b) ULV spray machines with nozzles capable of producing medium-size droplets (15 ± 2) mm;

c) Thermometer and hygrometer;

d) Timer (capable of counting in minute and second);

dd) Cage shelves and suspension ropes must be designed appropriately;

e) Personal protective gears: glasses, gloves, boots and clothes;

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h) Questionnaires for unwanted effects under Annex 2 attached hereto;

2. Technicians directly spraying ULV must be selected according to Annex 3 attached hereto.

3. Mosquitoes for experiments must be qualified female mosquitoes according to guidelines of WHO (WHO/CDS/CPC/MAL/98.2), reared in class II biological safety cabinets, susceptible to chemicals, empty of blood, at 5 – 7 days old, and filled with 10% glucose solutions.  

4. Test chambers:

a) Cut electricity of test chambers;

b) Close doors, stand at the door, hold a hose pointing to the inside of the room at a 45 degree angle, start machines and spray for a defined period.

c) After 60 minutes of making contact with chemicals and preparations, move all mosquitoes from test cages to new, clean cages with similar size or clean cups. Transfer these cages, cups and cages for comparison to laboratories and allow mosquitoes to suck on 10% glucose solution;

d) After 24 hours from the spray, read number of killed mosquitoes. If more than 20% of mosquitoes in comparison cages, cancel the experiment results.   If number of mosquitoes killed is lower than 5%, utilize number of mosquitoes killed for result calculation. Number of mosquitoes killed ranging from 5% to 20% after 24 hours shall be adjusted using Abbott formula:

% of killed mosquitoes = 

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dd) Test result schedules under Annex 1 attached hereto.

Article 6. Capacity and safety assessment

1. Capacity assessment: Qualified if 90% to 100% of mosquitoes are killed.

2. Safety assessment: Provide remarks about unwanted effects on individuals spraying the chemicals and preparations and on owners of buildings having laboratories (if any) based on interview questionnaires under Annex 2 attached hereto. Distribute interview questionnaire individually. Consider unqualified if at least 40% of questioned individuals observe: skin allergies, headaches or vertigo;

Article 7. Result return and experiment specimen storage

1. Result return: experimenting organizations shall provide experiment results using form under Annex 4 attached hereto.

2. Specimen storage: after conducting experiments, fresh specimen and used specimen must be stored for at least 2 years. Form for storage must contain following information: name of preparations (manufacturing brand, manufacturing batches, date of manufacture, expiry date), active ingredients (CAS number, WHO code), experiment dose, date of experiment, requesting agencies.

Chapter III

IMPLEMENTATION

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This Circular comes into force from January 1, 2016.

Article 9. Implementation

Director General of Health Environment Management Agency, Chief of the Ministry Office, Chief Ministry Inspector, Directors, Directors General, General Directors of Departments affiliated to Ministry Office are responsible for implementation of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Health Environment Management Agency) for solution./.

PP. MINISTER
DEPUTY MINISTER




Nguyen Thanh Long

ANNEX 1

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EXPERIMENT RESULT SCHEDULE

1. Type of mosquitoes tested: ……………………………………………………………

2. Date of test: ………………………………………………………………………

3. Name of preparation specimen: …………………………………………………

4. Active ingredient, concentration: ………………………………………………………

5. Dose: ………………………………………………………………

6. Capacity of test chambers: ………………………………………………………………

7. Experimenting entities: ……………………………………………………………………………

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9. Entities requesting experiment: ……………………………………………………………..

Number of mosquitoes in numbered testing cages

Number of tested mosquitoes killed after 24 hours

Number of mosquitoes for comparison killed after 24 hours

Results adjusted by Abbott formula (if any) Percentage

Cage 1: 25

/25

/25

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/25

/25

Cage 3: 25

/25

Cage 4: 25

/25

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Cage 5: 25

/25

Cage 6: 25

/25

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/25

Cage 8: 25

/25

Cage 9: 25

/25

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Cage 10: 25

/25

ANNEX 2

QUESTIONNAIRE ON UNWANTED EFFECTS OF EXPERIMENT SPECIMEN
(Attached to Circular No. 20/2015/TT-BYT dated July 27, 2015 of Minister of Health)

QUESTIONNAIRE ON UNWANTED EFFECTS

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(Interview as soon as moving mosquitoes to rooms for monitor)

I. Section for interviewer

1. Name of interviewer: ……………………………………………………………………

2. Date of interview: …………………………………………………………………………

3. Name of preparation specimen: …………………………………………………

4. Active ingredient, concentration: ………………………………………………………

5. Dose: ………………………………………………………………

6. Place of manufacturing ………………………………………………………………………

7. Date of manufacture and expiry date: ……………………………………………………

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9. Entities requesting experiment: ………………………………………………………………

10. Experimenting entities ………………………………………………………………………

11. Type of mosquitoes tested: ……………………………………………………………

12. Date and location of experiment ……………………………………………………………

13. Name of interviewee: ………………………………………………………………..

14. Occupation: ………………………………………………………………………………

II. Questions: (choose 5 volunteers and house owners, if any).

A. Questions for volunteers:

1. Do you directly spray in ULV for the experiment?

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2. Are you equipped with personal protective gear: clothes, glasses, netted hats, face masks, gloves, boots?

