Voluntary Report - public distribution

**Date:** 6/30/2004

**GAIN Report Number:** BR4614

BR4614

**Brazil**

**Biotechnology**

**Update on Biotechnology Issues in Brazil**

**2004**

**Approved by:**

![](media/image1.wmf)Oliver Flake, Agricultural Attache

U.S. Embassy

**Prepared by:**

Joao F. Silva, Agricultural Specialist

**Report Highlights:**

Brazil is moving closer to a more complete authorization of the use of
agricultural biotechnology. A recent court panel ruled in favor of the
authority of the Brazilian Technical Commission of Biosafety (CTNBio) to
waive environmental study reports, but upheld the ruling against
Monsanto Round Up Ready Soybeans (RRS). Legal specialists believe that
this decision will have a positive impact in the Senate where the
biosafety bill approved in the House is currently under review. However,
due to upcoming municipal elections in October and the mid-year
Congressional recess, the bill may not be voted on until the end of the
year.

Includes PSD Changes: No

Includes Trade Matrix: No

Unscheduled Report

Brasilia \[BR1\]

\[BR\]

[Update on Biotech issues in Brazil
2](#update-on-biotech-issues-in-brazil)

[Attachment 1: Court Decision 3](#attachment-1-court-decision)

[Attachment 1: Draft Bill on Biosafety
4](#attachment-1-draft-bill-on-biosafety)

[Note on Biosafety Bill 4](#note-on-biosafety-bill)

[Proposed Bill 5](#proposed-bill)

# Update on Biotech issues in Brazil

On June 28, 2004 a three-judge panel of the Regional Federal Court (TRF
in Portuguese), decided on the merits of a previous rule by the 6^th^
Federal Circuit ("lower court") on Monsanto's Round Up Ready Soybean
(RRS) case. The final panel decision (two votes against one) ruled as
follows:

a)  In favor of the legality (authority) of the National Technical
    Commission on Biosafety (CTNBio) to waive environmental impact
    studies and reports for biotech products. The lower court had ruled
    in 1999 that CTNBio had no authority to waive such environmental
    reports and ruled in favor of the Consumer Protection Institute
    (IDEC) of Sao Paulo and Greenpeace who filed the court case against
    Monsanto.

b)  In favor of the lower court case that ruled against Monsanto and
    required environmental study reports for their biotech product
    (RRS).

Monsanto already declared they will appeal against the decision of the
court panel that requires environmental study reports for its RRS, and
IDEC also declared they will appeal against the court panel for
recognizing the authority of CTNBio for authorizing biotech products for
commercial use. IDEC believes that CTNBio has only a "consultative"
power, and not a deliberative power to approve the final use of biotech
products. The appeal by both parties will be to the Superior Justice
Court (TSJ, in Portuguese).

The TRF final decision (Attachment 1) is a victory for the Brazilian
scientists that are lobbying for CTNBio to hold its authority to approve
biotech products, without environmental study reports and a loss to
Monsanto that continues to have its RRS prohibited by the courts, except
for the 2004/05 crop year, which plantings are under the terms of law
10,814/03.

CTNBio has not publicly released any statement until its board meeting
within 15 days. There are 15 biotech products pending approval by
CTNBio.

Legal analysts in Brasilia believe that this recent decision by the
three judges will have an impact on the current debate in the Senate
regarding the Draft Bill on Biosafety approved in the House, which
withdraws the power of CTNbio to approve commercial use of biotech
products, and allowed CTNbio only to approve research projects on
biotechnology. Attachment 2 provides a translation of the Draft Bill as
sent by the Office of the President to Congress in October 2003.

The Senate may not have enough time to approve (or change) the Draft
Bill approved by the House because Congress will go shortly into their
mid-year recess and municipal elections in October will restrain
Congress from voting on important issues. If this scenario materializes,
a new Provisional Measure will need to be issued by the President of
Brazil to allow the planting of the 2004/05 soybean crop, starting in
late August or early September in some areas in the south region.

