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Law, Regulation or Guideline
Record information and status
Record ID
45559
Status
Published
Date of creation
2008-06-25 15:52 UTC (pafca@mre.gov.br/7317)
Date of last update
2016-09-29 18:11 UTC (gutemberg.sousa@mctic.gov.br)
Date of publication
2017-08-01 20:18 UTC (dema@itamaraty.gov.br)

General Information
Country
  • Brazil
Jurisdiction
  • Brazil
Title of document
Normative Resolution No. 02 - National Technical Biosafety Comission
Legislative details
Type of document
  • National Regulation
Subject areas
  • Contained use
Types of LMOs addressed
  • All types of organisms
  • Derivatives
Brief description of the document including objective and scope:
It disposes of risks classification of Genetically Modified
Organisms (GMO) and biosafety levels to be applied to
activities and projects with GMO and its derivatives in
contention.

This regulation detemines risk classification of Genetically Modified
Organisms (GMO) and biosafety levels to be applied to
activities and projects with GMO and its derivatives in contained use.
Date of entry into force
2006-11-27
Document details
Document text
Information about document text
Normative Resolution No. 02 of November 27th, 2006.

It disposes of risks classification of Genetically Modified
Organisms (GMO) and biosafety levels to be applied to
activities and projects with GMO and its derivatives in
contention.


The National Technical Biosafety Commission (CTNBio), in
the use of its legal and regular attributions, decides:


CHAPTER I - General Dispositions
Article 1. The risk classification of GMO and the biosafety
levels to be applied to activities and projects in
contention with GMO and its derivatives that involve the
construction, cultivation, production, manipulation,
storage, research, technological development, education,
quality control and disposal obeying to the disposition on
this Normative Resolution.
Article 2. This Normative Resolution does not apply to the
planned OGM release on the environment that shall obey the
specific Normative Resolution.
Art. 3. For this Normative Resolution purposes, it is
considered:
I - Aviary - physical installation projected and used for
the breeding and maintenance of birds;
II - Vivarium - physical installation for breeding,
maintenance and manipulation of laboratory animals in
contention;
III - Vegetation House - physical installation projected
and used for growing plants in controlled and protected
environment. The walls and ceiling are generally
constituted of transparent or see-through material to allow
for the passage of solar light;
IV - GMO risk classes to human health and animals' health,
to the environment and to vegetables - risk degree
associated to donor organism, to the receptor organism, as
well as to the resulting GMO;
V - Contention - activities and projects with GMO in
conditions that do not allow for its escape or liberation
to the environment, being able to be executed in small or
big scale;
IV - Corral - physical installation aiming at the handling
of zoo technical interest;
VII - Exotic species - the one that is outside its natural
occurrence area;
VII - Invasive exotic species - every species that, when
outside its area of natural occurrence, threatens
ecosystems, habitats or species;
IX - Invasive species - the one that threatens ecosystems,
habitats or species;
X - Great scale - projects and activities of cultivation
with GMO in contention using volumes over 10 liters;
IX - HEPA (High Efficiency Particulated Air) - high
efficiency air filter that retains 99.00% of particles with
diameter of 0.3 micrometer or bigger;
XII - Infection room - place of maintenance and
manipulation of experimentally infected organisms;
XIII - Insert - a sequence of DNA/RNA inserted in the
receptor organism through genetic engineering;
XIV - Insects room - physical installation projected and
used for the creation, maintenance and manipulation of
insects;
XV - Biosafety level (NB) - contention level necessary to
allow for safe activities and projects with GMO and with
minimum risk for the operator and for the environment;
XVI - Donor organism - - organism that donates the sequence
of DNA/RNA that will be introduced through genetic
engineering in the receptor organism;
XVII - Receptor organism - organism on which the obtained
construction will be inserted through genetic engineering;
XVIII - Small scale - projects and activities of
cultivation with GMO in contention using volumes equal or
inferior to 10 liters;
XIX - weeds - plant that grows importunately in a culture,
and that competes for space and nutrients;
XX - Spontaneous plant - plant of natural occurrence;
XXI - Risk - possibility of negative event, scientifically
founded, for the human, animal, vegetables, other organism
health and environment, deriving from processes or
situations involving OGM and its derivatives;
XXII - Aquaculture Tank - physical installation projected
and used for the creation, maintenance and manipulation of
genetically modified aquatic organisms;
XXIII - Vector - insert path agent.


CHAPTER II
THE PRESENTATION OF ACTIVITIES AND PROJECTS PROPOSALS
WITH GMO IN CONTENTION
Article 4. For any activity and project that involves the
construction, cultivation, production, manipulation,
storage, research, technological development, education,
quality control and disposal that use GMO and its
derivatives in contention regime, the main technician
should forward to its institution's CIBio detailed
information in accordance with the Authorization Request
for Activities in Contention with GMO and its derivatives,
found on Resolution No. 1. CIBio, on its turn should obtain
from CTNBio, an authorization for each activity.