Yes      □          No        □

3. After spraying, did you enter the sprayed chambers to move the mosquitoes to another cage or cup for monitor?

Yes      □          No        □

4. After spraying or entering a sprayed chamber, did you feel irritated by the chemical?

Yes      □         No        □

5. If irritated, what are the symptoms?

Sneezing           □          Vertigo            □          Headache         □

Itchy, burning sensation □           Nausea            □          Other                □

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Runny nose                   □          Stuffed nose     □

Thank you!

B. Questions for house owners:

1. Do you feel irritated when entering the house 60 minutes after spraying?

Yes □   No □

2. If irritated, what are the symptoms?

Sneezing                       □          Vertigo □          Headache         □

Itchy, burning sensation □          Nausea □          Other                □

Coughing                      □          Itchy eyes         □

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Thank you!

ANNEX 3

AGREEMENT BETWEEN EXPERIMENTING AGENCY AND VOLUNTEERS
(Attached to Circular No. 20/2015/TT-BYT dated July 27, 2015 of Minister of Health)

EXPERIMENTING ENTITY
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No:…………

(Location and date)

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1. Name of individual in charge of experiment: ………………………………………………………

2. Under program: …………………………………………………………………………………

3. Authority in charge: …………………………………………………………………………………

4. Laboratory conducting experiment: ………………………………………………………………

Part I

NOTICE OF VOLUNTEER INVITIATION

1. Introduction:

We are entomologists affiliated to ……………………… (agency), conducting a biological test to experiment effectiveness, safety and unwanted effects of ULV mosquito insecticidal spray chemicals.    In order to assess effectiveness in eliminating mosquitoes of …………………… preparation(s) sprayed in ULV indoors with chamber volume of 30 m³ – 50 m³, we would like to invite Mr./Mrs./Ms. under normal health conditions to agree to participate in this experiment on a voluntary basis. 

2. Experiment purpose(s):

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3. Type of experiment:

Conduct biological experiment to assess effectiveness, safety and unwanted effects of ULV mosquito insecticidal spray preparation(s).

4. Volunteer selection:

Volunteers in this experiment must be active individuals holding technician titles, receiving training in entomology, performing entomology-related techniques skillfully or individuals having normal health conditions and receiving training to ensure strict compliance with technical requirements specified in the procedure.

5. Participation on a voluntary basis:

Volunteer agrees to participate on a voluntary basis (rather than by coercion)

6. Information on chemical to be experimented:

ULV mosquito insecticidal spray chemical used in this experiment is ……………………………, chemical formula: …………………………, according to classification of WHO: toxicity of ……………...   This experiment involves product with concentration of …………………… which has not been recorded for any significant unwanted effect.  However, individuals having a history of sensitivity and/or allergic reaction with used chemical should not participate.

7. Volunteers protected from diseases transmitted by carrier mosquitoes:

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8. Experiment outline, methods and procedures:

Experiment outline, methods, procedures and duration are specified in details under procedures. Volunteers must read thoroughly.

9. Unwanted effects, if any:

Strictly comply with instructions and equip with personal protective gear will prevent almost all unwanted effects.

10. Possible irritations:

Irritations possibly occur on volunteers susceptible to chemical in the experiment.

11. Volunteers must keep sufficient records of experiment results in provided schedules and other remarks during experiment period at request.

Part II

AGREEMENT

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Volunteer full name: ………………………………………………………………………………

Signature: …………………………………………………, ……/……/…… (date)

Researcher full name: ……………………………………………………………………………

Signature: …………………………………………………, ……/……/…… (date)

ANNEX 4

EXPERIMENT RESULT ANSWER SHEET
(Attached to Circular No. 20/2015/TT-BYT dated July 27, 2015 of Minister of Health)

EXPERIMENTING ENTITY
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SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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(Location and date)

EXPERIMENT RESULT ANSWER SHEET

(Attached to specific experiment results)

I. Name of chemical and/or preparation used in the experiment:

1. Experiment specimen: …………………………………………………………………………

2. Active ingredient component and concentration: ……………………………………………

3. Manufacturer: …………………………………………………………………………………

4. Manufacturer address: …………………………………………………………………………

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6. Expiry date:  ……………………………………………………………………………………

7. Number of specimen used for experiment and storage: ……………………………………

II.  Experiment purpose(s):

III. Entities requesting experiment:

IV. Experimenting entities:

V. Date and location of experiment:

VI. Result*:

1. Effectiveness:

2. Safety:

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1. Effectiveness:

2. Safety:

3. Propositions:

HEAD OF LABORATORY

DEPARTMENT/WARD

DIRECTOR/HEAD OF INSTITUTE

Note:

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** Propositions:

- Effectiveness: summarize effectiveness of chemical and/or preparation by each use method and concentration.

- Safety: summarize assessment regarding secondary effects of the chemical and/or preparation on experiment participants.

- Propositions: specify whether the chemical and/or preparation is eligible for circulation and for what purpose, by what method and in what concentration based on conclusion regarding effectiveness and safety.