# Attachment 1: Court Decision

+-----------------------------------------------------------------------+
| 5^th^ Panel of the *TRF* \[Regional Federal Court\] --1^st^ Region    |
| closes decision on transgenic soybean\                                |
| Monday, June 28, 2004                                                 |
+-----------------------------------------------------------------------+
|   ------------------------------------------------------------------  |
|                                                                       |
|   ------------------------------------------------------------------  |
|                                                                       |
|   ------------------------------------------------------------------  |
|       The judgment on merits at the TRF -- 1^st^ Region that          |
|   addresses the validity of the authorization for the growth and      |
|   trade of transgenic soybean granted by CNTBio \[National Technical  |
|   Commission on Biosafety\] in commercial scale was closed today at   |
|   09:00 p.m. The appeals court judges of the 5th panel decided, by    |
|   majority of votes, to acknowledge the legality of CNTBio's work.    |
|   The need for the performance of an environmental impact assessment  |
|   prior to the release of the soybean was determined on a decision    |
|   issued by a lower court judge. Dissatisfied with the decision, the  |
|   Federal Government and Monsanto and Monsoy corporations appealed    |
|   to the TRF. Once the trial started, the Appeals Court Judge         |
|   Antônio Ezequiel da Silva requested an examination of the court     |
|   records and today issued his decision stating that "it is           |
|   incumbent upon CNTBio's discretion to decide on the need to         |
|   request the performance of Environmental Impact Assessment (EIA)    |
|   and of the Report on Impact on the Environment (RIMA), as a         |
|   condition to release it in the environment and for commercial use   |
|   of genetically modified organisms (GMOs)", thus regarding CNTBio's  |
|   action as legal. Federal Associate Judge João Batista Gomes voted   |
|   for the need of the Environmental Impact Assessment so that the     |
|   democratic principle of protection to man and to the environment    |
|   was complied with. The two opinions closed the judgment of the      |
|   panel, since Federal Reporting Judge Selene Maria de Almeira had    |
|   already issued her opinion favorable to the appeals, in which she   |
|   was followed by Federal Associate Judge João Batista Moreira,       |
|   whereby Federal Associate Judge João Batista Moreira was defeated.  |
|   The Reporting Judge's opinion stated that the agency in charge of   |
|   granting the authorizations, the National Commission on Biosafety   |
|   -- CNTBio -- had been backed by a scientific study with all the     |
|   necessary technical requests, which would render her opinion        |
|   valid. Although Federal Associate Judge Antônio Ezequiel had voted  |
|   likewise the Reporting Judge, he did not follow part of the vote    |
|   that rendered null the initial decision granted in the preparatory  |
|   injunction of the preparatory civil action filed by the Attorney    |
|   General in the public interest, thus remaining defeated the         |
|   reporting judge as far as the rejection of the injunction. With     |
|   the pending injunction issue, the actual release and trade of       |
|   transgenic soybean in commercial scale would depend on this         |
|   latter. AC 1998.34.00.027682-0/DF Public Relations of the           |
|   TRF-1^st^ Region - Marília Maciel Costa                             |
|                                                                       |
|   ------------------------------------------------------------------  |
+-----------------------------------------------------------------------+

# Attachment 1: Draft Bill on Biosafety

## Note on Biosafety Bill

1\. This Bill establishes safety standards and mechanisms for
controlling the activities involving genetically modified organisms
(GMOs) and their derivatives, creates the National Biosafety Council
(CNBS), restructures the National Biosafety Commission (CTNBio), and
provides for the National Biosafety Policy as well as other provisions.

2\. The final text is the result of work conducted by an
Inter-Ministerial Group established by President Lula in February 2003
which was stepped up as from last June.

3\. The Bill is built on 8974/95 Law, the current Biosafety Law, and
includes improvements resulting mostly from suggestions of the organized
sectors of society through discussion seminars promoted by the
Inter-Ministerial Group.

4\. The purpose of the Bill is to give the country well defined,
long-lasting legislation on Biosafety that can prevent future court
disputes, encourage scientific research and protect people health and
environment.

5\. The National Biosafety Commission (CTNBio) will be made up of 26
members, including 10 from the scientific community, 8 from the Federal
Government, and 8 from civil society. Since civil society and Federal
Government representatives must necessarily have acknowledged
professional competence in their areas of expertise, a high-level CTNBio
will be ensured. And society\'s greater participation will allow the
merit review to be as multidisciplinary as possible while keeping its
technical-scientific character.

6\. CTNBio will play a consulting and advisory role and will produce
binding opinions for registration and inspection bodies when
applications are not granted on the ground that the GMO is not biosafe.
In cases of favorable opinions, registration and inspection bodies will
work on a complementary basis according to their legally established
competences.

7\. The qualification of CTNBio\'s members and the increased
representation of both scientific community and civil society will
contribute decisively to restore CTNBio\'s credibility.

8\. The Bill has maintained the competences of registration and
inspection bodies, thus preventing competence conflict with CTNBio.

9\. The twelve-minister National Biosafety Council (CNBS) has the major
role of advising the President of the Republic on GMO issues. The
Council is responsible for formulating the National Biosafety Policy and
making strategic decisions.

10\. CNBS\'s involvement in merit issues is not an option; such issues
are the responsibility of CTNBio and registration and inspection bodies.
Only by the order of the President of the Republic or at its members\'
request, will CNBS express its view about the convenience and
opportuneness of cases involving GMO releases, when favorable views are
presented by CTNBio and registration and inspection bodies.

