Circular No. 57/2012/TT-BNNPTNT stipulates the inspection, supervision, and handling of violations concerning prohibited substances in the category of Beta-agonists in animal husbandry.

 CIRCULAR

REGULATIONS ON INSPECTION, SUPERVISION AND HANDLING OF VIOLATIONS OF PROHIBITED SUBSTANCES BELONGING TO THE BETA-AGONIST GROUP IN ANIMAL RAISING

BELONGS TO THE BETA-AGONIST GROUP IN ANIMAL REARING

Pursuant to Decree No. 01/2008/NĐ-CP dated January 3, 2008 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/NĐ-CP dated September 10, 2009 of the Government amending Article 3 of Decree No. 01/2008/NĐ-CP dated January 3, 2008;

Pursuant to the Food Safety Law 2010;

Pursuant to the Animal Breeding Variety Law No. 16/2004/PL-UBTVQH11 dated March 24, 2004 of the Standing Committee of the National Assembly;

Pursuant to the Veterinary Law No. 18/2004/PL-UBTVQH11 dated April 29, 2004 of the Standing Committee of the National Assembly;

Pursuant to Decree No. 08/2010/NĐ-CP dated February 5, 2010 of the Government on feed management for animal husbandry;

Pursuant to Decree No. 08/2011/NĐ-CP dated January 25, 2011 of the Government on administrative penalties for violations in animal feed production;

Pursuant to Decree No. 123/2018/NĐ-CP dated September 17, 2018 of the Government amending and supplementing certain Decrees stipulating conditions for investment and business in the agricultural sector;

The Ministry of Agriculture and Rural Development issues this Circular stipulating the inspection, supervision, and handling of violations of prohibited substances belonging to the Beta-agonist group (Clenbuterol, Salbutamol, and Ractopamine) in animal raising.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the inspection, supervision, and handling of violations of prohibited substances belonging to the Beta-agonist group (Clenbuterol, Salbutamol, and Ractopamine) in animal raising.

Article 2. Applicability

This Circular applies to organizations and individuals within and outside Vietnam related to activities in animal feed production and trade, veterinary drug production and trade; livestock and poultry breeding facilities; slaughterhouses, processing, and trading facilities of livestock and poultry products in Vietnam.

Article 3. Principles of Inspection and Supervision

Clause 1. State management agencies with authority over agriculture and rural development, while performing their duties of inspection and supervision regarding food safety in animal raising and veterinary practices, have the right to decide on applying forms of handling and levels of fines for violations concerning prohibited substances belonging to the Beta-agonist group in livestock and poultry raising, and provide information to the press in accordance with the provisions of the law.

Clause 2. Owners of breeding facilities; producers and traders of animal feed and veterinary drugs; slaughterhouses, processing, and trading facilities of livestock and poultry products:

Point a. Shall proactively control the production and trading processes to ensure that there are no prohibited substances belonging to the Beta-agonist group in breeding materials and animal products through signing commitments with trading partners in purchasing and supplying breeding materials and veterinary drugs, or committing to local authorities not to produce, trade, or use prohibited substances in animal raising.

Point b. Shall proactively take samples or hire others to take samples for analysis and testing of prohibited substances in breeding materials and animal products at their production and trading facilities.

Point c. Shall not dispose of or consume breeding materials, products, and animals under inspection without a conclusion and permission from the inspection agency.

Chapter II
INSPECTION AND SUPERVISION ACTIVITIES

Article 4. Inspection Targets

Clause 1. At animal feed production and trading facilities, veterinary drug production and trading facilities: animal feed; veterinary drugs.

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

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

Clause 4. At trading facilities of livestock and poultry products: meat samples; organ samples.

The inspection team shall proceed as follows:

Clause 1. Step 1: Take samples of animal feed, veterinary drugs, drinking water, and animal products according to the methods prescribed in Appendix I attached hereto and other relevant current laws.

Clause 2. Select the testing method as prescribed in Clause 1 of Article 6 of this Circular to conduct analysis and evaluation.

Article 6. Methods of inspection and handling of analytical results

1. Inspection methods: Inspection by evaluating the presence of Clenbuterol, Salbutamol, and Ractopamine, which belong to the Beta-Agonist group, in animal feed, drinking water, veterinary drugs, urine, blood samples, and livestock products through one of the following two methods:

a) The first method (applicable when a quick test result is needed):

Conduct qualitative analysis using a rapid test kit or semi-quantitative analysis using a general ELISA kit for the Beta-Agonist group or separate qualitative tests for each of Clenbuterol, Salbutamol, and Ractopamine. The detection limit (LOD) of the rapid test kit and ELISA kit must be less than 0.2 ppb. If the result is negative, the inspection process ends.

If the result is positive, further quantitative analysis must be conducted using chromatography to confirm whether the sample is truly positive for prohibited substances in the Beta-Agonist group.

b) The second method:

Immediately conduct quantitative analysis using chromatography for Clenbuterol, Salbutamol, and Ractopamine.

2. Handling of analytical results

a) If the result is negative by the above analytical methods, it is confirmed that the sample does not violate (or the sample is negative for prohibited substances in the Beta-Agonist group).

b) A positive result from quantitative analysis serves as the basis for handling violations and announcing the violation sample (or the sample is positive for prohibited substances in the Beta-Agonist group). The criteria for confirming a positive sample are specified in Appendix II issued with this Circular.

Article 7. Handling Violations

In cases where the tested sample has a positive result from quantitative analysis for prohibited substances in the Beta-Agonist group, the competent state management agency shall take the following steps:

1. Notify the organization or individual whose sample tested positive for prohibited substances in the Beta-Agonist group.

2. Handle the violations according to relevant laws.

3. In addition to administrative penalties prescribed by law, the organization or individual committing the violation must also apply the following measures:

a) For breeding facilities: Must immediately stop using agents causing positive prohibited substance results and continue raising livestock until retesting shows a negative result before selling. The breeding facility must bear all testing costs.

b) For slaughterhouses: Compel the destruction of all livestock or compel the slaughterhouse to continue confining the violating animals under conditions ensuring veterinary hygiene requirements until retesting shows a negative result for prohibited substances, then they can be slaughtered and put on the market. The slaughterhouse must bear all costs related to destruction, confinement, and testing.

The period for continuing to confine livestock that have tested positive for prohibited substances may last from 3 to 15 days, depending on the extent of use, duration of use, and type of prohibited substance used.

c) For businesses dealing in livestock and poultry products: Compel the recall and destruction of all livestock and poultry products. The business must bear all costs related to recall, destruction, and testing.

d) For businesses producing and trading in animal feed and veterinary drugs: Compel the recall and destruction of batches of products found to be positive. The business must bear all costs related to recall, destruction, and testing.

4. Publicly announce organizations and individuals who violated on mass media.

Chapter III
LIMITATION OF LIABILITY

Article 8. Responsibilities of the Livestock Breeding Department

1. To unify and organize the implementation of inspection, supervision, and handling of violations related to prohibited beta-agonist substances in livestock breeding at livestock and poultry breeding facilities; feed production and trading facilities.

2. To direct and coordinate with local specialized inspection agencies to inspect and supervise the use of prohibited substances in livestock breeding at livestock and poultry breeding facilities; feed production and trading facilities.

3. To organize guidance, propaganda, and training on food safety knowledge for entities under its management.

Article 9. Responsibilities of the Animal Health Department

1. To unify and organize the implementation of inspection, supervision, and handling of violations related to prohibited beta-agonist substances in livestock breeding at veterinary drug production and trading facilities; slaughterhouses, processing, and trading facilities for livestock and poultry products.

2. To direct and coordinate with local specialized inspection agencies to inspect and supervise the use of prohibited substances in livestock breeding at veterinary drug production and trading facilities; slaughterhouses, processing, and trading facilities for livestock and poultry products.

3. To organize guidance, propaganda, and training on ensuring food safety knowledge for entities under its management.

Article 10. Responsibilities of the Department of Agriculture and Rural Development

1. To implement inspection, supervision, and handling of violations related to the use of prohibited beta-agonist substances at livestock and poultry breeding facilities; feed production and trading facilities; veterinary drug production and trading facilities; slaughterhouses, processing, and trading facilities for livestock and poultry products within its jurisdiction.

2. To direct, guide, and inspect the implementation of this Circular throughout the province or city.

3. To organize guidance, propaganda, and training on ensuring food safety knowledge for entities under its management.

Article 11. Responsibilities of livestock breeding facilities; slaughterhouses, processing facilities for livestock and poultry; trading facilities for livestock and poultry products; feed production and trading facilities, veterinary drug production and trading facilities

1. To comply strictly with the regulations of the Ministry of Agriculture and Rural Development regarding the prohibition of using substances belonging to the beta-agonist group in livestock breeding.

2. To maintain production and trading conditions that ensure food safety according to the law.

3. Not to tolerate or cover up; must proactively detect and report acts of producing, trading, and using prohibited substances in livestock breeding.

Chapter IV
IMPLEMENTING PROVISIONS

Article 12. Effective Date

1. This Circular takes effect from December 22, 2012.

2. This Circular replaces Circular No. 54/2010/TT-BNNPTNT dated September 15, 2010 of the Ministry of Agriculture and Rural Development on the regulation of inspection and supervision of substances belonging to the beta-agonist group in livestock breeding.

Article 13. Implementation Organization

1. The Livestock Breeding Department and the Animal Health Department shall provide guidance, monitor, direct, and inspect the implementation of this Circular for entities under their management.

2. Heads of units, organizations, and individuals related shall be responsible for implementing this Circular.

During the implementation process, if there are difficulties or obstacles, relevant agencies, units, and individuals are requested to report to the Ministry of Agriculture and Rural Development for review and amendment.

 

ANNEX I

SAMPLING PROCEDURE AND SAMPLE MANAGEMENT
(Annexed to Circular No. 57/2012/TT-BNNPTNT dated November 7, 2012 of the Ministry of Agriculture and Rural Development)

1. Feed samples are taken from feed production and trading facilities and livestock and poultry breeding facilities. The sampling procedure is carried out in accordance with the provisions of the Vietnamese Standard (TCVN 4325:2007).

Each feed sample to be tested is divided into three parts, each part sealed and contained in appropriate sample containers, fully recording relevant information (sample name, sampling time, sample address, sampler, sample condition), with one part sent for testing, one part retained at the sampling facility, and one part retained at the sampling agency for comparison purposes.

2. Veterinary drug samples are taken from veterinary drug production and trading facilities and livestock and poultry breeding facilities. The sampling method follows the Vietnamese Standard (QCVN 01-03:2009). The number of samples, quantity, and sealing of samples are similar to those of feed samples.

Each veterinary drug sample to be tested is divided into three equal parts, each part sealed and contained in appropriate sample containers, fully recording relevant information (sample name, sampling time, sample address, sampler, sample condition), with one part sent for testing, one part retained at the sampling facility, and one part retained at the sampling agency for comparison purposes.

3. Drinking water samples are taken from livestock and poultry breeding facilities from different drinking water sources within the facility (water tanks, direct drinking faucets, watering troughs).
various drinking water sources within the facility (water tanks, direct drinking faucets,
drinking troughs).

Each drinking water sample to be tested is divided into three equal parts (200 ml each), sealed and contained in appropriate sample containers, fully recording relevant information (sample name, sampling time, sample address, sampler, sample condition), with one part sent for testing, one part retained at the sampling facility, and one part retained at the sampling agency for comparison purposes.

4. Urine or blood samples are directly collected (at least 150 ml for urine and 15 ml for blood) from livestock and poultry raised at breeding facilities and slaughterhouses. Samples are stored at a temperature not exceeding 4°C after collection.

The number of urine or blood samples to be collected depends on the scale of the breeding facility and the scale of the slaughterhouse. Specific sample quantities are defined according to the scale of the breeding facility for each group of livestock as follows:

Scale under 10 animals: Collect at least 2 samples from 2 animals

Scale from 11 to 50 animals: Collect at least 3 samples from 3 animals

Scale from 51 to 100 animals: Collect at least 4 samples from 4 animals

Scale of 100 animals or more: Collect at least 5 samples from 5 animals

Urine sampling can be done by collecting urine directly from the flow when the animal is urinating, or by using a plastic bag attached to the urinary organ of male animals or using a urinary catheter for female animals.

Each urine or blood sample taken for testing shall be divided into three equal parts, each part sealed and stored in appropriate containers, fully labeled with relevant information as prescribed (similar to food samples), including one part sent for testing, one part retained at the sampling facility, and one part retained at the sampling authority for comparison purposes. Urine and blood samples must always be kept cold at a temperature not exceeding 4 degrees Celsius.

5. Meat and meat products (animal products) samples shall be taken from slaughterhouses, processing facilities, and meat retail establishments. The sampling procedure shall be carried out in accordance with the provisions of the Vietnamese Standard (TCVN 4833-1:2002).

6. Samples after collection must be sealed, signed by representatives of the sampling authority, the sampler, and the representative of the sampled entity. In cases where the representative of the sampled entity does not sign, the seal with the signature of the sampler still has legal validity.

7. All retained samples must be kept until the final conclusion of the inspection and verification team.

8. A record of sample collection, storage, and sending to the laboratory designated by the Ministry of Agriculture and Rural Development shall be established.

 

ANNEX II

REGULATIONS ON POSITIVE SAMPLES ACCORDING TO QUANTITATIVE TESTING METHODS
(Annexed to Circular No. 57/2012/TT-BNNPTNT dated November 7, 2012 of the Ministry of Agriculture and Rural Development)

A sample is considered positive if the quantitative analysis result is higher than or equal to one of the values (in ppb) listed in the table below: