Circular 20/2015/tt-Byt: Guide To Assay Process Chemicals, Preparations Kill Mosquito Spray Particles Can Form Small Positive

Original Language Title: Thông tư 20/2015/TT-BYT: Hướng dẫn quy trình khảo nghiệm hóa chất, chế phẩm diệt muỗi dạng phun hạt thể tích cực nhỏ

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Circular assay process chemicals, preparations for kill mosquito spray particles can form small positive _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ chemical Law bases the number 2007/QH12 on November 21, 2007;
Pursuant to the law of product quality, commodity number 05/2007/QH12 on November 21, 2007;
Pursuant to Decree No. 63/2012/ND-CP on August 31, 2012 of the Government functions, tasks, powers and organizational structure of the Ministry of health;
At the suggestion of the Director of environmental health management;
The Minister of Health issued a circular assay process chemicals, preparations kill mosquito spray particles can form small positive.
Chapter I GENERAL PROVISIONS article 1. Scope this circular defined evaluation method in force, the safety of chemicals, products kill mosquito spray particles can form small positive sign in Vietnam.
Article 2. Explanation of terms In this circular, the terms and abbreviation notation is understood as follows: 1. ULV is an acronym of the English phrase "Ultra Low Volume" is extremely small volume.
2. CAS number is the acronym of the English phrase "Chemical Abstract Service Registry number" means the Chemical Abstracts registration code consists of numbers identify the chemical elements, chemical compounds.
3. The WHO code is the acronym of the English phrase "World Health Organisation code" is the chemical code as defined by the World Health Organization.
Chapter II article 3 ASSAY METHOD. Assay methods using biological test engineering reviews safety and effectiveness and undesirable effects of ULV spray preparations, chemicals that kill mosquito. Each assay includes 3 testing and all tests must comply with the requirements, how to conduct and evaluate the provisions of this circular. The test can be conducted simultaneously in one day or in the days vary but must guarantee the same conditions for the same.
Article 4. Requirements for testing 1. Requirements for equipment and instruments: a mosquito Cage high cylindrical 20) cm, diameter 20 cm, coated tuyn screen size 32-36 hole/cm2. The number of nested 12/1 test (the test marking cages 10 jerseys are red, numbered from 1 to 10 and 2 cages confronting Mark Green, numbered 1 and 2);
ULV spraying Machines with b) injector reached the average particle size (15 ± 2) mm;
c) thermometer, humidity design;
d) time tracking clock (capable of counting the seconds and count the minutes);
hanging wire cages and Price) must be designed appropriately;
e) personal protective apparel: glasses, masks, gloves, boots, clothing;
g) assay results items specified in annex 1 attached herewith;
h) questionnaire interview unwanted effects specified in Appendix 2 attached to this circular;
2. direct technician perform the ULV spray must be selected provisions in Appendix 3 attached to this circular.
3. Mosquitoes use to assay to be mosquito-standard according to the guidelines of the World Health Organization (WHO/CDS/CPC/MAL/98.2), was bred in the room raising biosafety level II, susceptible to chemicals, blood, yet fellow 05-07 on age,-10% glucose solution.
4. Test: a test of power Cut);
b) closed the room and right in the door holding the nozzle off the 45 degrees inwards, press and proceed to spray from time to time.
c) After 60 min of exposure to chemicals, since the spray products, move all the mosquitoes in cages to test new, clean cages with the same size or clean Cup. Turn the cage or this Cup and cages of mosquitoes for testifying to the laboratory and for mosquito-10% glucose solution;
d) after 24 hours from now, reading the number of dead mosquito spray. If the batch after 24 hours of confronting the dead mosquitoes on the 20% they must cancel the results assay. If the number of dead mosquitoes in cages for witnesses under 5% is considered normal, the mean number of dead mosquitoes are retained for assay results. The number of mosquitoes in the cage for evidence after 24 hours died from 5% to 20%, then the result is adjusted using the Abbott formula: where: X = percentage of mosquitoes killed in experimental plots of ULV spray and Y = the proportion of dead mosquito in confronting batch.
DD) assay results recorded according to the form prescribed in annex 1 attached to this circular.
Article 6. Reviews of the effect and safety 1. Reviews the effect: mosquito death rate from 90%-100% is satisfactory effect.
2. safety reviews: reviews the unwanted reaction for direct chemical injection, and the landlord has the test room (if available) based on the interview questionnaire stipulated in Appendix 2 attached to this circular. Play interview questions each person independently. If people are asked to have one of these signs: skin allergies, headaches, captured dizzy ≥ 2/5 is not satisfactory;
Article 7. Paid results and assay samples 1. Pay for results: organizations perform the assay the assay results to answer according to the form prescribed in Appendix 3 attached to this circular.
2. Save the template: after raw sample and assay the samples used must be stored for at least 2 years. Templates save log information needed: name (manufacturer, production batch, production date, expiry date), active substances (CAS number, the WHO code), the dose tested, the test date, the Agency requested.
Chapter III the TERMS of the IMPLEMENTATION of article 8. Effective enforcement of this circular is effective as from January 1, 2016.
Article 9. Implementation of environmental management Bureau Chief, Chief, Chief Inspector, Ministry Director, Bureau Chief, General Director of the Service Bureau, Directorate of the Ministry of health is responsible for the implementation of this circular.
In the process, if there are problems, the agencies, organizations and individuals to reflect on the Ministry of health (environmental health administration) to study the resolution./.