Circular No. 52/2012/TT-BNNPTNT amending and supplementing certain Articles of Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011, and Circular No. 54/2011/TT-BNNPTNT dated August 3, 2011.

CIRCULAR

Amending and supplementing certain articles of Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011

and Circular No. 54/2011/TT-BNNPTNT dated August 3, 2011

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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 Law on Standards and Technical Regulations 2006; Decree No. 127/2007/NĐ-CP dated August 1, 2007 of the Government detailing and guiding the implementation of certain provisions of the Law on Standards and Technical Regulations;

Pursuant to the Law on Product Quality 2007; Decree No. 132/2008/NĐ-CP dated December 31, 2008 of the Government detailing and guiding the implementation of certain provisions of the Law on Product Quality;

Pursuant to the Food Safety Law 2010; Pursuant to Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing and guiding the implementation of certain provisions of the Food Safety Law;

Pursuant to the proposal of the Director of the Department of Science, Technology and Environment;

The Minister of Agriculture and Rural Development promulgates this Circular amending and supplementing certain articles of Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011 and Circular No. 54/2011/TT-BNNPTNT dated August 3, 2011.

Article 1. Amending and supplementing certain articles of Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011 of the Ministry of Agriculture and Rural Development regarding the evaluation, designation, and management of agricultural and rural development laboratories.

1. Clause 2, Article 2 shall be amended and supplemented as follows:

"2. Inter-laboratory comparison: is the process of assessing the quality of testing results between two or more laboratories organized by an independent entity through comparing analytical results on identical samples with the common value obtained from participating laboratories."

2. Supplement Clause 5 of Article 2 as follows:

"5. Proficiency testing: The execution of tests on the same sample by two or more laboratories under predetermined conditions to evaluate the ability to perform that test by the laboratory."

3. Clause 3, Clause 5, and Clause 9 of Article 3 are amended and supplemented as follows:

"3. The Fisheries General Department is the authority responsible for evaluating and designating fish seed laboratories; feed, raw materials for feed production, additives, biological preparations, water quality for aquaculture, chemicals for treating aquaculture environments;"

"5. The Livestock Production Department is the authority responsible for evaluating and designating livestock seed laboratories; feed for livestock, raw materials for feed production, preservatives used in livestock feed, biological preparations serving livestock breeding and livestock breeding environment;"

"9. The Processing, Marketing of Forestry, Aquatic Products and Salt Industry Department is the authority responsible for evaluating and designating salt and salt product laboratories; agricultural machinery and equipment; chemical additives used in processing and preserving forestry products;"

4. Supplement Clause 4 of Article 6 as follows:

"4. Periodic assessment, applicable to laboratories that have been designated."

5. Supplement Point d, Clause 1 of Article 9 as follows:

"d) Periodic assessment."

6. Supplement Point g, Clause 1 of Article 10 as follows:

"g) The number of files for laboratories applying for designation in one field: five sets; for multi-field laboratories: seven sets."

7. Clause 2 of Article 12 shall be amended and supplemented as follows:

"2. The decision to establish the assessment team must clearly state the scope, content of the assessment, list, and assignment of responsibilities for each member."

8. Supplement Clause 3 of Article 12 as follows:

"3. Composition of the assessment team

a) For laboratories applying for designation in one field: The assessment team consists of three to five members including representatives of the Bureau/General Department according to the designated field and experienced assessors.

b) For laboratories of the Bureau/General Department with laboratories: The assessment team consists of three to five members including representatives of the Bureau/General Department, the Science, Technology and Environment Department and experienced assessors.

c) For multi-disciplinary laboratories (two fields or more): The assessment team consists of five to seven members including representatives of the Science, Technology and Environment Department, relevant Bureau/General Departments and experienced assessors."

9. Clause 1 of Article 17 is amended and supplemented as follows:

"1. In case the laboratory applying for designation meets the requirements set out in Article 5, within five working days, the evaluation and designation authority specified in Clauses 1 to 9 of Article 3 shall report the assessment results to the Ministry (Science, Technology and Environment Department) to request the issuance of a laboratory code. Upon receipt of the request, within five working days, the Science, Technology and Environment Department shall issue the laboratory code in writing. Within five working days after receiving the laboratory code, the evaluation and designation authority specified in Clauses 1 to 9 of Article 3 shall issue the designation decision and notify the result to the Ministry (Science, Technology and Environment Department); the evaluation and designation authority specified in Clause 10 of Article 3 shall submit the designation decision to the Ministry for issuance."

10. Article 21 is amended and supplemented as follows:

"Article 21: Inspection and supervision

1. The evaluation and designation authority specified in Article 3 is responsible for conducting periodic assessments of designated laboratories (once a year) and ad hoc assessments when required.

2. The Science, Technology and Environment Department leads the establishment of the annual periodic assessment team for multi-disciplinary laboratories and laboratories designated by multiple units under the Ministry. The composition of the annual periodic assessment team includes representatives of the Science, Technology and Environment Department, the Legal Affairs Department, and relevant Bureaus/General Departments."

11. Clause 2 of Article 22 is amended and supplemented as follows:

"2. Quarterly, the Science, Technology and Environment Department publishes a list of laboratories along with the designated tests on the Ministry of Agriculture and Rural Development's website."

12. Clause 9 of Article 24 is amended and supplemented as follows:

"9. Paying fees for designation assessment and periodic assessment as prescribed."

Article 2. Amend and supplement some articles of Circular No. 54/2011/TT-BNNPTNT dated August 3, 2012 of the Ministry of Agriculture and Rural Development on the capacity of laboratories for quality and food safety testing of forestry, fisheries, and salt products.

1. Clause 1 of Article 4 shall be amended and supplemented as follows:

"1. The laboratory or the organization owning such laboratory must have legal personality and be registered for inspection activities according to Circular No. 08/2009/TT-BKHCN dated April 8, 2009 of the Ministry of Science and Technology guiding the requirements, procedures, and formalities for registering fields of conformity assessment activities or tasks assigned by competent authorities."

2. Point a Clause 4 Article 5 shall be amended and supplemented as follows:

"a) The laboratory must select a provider of proficiency testing/certified reference material comparison programs (PT/CRM) that can meet the appropriate requirements regarding the subject matter, analytical criteria, and participate regularly with a frequency of at least once every three years per criterion or group of criteria, wherein:

- The laboratory participating in PT/CRM programs must comply with the requirements of PT/CRM programs designated by the accreditation body, appointed organizations, or lead organizations; organized by international and regional organizations; provided by suppliers/organizations applying ISO/IEC 17043 Conformity Assessment - General Requirements for Proficiency Testing or equivalent organizations, and must achieve satisfactory results;

- The laboratory must retain all results from all PT/CRM programs it participates in. This file is part of the review process conducted by the accreditation body, appointing organization."

Article 3. Effectiveness

1. This Circular takes effect from December 7, 2012.

2. Repeal Article 21 of Circular No. 16/2011/TT-BNNPTNT dated April 1, 2011 of the Ministry of Agriculture and Rural Development on the evaluation, designation, and management of agricultural and rural development laboratories.

3. In the course of implementing this Circular, if there are difficulties or obstacles, organizations and individuals shall report to the Ministry of Agriculture and Rural Development for consideration and amendment.