MINISTRY OF HEALTH | SOCIALIST REPUBLIC OF VIETNAM |
No. 21/2015/TT-BYT | Hanoi, July 27, 2015 |
CIRCULAR
EXPERIMENTING PROCEDURES FOR ELECTRIC-OPERATED CHEMICAL MOSQUITO REPELLENT, INSECTICIDAL SHEETS
Pursuant to Law on Chemicals No. 06/2007/QH12 dated November 21, 2007;
Pursuant to Law on Products and Goods Quality No. 05/2007/QH12 dated November 21, 2007;
Pursuant to Decree No. 63/2012/ND-CP dated August 31, 2012 of Government on functions, tasks, powers, and organizational structure of Ministry of Health;
At request of Director General of Health Environment Management Agency;
Minister of Health promulgates Circular providing guidelines on experimenting procedures for electric-operated chemical mosquito repellent, insecticidal sheets.
Chapter I
GENERAL PROVISIONS
Article 1. Scope
This Circular prescribes methods of assessing efficacy and safety of electric-operated chemical mosquito repellent, insecticidal sheets for circulation in Vietnam.
Article 2. Term interpretation
In this Circular, terms below are construed as follows:
1. “KT” refers to knock down time.
2. “CAS number” refers to Chemical Abstract Service Registry number.
3. “WHO code” refers to World Health Organization code.
Chapter II
EXPERIMENTING METHODS
Article 3. Experimenting methods
Employ experimental biology techniques in a 180cm x 180cm x 180cm Peet Grady Chamber to experiment efficacy, safety and unwanted effects of chemical mosquito repellent, insecticidal sheets. Each experiment consists of 3 tests which must all comply with requirements, implementation and assessment under this Circular.
Article 4. Test requirements
1. Requirements for tools and equipment:
a) 20cm x 20cm x 20cm mosquito cages covered in net with 32-36 holes/cm2, cages for experimenting are marked in red and numbered from 1 to 4, cages for comparison are marked in green and numbered 1 and 2, number of cages required for the experiment depends on length of the experiment;
b) Personal protective gears: clothes, glasses, netted hats, gloves, face masks, boots;
c) Graphs for calculating KT50, KT90;
d) Test result schedules under Annex 1 attached hereto;
dd) Questionnaires for unwanted effects under Annex 2 attached hereto;
2. Technicians directly conducting the experiment 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, at 5 – 7 days old, and not fed with blood but fed with 10% glucose solutions.
4. Laboratories must satisfy ISO/IEC 17025:2005 standards and consist of: 1 laboratory and 1 room for comparison satisfying standards under Annex 4 attached hereto. These rooms must have similar conditions with normal temperature, humidity and each room must contain a 180cm x 180cm x 180cm Peet Grady Chamber. In addition, a room for monitoring killed mosquitoes after 24 hours at temperature of 27°C ± 2°C and approximate humidity of 80% ± 10% is required.
Article 5. Steps of conducting the experiment
1. Preparation:
a) Prepare a box containing at least 6 sheets of mosquito repellent, insecticidal chemical, in which: 3 sheets are used for 3 experiments and 3 sheets for specimen storage. These sheets must be in the same manufacture batch, within expiry date and intact;
b) Prepare 1000 mosquitoes satisfying requirements under Clause 3 this Article for each experiment and place 25 mosquitoes in each cage;
c) In each Peet Grady Chamber for experiment, hang 4 mosquito cages in 4 corners 80 cm away from ceiling and 10 cm from the nearest wall;
d) In Peet Grady Chamber for comparison, hang 2 mosquito cages in 2 opposite corners.
2. Experiment:
a) In the first hour of experiment:
- Ignite chemical mosquito repellent sheets for 30 minutes consecutively in rooms other than the room in which the Peet Grady Chambers are situated and rooms for monitoring killed mosquitoes after 24 hours are situated;
- After chemical mosquito repellent sheets are ignited for 30 minutes, place them in the middle of the Peet Grady Chambers for experimentation and count number of mosquitoes knocked down once every 9 minutes for 1 minute. Count for a total of 6 times throughout 60 minutes of experiment;
- Transfer knocked down mosquitoes in laboratories and mosquitoes in comparison cages to cages with equivalent size or clean cups; transfer to rooms for monitor and allow them to feed on 10% glucose solution;
b) In the second hour of the experiment: replace all mosquitoes for experiment and mosquitoes for comparison to conduct the experiment in the second hour according to Point a of this Clause;
c) In every subsequent 2 hours: replace all mosquitoes for experiment and mosquitoes for comparison to conduct the experiment according to Point a of this Clause;
d) After 24 hours: count number of mosquitoes killed among the mosquitoes knocked down and in comparison cages. If more than 20% of mosquitoes in comparison cages are killed, cancel the experiment results. If less than 5% of the mosquitoes for comparison are killed, retain the number of killed mosquitoes for result calculation. If number of mosquitoes killed range from 5% to less than 20%, adjust the results with following formula
In which: X= percentage of mosquitoes killed in the test cages and Y = percentage of mosquitoes killed in the comparison cages.
