Circular No. 57/2012/TT-BNNPTNT dated November 07, 2012 of the Ministry of Agricultural and Rural Development on the inspection, supervision, and penalties for the use of substances in the group of beta-agonist that are banned from breeding

CIRCULAR

ON THE INSPECTION, SUPERVISION, AND PENALTIES FOR THE USE OF SUBSTANCES IN THE GROUP OF BETA-AGONIST THAT ARE BANNED FROM BREEDING

Pursuant to the Government s Decree No. 01/2008/ND-CP dated January 03^rd2008, defining the functions, tasks, powers and organizational structure of the Ministry of Agriculture and Rural development; the Government s Decree No. 75/2009/ND-CP dated September 10^th2009, amending Article 3 of the Government s Decree No. 01/2008/ND-CP dated January 03^rd2008;

Pursuant to the Law of Food safety 2010;

Pursuant to the Ordinance on Livestock breed No. 16/2004/PL-UBTVQH11 dated March 24^thof the Standing committee of the National Assembly;

Pursuant to the Ordinance on Veterinary medicine No. 16/2004/PL-UBTVQH11 dated March 14^thof the Standing committee of the National Assembly;

Pursuant to the Government s Decree No. 08/2010/ND-CP dated February 05^th2010 on the management of animal feed;

Pursuant to the Government s Decree No. 08/2011/ND-CP dated January 25^th2011 on the administrative penalties for violations of animal feed;

At the proposal of the Director of the Department of Livestock Production,

The Ministry of Agriculture and Rural development promulgates a Circular on the inspection, supervision, and penalties for the use of substances in the group of Beta-agonist that are banned from breeding

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular deals with the inspection, supervision, and penalties for the use of substances in the group of Beta-agonist (Clenbuterol, Salbutamol and Ractopamine) that are banned from breeding.

Article 2. Subjects of application

This Circular is applicable to organizations and individuals in Vietnam and overseas that are related to the production and trade of animal feed, veterinary medicines; breeding premises; slaughterhouses, premises that process and trade products of livestock and poultry in Vietnam.

Article 3. The rules for inspection and supervision

1. Competent agencies in charge of the State management of the agriculture and rural development, when carrying out inspection and supervision of food safety in breeding and veterinary medicine, are entitled to impose penalties for the use of substances in the group of beta-agonist that are banned from breeding, and provide information to the press as prescribed by law.

2. The owners of breeding premises and premises that produce, trade animal feed and veterinary medicines; slaughterhouses, premises that process and trade products of livestock and poultry must:

a) Actively control the production and trade, avoid the existence of prohibited substances in the group of Beta-agonist in their breeding supplies and breeding products by signing commitments with their partners when trading breeding supplies, veterinary medicines, and products of livestock and poultry; or commitments with the local authority not to produce and use substances banned from breeding.

b) Actively take samples or hire other people to take samples in order to test for the prohibited substances in their breeding supplies and products.

c) Not Sell the supplies, products, and animals being the subjects of inspection without the conclusion and permission of the inspecting agency.

Chapter II

THE INSPECTION AND SUPERVISION

Article 4. Subjects of inspection

1. At premises that produce or trade animal feed and veterinary medicines: animal feed and veterinary medicines.

2. At breeding premises: animal feed, drinking water for livestock and poultry; veterinary medicines; urine or blood of livestock and poultry.

3. At slaughterhouses: urine of livestock; meat samples; organ samples.

4. At premises that trade livestock products: urine of livestock; meat samples; organ samples.

Article 5. The inspection order

1. Step 1: Take samples of animal feed, veterinary medicines, drinking water, and products of animals using the method provided in Annex I promulgated together with this Circular, and other relevant laws.

2. Step 2: Choose a method of inspection provided in Clause 1 Article 6 of this Circular to carry out the analysis and assessment.

Article 6. The method of inspection and handling the analysis results

1. Method of inspection: finding the existence of Clenbuterol, Salbutamol and Ractopamine in the group of Beta-Agonist in animal feed, drinking water, veterinary medicines, urine, blood samples, and other products of livestock and poultry using one of the following two methods:

a) Method 1 (used for quick results):

Perform the qualitative analysis using the quick test kit, or perform the semi-qualitative analysis using the ELISA kit for the group of Beta-agonies, or separately for Clenbuterol, Salbutamol and Ractopamine The limit of detection of the quick test kit and ELISA kit must be lower than 0.2 ppb. The test will end if it proves negative.

If the test proves positive, carry out the quantitative analysis using chromatography techniques to confirm that the sample really tests positive for the prohibited substances in the Beta-agonist group.

b) Method 2:

Immediately carry out the quantitative analysis of Clenbuterol, Salbutamol and Ractopamine using chromatography techniques

2. Handling the analysis results

a) The sample is considered not violating (or the sample tests negative for the prohibited substances in the group of Beta-agonist) if the test proves negative after carrying out the analysis techniques above.

a) The quantitative analysis that proves positive (or the sample that tests positive for the prohibited substances in the group of Beta-agonist) is the basis for handle the violation and announce the violating sample. The bases for confirming that the sample tests positive are provided in Annex II promulgated together with this Circular.

Article 7. Handling the violations

If the sample tests positive for the prohibited substances in the group of Beta-agonist in the quantitative analysis, the competent State management agencies shall:

1. Notify the result to the organization or individual that have the sample that test positive for the prohibited substances in the group of Beta-agonist.

2. Handle the violations in accordance with relevant laws.

3. Apart from the administrative penalties, the organization or individual that commits the violations is also compelled to take the following measures:

a) The breeding premises must immediately stop using the factors that make the test prove positive for the prohibited substances, and keep raising the livestock and poultry without selling them until the next test proves negative. The breeding premises must incur the inspection cost.

b) The slaughterhouses must destroy all the livestock and poultry, or may keep raising them as long as the requirements for veterinary hygiene are satisfied until the test proves negative for the prohibited substances. Then they may be slaughtered and sold to the market. The slaughterhouse must incur the cost of the destruction, imparkment, and inspection.

The period of imparking the livestock and poultry that test positive for the prohibited substances may last for 3 – 15 days, depending on the dose, the length, and the kind of prohibited substances being used.

c) The premises that trade products of livestock and poultry must recall and destroy all the products of livestock and poultry. The trading premises must incur the cost of the recall, destruction, and inspection.

d) The premises that produce or trade animal feed and veterinary medicines must recall and destruct the consignments that test positive. The premises must incur the cost of the recall, destruction, and inspection.

4. The violating organizations and individuals shall be announced on the mass media.

Chapter III

RESPONSIBILITY AND AUTHORITY

Article 8. Responsibility of the Department of Livestock production

1. Unify and organize the inspection, supervision, and penalties for the use of Beta-agonist substances banned from breeding at breeding premises and premises that produce and trade animal feed.

2. Direct and cooperate with local specialized inspecting agencies and organize in inspecting and supervising the use of substances banned from breeding at breeding premises and premises that produce and trade animal feed.

3. Provide instruction, dissemination, and training about the knowledge of food safety and hygiene for the subjects under their management.

Article 9. Responsibility of the Department Of Animal Health

1. Unify and organize the inspection, supervision, and penalties for the use of Beta-agonist substances banned from breeding at premises that produce and trade veterinary medicines; slaughterhouses, premises that produce and trade products of livestock and poultry.

2. Direct and cooperate with local specialized inspecting agencies and organize in inspecting and supervising the use of substances banned from breeding at premises that produce and trade veterinary medicines; slaughterhouses, premises that produce and trade products of livestock and poultry.

3. Provide instruction, dissemination, and training about the knowledge of food safety and hygiene for the subjects under their management.

Article 10. Responsibility of Services of Agriculture and Rural development

1. Organize the inspection, supervision, and penalties for the use of Beta-agonist substances banned from breeding at local breeding premises; premises that produce and trade animal feed; premises that produce and trade veterinary medicines; slaughterhouses, premises that produce and trade products of livestock and poultry.

2. Guide and inspect the implementation of this Circular within their provinces or cities.

3. Provide instruction, dissemination, and training about the knowledge of food safety and hygiene for the subjects under their management.

Article 11. Responsibility of breeding premises; slaughterhouses, premises that process and trade products of livestock and poultry premises that trade products of livestock and poultry; premises that produce and trade animal feed and veterinary medicines

1. Comply with the regulations of the Ministry of Agriculture and Rural development on the prohibition against the use of Beta-agonist in breeding.

2. Maintain the production and trading conditions, ensuring the food safety and hygiene as prescribed by law.

3. Actively detect and report the production, trade, and use of substances banned from breeding without tolerating them.

Chapter IV

IMPLEMENTATION PROVISIONS

Article 12. Effects

1. This Circular takes effect on December 22^nd2012.

2. This Circular supersedes the Circular No. 54/2010/TT-BNNPTNT dated September 15^th2010 of the Ministry of Agriculture and Rural development, on inspecting and supervising the use of the substances in the group of Beta-agonist in breeding.

Article 13. Implementation organization

1. The Department of Livestock production and the Department Of Animal Health shall guide, monitor, and inspect the implementation of this Circular of the subjects under their management.

2. Heads of relevant organizations and individuals concerned are responsible for the implementation of this Circular.

Organizations and individuals are recommended to send feedbacks on the difficulties arising during the course of implementation to the Ministry of Agriculture and Rural development for amendment and supplementation./.

ANNEX I

THE PROCESS OF TAKING AND MANAGING SAMPLES
(Promulgated together with the Circular No. 57/2012/TT-BNNPTNT dated November 07^th2010 of the Ministry of Agriculture and Rural development)

1. Samples taken at premises that produce and trade animal feed, breeding premises. The sampling process is provided in the Vietnam’s Standards TCVN 4325:2007.

A food sample is separated into 03 parts, each part is sealed and stored in appropriate sample containers that bear relevant information (sample name, sampling time, sample address, sample taker, sample status). One of them shall be tested, 01 part is stored at the sampled premises, and 01 part is kept at the sampling agency for comparison.

2. The veterinary medicine samples are taken at premises that produce or trade animal feed and veterinary medicines, and breeding premises. The sampling method is provided in the Vietnam’s Regulation (QCVN 01-03:2009). The sample quantity and sample seal are similar to that of food samples.

A veterinary medicine sample is separated into 03 parts, each part is sealed and stored in appropriate sample containers that bear relevant information (sample name, sampling time, sample address, sample taker, sample status). One of them shall be tested, 01 part is stored at the sampled premises, and 01 part is kept at the sampling agency for comparison.

3. The drinking water sample is taken at breeding premises from various water sources in the premises (the pool, direct faucet, drinking trough).

A water sample is separated into 03 equal parts, each part (200 ml) is sealed and stored in appropriate sample containers that bear relevant information (sample name, sampling time, sample address, sample taker, sample status). One of them shall be tested, 01 part is stored at the sampled premises, and 01 part is kept at the sampling agency for comparison.

4. The urine samples or blood samples shall be taken directly (at least 150 ml of urine and 15 ml of blood) from the livestock and poultry at the breeding premises and slaughterhouses. That samples taken shall be preserved at 4⁰C or lower.

The amount of urine or blood samples being taken depends on the scale of the breeding premises and the slaughterhouse. The specific amount of samples according to the scale of the breeding premises:

Fewer than 10 head: take at least 2 samples from 2 animals.

11 - 50 head: take at least 3 samples from 3 animals.

51 - 100 head: take at least 4 samples from 4 animals.

More than 100 head: take at least 5 samples from 5 animals.

The urine samples may be taken directly when the animals are excreting, or using a nylon bag attached to the urinary organ of the male, or a urinary catheter on a female.

A urine sample or blood sample is separated into 3 equal parts, each part (01 ml) is sealed and stored in appropriate sample containers that bear relevant information (similarly to that of food samples). One of them shall be tested, 01 part is stored at the sampled premises, and 01 part is kept at the sampling agency for comparison. That urine and blood samples taken must always be preserved at 4⁰C or lower.

5. The samples of meat and meat products (animal products) are taken at slaughterhouse, premises that process and trade meat. The sampling process is provided in the Vietnam’s Standards TCVN 4833-1:2002.

6. The samples taken must be sealed and signed by the representative of the sampling agency, the sample taker, and the representative of the sampled premises. If the representative of the sampled premises refuses to sign, the seal bearing the signature of the sample taker is still legitimate.

7. All samples taken must be kept until the final conclusion of the Inspectorate is given.

8. Make the sampling record, preserve the samples, and send them to a laboratory appointed by the Ministry of Agriculture and Rural development.

ANNEX II

THE IDENTITY OF SAMPLES THAT TEST POSITIVE ACCORDING TO THE QUANTITATIVE METHOD
(Promulgated together with the Circular No. 57/2012/TT-BNNPTNT dated November 07th 2010 of the Ministry of Agriculture and Rural development)

A sample is considered to test positive when the result of the quantitative analysis is higher or equal to one of the value (in ppb) in the table below: