Normative Resolution No. 01 of June 20th, 2006.

It disposes of installation and functioning of the
Biosafety Internal Commissions (CIBios) and of criteria and
procedure for request, issue, review, extension, suspension
and cancelling of the Biosafety Quality Certificate (CQB).

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

CHAPTER I:
PRELIMINARY DISPOSITIONS:
Article 1. The installation and functioning of Biosafety
Internal Commissions (CIBios), the criteria and procedures
for request, issue, review, extension, suspension and
cancelling of the Biosafety Quality Certificate (CQB) shall
obey the disposition on this Normative Resolution.
Sole Paragraph. For the purposes of this Normative
Resolution, the Biosafety Quality Certificate - CQB is
constituted of accreditation that CTNBio concedes to
institutions to develop projects and activities with
Genetically Modified Organisms (GMO) and its derivatives.
Article 2. The CIBios of the institutions that have CQB
issued by the National Technical Biosafety Committee
(CTNBio) will constitute on a national biosafety web whose
constitution and functioning will follow the norms
established by Law No.11.105, of March 24th, 2005, its
regulating Decree and the CTNBio Normative Resolutions.

CHAPTER II
THE BIOSAFETY INTERNAL COMMISSIONS
Article 3. The institution dedicated to teaching,
scientific research, technological development and
industrial production that uses genetic engineering
techniques and methods, or executes researches with
Genetically Modified Organisms (GMO) and its derivatives
shall create a Biosafety Internal Commission (CIBio).
Paragraph 1. The institution dealt with on this article
caput shall appoint a main technician responsible for each
specific project.
Paragraph 2. The institution that intends to import GMO and
its derivatives for the use in research activities shall
install its CIBio.
Paragraph 3. The institutions shall know the legal role of
the CIBios and their authority, and ensure the necessary
support for the fulfillment of their obligations, promote
their habilitation in bio-safety and improve their
recommendations, guaranteeing that they can supervise the
activities with GMO and its derivatives.
Paragraph 4. CIBio is an essential component for the
monitoring and surveillance of activities with GMO and
their derivatives, foreseen on art. 1 of Law 11.105 of
2005, and for the fulfillment of bio-safety norms.
Article 4. The institutions' legal responsible party will
constitute and name the CIBio.
Article 5. CIBio shall be constituted by honest people,
with scientific knowledge and experience to evaluate and
supervise the works with GMO and its derivatives developed
at the institution, being able to include a member from
outside the scientific community.
I- CIBio will be composed by, at least, three specialists
in areas compatible with the institution action, being one
of them assigned by the President and the other members;
II – the institution's legal responsible party shall name a
president amongst CIBio's specialist members;
III – The member from outside the scientific community may
be an employee form the entity, as long as he is prepared
to consider the widest interests of the community;
IV – whenever there is need of changing CIBio's President
or members, this Commission should request CTNBIo's
approval of its new composition, attaching the document of
indication by the institution's legal responsible person,
and the specialist's curriculum.
Article 6. Each institution shall install one or more
CIBios regarding its administrative and technical
structure.
I – the institution that installs more than one CIBio shall
forward its installation process to CTNBio, requesting a
CQB for each one, appointing the units that will be
responsible for each CIBio;
II – whenever a CIBio is deactivated, the institution's
legal responsible person should inform CTNBio, within 30
(thirty) days, and appoint a CIBio that shall be
responsible for the units that were under the
responsibility of the deactivated CIBio, justifying the
decision;
III – in cases where CIBio is not working, CTNBio shall
cancel the CQB and determine the suspension of all the
activities that are being executed with GMOs and their
derivatives.
Art. 7. At the moment of CQB request appreciation, CTNBio
shall verify the fulfillment of the norms for CIBio
installation.
Art. 8. It is CIBio's responsibility in the scope of its
institution:
I – forward to CTNBio all pleas and documents involving
projects and activities with GMO and its derivatives
foreseen on art. 1 of Law 11.105, of 2005, according to
CTNBio's specific norms, for analysis and decision
purposes;
II – evaluate and review all GMO and its derivatives
activities proposals conducted at the operative units, as
well as identify all the factors and risk situations to
human health and to the environment, and make
recommendations to everyone involved about such risks and
how to manage them;
III- evaluate the qualification and experience of the
personnel involved in the activities proposed, in order to
guarantee biosafety;
IV- keep record of the individual follow-up of each
activity or project being developed, involving GMO and its
derivatives and their risk evaluations through annual
reports;
V- elaborate and divulge norms, and decide about specific
subjects in the scope of the institution in bio-safety
procedures, always in consonance with CTNBio's norms;
VI – execute, at least, one annual inspection of the
installations included on CQB to ensure the fulfillment of
the requirements and required bio-safety levels, keeping
record of inspections, recommendations and deriving
actions;
VII – keep workers and other members of the collectivity
who are subject to risk situations deriving from the
activity informed about possible damages to health and
protection means and safety prevention, as well as about
procedures in case of accidents;
VIII – establish preventive programs, of habilitation in
biosafety and inspection to guarantee the functioning of
the installations under its responsibility, within
biosafety patterns and norms defined by CTNBio;
IX – based on CTNBio's Normative Resolutions, authorize the
transfer of GMO and its derivatives, within the national
territory, to another unit that has CQB compatible with the
risk class of the transferred GMO, assuming all the
responsibility deriving from such transfer;
X – guarantee that its recommendations and CTNBio's
recommendations are observed by the Main Technician;
XI – guarantee the observation of biosafety levels defined
by the CTNBio's norms;
XII – adopt necessary means to inform to CTNBIo, to public
health, environment, agribusiness defense authorities, to
the collectiveness and other employees of the institution
or company about the risks that they may be submitted to,
as well as the procedures to be taken in case of accidents
with GMO;
XIII – immediately notify CTNBio and the other organs and
entities of record and inspection about accident or
incident that may provoke dissemination of GMO and its
derivatives;
XIV – investigate accidents that occur on the course of
researches and projects in the genetic engineering area and
send the respective report to the competent authority,
within 5 (five) days from the date of the event;
XV – formally consult CTNBio, whenever it deems necessary;
XVI – perform other attributions in accordance with
CTNBio's delegation.
Article 9. CIBio will meet at least once every semester and
will promote special meetings whenever necessary, or
whenever requested by one of the members.
Sole Paragraph. Minutes shall be prepared at every meeting.
Article 10. CIBio shall annually forward to CTNBio a report
of the activities developed in the ambit of the operative
unit, according to the attached model, until the 31st
(thirty first) day of March of each year, under penalty of
suspension of CQB and interruption of activities.

CHAPTER III
THE MAIN TECHNICIAN
Article 11. The main technician responsible for activity
involving GMO and its derivatives is responsible for:
I – guaranteeing the fulfillment of biosafety norms in
accordance with CTNBio's and CIBio's recommendations;
II – presenting to CIBio an activities proposal, specifying
the biosafety measures that will be adopted;
III – presenting to CIBio, before the beginning of any
activity, the information and documentation as set up on
the respective CTNBio's Normative Resolutions;
IV – ensuring that the activities are not started until the
issuance of the favorable technical decision by CTNBio, and
whenever it is the case, authorized by the organ of
competent registration and inspection;
V – requesting previous authorization to CIBio to execute
any change in the activities previously approved, so that
it is presented to CTNBio for approval;
VI – sending to CIBio the request for the importation of
biological material involving GMO and its derivatives, so
that it is submitted to CTNBIo for approval;
VII – requesting to CIBio authorization for transfer of GMO
and its derivatives, within the national territory, based
on the CTNBio's Normative Resolutions;
VIII – guaranteeing that the technical and the support team
involved in the activities with GMO and its derivatives
receive the appropriate training in biosafety and that they
are aware of the potential risk situations of such
activities, and of the individual and collective protection
procedures in the work environment, through signing of a
specific statement;
IX – notifying CIBio about the changes in the project
technical team, sending the curriculum of possible new
members;
X – immediately reporting to CIBio, all the accidents and
aggravations to health that are possibly related to the
activities with GMO and its derivatives;
IX – ensuring, with the responsible entity, the
availability and maintenance of equipments and bio-safety
infrastructure;
XII – providing to CIBio additional information, whenever
requested, as well as attending to possible audits of
CIBio.