dd) Each experiment must be repeated 3 times in the same conditions;
e) Record result using form under Annex 1 attached hereto;
g) KT50 and KT90 are calculated on diagrams.
Article 6. Efficacy and safety assessment
1. Efficacy assessment: qualified if 90% to 100% of the mosquitoes are killed after 24 hours.
2. Safety assessment: rely on questionnaire on unwanted effects of experiment specimen under Annex 2 hereof, consider unqualified if at least 40% of questioned individuals experience either vertigo, headache or coughing.
Article 7. Result return and experiment specimen storage
1. Result return: experimenting organizations shall respond to experiment results using form under Annex 5 attached hereto.
2. Specimen storage: after conducting experiment, store the preparation specimen 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
Article 8. Entry into force
1. This Circular comes into force from January 1, 2016.
2. Experimenting procedures for assessment of efficacy and safety of volatile chemical mosquito insecticidal sheets attached to Decision No. 120/2000/QD-BYT dated January 24, 2000 of Minister of Health expires from the effective date hereof.
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 |
ANNEX 1
EXPERIMENT RESULT SCHEDULE
(Attached to Circular No. 21/2015/TT-BYT dated July 27, 2015 of Minister of Health)
EXPERIMENT RESULT SCHEDULE
1. Type of mosquitoes tested: ……………………………………………………………
2. Date of test: ………………………………………………………………………
3. Model of chemical sheet: ………………………………………………………………………
4. Electric mosquito repellent: ……………………………………………………………………
5. Active ingredient, concentration: ………………………………………………………
6. Duration of effect: ............................................................................................................
7. Testing individuals: ………………………………………………………………………
8. Testing units: ……………………………………………………………………………
9. Requesting entities: ………………………………………………………………
Experiment hour | Number of mosquitoes tested | Experiment batch | Comparison batch | Adjustment (if any) | |
|
| Number of mosquitoes knocked down | Number of mosquitoes killed after 24 hours | Number of mosquitoes killed after 24 hours |
|
1st hour | 100 | /100 |
| /50 |
|
2nd hour | 100 | /100 |
| /50 |
|
4th hour | 100 | /100 |
| /50 |
|
6th hour | 100 | /100 |
| /50 |
|
8th hour | 100 | /100 |
| /50 |
|
ANNEX 2
QUESTIONNAIRE ON UNWANTED EFFECTS OF EXPERIMENT SPECIMEN
(Attached to Circular No. 21/2015/TT-BYT dated July 27, 2015 of Minister of Health)
QUESTIONNAIRE ON UNWANTED EFFECTS OF EXPERIMENT SPECIMEN
(Interview as soon as moving mosquitoes to rooms for monitor)
I. Section for interviewer:
1. Name of interviewer: ……………………………………………………………………
2. Date of interview: …………………………………………………………………………
3. Preparation specimen for experiment: ……………………………………………………………………………
4. Active ingredient, concentration: ………………………………………………………
5. Duration of effect as declared: .......................................................................................................................
6. Manufacturing place: …………………………………………………………………………
7. Date of manufacture and expiry date: ……………………………………………………
8. Experiment purpose(s): ………………………………………………………………………
9. Entities requesting experiment: ……………………………………………………………
10. Testing units: ……………………………………………………………………………
11. Experiment procedure: ………………………………………………………………………
12. Test subjects: ………………………………………………………………………………..
13. Date and location of experiment ……………………………………………………………
14. Name of interviewee: ……………………………………………………………………
15. Occupation: ………………………………………………………………………………
II. Questions: (select 5 experiment volunteers who participate in the experiment from start to finish).
1. How long did you participate in experimenting electric-operated chemical mosquito repellent, insecticidal sheets? ……… hour
2. Are you equipped with personal protective gear: clothes, glasses, netted hats, face masks, gloves, boots?
Yes □No □
3. Did you notice any smell after the chemical sheets are electrically ignited for 30 minutes and throughout the experiment duration?
Yes □No □
4. If yes, is the smell unpleasant?
Yes □No □
5. If yes, what are the symptoms?
Sneezing | □ | Vertigo | □ | Headache | □ |
Irritation | □ | Nausea | □ | Other | □ |
Coughing | □ | Itchy eyes | □ |
|
|
Runny nose | □ | Stuffed nose | □ |
|
|
Thank you!
ANNEX 3
AGREEMENT BETWEEN EXPERIMENTING AGENCY AND VOLUNTEERS
(Attached to Circular No. 21/2015/TT-BYT dated July 27, 2015 of Minister of Health)
EXPERIMENTING ENTITY | SOCIALIST REPUBLIC OF VIETNAM |
No. ………… | .............(Location and date) |
AGREEMENT BETWEEN EXPERIMENTING ENTITY AND VOLUNTEERS
1. Individuals in charge of the experiment:
2. Within program of:
3. Presiding entity:
4. Laboratory for conducting experiment:
Part I
NOTICE OF VOLUNTEER INVITIATION
1. Introduction:
We are entomologists affiliated to …………………… (agency), and conducting biological experiment to assess efficacy, safety and unwanted effects of electric-operated chemical mosquito repellent, insecticidal sheets. In order to assess unwanted effects of electric-operated chemical mosquito repellent, insecticidal sheets in the Peet-Grady Chamber. We hereby invite Mr./Mrs./Ms. who is having normal health conditions to participate in this experiment on a voluntary basis.
2. Experiment purpose(s):
The experiment aims to provide an assessment regarding efficacy, safety and unwanted effects of electric-operated chemical mosquito repellent, insecticidal sheets ……………………………….. in Peet-Grady Chamber.
3. Type of experiment:
The biological experiment aims to survey efficacy, safety and unwanted effects of electric-operated mosquito repellent, insecticidal sheets.
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 voluntary basis:
Volunteer agrees to participate on a voluntary basis (rather than by coercion)
6. Information on repellent chemical to be experimented:
The electric-operated chemical mosquito repellent, insecticidal sheets used in this experiment are ………………, chemical formula: ……………………………, toxicity according to WHO classification ………………… This experiment involves a preparation with concentration of ………………… which has not been recorded for any 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:
Mosquitoes used in the experiment are a type of mosquitoes registered for rearing in class II biological safety cabinets, recently hatched, and not fed with blood but fed with 10% glucose solution and thus do not carry pathogens. Volunteers have receive proper technical training and equipped with personal protective gear to protect the body from mosquito bites.
8. Experiment outline, methods and procedures:
Experiment 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
I have read through experiment procedures and notice of volunteer invitation above. In addition, I have received adequate explanation for my questions. I hereby agree to participate in this experiment as a volunteer.
Volunteer full name: ………………………………………………………………………………
Signature: ……………………………………………………………, ……………………(date)
Volunteer full name: ………………………………………………………………………………
Signature: ……………………………………………………………, ……………………(date)
ANNEX 4
PEET GRADY CHAMBER
(Attached to Circular No. 21/2015/TT-BYT dated July 27, 2015 of Minister of Health)
PEET GRADY CHAMBER
Note:
A: Ventilation fan.
B: Fluorescent light.
C: Specimen entrance (upper window).
D: Observation glass pane.
E: Main entrance.
F: Mosquito entrance.
G: Specimen entrance (lower window).
ANNEX 5
EXPERIMENT RESULT ANSWER SHEET
(Attached to Circular No. 21/2015/TT-BYT dated July 27, 2015 of Minister of Health)
EXPERIMENTING ENTITY | SOCIALIST REPUBLIC OF VIETNAM |
No. ………… | .............(Location and date) |
EXPERIMENT RESULT ANSWER SHEET
(Attached to specific experiment results)
I. Name of chemical and/or preparation used in the experiment:
1. Name of experiment specimen:
2. Ingredient and active ingredient concentration:
3. Manufacturers:
4. Manufacturer’s address:
5. Date of manufacture:
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. Efficacy:
2. Safety:
VII. Conclusion**:
1. Efficacy:
2. Safety:
3. Propositions:
HEAD OF LABORATORY | DEPARTMENT/WARD | DIRECTOR/HEAD OF INSTITUTE |
Note:
* Results must specify methods of assessment and assessment results of effectiveness of the chemical and/or preparation on tested insects by concentration and use methods on product labels; methods of assessment and assessment results of secondary effects of the chemical and/or preparation on experiment participants.
** 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.
---------------
This document is handled by Vinas Doc. Document reference purposes only. Any comments, please send to email: [email protected]