RULEBOOK ON RESIDUE MONITORING IN LIVE ANIMALS, ANIMAL FOODSTUFFS AND FEED

Based on Article 38 of the Law on Public Administration (Official Journal of the Republic of Montenegro No. 38/03) in relation to the Article 42 paragraph 3 and Article 106 paragraph 1 of the Veterinary Law (Official Journal of the Republic of Montenegro No. 11/2004) the Ministry of Agriculture, Forestry and Water Management hereby adopts

RULEBOOK ON RESIDUE MONITORING IN LIVE ANIMALS, ANIMAL FOODSTUFFS AND FEED

RULEBOOK CONTENTS

Article 1

This Rulebook lays down measures for systematic control of pharmacologically active substances or metabolites thereof, as well as residues of other substances in animals, foodstuffs of animal origin and animal feed (hereinafter referred to as: monitoring).
Pharmacologically active substances or metabolites thereof, as well as residues of other substances referred to in paragraph 1 of this Article are stated under the Annex I, which is printed together with this Rulebook as its integral part.

Article 2

For the purpose of this Rulebook, the following terms shall apply:
(a) unauthorized substances or products means substances or products administering of which to animals is prohibited by laws or in compliance with the law;
(b) illegal treatment means use of unauthorized substances or products or the use of authorized substances or products for purposes other than those for which they are allowed or under conditions other than those laid down;
(c) residues means residues of pharmacologically active substances, or of their metabolites and residues of other substances transmitted to animal foodstuffs and likely to be harmful to human health;
(d) sample means a sample taken, in compliance with the prescribed procedure, by the authorized person and presented for analysis;
(e) batch of animas means a group of animals of the same species, in the same age range, reared on the same farm or household at the same time and under the same conditions of rearing;
(f) farm or household means any establishment, facility or place where animals are kept and reared.

RESIDUE MONITORING PROGRAM

Article 3

Residue monitoring program determines residues in animals, foodstuffs and feed.
Rearing of animals and production of foodstuffs of animal origin and animal feed shall be systematically controlled and monitored for the purpose of detecting the presence of the residues listed in Annex I of this Rulebook in the following:
a) live animals, their excrement and body fluids and tissues;
b) foodstuffs of animal origin;
c) animal feed and drinking water.

Article 4

The substances and residue groups referred to in Annex I of this Rulebook are analyzed according to animal species, in accordance with Annex II, which is printed together with this Rulebook as its integral part, under the program that lays down specific measures for revealing their occurrence (hereinafter referred to as: the Program) and the following, in particular:

a) in animals, drinking water of animals and in animal feed in places where animals are bred or kept;
b) in animals, their excrement and body fluids, tissues and foodstuffs of animal origin.

The sampling level and frequency is set by the Program referred to in the paragraph 1 of this Article in accordance to the Annex III which is printed together with this Rulebook as its integral part.

Article 5

The Program lays down the special conditions depending on the probability of residue occurrence.

The Program includes the following:
a) an overview of legislation on the use of substances listed in Annex I and, in particular, provisions on their prohibition or authorization for distribution and placing on the market and the rules governing their administration;
b) the organizational structure of the bodies involved in implementation of the Program,
c) a list of authorized laboratories with details of their capacity for sample processing and analysis,
d) maximum levels of residues to be controlled, in compliance with this Rulebook,
e) a list of substances to be controlled, methods of analysis, standards for interpreting the results obtained and, in case of residues in Annex I, the number of samples to be taken giving reasons for this number;
f) the number of samples to be taken in relation to the number of animals of the species concerned slaughtered in preceding year in accordance with the sampling levels and frequencies laid down in Annex III,
g) methods for collection of official samples and particulars that are to appear on samples,
h) the type of measures laid down by the Directorate with regard to animals or foodstuffs of animal origin in case prohibited residues have been detected.

Article 6

Records shall be kept on samples taken and monthly reports shall be drawn, in accordance with the Program.
The monthly reports on samples taken and the Program implementation shall be presented by the authorized person to the Veterinary Directorate (hereinafter referred to as: the Directorate) by the 10th day of the month for the previous month.

Article 7

Additional analyses may be imposed by the Administration in case of natural disasters and other emergencies, when presence of prohibited residues in animals and foodstuffs of animal origin is suspected and in other cases that require urgent action.

The Administration shall draw up annual Report on results of residue monitoring to the Ministry of Agriculture, Forestry and Water Management by March 31 of the current year for the previous year.






RESPONSIBILITY ON THE PART OF LEGAL AND NATURAL PERSONS ENGAGED IN PRODUCTION OF LIVE ANIMALS AND FOODSTUFFS OF ANIMAL ORIGIN


Article 8

The natural and legal persons in facilities for slaughtering, treatment and processing of foodstuffs of animal origin may use only the animals:
a) for which the owner or the keeper has submitted the health certificate proving that the animal concerned is in good health condition;
b) for which the owner or keeper is able to guarantee that the prescribed withdrawal times from the latest treatment till placing on the market for foodstuffs derived from treated animals have been observed
c) the animals from farms or households and foodstuffs of animal origin:
- do not contain residue levels which exceed maximum permitted limits,
- do not contain any trace of prohibited residues.

Article 9

The veterinarian treating animals on a farm or a household is obliged to monitor the rearing conditions and use of substances and products referred to in the Annex I of this Rulebook.

The veterinarian is obliged to enter in a treatment register kept on the farm the date and time, name and method of administering the medication, the identification - identification number of the animal treated and the withdrawal period prescribed.

The owner or keeper of the animal is obliged to administer only the veterinary medications prescribed, with approval and under control of the veterinarian and to abide by instructions of the producer of the medication and withdrawal period prescribed.


Article 10

The competent authority shall:
a) where illegal treatment is suspected, request from the owner or keeper of the animal or the veterinarian that provides health protection services on the farm or the household, to provide all the necessary documents on the nature of the therapy treatment referred to in the Article 9, paragraph 2;
b) where illegal treatment is established or where use of unauthorized substances or products has been established, conduct or order:
1) taking of samples of body fluids or excrements from a number of selected animals and foodstuffs, by random order, without prior notice, on the farm or on the household of origin, place of keeping or departure,
2) checks aimed at detection of the use of unauthorized substances or products on the farm or household where the animals are being reared including farms administratively connected (with that farm), on the farms or households of origin or the place of departure.
3) control of animal feed and drinking water on the farm or household of origin or departure, and for aquaculture animals control of water in which they are caught or farmed;
4) controls provided for in Article 11 paragraph 1. item a),
5) all other controls required in order to determine the origin of unauthorized substances;
c) where the residues prohibited or in quantities above the maximum permitted levels are established in foodstuffs of animal origin, animal tissues or organs, controls prescribed in the monitoring program implementation shall be made.

Article 11

The methodology of controls provided for by this Rulebook is implemented without previous notice, as follows:
- at the place of production, storage and distribution of animal feed<
- during the keeping and rearing of animals and production and storage of foodstuffs of animal origin.

The animal owner or keeper or the person authorized to dispose of the animals or representative thereof shall enable checks prior to animal slaughter and shall particularly cooperate with the competent authority or authorized staff.

Article 12

The contract concluded with the authorized laboratory for program implementation shall lay down the mutual rights and obligations, in particular, as regards:

a) implementation of residue monitoring in live animals, foodstuffs of animal origin and animal feed,
b) coordination of the work of other authorized laboratories responsible for analysis of one residue or residue group, coordination of the standards and methods of analysis for each residue or residue group,
c) expert assistance to the Directorate in drawing up the Program,
d) periodical organization of comparative testing for a residue or residue group,
e) dissemination of information obtained from other authorized laboratories,
f) presenting the reports to the Directorate, at least once a month;

Laboratory testing is done in line with methods laid down by the Annex IV, which is published together with this Rulebook and is its integral part.
The list of authorized or diagnostic laboratories (hereinafter referred to as: the authorized laboratory) shall be published in the Official Journal of the Republic of Montenegro at the end of the current year for the following year.

Article 13

Samples shall be taken in accordance with Annexes III in order to be examined in authorized laboratories.

The detailed sampling rules are described in the Instructions which are the integral part of this Program.

Article 14

Where positive results of analysis are obtained, the authorized person shall immediately:
a) collect all the information required for identification of the animal and farm or household of origin or departure;
b) collect all details on checks and results of these checks;
c) conduct or order conducting of investigations on the farm or household of origin or departure in order to establish the reasons for the presence of residues;
d) in case of illegal treatment, conduct an investigation of the source of the substances or products: at the place of production, handling, storage, transport, administration, distribution or sale, as appropriate;
e) conduct all other investigations deemed necessary;
f) clearly identify the animals from which samples have been taken and order the prohibition of movement of animals from the farm or household in line with the results of the checks.

Article 15

When illegal treatment is established, the authorized person shall:
- ensure that the animals covered by the investigation referred to in point (b) of Article 10 of this Rulebook is immediately placed under official surveillance,
- ensure that all the animals are clearly marked,
- implement sampling of a statistically representative sample, as prescribed.

Article 16

Where results of the analysis show that maximum limit for residues of authorized substances or products are exceeded, the competent authority shall carry out or order carrying out of the control in the farm or household of origin or departure in order to establish the reasons why the residues limit was exceeded.

In accordance with the results of the control stated in paragraph 1 of this Article, the competent authority shall take or order taking of all the measures necessary to safeguard public health, including the prohibition on placing of the market for public consumption animals and foodstuffs of animal origin from the farm or household, or from the establishment of slaughter, treatment, processing, collecting or storage, for a specific period of time.

In case of repeated exceeding of maximum residue limits and in case the owner or keeper of animals places on the market, or when producer places foodstuffs of animal origin on the market, the competent authority shall conduct or order conducting of the intensified controls on the animals, foodstuffs of animal origin from the farm or household, establishment for slaughter, treatment, processing, collecting or storage that are checked, for a period of at least six months, while foodstuffs of animal origin or carcasses are impounded pending the results of analysis of the samples.

The competent authority declares as unfit for public consumption all the carcasses or foodstuffs of animal origin where results of the analysis show that the maximum residue limits of residues tested have been exceeded.

Article 17

The competent authority shall notify the Directorate of the results of examination under the Article 16 of this Rulebook.

Article 18

The Directorate shall keep separate records on results of examination under for the purpose of the monitoring.

Article 19

This Rulebook shall enter into force on the eighth day from the day of its publishing in the Official Journal of the Republic of Montenegro.

No. 32/05-0101-5369
Podgorica, July 17, 2006.

The Ministry of Agriculture, Forestry and Water Management
Minister
Milutin Simovic, MSc. manu propria


ANNEX I


GROUP A - Substances having anabolic effect and unauthorized substances

A1. Stilbenes, stilbene derivatives, and their salts and esters
A2. Antithyroid substances
A3. Steroids
A4. Resorcylic acid lactones including zeranol
A5. Beta-agonists
A6.
Aristolochia spp. and products derived from it
Chloramphenicol
Chloroform
Chlorpromazine
Colchicine
Dapsone
Dimetridazole
Metronidazole
Nitrofurans including Furazolidone
Ronidazole


GROUP B - Veterinary drugs and environmental contaminants

B1. Antibacterial substances, including sulphonamides, quinolones
B2. Other veterinary drugs
a) Anthelmintics
b) Anticoccidials, including nitroimidazoles
c) Carbamates and pyrethroids
d) Sedatives
e) Non-steroidal anti-inflammatory drugs
f) Other pharmacologically active substances
B3. Other substances and environmental contaminants
a) Organochlorine compounds including PCBs
b) Organophosphorus compounds
d) Chemical elements
e) Mycotoxins
f) Dyes
f) Other substances
(*) Including unlicensed substances which could be used for veterinary purposes
















ANNEX II

GROUPS OF SUBSTANCES TO BE DETERMINED IN ANIMAL SPECIES AND
FOODSTUFFS OF ANIMAL ORIGIN

Substance
groups Animal species or foodstuffs of animal origin
bovine,
ovine,
caprine,
porcine,
equine animals Poultry Aquaculture animals Milk Eggs Rabbit meat
and meat
of wild (*)
game and
farmed game
Honey
A1 X X X X
A2 X X X
A3 X X X X
A4 X X X
A5 X X X
A6 X X X X X X

B1 X X X X X X X
B2a X X X X X
B2b X X X X
B2c X X X X
B2d X
B2e X X X X
B2f

B3a X X X X X X X
B3b X X X
B3c X X X X X X
B3d X X X X
B3e X
B3f


* Only residues of heavy metals are analyzed where wild game is concerned





















ANNEX III


SAMPLING LEVELS AND FREQUENCY

This Annex lays down the minimum number of animals from which the samples are taken and the minimum number of samples of foodstuffs of animal origin to be analyzed. Presence of one or more substances may be analyzed in each sample.

Bovine, porcine, ovine, caprine and equine animals

1. Bovine animals

The minimum number of animals to be checked throughout a year for all kinds of residues must at least equal 0.4% of the total number of bovine animals slaughtered the previous year, as follows:

Group A: 0.25% divided as follows:

- one half of the samples are taken from live animals on the farm or household; (by derogation, 25% of samples taken for the purpose of analysis of Group A5 substances can be taken from feed, drinking water for animals, etc.)
- one half of the samples are taken at the slaughterhouse.

Each sub-group in Group A must be checked each year in at least 5% of the total number of samples collected for the purpose of analysis of Group A substances.

The balance, which refers to analysis of specific Group A substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.

Group B: 0.15%, as follows

- 30 % of the samples are checked for Group B 1 substances.
- 30 % of the samples are checked for Group B 2 substances.
- 10 % of the samples are checked for Group B 3 substances.

The balance, which refers to analysis of specific Group B substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.

2. Porcine animals

The minimum number of animals to be checked each year for residues listed in Annex I must at least equal 0.05% of the total number of pigs slaughtered the previous year, as follows:

Group A: 0.02 %

When sampling is done at the slaughterhouse, additional analysis of drinking water, feed, faeces, is undertaken at the place where animals are kept or reared the farm or the household, so that it covers by sampling at least one farm or household per 100 000 pigs slaughtered the previous year.

Each sub-group in Group A is checked each year in a minimum of 5% of the total number of samples collected for the purpose of analysis of Group A substances.

The balance, which refers to analysis of specific Group A substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.


Group B: 0.03%, as follows:

- 30 % of the samples are checked for Group B 1 substances.
- 30 % of the samples are checked for Group B 2 substances.
- 10 % of the samples are checked for Group B 3 substances.

The balance, which refers to analysis of specific Group B substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.


3. Ovine and caprine animals

The minimum number of animals to be checked each year for residues listed in Annex I must at least equal 0.05% of the total number of ovine and caprine animals over three months of age slaughtered the previous year, as follows:

Group A: 0.01%

Each sub-group in Group A is checked each year in a minimum of 5% of the total number of samples collected for the purpose of analysis of Group A substances.

The balance, which refers to analysis of specific Group A substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.

Group B: 0.04%, as follows

- 30 % of the samples are checked for Group B 1 substances.
- 30 % of the samples are checked for Group B 2 substances.
- 10 % of the samples are checked for Group B 3 substances.

The balance, which refers to analysis of specific Group B substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.


4. Equine animals

The number of samples is to be determined by the competent authority on the basis of assessment of the situation in the field (suspected use of unauthorized substances, other problems identified)

Poultry

(broiler chickens, laying hens, turkeys, other poultry)

A sample of poultry consists of one or more animals depending on the requirements of the analytical methods.

For each category of poultry (broiler chickens, laying hens, turkeys, and other poultry), the minimum number of samples taken each year must at least equal one sample per 200 tons of annual production (deadweight). Where annual production of a specific poultry category exceeds 5,000 tons, each group of substances is analyzed in minimum 100 samples.

The samples are allocated as follows:

Group A: 50% of the total number of samples

Of the number stated above, at least 1/5 is taken in farms or households.

Each sub-group in Group A is checked each year in a minimum of 5% of the total number of samples collected for the purpose of analysis of Group A substances.

The balance, which refers to analysis of specific Group A substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.

Group B: 50% of the total number of samples, as follows:

- 30 % of the samples are checked for Group B 1 substances.
- 30 % of the samples are checked for Group B 2 substances.
- 10 % of the samples are checked for Group B 3 substances.

The balance, which refers to analysis of specific Group B substances, is allocated in line with the experience, that is, in line with existing data on use of specific substances.

Aquaculture products

1. Farmed finfish

A sample is one or more fish, depending on the size of the fish in question and of the requirements of the analytical method.

The minimum number of samples taken per annum is one sample per 100 tons of annual production.

The substance to be analyzed is determined according to the frequency of use of the substance in question.

The samples are allocated as follows:

Group A: one third of the total number of samples taken:

All the samples are taken at the farm, in all stages of farming, including taking samples of fish intended for human consumption, immediately before placing it on the market.

Group B: two thirds of the total number of samples, as follows:

- preferably at the farm, or fish ready to be placed on the market for human consumption;
- at the establishment for processing, or at the place of wholesale or storage, where samples of fresh fish are taken together with all the necessary data in order to be able to prove the origin of the fish in the event of positive results.

In all the cases of taking samples from a farm, such samples are taken from at least 10% of registered production area.

2. Other aquaculture animals

When there is reason to suspect that veterinary medicinal products or chemical products are applied to the other aquaculture animals or when environmental contaminants are suspected, sampling in farming sites must be undertaken.

Milk

1. Bovine milk

Sampling:

Each official sample is taken by the competent authority in such a way that the farm or household of origin can always be proved.

The samples are taken:

(a) at the farm or household from the collection tank,
(b) in the dairy before emptying the collection tank.

Samples are taken only from raw milk.

The sample quantity depends on requirements of the analytical method used.

Sampling level and frequency:

The annual number of samples is 1 per 15,000 tons of the annual milk production, taking at least 300 milk samples per annum in such a way that:
(a) 70% of the samples are examined for the presence of residues of veterinary medicinal products. In this case, each sample has to be tested for at least four different substances from at least three groups among groups A6, B1, B2 (a) and B2 (e) in Annex 1.
(b) 15% of the samples are examined for the presence of residues from group B3 of Annex I.
(c) 15% of samples are examined in line with the situation in the field (suspected use of unauthorized substances, other problems identified).


2. Milk from other species (ovine, caprine, equine)

The number of samples is determined in line with the production level and the problems identified. The milk from these species must be included in the sampling plan as additional samples to those taken for bovine milk.

Eggs

1. Hen eggs

Sampling:

Each official sample is taken by the competent authority in such a way that it is always possible to establish the origin of the eggs (farm or household).

The samples are taken:

(a) at the farm or household;
(b) at the establishment for packing and storage of the eggs.

One sample consists of at least 12 eggs, depending on the requirements of the analytical method used.



Sampling level and frequency:

The number of samples to be taken each year is at least equal to 1 per 1,000 tons of the annual production of consumption eggs, with a minimum of 200 samples.

The samples represent the characteristic proportion of all egg classes intended for human consumption.

At least 30% of samples must be taken from egg packing and storage establishments.

Allocation of the samples:

(a) 70% of the samples are tested for at least one substance from each of the groups: groups A6, B1 and B2 (b) in Annex I.
(b) 30% of the samples are taken and tested according to the situation in the field, but some analyses for residues of substances in Group B3 (a) of Annex I are to be undertaken.

2. Eggs from other species of poultry

The number of samples is determined depending on the production level and the problems identified in the production.

The eggs from these species must be included in the sampling plan as additional samples to those taken for hen eggs.

Rabbit meat and the meat-of wild game and farmed game

1. Rabbit meat

Sampling:

One sample consists of one or more animals from the same producer, according to the requirements of the analytical method.

Each official sample is taken by the competent authority in such a way that it is always possible to establish the origin of the sample.

The samples are taken depending on the structure of the rabbit production:

(a) at the level of the farm or household,
(b) in the registered slaughterhouses

For the purpose of control of unauthorized substances in the place of keeping or breeding, some additional samples of drinking water and feed may be taken.

Sampling level and frequency:

The minimum number of official samples to be analyzed each year must be 10 per 300 tons of the annual production (dead weight). The aforementioned number of samples refers to the first 3,000 tons of production, with 1 sample for each additional 300 tons.

The samples are allocated as follows:
Group A: 30% of the total number of samples, as follows:
- 70% of the samples are checked for Group A6 substances,
- 30% of the samples are checked for substances of other sub-groups in Group A.
Group B: 70% of the total number of samples, as follows:
- 30% of the samples are checked for Group B1 substances
- 30% of the samples are checked for Group B2 substances
- 10% of the samples are checked for Group B3 substances

The balance is allocated according to the situation in the field.


2. Farmed game

Sampling:

The quantity of the sample depends on the requirements of the analytical method used.

The samples are taken at the processing facility in such a way that the origin of the game can be established.

For the purpose of control of unauthorized substances in the place of keeping or breeding, some additional samples of drinking water and feed may be taken.

Sampling level and frequency

Minimum 100 samples are taken each year.

The samples are allocated as follows:

Group A: 20% of the total number of samples
The majority of the samples are analyzed for substances of groups A5 and A6.

Group B: 70% of the total number of samples, as follows:

- 30% of the samples are checked for Group B1 substances,
- 30% of the samples are checked for Group B2 a) and B2 b) substances,
- 10% of the samples are checked for Group B2 c) and B2 e) substances,
- 30% of the samples are checked for Group B3 substances.

The balance of 10% is analyzed according to the situation in the field.

3. Wild game

Sampling:

The sample quantity should be adequate for requirements of the analytical method used.

The samples are taken at the processing plant of the game or at the hunting place in such a way that the area where the game was hunted can be established.

Sampling level and frequency:

Minimum 100 samples are taken each year.

These samples are analyzed for residues of chemical elements.



Honey

Sampling:

The sample size depends on the requirements of the analytical method used.

The samples are taken at any point in the honey production chain, in such a way that it is possible to establish the origin of the honey.

Sampling level and frequency:

The number of samples taken each year must at least equal 10 per 300 tons of the annual production for the first 3,000 tons of production, and one sample for each additional 300 tons.

The samples are allocated as follows:
- Group B1 and Group B2 c): 50% of the total number of samples,
- Group B3 a), b) and c): 40% of the total number of samples.

The balance of 10% is allocated according to the experience, where mycotoxins are given particular consideration.




































Annex IV
TABLE 1

Suitable confirmatory methods for organic residues or contaminants

Measuring technique Substance Annex I
LC or GC with mass spectrometric detection Groups A and B Only if following either an on-line or an off-line chromatographic separation.
Only if full scan techniques are used or using identification points 3 (group B) or 4 (group A)
LC or GC with IR spectrometric detection Groups A and B Specific requirements for absorption in IR spectrometry
LC scan DAD Group B Specific requirements for absorption in UV spectrometry
LC fluorescence Group B Only for molecules that exhibit native fluorescence and molecules fluorescing after transformation or separation
2-D TLC-scanning UV/VIS Group B Two-dimensional HPTLC and co-chromatography are mandatory
GC electron capture detection Group B Only if two different polarities are used
LC immunogram Group B Only if at least two different chromatographic systems or a second, independent detection method are used
LC-UV/VIS (single wavelength) Group B Only if at least two different chromatographic systems or a second, independent detection method are used


Table 2

Suitable confirmatory methods for chemical elements


Technique Measured parameter
Differential pulse anodic stripping voltametry Electric signal
Atomic absorption spectrometry
Flame Absorption wavelength
Hydride generation Absorption wavelength
Cold vapour Absorption wavelength
Electrothermal atomisation Absorption wavelength
Atomic emission spectrometry Emission wavelength
Inductively coupled plasma
Mass spectrometry
Inductively coupled plasma


* The Rulebook was published in the Official Journal of the Republic of Montenegro No. 46/2006, July 21, 2006.