Paragraph 1 - CIBio may authorize activities and projects
that involve GMO of Risk Class I, defined on item I of art.
8 of this Normative Resolution.
Paragraph 2 - Whenever there are changes on activities
previously approved, the procedure specified on this
article caput shall be adopted.
Paragraph 3 - Doubts about the application of this
Normative Resolution shall be solved with the Institution's
CIBio, who, according to the case, will request
clarification from CTNBio.
Paragraph 4 - In case of great scale activities and
projects, CIBio should inform CTNBio the detailed
methodology of GMO identification.
Art.5. After the activity is approved by CTNBio, the
institution's legal responsible person, CIBio and the main
technician are in charge of guaranteeing the true
fulfilling of the norms defined by CTNBio for the
activities and projects with GMO in contention.
Sole Paragraph. The main technician is responsible for
fulfilling the biosafety norms in accordance with CIBio's
recommendations, and with CTNBio's Normative Resolutions of
CTNBio, and should ensure that the technical and support
teams involved in the activities with GMO and its
derivatives receive appropriate training in biosafety and
that they are aware of the potential risk situations of
such activities, and of the procedures and individual and
collective protection in the work environment.


CHAPTER III
ACCIDENT OR ACCIDENTAL RELEASE OCCURRENCE
Article 6. All GMO activities and projects and its
derivatives in contention should be planned and executed in
accordance with CTNBio's Normative Resolutions in order to
avoid accidents or accidental release.
Paragraph 1 - accident or accidental release occurrence of
GMO and its derivatives should be immediately communicated
to CIBio, and by the latter to CTNBio and to the pertinent
registration and inspection organs and entities, attaching
reports of the corrective actions already taken and the
names of the people and authorities that have been
notified, within five days from the date of the event.
Paragraph 2 - The communication to CTNBio and to its
pertinent registration and inspection organs and entities
does not exempt CIBio from any other obligation it may have
regarding the legislation in force.
Paragraph 3 - CIBio should inform the workers and other
members of the collectivity about the risks deriving from
the accident or the accidental release of GMO and their
derivatives.
Paragraph 4 - CIBio shall immediately install investigation
about the occurrence of accident or accidental release of
GMO and their derivatives, sending conclusions to CTNBio,
within 30 days.
Paragraph 5 - As soon as CTNBio becomes aware of any
accident or incident that may have provoked adverse effects
to human and animal's health, to vegetables or to the
environment, it will immediately communicate the Public
Prosecution Service.


CHAPTER IV
RISK CLASSIFICATION
Art. 7. GMOs will be classified in four risk classes,
adopting as criteria the pathogenic potential of the donor
and receptor organisms, the transferred nucleotide
sequences, their expressions in the receptor organism, the
resulting GMO, and its adverse effects to human and
animal's health, to vegetables and to the environment.
Paragraph 1. For genes that codify products that are
harmful to human and animal health, to vegetables and to
the environment, the vector used shall have limited
capacity to survive outside the contention environment.
Paragraph 2. Every genetically modified organism should
have a marker capable of identifying it amongst a
population of the same species.
Article 8. The GMO risk classes will be defined on the
following form:
I - Risk Class 1 (low individual risk and low risk for the
community): The GMO that has DNA/RNA sequences from the
donor and receptor organism that does not cause aggravation
to human and animal's health and adverse effects to
vegetables and to the environment;
II - Risk Class 2 (moderate individual risk and low risk to
the collectivity): The GMO that has DNA/RNA sequences from
the donor or receptor organism with moderate risk of
aggravation to human and animal's health, that has low risk
of dissemination, and of causing adverse effects to
vegetables an to the environment;
III- Risk Class 3 (high individual risk and moderate risk
to the community): GMO that has DNA/RNA sequences from the
donor or receptor organism, with high risk of aggravation
to human and animal's health, that has low or moderate risk
of dissemination and of causing effects to vegetables and
to the environment;
IV- Risk Class 4 (high individual risk and high risk for
the collectivity): GMO that has DNA/RNA sequences from the
donor or receptor organism with high risk of aggravation to
human and to animal's health, which has high risk of
dissemination, and of causing adverse effects to vegetables
and to the environment.
Paragraph 1. The resulting GMO risk class shall not be
inferior to the risk class of the receptor organism, except
in cases where there is reduction of the virulence and
pathogenesis of GMO.
Paragraph 2. The GMO that has DNA/RNA sequences of
organisms or infectious agents without potential of
expression in activities and projects proposed will be
classified in the same risk class of the receptor organism.
Paragraph 3. The GMO that has DNA/RNA sequences deriving
from higher risk class organism and with potential of
expression may, at CTNBio's discretion, be classified in
the risk class of their receptor organism, as long as it is
recognized as not associated to toxicity or pathogenesis in
activities and projects proposed.
Paragraph 4. For risk classification, one should also
consider:
a) The possibility of recombination of sequences inserted
in the GMO, that take to the complete and functional
reconstitution of genomes of infectious agents;
b) Other processes that generate an infectious genome;
c) Genes that codify toxic substances to men, animals,
vegetables or that cause adverse effects to the
environment;
d) Genes resistant to antibiotics of wide clinical use.
Paragraph 5. The following are classified as risk class 2
or higher:
a) those vegetables genetically modified that are weeds or
spontaneous plants, that may cross with the latter in an
area that make such crossing possible, generating fertile
descendents with bigger capacity of invasion and damage to
the environment than the parents; and
b) Organisms genetically modified that are biological
vectors of agents that cause aggravation to human health,
animals, vegetables or to the environment.
Paragraph 6. The GMO that becomes more able to survival on
the environment than the native organisms, and that, at
CTNBio's discretion, represents a potential menace to
biodiversity, may have its risk class increased.
Paragraph 7. The following lists will be used as base for
information of infectious agents for humans and animals by
risk class: the list published by the Ministry of Health,
the list of plants quarantine by risk class, published by
the Ministry of Agriculture, Cattle Breeding and Supply and
the list of invasive plants published by the Ministry of
Environment.


CHAPTER V
BIOSAFETY LEVELS
Art. 9. The biosafety level of activities and projects will
be determined according to GMO of higher risk class
involved.
Sole Paragraph. The activities and projects involving GMO
and its derivatives should have a previous detailed and
careful analysis of all the experimental conditions, and
one should use the biosafety level adequate to the risk
class of the handled GMO.
Art. 10. There are four Biosafety Levels: NB-1, NB-2, NB-3
and NB-4, crescent on higher degree of contention and
complexity of the protection level, in accordance with the
GMO risk class.
I - Biosafety Level 1 (NB-1): adequate to activities and
projects that involve risk class 1 GMO, executed on the
following conditions:
a) It is not necessary that the installations are isolated
from the other physical dependences of the institutions,
being the activities and projects generally conducted on
tables, vivarium or vegetation house;
b) The technical and support team should have specific
training on procedures executed at the installations and
should be supervised by the main technician;
c) The NB-1 installations should be designed in order to
allow for easy cleaning and decontamination;
d) The surface of the tables should be impermeable to water
and resistant to acids, alkali, organic solvents and
moderate heat;
e) The spaces between the tables, cabinets and equipments
should be enough in order to allow for easy cleaning;
f) GMOs are manipulated in areas signaled with the
universal biological risk symbol, with access restricted to
the technical and support team, or to authorized people;
g) The work surfaces should be decontaminated once a day or
whenever contamination occurs;
h) Every contaminated liquid or solid residue should be
decontaminated before being discarded, as well as every
material or equipment that may have come into contact with
the GMO;
i) Mechanical dispositive should be used for transferring
and measuring fluids;
j) Food should be kept in specific areas for such end,
outside the installations, being prohibited to eat, drink,
smoke and apply cosmetics on work areas;
k) Before leaving the installations, hands should be washed
whenever there has been manipulation of organisms
containing recombinant DNA/RNA;
l) Sinks for washing hands and equipments of individual and
collective protection should be used to minimize the
exposure risk to GMO;
m) the admission of animals that are not related to the
work in execution is prohibited at the installations;
n) Extreme precaution should be taken when needles,
syringes and broken glass are manipulated, in order to
avoid self-inoculation and production of aerosols during
use and discard. Needles should not be bended, broken,
recapped or removed from the syringe after use. Needles,
syringes and broken glass should be immediately put in
recipient resistant to perforations and autoclaved before
being discarded;
o) Contaminated material can only be taken from the
installations in rigid and leak proof recipients;
p) An insects and rodents control adequate routine program
should be provided. All areas that allow ventilation should
have physical barriers to impede insects and other animals
from passing;
q) A Biosafety Manual should be prepared in accordance with
the specificities of the activities executed. All personnel
should be warned about the possible risks and about the
need of following the specification of each work routine,
biosafety procedures and practices established on the
Manual;
r) Records of each activity or project developed with GMO
and its derivatives should be kept;
s) Activities and projects with organisms not genetically
modified that occur at the same time and at the same
installations with manipulation of GMO should respect GMO
risk classification;
t) All material coming from GMO and its derivatives should
be discarded in order to prevent its use as food by
animals, or by men except in case it is the objective of
the experiment, or if specifically authorized by CIBio or
CTNBio;
I - Biosafety Level 2 (NB-2): adequate to the activities
and projects that involve GMO risk class 2, carried out on
the following conditions:
a) the installations and procedures required for NB-2
should attend the specifications established for NB-1 added
with the need of having an autoclave available inside it,
in order to allow the decontamination of all the material
before disposal, without the transit of the GMO through
corridors and other uncontrolled spaces;
b) Cabinets of biological safety should always be used
(Class I or II);
c) It is the Main Technician's responsibility to evaluate
each situation and authorize who may have access to, or
work at NB-2 installations;
d) A risk level sign should be put up, identifying the GMO,
and the name of the Main Technician, complete address, and
different possibilities of its location or of other
responsible person, and contact with CIBio;
e) The Main Technician should establish policies and
procedures, providing wide information to everyone who work
at the installations about the potential risk related to
the activities and projects conducted there, as well as
about specific requisites for the entrance in places where
there is the presence of animals for inoculation;
f) inside the installations, the frequenters should use the
appropriate equipments of individual protection such as
overalls, gloves, hats, masks, glasses, protectors for the
feet, among others, what should be taken off before the
person leaves the accredited installations;
g) After use, the non-disposable individual protection
equipments should be cleaned up, and kept outside the
contaminated area, and people should be trained for their
handling and appropriate storage;
h) All necessary requisites for the entrance in the
accredited installations should be indicated at the
entrance door;
i) The work surfaces of the safety cabinets and other
contention equipments should always be decontaminated at
the end of the activities with GMO;
j) For less risky experiment executed at the same time at
the same place, NB-2 level should be adopted;
k) Whenever appropriate, the technical and the support team
should be vaccinated against the infectious agents related
to experiments conducted at NB-2 installations;
l) periodic medical exams for workers at the installations
where activities and projects are executed with GMO should
be requested to CTNBio, including laboratory clinical
evaluation in accordance with the GMO involved, taking in
consideration necessary protection and prevention measures;
III - Biosafety Level 3 (NB-3): adequate to the activities
and projects that involve GMO risk class 3. The
installations and required procedures for NB-3 should
fulfill the specifications established for NB-1 and NB-2,
plus:
a) The installations should be separated from the nonrestricted
transit areas of the building;
b) the physical separation between NB-3 installations and
the other installations, laboratories or access corridors
should be through double door system, with automatic lock
through inter-locking, and with a room for changing
clothes, for showers, air blockage, and other devices for
the access in two phases;
c) NB-3 installations should have emergency energy source
with automatic activation, supplying all energetic needs;
d) The air system at the installations should be
independent and should foresee a different pressure and
unidirectional flow in order to ensure different pressure
that does not allow the risk agent to leave. Manometers
should be attached to the air system, with alarm system,
that accuses any alteration suffered on the pressure level
required for the different rooms;
e) There should not exist air exhaustion to other areas of
the building. Therefore, the exhaustion air should not be
recycled and should be filtered through filter HEPA before
being eliminated to the outside area of the installations,
and there should have constant verification of the air flow
in the installations;
f) All procedures that involve manipulation of GMO risk
class 3 should be conducted inside Class II or III
biological safety cabinet. Manipulators should use
individual protection equipment;
g) the exit air of the biologic safety cabinets with HEPA
filters of high efficiency (Class I or II) should be taken
out directly to the outside part of the building through
exhaustion system;
H) The indoor walls, floors and ceilings surfaces should be
resistant to water, in order to allow for easy cleaning.
All the surface should be sealed and without reentrance, to
make cleaning and decontamination easier;
i) The installations furniture should be rigid, with spaces
between the benches, cabinets and equipments to allow for
easy cleaning;
j) Next to the exit door of the anti-room of each NB-3
installation there should be at least one wash basin. The
faucet should have an on/off automatic system, or pedals
system. All graters should have a closing device;
k) The installations windows should be sealed, with safety
double glass;
l) Inside the installations there should be autoclave for
residues decontamination with double door system;
m) All effluent liquid from the installations should be
decontaminated before liberation to the system of sanitary
sewer, through treatment in contention boxes;
n) The vacuum lines should be protected with high
efficiency air filter, and collectors with disinfectant
liquid;
o) The technical team should have specific training in the
handling of class 3 risk infectious agents, and it should
be supervised by scientists with wide experience with such
agents;
p) The whole technical team should take a shower when
getting in and out of NB-3 installations;
q) Specific and complete uniform should be worn in the
installations where class 3 risk GMO is manipulated. It is
prohibited to wear such clothes outside the installations,
and they must be decontaminated before being taken to the
laundry or to discard;
r) Appropriate facial or breathing masks should be worn in
NB-3 installations;
s) No biological material with propagation capacity may
leave the installations;
t) Appropriate communication system with the outside should
be available;
u) Video cameras should be installed at the entrance and
exit of the installations;
v) Serum reference-samples from the technical team
collected annually should be kept for health surveillance;
w) Every year workers of the installations where activities
and projects with GMO are executed should go through
medical examinations, including laboratory clinical
evaluation, in accordance with the GMO involved, taking in
consideration the appropriate protection and prevention
measures;
x) NB-3 laboratory animals should be kept in confinement
system (systems of boxes with HEPA filter and rigid walls).
These animals manipulation should be made in class II or
III biological safety cabin;
y) For less risky experiment executed at the same time and
place, level NB-3 should be adopted;
IV - Biosafety Level 4 (NB-4): adequate to activities and
projects that involve GMO of risk four class. The
installations and required procedures for NB-4 should
fulfill the specifications established for NB-1, NB-2 and
NB-3 plus:
a) NB-4 installation should be located at a separate
building, or at a clearly marked and isolated area of the
institution, and have 24 hours surveillance per day;
b) Cameras at the personnel entrance and exit should be
foreseen, separated by shower;
c) The manipulations with GMO of risk class 4 should be
carried out in Class II or III biological safety cabin,
associated to personal protection clothes with positive
pressure, ventilated by life support system;
d) A double-door autoclave system should be foreseen, as
well as a fumigation chamber, or ventilation system with
pressurized anti-chamber for materials flow to the interior
of the laboratory;
e) The soil draining system should have deposit with
chemical disinfectant efficacious enough for the agent
being used, directly connected to a collector system of
liquids decontamination;
f) The sewer and the ventilation system should be attached
to high efficiency HEPA filters. Filters and sewers
installations should be confined to the contention area;
g) Systems of light supply, air ducts, and utilitarian
lines should be preferably built-in to avoid accumulating
dust;
h) Materials and equipments that cannot be decontaminated
at the autoclave should go through an immersion tank with
disinfectant, or fumigation chamber;
i)Before being liberated from the installations, the
effluent liquid should be decontaminated by heat;
j) Liquids liberated from showers or sanitary toilets
should be decontaminated with chemical products, or by
heat;
k) The installations should have an anti-room for the team
to put on specific clothes (diving-dress) with positive
pressure and life support system. The system should
foreseen alarms and tanks for emergency breathing;
l) The installations should have shower for the chemical
decontamination of the clothes surfaces before leaving the
area;
m) the insufflation air entrance should be protected with
HEPA filter, and its elimination to the outside should be
made through exhaustion ducts, each one with two HEPA
filters put in series and with alternate automated
exhaustion circuit;
n) The air system should be revised and validated annually
by a firm with proved experience;
o) No material should be removed from the installations
unless it has been autoclaved or decontaminated; exception
is made to biological materials that necessarily have to be
taken on a viable or intact way;
p) The viable biological material, when removed from Class
II or III cabins or from NB-4 installations should be put
into unbreakable contention recipient and sealed. The
latter, on its turn, should be conditioned inside a second
recipient, also unbreakable, and sealed, that goes through
an immersion tank containing disinfectant, or through a
fumigation chamber, or, yet, through an air barrier system;
q) Equipments or materials that do not resist to high
temperatures should be decontaminated by using gas or vapor
in specific chamber;
r) Access to installations should be blocked by
hermetically closed doors, containing an internal visual
monitoring system;
s) The entrance should be controlled by the Main
Technician, or qualified person appointed by him. Besides
the access system through magnetic card or digital codes,
the responsible person should request institutional
identification from each user;
t) Authorized people should strictly fulfill the procedure
instructions for entrance and exit form the installations;
u) There should be a record of entrance and exit of
personnel, with date, time and signatures;
v) Protocols should be defined for emergency situations;
w) The person responsible for the safety of area of access
to the installations should be able to turn on the
emergency system, if necessary;
x) All this information should be registered and filed for
a 5 year period;
y) Before coming into the installations, people should be
advised about the potential risk, and habilitated for the
fulfillment of appropriate safety measures;
z) The entrance and exit of the team from the installations
should only occur after the use of the shower and clothes
change;
aa) the entrance and exit of the team through pressurized
anti-chamber should only occur in emergency situations;
bb) to get into the installations, the common clothes
should be exchanged for complete protective and disposable
clothes. Before leaving the installations to the bathing
area, the protection clothes should be left in a specific
area for decontamination before discard;
cc) a notification system should be organized for
accidents, exposure, and absence of the team from the
installations, as well as a medical surveillance system.
One should also foresee a quarantine, isolation and medical
care unit for contamination suspects.


CHAPTER VI
BIOSAFETY LEVELS IN GREAT SCALES
Art. 11. Activities and projects in contention involving
cultivation of GMO in great scale should follow the
biosafety norms established on Chapter V of this Normative
Resolution, and have supervision and additional contention
measures.
Paragraph 1. Besides the biological risks related to
activities with GMO and its derivatives in great scale,
risks related to toxicity of products, and to physical,
mechanical, and chemical aspects of the production process
should also be considered.
Paragraph 2. The institutions should keep a health
surveillance program of all the workers that act on the
installations that keep activities with GMO.
Paragraph 3. Clinical and laboratory exams should be made
annually.