CHAPTER IV
THE BIOSAFETY QUALITIY CERTIFICATE (CQB)
Article 12. The public or private law institution that
intends to execute laboratory research, contention or field
regime, as part of the GMO acquisition process, or as GMO
biosafety evaluation, which encompasses, in the
experimental ambit, the construction, cultivation,
manipulation, transportation, transfer and importation,
exportation, storage, release in the environment and
disposal of GMO, shall request with CTNBio the issuance of
CQB.
Article 13. Public and private organizations, national and
foreign ones, financers or sponsors of activities, or to
education with live organisms manipulation, to scientific
research, and to technological development, and to
industrial production, should require presentation of CQB,
under penalty of becoming co-responsible for eventual
effects deriving from the unfulfilling of Decree No. 5.591,
of November 22nd, 2005.
Sole Paragraph. The institution that intends to import GMO
and its derivatives, for the use in research activities
should request CQB.
Art. 14. The CQB shall be issued by CTNBio through request
from CIBio of the interest institution, what should be
accompanied by documentation that is on this Normative
Resolution Attachment.
I – after receiving the CQB request, the Executive
secretariat of CTNBio should check if the required
documentation is complete, and within 30 (thirty) days, it
shall manifest itself about the documentation presented;
II - CTNBio may require complementary information, and when
is deems necessary, it shall execute audits on the
installations to be certified;
III – if there is need for presentation of new documents,
the interested party should forward them within 90 (ninety)
days from the date of receipt of the correspondence that
was sent to it, under penalty of process filing;
IV – after receiving all the information, and whenever it
is the case, after the audit, CTNBio shall decide about the
issuance of CQB within 120(one hundred and twenty) days
after the disclosure of the previous statement on the
Official Gazette and on SIB.
V – For CQB issuance, CTNBio shall consider the competence
and adequacy of the functions board and the infrastructure
available for the works with GMO and its derivatives.
Article 15. CQB will be issued to an operative unit inside
an institution, and such unit may be constituted of one or
more laboratories, or another kind of functioning
infrastructure.
Sole Paragraph. According to its needs, the institution
shall request one or more CQBs.
Article 16. Whenever an institution that owns a CQB intends
to alter any component that may modify the conditions
approved on the CQB issuance, its CIBio should request
review or extension of its CQB with CTNBio.
I – Whenever the institution intends to amplify the
installations described on its CQB, its CIBio should
request, with CTNBio, the extension of the CQB for the
installations that will be added.
II – whenever a new activity requests a classification
alteration of GMO risk and its derivatives, CIBio shall
request the review of its CQB with CTNBio;
III – CIBio of the institution that owns a CQB that fails
to develop projects and activities with GMO and its
derivatives shall request, with CTNBio, the CQB
cancelation.
IV – in processes regarding the review, extension and
cancellation of CQB, if it is necessary to present new
documents, the interested party shall manifest himself
within 90 (ninety) days from he date of notification
receipt sent to him, under penalty of process filing.
V – In the process of acquisition or incorporation of the
institution that owns a CQB, the acquiring institution or
the incorporator shall be responsible for the CQB
regularization or cancelation request of the acquired or
incorporated institution, within 90 (ninety) days.
a) If the acquirer or incorporator is also an owner of CQB,
and intends to continue developing the activities and
projects with GMO and its derivatives on the institution's
accredited installations acquired or incorporated, the
president of its CIBio shall request with CTNBio the
immediate cancellation of the institution's CQB acquired or
incorporated and request the extension of its CQB for the
new installations or the issuance of another CQB.
b) If the acquirer or incorporator is not a CQB owner and
intends to continue developing activities and projects with
GMO and its derivatives on the accredited installations of
the acquired or incorporated institutions, its CIBio's
president shall request with CTNBio the immediate
cancellation of the acquired or incorporated institution's
CQB and the issuance of a new CQB.
c) If the acquirer or incorporator institution does not
intend to develop activities and projects with GMO and its
derivatives at the accredited installations of the acquired
or incorporated institution, its legal responsible party or
its CIBio's president should request with CTNBio the
immediate cancellation of the acquired or incorporated
institution's CQB.
VI – It is the CQB's owner's job to request the
cancellation, whenever it is the case, of areas, including
leased ones, and installations under his administrative,
technical or scientific responsibility, attaching the
report of the activities of the last 12 (twelve) months.
Article 17. CTNBio will publish on the Official Gazette and
will advertise on the Biosafety Information System (SIB)
every issuance, revision, extension, suspension and
cancelation of CQB and will forward the respective process
to the competent organs and entities of registration and
inspection and a copy of the technical decision of the
opinion to the interested CIBio.

CHAPTER V
FINAL AND TRANSITORY DISPOSITIONS
Article 18. Natural people or legal entities involved in
any of the phases of the process of agricultural
production, commercialization or transportation of
genetically modified products, that may have received
license for commercial use, are excused from the
presentation of CQB, and CIBio constitution specifically
for these products.
Art.19. CTNBio shall, together with one or more
registration and inspection organs and entities, carry out
audits at the institutions owners of CQB, and should, based
on its results, keep, suspend or cancel the inspected
institution's CQB.
Sole Paragraph. At the CTNBio's discretion and considering
GMO risk classes and its derivatives, the issuance, review,
extension and cancellation of CQB may depend on the audit
of the installations.
Article 20. Whenever CTNBio realizes the unfulfilling of
biosafety norms or existence of serious risk situations for
human health, for animals, for vegetables, or for the
environment, it should determine the immediate suspension
of the activities.
Sole Paragraph. Whenever the activity suspension is
determined, CTNBio shall communicate the decision to the
registration and inspection organs and entities.
Article 21. After evaluation of new conditions presented by
the institution, CTNBio shall issue a new CQB for the
operative unit, whose CQB was cancelled, or reactivate the
suspended CQB.
Article 22. CTNBio shall deliberate about situations that
are not foreseen on this Normative Resolution.
Article 23. Normative Instructions of CTNBio No.1 of
September 06th, 1996, and No. 14 of June 25th, 1998 are
revoked.
Art. 24. The acts practiced based on Normative Instructions
No. 1 and 14 of CTNBio are validated.
Art. 25. The present Normative Resolution is in force on
the date of its publication.
Brasília, June 20th, 2006.

