Circular No. 21/2015/TT-BYT guiding the testing procedure for mosquito repellent and killing chemical sheets using electricity

CIRCULAR

Guidelines for the testing process of chemical mosquito repellent and killing sheets used with electricityFor power plants invested under the Build-Operate-Transfer (BOT) model, n is determined according to the operational period of the power plant stipulated in the BOT contract.

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 Pursuant to the Chemicals Law No. 06/2007/QH12 dated November 21, 2007;

Pursuant to the Law on Product Quality and Goods No. 05/2007/QH12 dated November 21, 2007;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Medical Environment Management Department;

The Minister of Health issues this Circular guiding the testing process of chemical mosquito repellent and killing sheets used with electricity.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the methods for evaluating the efficacy, safety, and adverse effects of chemical mosquito repellent and killing sheets used with electricity for registration and circulation in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the terms and abbreviated notations shall be understood as follows:

1. KT is the abbreviation for the English phrase "Knock down time," which means the knockdown time.

2. Chlordane is the abbreviation for the English phrase "Chemical Abstract Service Registry number," which is the chemical summary registration code consisting of a chain of identifying numbers for elements and chemical compounds.

3. WHO code is the abbreviation for the English phrase "World Health Organization code," which is the chemical code according to the World Health Organization's regulations.

Chapter II

TESTING METHODS

Article 3. Testing Methods

Use the biological test method in a Peet Grady chamber measuring 180cm x 180cm x 180cm to evaluate the efficacy, safety, and adverse effects of chemical mosquito repellent and killing sheets. Each test consists of three trials, and all trials must comply with the requirements, procedures, and evaluation criteria set forth in this Circular.

Article 4. Requirements for Testing

1. Requirements for equipment and devices:

a) Mosquito cages made of 32-36 mesh/cm² netting measuring 20cm x 20cm x 20cm, marked with red color and numbered from 01-04, and two control cages marked with blue color and numbered from 01-02, the quantity of cages needed for testing depends on the number of hours of testing;

b) Personal protective equipment: clothing, goggles, protective face mask, gloves, boots;

c) Graphs for calculating KT50, KT90;

d) Result recording sheet as specified in Appendix 1 issued together with this Circular;

đ) Questionnaire form for recording adverse effects as specified in Appendix 2 issued together with this Circular;

2. The technicians directly conducting the tests must be selected according to the provisions in Appendix 3 issued together with this Circular.

3. The mosquitoes used for testing must be female mosquitoes meeting the standards as guided by the World Health Organization (WHO/CDS/CPC/MAL/98.2), raised in a Biosafety Level II laboratory, sensitive to chemicals, having not sucked blood, aged 5-7 days old, and fed with 10% glucose solution.

4. The testing room must meet the ISO/IEC 17025:2005 standard, including one testing room and one control room as specified in Appendix 4 issued together with this Circular. These rooms must have similar conditions with normal temperature and humidity, and each room must contain one Peet Grady chamber measuring 180cm x 180cm x 180cm. Additionally, a room for observing dead mosquitoes after 24 hours at a temperature of 27°C ± 2°C and relative humidity of 80% ± 10% must be prepared.

Article 5. Steps for Conducting Tests

1. Preparation:

a) Prepare a box containing at least six chemical mosquito repellent and killing sheets, of which: three sheets are used for three trials and three sheets are kept as samples. These chemical mosquito repellent and killing sheets must be from the same production batch, within their shelf life, and in perfect condition;

b) Prepare 1,000 mosquitoes meeting the standards as specified in Clause 3 of this Circular for one trial, and divide them into each cage with 25 mosquitoes;

c) In each Peet Grady testing chamber, hang four mosquito cages at four corners, maintaining a distance of 80cm from the ceiling and 10cm from the walls;

d) In the Peet Grady control chamber, hang two mosquito cages at two opposite corners.

2. Testing:

a) During the first hour of testing:

- Burn the mosquito repellent sheet continuously for 30 minutes at a location other than the testing room, the room with the Peet Grady control chamber, and the room for observing dead mosquitoes after 24 hours;

- Place the burned mosquito repellent sheet in the middle of the Peet Grady testing chamber and count the number of knocked-down mosquitoes every nine minutes, counting for one minute each time. A total of six counts of knocked-down mosquitoes during the 60-minute testing period;

- Transfer the knocked-down mosquitoes in the testing room and all mosquitoes in the control cages to cages of similar size or clean cups; then transfer them to the observation room and feed them with 10% glucose solution;

b) During the second hour of testing: replace all testing and control mosquitoes to continue the second hour of testing as specified in Point a of this Clause;

c) During each subsequent two-hour period: replace all testing and control mosquitoes to continue testing as specified in Point a of this Clause;

d) After 24 hours: count the number of dead mosquitoes among the knocked-down ones and in the control cages. If the control group has more than 20% dead mosquitoes after 24 hours, the results must be discarded. If the control group has less than 5% dead mosquitoes, it is considered normal, meaning the number of dead mosquitoes in the testing group will remain unchanged for the result calculation. If the control group has between 5% and less than 20% dead mosquitoes, the result will be adjusted using the formula

% mortality rate =   × 100

Where: X = percentage of dead mosquitoes in the testing group, Y = percentage of dead mosquitoes in the control group.

đ) Each test must be repeated three times under similar conditions;

e) Record the results according to the model specified in Appendix 1 issued together with this Circular;

g) KT50 and KT90 are calculated from the graph.

Article 6. Evaluation of Effectiveness and Safety

1. Evaluation of effectiveness: if the percentage of dead mosquitoes is from 90% to 100% within 24 hours, it meets the requirements.

2. Evaluation of safety: based on the questionnaire for adverse effects of the test sample as specified in Appendix 2 attached hereto, if two out of five respondents exhibit any of the following symptoms: dizziness, headache, cough, then it does not meet the requirements. dizziness, headache, cough ≥ 2/5 then it does not meet the requirements.

Article 7. Reporting Results and Storing Test Samples

1. Reporting results: the organization conducting the test shall report the test results according to the form prescribed in Appendix 5 attached hereto.

2. Storing samples: after testing, the test product samples must be stored for at least two years. The storage samples need to be recorded in a logbook: name of the product (manufacturer, production batch, date of manufacture, expiration date), active ingredient (CAS number, WHO code), dosage tested, testing date, requesting agency.

Chapter III

IMPLEMENTING PROVISIONS

Article 8. Effective Date

1. This Circular takes effect from January 1, 2016.

2. The process for evaluating the effectiveness and safety of chemical impregnated mosquito repellent pads for mosquito control issued pursuant to Decision No. 120/2000/QĐ-BYT dated January 24, 2000 of the Minister of Health ceases to be effective from the date this Circular takes effect.

Article 9. Implementation Organization

The Director of the Department of Environmental Health Management, the Head of the Ministry's Office, the Inspector General, the Heads of Departments, Bureaus, and General Departments under the Ministry of Health are responsible for implementing this Circular.

During implementation, if there are any difficulties, agencies, organizations, and individuals should reflect them to the Ministry of Health (Department of Environmental Health Management) for research and resolution./.