Paragraph 4. Situations of potential risk should be
described, and clinical and laboratory exams should include
indicators for long term monitoring, such as the
constitution of serology bank with specific markers, for
epidemiologic surveillance purposes.
Paragraph 5. In case of accidents, one should inform
CTNBio, investigate causes and consequences to health and
to the environment, and institute cares and immediate
treatments, as well as follow-up the case according to the
kind of accident.
Art. 12. A procedures and training manual of the technical
and support team should be arranged to ensure that GMO is
manipulated with safety, and that the work area is kept
clean and organized.
Art. 13. Before any discard, GMO, its derivatives and solid
and liquid effluents should be inactivated to prevent its
dissemination and adverse effects to health and to the
environment.
Sole Paragraph. The deactivation should be proved by the
laboratory.
Art. 14. A contingence plan should be established,
including adequate measures to contain and neutralize
spillage.
Art. 15. For Biosafety level in Great Scale - NBGE-1, the
manipulation of GMO should be executed in closed system or
in contention installation.
Paragraph 1. The addition of material to a system, samples
collection, and the transfer of culture liquid inside
systems, or between them should be conducted in order to
minimize the formation of aerosol, or contamination of
surfaces exposed in the work environment.
Paragraph 2. To minimize the escape of viable GMO,
exhaustion gases removed from the closed system, or from
contention equipments should go through HPA filters, or
through equivalent procedure.
Paragraph 3. Any closed system, or contention equipment
that has viable GMO should only be opened after adequate
sterilization.
Paragraph 4. Emergency plans should include adequate
methods and procedures for eventual spillage, accidents and
loss of GMO culture.
Paragraph 5. The universal symbol of biological risk should
be affixed to closed systems, and to contention equipments,
when used for GMO contention.
Paragraph 6. Any spillage or accident that results on
exposure to GMO should be immediately communicated to the
Main Technician, to CIBio, to CTNBio, and to the competent
authorities.
Art. 16. For Biosafety Level in Great Scale - NBGE-2, the
norms established for NBGE-1 should be followed, plus the
following measures:
I - the contention equipments, besides the GMO manipulation
procedures in volumes of up to 10 liters, should
correspond, at least, to the required for NB-2;
II - The rotational seal and other mechanic devices
directly associated to the closed system, used on the
propagation and growth of GMO, should be constructed in
order to avoid leakage, or be contained in ventilated
compartment with exhaustion through HEPA like filters or
equivalent system;
III - the closed system, used for the propagation and
growth of GMO, as well as the equipment used for GMO
contention operations, should have sensors for monitoring
the integrity of the confinement during the operations;
IV - The system for the propagation and growth of GMO
should be tested regarding the integrity of the contention
devices;
V - Tests should be conducted before the introduction of
GMO, and after any modification or exchange of essential
devices of contention;
VI - Procedures and methods used on tests shall be
appropriate for the equipment drawing, and for the recovery
and detection of the tested organism. The reports and the
tests results should be kept on files; and
VII - The contention system, used for the propagation and
growth of GMO, should be permanently identified. This
identification should be used in all tests, functioning and
maintenance reports, and in all documents regarding the use
of such equipment for research or production activities
with GMO.
Art.17. For Biosafety Level in Great Scale - NBGE-3, the
following norms should be established for NBGE-1 and NBGE-
2, plus the following measures:
I- GMO should be manipulated in a closed system with
biosafety measures required for NB-3;
II - To preserve the contention integrity, the closed
system used for propagation and growth of GMO, should be
operated in order to keep the space above the culture
environment on the system under the lowest possible
pressure, consistent with the equipment construction; and
III - the closed systems and contention equipments used on
the manipulation of GMO cultures shall be located in
controlled area with the following characteristics:
a) the controlled area shall have a separate entrance. It
should have a space with two doors, such as a pressurized
anti-chamber, an anti-chamber or room for changing clothes,
separating the controlled area from the rest of the
installations;
b) The surfaces of the walls, ceilings, and the pavement of
the controlled area should allow for easy access and
decontamination;
c) eventual perforations in the controlled area should be
sealed to allow for decontamination of the environment with
liquid or gases;
d) the pipes and wiring in the controlled area should be
protected against decontamination;
e) the installations for washing hands, equipped with
valves that can be turned on with the foot or elbow, or an
on/off automatic system should be present in each main work
area, next to each main exit;
f) shower should be available near the controlled area;
g) the controlled area should be planned in order to
prevent the exit of culture liquid to the outside, in case
of accidental spillage, exit from the closed systems, or
from the contention equipments;
h) the controlled area should have ventilation system able
to control the air flow. It should come from areas with
less potential of contamination towards areas with more
potential of contamination;
i) if the ventilation system results in positive pressure,
the system should be planned in order to prevent the
reversion of the flow, or have an alarm that will indicate
such eventual reversion. The air that leaves the controlled
area should not circulate again in other installations, and
it should be filtered through HEPA filters.
IV- The operational procedures should follow the biosafety
measures established on NBGE-1, NBGE-2 and NB-3.


CHAPTER VII
THE PHYSICAL INSTALLATIONS AND PROCEDURES IN CONTENTION FOR
ACTIVITIES AND PROJECTS WITH GENETICALLY MODIFIED
VEGETABLES
Art. 18. The activities and projects in contention
involving genetically modified vegetables from risk class 1
should follow the biosafety norms required for NB-1, plus:
I - the vegetation house should be kept locked, except when
there are people working inside it;
II - the access limitation should be restricted to the
technical team directly involved with experiments in
progress;
III - windows or laterals and structures on the ceiling may
be open for ventilation, and they should have protection
nets anti-aphid to prevent pollinators' entrance. Pollen
barriers are not required, except when dealing with
allogamous and anemophily plants, whose pollen dispersion
should be avoided for protection of the reproductive
structures, or for physical barriers;
IV - the floor should be made of pebbles, or other porous
material, recommending, thou, that the pavement is made of
concrete;
V- the maintenance of a file, at an easy accessed place at
the entrance of the vegetation house with updated
information about experiments in progress, and about
vegetables, animals or micro-organisms that are introduced
or taken from the vegetation house;
VI - practice manual for the use of installations, warning
the users about the consequences of the non-observance of
the rules, and also, informing the procedures to be taken
in case of an accidental release of GMO potentially causing
environmental impact;
VII - a compulsory program of undesirable species control,
such as invasive plants, animals or pathogens, inside the
vegetation house;
VIII - animals used in experiments referred to in this
article caput should be impeded from escaping;
IX - vegetables, seeds or live tissues can only be taken
out of the vegetation house aiming at research in
installations in regime of contention or storage. For
planned released in the environment, there should be
authorization from CTNBIo.
Art.19. The activities and projects in contention involving
risk class 2 genetically modified vegetables should fulfill
the biosafety norms required for NB-2, and the
specifications described on article 18 of this Normative
Resolution, plus:
I - vegetation house should be built with rigid transparent
material with an anti-chamber;
II - forced ventilation system with protection against the
entrance of animals at the air entrance and exit;
III - floor made of concrete or impermeable material;
IV - liquid draining system that includes a contention box
for decontamination and inactivation;
V - exhausts equipped with a closing system when they are
not being used. The entrance and exit system should prevent
air reflux.
VI - signalization with the universal symbol of biological
risk indicating the presence of genetically modified
organisms, and risk classification;
VII - closed and unbreakable recipients for the
introduction or withdrawal of organisms from the vegetation
house;
VIII - growth chamber, or growth room inside a building
that fulfills NB-2 specifications;
IX - clothing and equipments for individual protection
appropriate to the conduction of experiments, preferably
disposable ones. Such clothing and equipment should be
taken off before leaving the installations and should be
decontaminated before being discarded or washed.
Art. 20. The activities and projects in contention
involving risk class 3 genetically modified vegetables
should fulfill the biosafety norms required for NB-3, and
the specifications of articles 18 and 19 of this Normative
Resolution, plus:
I - the vegetation house should be hedged in, and it may be
protected by additional safety measures, besides being
separated from other areas of free transit;
II - it should have a closed structure, with continuous
cover, and whose entrance is protected by two sets of doors
with automatic closing and inter-locking;
III - the internal walls and the floor should be
impermeable and resistant to corrosion;
IV - it should have a cabin with two doors from clothes
changing;
V - all procedures should minimize the generation of excess
of effluents during irrigation, transplant or any other
manipulation;
VI - viable experimental materials that were introduced or
taken from the vegetation house should be transported in a
second closed and unbreakable recipient;
VII - if it is possible to have the presence of propagating
structures on the surface of the second recipient, it
should be decontaminated;
Art. 21. Specific norms for activities and projects with
risk class 4 genetically modified vegetables shall be
edited by CTNBio whenever necessary.


CHAPTER VIII
THE PHYSICAL INSTALLATIONS AND PROCEDURES IN CONTENTION FOR
ACTIVITIES AND PROJECTS WITH GENETICALLY MODIFIED ANIMALS
Art. 22. The installations of contention for activities and
projects with genetically modified animals include
vivarium, insect room, aquiculture tank, corral, aviary,
infection room, among others;
Art. 23. The activities and projects in contention
involving risk class 1 genetically modified animals should
fulfill the biosafety norms required for NB-1, plus:
I - the installations for maintenance and manipulation of
genetically modified animals should be physically separated
from the rest of the laboratory, and there should have
controlled access to it;
II - the entrance to the installations should be kept
locked, being the access restricted to people accredited by
the institution's CIBio;
III - the installations construction should take in
consideration the kind of genetically modified animal to be
kept and manipulated, but always taking the necessary care
to prevent it from escaping;
IV - all areas that allow ventilation (including the
entrance and exit of air conditioning) should have physical
barriers to prevent insects and other animals from passing;
V - drains and other similar devices, if there is any,
should have barriers to avoid the possibility of escaping,
or the entrance of contaminated material;
VI - animals from different species, and not involved on
the same experiment should be allocated in separate
physical areas;
VII - the installations of air curtains with flow from the
top to the bottom on the insect room access doors is
recommended;
VIII - aquiculture tanks should have water renovation in
separate system, and all the disposable water should go
through sewage tank with disinfection, before going to
pluvial net;
IX - corral for samples inspection and collection should
have adequate infrastructure for the handling of animals,
as well as pickets with double fence, to avoid the transit
between areas, and, whenever possible, draining system
going through disinfection tank;
X - it is recommended that the entrance of sawdust, ration
or any other food or material to be used with animals
occurs after autoclave or irradiation;
XI - all contaminated material should be appropriately
conditioned for disinfection, or inactivation, what may
occur outside the installations;
XII - procedures norms should be widely spread to people
with authorized access;
XIII - procedures norms copies, including those regarding
emergency situations, should be kept inside the
installations;
XIV - in case of maintenance of a crio-preserved
genetically modified embryo bank, it should be located at
the installations accredited by CTNBio.
Art. 24. The activities and projects in contention
involving risk class 2 genetically modified animals should
fulfill the biosafety norms required for NB-2, and the
specifications of article 23 of this Normative Resolution,
plus:
I - it is necessary to have an anti-chamber between the
free circulation area, and the area where the animals are
allocated;
II - the anti-chamber should be separated by a double-door
system with inter-locking;
III - all the ventilation entrances and exits should have
physical barriers that block the passage of insects and
other animals between the rooms and external area;
IV - the windows should have fixed glass and be
hermetically closed, and, when necessary, be double;
V - the installations should have emergency lights and be
linked to generators, if possible;
IV - it is necessary to change clothes before going from
the anti-room to the animals' room. If possible, disposable
clothes should be worn inside the animals' room;
VII - after rigorous inspection to verify the presence of
insects, clothes should be conditioned in an appropriately
closed and autoclaved recipient;
VIII - sawdust, ration or any other food or material to be
used with animals should be submitted to autoclaving or
irradiation;
IX - the exit of material should be made through doubledoor
passage chambers for sterilization or inactivation;
X - in vivarium, animals' drinking water should be
filtered, acidulated or autoclaved;
XI - in vivarium, the air flow should suffer 20 renovations
per hour;
XII - it is recommended that there is sanitary,
parasitological, microbiologic, of micro-plasma and
virologist control of the animals;
XIII - animals genetic control should be made, if possible,
at each new generation;
XIV - infection rooms with genetically modified animals
should be located in areas specifically isolated and duly
accredited by CTNBio.
Art. 25. The activities and projects in contention
involving risk class 3 genetically modified animals should
fulfill the biosafety norms required for NB-3, and the
specifications of articles 23 and 24 of this Normative
Resolution, plus:
I - the installations should have, at least, the following
distinct areas: Anti-Room, Materials Room, Rooms for
Animals, and Experiments Room;
II - the anti-room should have three divisions. On the
first division, there should be individual closets for the
user to keep his clothes. On the central division, there
should be showers activated by independent system of hands
use. On the third division, there should be closed closets
to keep sterilized clothes to be worn by users and bags to
keep the clothes already used at the installations that
should be autoclaved before being discarded.
III - the insufflated air should be sterilized. The air
exit should also have sterilizing filters for air
purification before it is released to the outside.
IV - the animals' and experiments rooms should necessarily
have negative air pressure in relation to the other rooms.
V- the installations should have automatic control system
to detect alterations on the atmospheric pressure, and it
should be able to activate the alarm;
VI - animals should be allocated, when pertinent, in microisolators
system, or in equivalent systems;
VII - when there are faucets, they should allow activation
without using the hands;
VIII - all material to be discarded should be previously
decontaminated inside the installations. This should occur
by using autoclave of double door;
IX - dead animals and excrements should be incinerated.
Art. 26. Specific norms for activities and projects with
risk class 4 genetically modified animals should be edited
by CTNBio whenever necessary.
Art.27. This Normative Resolution revokes Normative
Instruction No. 06 of February 26th, 1997, No. 7 of June
6th, 1997, No. 12 of May 27th, 1998, No. 15 of July 8th,
1998.
Art. 28. This Normative Resolution is force from its
publication date.


Walter Colli
CTNBio's President
Regulatory contact information
Contact person
National Technical Biosafety Commission
Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14
Brasília, DF
Brazil, CEP - 70610-200
Phone:(5561) 3411-5516
Fax:(5561) 3317-7475
Email:ctnbio@mct.gov.br
Url:National Technical Biosafety Comission