficacy testing, at least nine albino guinea pigs, each weighing between 400 and 600 g, are sensitised by intramuscular injection of 0,0001 mg of wet mass of the live strain M. bovis AN5 dispersed in 0,5 ml 9 g / l sodium chloride solution R in bovine tuberculin or an adequate dose of inactivated or live M. avium in an aviary tuberculin deep into the muscle. At least four weeks after sensitisation of guinea pigs, their hips should be shaved to prepare a site for up to four injection sites on each side. Dilution of the test preparation and reference preparation in isotonic saline solution in phosphate buffer (pH 6,5-7,5) containing 0,005 g / l polysorbate 80 R shall be prepared. At least three doses of the reference preparation and at least three doses of the test preparation shall be used. The dosage shall be chosen in such a way that the changes resulting are at least 8 mm in diameter and not more than 25 mm in diameter. Dilution is randomly divided into places using a Latin square distribution. Inject each dose intradermal at a constant volume of 0,1 to 0,2 ml. The averages of changes shall be measured after 24 to 28 hours and the test result shall be calculated using the usual statistical methods and provided that the averages of changes are directly proportional to the log concentration of tuberculins.
The test is only valid if the expected error limits (P = 0,95) are between 50% and 200% of the estimated effectiveness. For bovine tuberculin, the estimated efficacy should not be less than 66% and greater than 150% of the determined efficacy. For aviary tuberculin, the estimated efficacy should not be less than 75% and more than 133% of the determined efficacy. For both tuberculins, bovine and aviary, the determined efficacy should not be less than 20000 MJ / ml.
2.1.6 Storage
Store at 5 ± 3 ° C and protect from light.
2.1.7 Labelling
The designation shall indicate:
- efficiency in international units per millilitre,
- the name and quantity of all added substances,
- for lyophilised products:
- the name and volume of the solvent to be added,
- that the product should be used immediately after reconstitution.
2.2. Investigation methods
2.2.1. The following shall be recognised as officially established intradermal tuberculination:
- simple intradermal tuberculin: this examination requires one application of bovine tuberculin,
- Simultaneous intradermal tuberculin: this examination requires one intradermal injection of bovine tuberculin and one intradermal injection of aviary tuberculin which are administered concomitantly.
2.2.2. Doses of tuberculin injected:
- at least 2000 MJ of bovine tuberculin,
- at least 2000 MJ of aviary tuberculin.
2.2.3. The volume of each injection dose shall not exceed 0,2 ml.
2.2.4 Tuberculination is performed by injecting tuberculin (s) into the skin of the neck. The puncture sites are located at the forefront and middle-third of the neck. If the same animal is administered to aviary and bovine tuberculins, the injection site of the aviary tuberculins is about 10 cm from the highest point of the neck and the injection site of bovine tuberculin is about 12,5 cm below on a line approximately parallel to the shoulder line or on different sides of the neck; in pups where there is no space for adequate separation of the areas on one side of the neck, an injection shall be carried out on each side of the neck at the same places at the centre of the middle third of the neck.
2.2.5 Tuberculinisation and evaluation of reactions shall be carried out as follows:
2.2.5.1. Procedure:
The injection sites are cut and cleaned. The skin fold in each cut area shall be held between the forefinger and the thumb, measured by a sliding scale and recorded. A dose of tuberculin should then be injected by the procedure to ensure that tuberculin is administered intradermal. A short sterile needle with a bevelled edge pointing out can be used, with a calibrated syringe filled with tuberculin, which is tilted to deeper layers of skin. The correct application is confirmed by touching a pea-shaped swelling at each injection site. The thickness of the skin fold at each injection site should be measured again 72 hours (± 4 hours) after injection and recorded.
2.2.5.2 Evaluation of reactions
Assessment of reactions is based on clinical observations and reported increases in skin fold thickness at injection sites 72 hours after injection of tuberculin (s).
(a) Negative reactions: if only limited swelling is observed with an increase in skin thickness of not more than 2 mm, without clinical signs such as diffuse or extensive swelling, effusion, necrosis, pain or inflammation of the lymph vessels in this area or lymph nodes.
(b) Dubious reactions: if no clinical signs referred to in (a) are found and if the increase in skin fold thickness is greater than 2 mm and less than 4 mm.
(c) Positive reactions: if the clinical signs referred to in (a) are found and the thickness of the skin fold at the injection site is 4 mm or more.
2.2.5.3. Evaluation of officially established intradermal tuberculination:
2.2.5.3.1. Simple intradermal tuberculination:
(a) Positive: positive reactions of bovine animals as defined in paragraph 2.2.5.2 (c);
(b) Dubai: a Dubai reaction as defined in paragraph 2.2.5.2 (b);
(c) Negative: negative reactions of bovine animals as defined in paragraph 2.2.5.2 (a);
Animals in which the single intradermal tuberculination is dubious shall be examined by further intradermal tuberculin after at least 42 days.
Animals that are not negative in this second test are considered positive in this test.
If there is a suspicion of a false positive reaction or a distorted reaction, animals in which single intradermal tuberculination is positive may be examined by simultaneous intradermal tuberculination.
2.2.5.3.2. Simultaneous intradermal tuberculinisation for the determination and maintenance of the official tuberculosis-free status of:
(a) Positive: positive reactions to bovine tuberculin, which is more than 4 mm larger than those to aviary tuberculin, or the presence of clinical signs;
(b) Dubious: positive or dubious reactions to bovine tuberculin, which is 1 to 4 mm greater than those to avian tuberculin, and absence of clinical signs;
(c) Negative: negative reactions to bovine tuberculin or positive or dubious reactions to bovine tuberculin which is equal to or less than positive or dubious reactions to aviary tuberculin and in both cases absence of clinical signs.
Animals in which the simultaneous intradermal tuberculination is dubious shall be examined by further intradermal tuberculin after at least 42 days. Animals that are not negative in this second test are considered positive in this test.
2.2.5.3.3. The status of officially tuberculosis-free herd may be temporarily suspended and intra-Community trade in animals from the herd shall not be allowed until the following animal status has been established:
(a) animals for which simple intradermal tuberculin treatment has been considered to be oak;
(b) animals for which single intradermal tuberculin has been considered positive but are to be reexamined by simultaneous intradermal tuberculin;
(c) animals in which simultaneous intradermal tuberculin has been considered to be oak.
2.2.5.3.4. Where Community legislation requires animals to be examined by intradermal tuberculin prior to movement, the result of the examination shall be evaluated by not allowing intra-Community trade in any animal showing an increase in skin thickness of more than 2 mm or showing clinical signs.
2.2.5.3.5. In order to allow for the detection of the maximum number of infected and sick animals in the herd or region, the State Veterinary Administration may adapt the criteria for assessing the results of the examination in order to achieve an increase in its sensitivity, all of the dubious reactions referred to in points 2.2.5.3.1 (b) and 2.2.5.3.2 (b) being considered positive.
3. ADDITIONAL TESTS
In addition to tuberculinisation, the State Veterinary Administration may authorise the use of the GAME test provided for in the OIE Manual of Standards for Investigation and Vaccines, 4th edition, 2000, Chapter 2.3.3 (bovine tuberculosis), in order to allow for the detection of the maximum number of infected and sick animals in the herd or region. ';
Efficacy
This Decree shall take effect on 1 January 2008.
Minister:
Mgr. Gandalovich v. r.
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Regulation Information
| Citation | Decree No. 316 / 2007 Coll., amending Decree No. 299 / 2003 Coll., on measures to prevent and control diseases and diseases communicable from animals to humans, as amended |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.12.2007 |
|---|---|
| Effective from | 01.01.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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