Circular No. 20/2015/TT-BYT guiding the testing procedures for chemical substances and mosquito larvicide products in the form of ultra-low volume spray

CIRCULAR

Guidelines for the testing process of chemical substances and mosquito control products in ultra-low volume spray form form spray volume positive chargedỏ

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

Pursuant to the Product Quality Law 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 substances and mosquito control products in ultra-low volume spray form.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the methods for evaluating the efficacy, safety, and adverse effects of chemical substances and mosquito control products in ultra-low volume spray form for registration and circulation in Vietnam.

Article 2. Interpretation of Terms

In this Circular, the following terms and abbreviations have the meanings set forth below:

1ULV is an abbreviation for the English term "Ultra Low Volume," which refers to extremely small volume particles.

2. Chlordane CAS RN

3. is an abbreviation for the English term "Chemical Abstracts Service Registry Number," which is a summary registration code consisting of a series of identifying numbers for chemical elements and compounds. WHO code

Chapter II

is an abbreviation for the English term "World Health Organization code," which is the chemical code as defined by the World Health Organization.

Article 3. Testing Method

Biological testing techniques shall be used to evaluate the efficacy, safety, and adverse effects of chemical substances and ultra-low volume spray mosquito control products. Each test shall include three trials, and all trials must comply with the requirements, procedures, and evaluation methods specified in this Circular. These trials may be conducted on the same day or on different days but must ensure similar conditions.

Article 4. Requirements for Trials

1. Requirements for equipment and devices:

a) A cylindrical mosquito cage measuring 20 cm high and 20 cm in diameter, covered with a mesh screen of 32-36 holes per square centimeter. The number of cages required for each trial is 12 (10 experimental cages marked red and numbered from 01 to 10, and 2 control cages marked blue and numbered 01 and 02).

b) An ultra-low volume sprayer with a nozzle producing particle sizes of (15 ± 2) mm.

c) Thermometer and hygrometer.

d) A stopwatch capable of counting seconds and minutes.

e) The rack and hanging wires for the cages must be designed appropriately.

f) Personal protective equipment: goggles, mask, gloves, boots, and clothing.

g) The record sheet for the test results as prescribed in Appendix 1 attached to this Circular.

h) The questionnaire for adverse effects as prescribed in Appendix 2 attached to this Circular.

2. The technician directly performing the ultra-low volume spraying must meet the criteria specified in Appendix 3 attached to this Circular.

3. Mosquitoes used for testing must be female mosquitoes meeting the standards as directed by the World Health Organization (WHO/CDS/CPC/MAL/98.2), raised in a Biosafety Level 2 laboratory, sensitive to chemicals, not blood-fed, and between 5-7 days old, fed on a 10% glucose solution.

4. Testing Room:

a) Disconnect power supply to the testing room.

b) Close the door of the testing room and hold the nozzle at a 45-degree angle towards the inside of the room, press the machine, and proceed with the spraying according to the predetermined time.

c) After 60 minutes of exposure to the chemical substance or product from the moment of spraying, transfer all mosquitoes in the experimental cages to new, clean cages of similar size or clean cups. Move these cages or cups and the control cages to the laboratory and allow the mosquitoes to feed on a 10% glucose solution.

d) After 24 hours from the moment of spraying, count the number of dead mosquitoes. If the control group has more than 20% dead mosquitoes after 24 hours, the test results must be discarded. If the number of dead mosquitoes in the control group is less than 5%, it is considered normal, meaning the number of dead mosquitoes from the test will be retained for calculation purposes. If the number of dead mosquitoes in the control group ranges from 5% to 20%, the test results will be adjusted using the Abbott formula:

Where: X is the percentage of dead mosquitoes in the ultra-low volume spray test group, and Y is the percentage of dead mosquitoes in the control group.

e) Test results shall be recorded according to the model prescribed in Appendix 1 attached to this Circular.

Article 6. Evaluation of Effectiveness and Safety

1. Evaluation of Effectiveness: A mortality rate of mosquitoes from 90% to 100% is considered to meet the requirements.

2. Evaluation of Safety: Observe and record any adverse reactions experienced by individuals directly applying chemicals, formulations, and homeowners with testing rooms (if applicable) based on the interview questionnaire specified in Appendix 2 issued together with this Circular. Conduct individual interviews for each person. If among those interviewed, there are signs of skin allergy, headache, dizziness in at least 2 out of 5 people, then the safety requirement is not met;

Article 7. Reporting Results and Sample Retention

1. Reporting Results: The organization conducting the testing shall provide the testing results according to the form prescribed in Appendix 4 issued together with this Circular.

2. Sample Retention: After testing, the original samples and all used samples must be retained for at least two years. The retention samples need to record the following information in a logbook: product name (manufacturer, production batch, date of manufacture, expiration date), active ingredient (CAS number, WHO code), test dosage, test date, requesting agency.

Chapter III

IMPLEMENTING PROVISIONS

Article 8. Effective Date

The Director of the Ministry's Office, the Inspector General of the Ministry, the Heads of Departments, the Directors of the Vietnam Inland Waterway Administration, the Vietnam Maritime Administration, the Vietnam Ship Survey Bureau, the Directors of Provincial Department of Transport, the Heads of relevant agencies, organizations, and individuals are responsible for implementing this Circular./.

Article 9. Implementation Organization

The Director of the Department of Environmental Health Management, the Head of the Ministry's Office, the Inspector General of the Ministry, the Heads of Departments, Bureaus, and General Departments under the Ministry of Health are responsible for implementing this Circular. During implementation, if any difficulties arise, agencies, organizations, and individuals should report them to the Ministry of Health (Department of Environmental Health Management) for research and resolution.

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