Walter Colli

ATTACHMENT
Information necessary for the acquisition of Biosafety
Quality Certificate – CQB.
1. Constitution of the interested legal entity:
- CNPJ Number;
- Complete address, telephone, Fax and Email of the
Operative Unit;
- Complete address, telephone, Fax and Email of the Company
or Institution;
- Name, identity, CPF, address, telephone and Email of the
Legal Responsible party for the Company or Institution;
- Name, identity, CPF, address, telephone and Email of the
Legal Responsible Party for the Operative Unit;
- Name, identity, CPF, address, telephone and email of the
CIBio's president;
- Emergency telephone number;
- Include the schedule of the Operative Unit to which CQB
is being requested, and its position in the Institution.
2. Objective of the CQB concession request.
Mark one or more of the options below:
- Research in contention regime ( )
- Commercial Use ( )
- Planned release on the environment ( )
- Transportation ( )
- Product Evaluation ( )
- Detection and identification of GMO ( )
- Disposal ( )
- Education ( )
- Storage ( )
- Industrial Production ( )
- Others – specify:
3. Activities developed with:
- Animals ( )
- Plants ( )
- Virus ( )
- Microorganisms ( )
- Fungus ( )
- Derivatives ( )
- Others – specify:
4. Roll of GMO and derivatives that are object of the
activities. Mention the common name, scientific name of the
species, introduced genes, their origin and specific
functions.
5. Inform the Risk class of Genetically Modified Organisms
(GMO) object of the activities to be developed, in
accordance with CTNBio's Normative Resolutions.
6. Summary of research projects or other activities that
will be developed with GMO and its derivatives. Attach
request for authorization in contention with GMO and its
derivatives.
7. Description of installations that will be used in the
activities with GMO and its derivatives.
7.1. Specify in details the Laboratories, Vegetation
Houses, Experimental Fields, benefiting unit and seeds
storage, cold chamber, handling room and preparation of
experiments, vivarium and other installations, naming and
identifying each one on the low plant to be attached to the
process.
7.2. inform location, dimensions and special
characteristics related to bio-safety, fulfilling the
specific norms of CTNBio. In field experimental units,
specify the location and dimension of the area to be
accredited.
7.3. Present location plant of the area contiguous to the
installations.
8. Make a list of the main equipments used on experiment,
the measures, and the Equipments for Individual and
Collective Protection (EPI and EPC) available at the
Operative Unit, informing its location on the low plant,
when necessary.
9. List names, CPF, professional formation, titles and
habilitation in biosafety of the technical team involved on
the work with GMO and its derivatives, presenting
curriculum vitae of each participant that is not registered
on Lattes Platform.
10. Specify the conditions for emergency medical assistance
at the institution.
11. Specify composition of the Biosafety Internal
Commission – CIBio, with curriculum registered at CNPq
Lattes Platform of the members and of the President. Attach
formal documentation appointing and naming the members and
President of CIBio.
12. Telephone and E-mail of CIBio.
13. Statement:
Formal statement of the interested parties regarding the
technical competence and the infrastructure of the
Operative Unit for the execution of the programmed job
(model below).
STATEMENT
I declare, in order to obtain a Biosafety Quality
Certificate – CQB, foreseen by Law No. 11.105, of March
24th, 2005, to be issued by the National Technical
Biosafety Committee – CTNBio, that
(name of the Operative Unit) (Entity)
has the adequate infrastructure and technical personnel
competent enough to safely develop activities of
(nature of the activities, example: research in contention
regime)
with
(kind of organisms, example: animals, plants,
microorganisms, fungus, or derivatives) genetically
modified of the Risk Class
(name of the Operative Unit)
is willing to receive the CTNBio's members at any time or
moment, for the evaluation of the physical, technical
conditions, of infrastructure and of the institution's
personnel, aiming at the issuance, review, extension,
suspension and cancellation of CQB.
Legal responsible party for the Institution President of
CIBio.
GUIDE FOR THE ELABORATION OF ANNUAL REPORT
1. Institution:
2. CQB No.:
3. Period it refers to:
4. Information about alterations occurred at the
composition of CIBio:
5. List of operative units and installations used,
specifying biosafety levels, main technician, research
projects or activities finished or being carried out, with
objectives, list of organisms genetically manipulated and
information regarding the manipulated genes, including the
summary of the most relevant results obtained and refer to,
if that is the case, publications and patent requests.
6. Description of any accidents or aggravations to health
possibly related to works with GMO and its derivatives and
measures of curtailment, control and prevention.
7. Description of habilitation activities in biosafety of
GMO and its derivatives.
8. Description of biosafety measures that have been adopted
and their possible efficiency to avoid damages.
9. Mention the environmental releases at the Units with
respective numbers of Processes at CTNBio:
a. Concluded:
b. In process:
c. Suspended:
d. Cancelled::
10. List the conclusion reports of planned release
experiments of GMO and its derivatives on the environment
that have obtained technical decision and favorable opinion
of CTNBio.
11. Attach a copy of CIBio's meetings minutes.
12. Describe the institutional difficulties for the good
functioning of the CIBio's activities.
13. List the imported material (GMO and derivatives) and
respective quantities for projects execution.
14. Inform if there is inspection by the organs and
entities of registration and inspection. If there is,
indicate the date, inspection team and No. and term of
Inspection, and, if there is one, the No. of Infraction
Record.
15. Inform other occurrences that CIBio deem necessary to
report to CTNBio.
16. Inform eventual alterations on the installations
description, attaching the new low plant.
Date:
CIBio's President's Signature
REQUEST OF AUTHORIZATION FOR ACTIVITIES IN CONTENTION WITH
GMO AND ITS DERIVATIVES
Dear Mr. President of CTNBIo
1. CIBio's President's name.
2. Institution and address.
CQB No.:
Fax: Phone: E-mail
3. Main Technician's name:
Requests from CTNBio authorization for contention work with
GMO described below.
4. Description of GMO or derivative. Mention the common
name, scientific name of the species, modified genes, their
origin and specific functions, including:
a. Receptor organism:
b. Parental organism:
c. Genetic construction used:
d. Vector:
5. Classification on Biosafety level of the laboratory or
of the Operative Unit where the project or activity will be
conducted with the GMO or derivative, in accordance with
the Normative Resolutions of CTNBio.
6. Specify, whenever it is the case, the volume and maximum
concentration of GMO or derivative to be used.
7. Objective of the work (research, production, development
of methodology, education, etc).
8. Summary of research project or activity that will be
developed with GMO and its derivatives (include
bibliographic references, if there is any).
9. Inform if the contention work aims at later releases on
the environment.
10. Short description of operative procedures to be
employed on the experiments and Biosafety Level (NB)
planned.
11. List the equipments to be used during the contention
work with GMO.
12. List the procedures of cleanliness, disinfection,
decontamination and disposal of material/residues.
13. Analyze the possible predictable risk situations and
aggravations to health associated to GMO.
14. Curriculum Vitae of team involved on the project, when
not included on Lattes Platform.
15. Attach previous opinion of CIBio.

Date:

Main Technician Signature:

CIBio's President's Signature: