MINISTRY
OF HEALTH
-------
|
SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
----------------
|
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
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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
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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.
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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:
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- 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
% of
killed mosquitoes = x
100
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;
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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
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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
DEPUTY MINISTER
Nguyen Thanh Long
ANNEX
1
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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: ……………………………………………………………………………
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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
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100
/100
/50
2nd hour
100
/100
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4th hour
100
/100
/50
6th hour
100
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/50
8th hour
100
/100
/50
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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: ………………………………………………………
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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: ……………………………………………………………………
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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?
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□
Vertigo
□
Headache
□
Irritation
□
Nausea
□
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□
Coughing
□
Itchy eyes
□
Runny nose
□
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□
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
Independence – Freedom – Happiness
----------------
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.............(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
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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)
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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.
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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
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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.
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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
Independence – Freedom – Happiness
----------------
No.
…………
.............(Location
and date)
EXPERIMENT
RESULT ANSWER SHEET
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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):
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IV. Experimenting
entities:
V. Date and location of
experiment:
VI. Result*:
1. Efficacy:
2. Safety:
VII. Conclusion**:
1. Efficacy:
2. Safety:
3. Propositions:
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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.
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