11\. The Bill provides that, whenever a risk is involved, a
Precautionary Principle applies.The Precautionary Principle provision
meets the claim of all those that expressed their views on the issue.

12\. The Biosafety Information System (SIB) is also established to give
publicity to actions and documents related to Biosafety in the country.
This System will be managed by the Ministry of Science and Technology,
which will also host CTNBio. SIB is intended to give greater publicity
to CTNBio\'s actions.

13\. The Bill provides that GMO research will have simplified treatment.

14\. Funding from penalties enforcement will be allocated to public
laboratories to conduct GMO research.

In the light of the foregoing, the Office of the Chief of Staff for the
Presidency considers that, once passed, the released Biosafety Law Bill
will put an end to the court dispute period that has been going on for
years, as it will harmonize the current national legislation and assure
that technical-scientific analyses will prevail over occasional
political decisions related to the release of GMOs. Its provisions will
give the country an adequate process of support for GMO research and
licensing that will be able to ensure agility and safety in the
treatment of this important technology.

> Brasília, October 31, 2003
>
> Office of the Chief of Staff for the Presidency

  -------------- --------------------------------------------------------
                 

  -------------- --------------------------------------------------------

## Proposed Bill

  -- --------------------------------------------------------------------
     Sets up safety standards and inspection mechanisms to control
     activities involving genetically modified organisms - GMOs and GMO
     derivatives, establishes the National Biosafety Council - CNBS,
     restructures the National Biosafety Commission - CTNBio, establishes
     the National Biosafety Policy and makes other provisions*.*

  -- --------------------------------------------------------------------

THE NATIONAL CONGRESS decrees:

CHAPTER I

PRELIMINARY PROVISIONS

Art.1. This Law establishes safety standards and mechanisms for
inspection of GMOs and GMO derivative construction, cultivation,
production, handling, transport, transfer, commercialization, import,
export, storage, research, consumption, release or disposal, aiming at
protection of human, animal and plant life and health and the
environment.

Art.2.The activities mentioned in art. 1 must comply with this Law and
Law no. 6.938, of August 31, 1981 and its regulations to effectively
prevent and mitigate threats to human health and the environment under
precautionary principles.

Art.3. Activities and projects related to education involving
manipulation of living organisms, scientific research, technological
development, and industrial production involving GMOs and their
derivatives shall be conducted by public or private entities which shall
be held responsible for securing compliance with this Law and its
regulations, as well as for potential effects or consequences arising
from non compliance.

§1.For the purposes of this Law, activities and projects conducted by
public or private entities are those carried out in the facilities of
such public or private entities or elsewhere under their technical or
scientific responsibility.

§ 2 The activities and projects in this article shall not be carried out
by individuals as independent autonomous agents even if they have an
employment relationship or any other type of relationship with companies
or other entities.

§3 Without prejudice to the application of biosafety standards set forth
in this Law, the Government shall adopt simplified treatment to research
activities respecting the purpose of the activity, and the type and
class of GMO risk, as provided for in the proper regulation.

§4 Domestic, foreign or international public or private organizations
that fund or sponsor the activities or projects mentioned in this
article shall require the proper Specific Business License issued by the
relevant registration and inspection agencies and entities listed in.
art.14, otherwise they shall be held co-responsible for the effects of
non compliance with such provisions.

Art.4 For the effects of this Law, the following definitions shall
apply:

I-organism: any biological entity capable of reproducing or transferring
genetic material, including viruses, prions and other classes that may
come to be known;

II-deoxyribonucleic acid (DNA), ribonucleic acid (RNA): genetic material
that encodes genetic information determining inheritance of specific
traits by offspring;

III-recombinant DNA/RNA molecules: molecules resulting from modification
of natural or synthetic DNA/RNA segments, as well as those resulting
from their multiplication;

IV-genetically modified organism (GMO): an organism whose genetic
material (DNA/RNA) has been modified by any genetic engineering
technique;

V-genetic engineering: production and manipulation of recombinant
DNA/RNA molecules;

VI - GMO derivative: product obtained from GMO that lacks capacity for
autonomous replication or does not include any viable GMO form;

VII- human germ cell: parent cell that produces gametes found in male
and female glands and its direct descendants in any degree of ploidy.

Sole paragraph - GMOs do not include organisms resulting from techniques
that involve direct introduction into an organism of hereditary
material, provided that such techniques do not involve the use of
recombinant DNA/RNA molecules or GMOs, such as: in vitro insemination,
conjugation, transduction, transformation, polyploid induction and any
other natural process.

Art. 5 This Law shall not apply when genetic modification is obtained
through the following techniques, provided the GMO is not used as
receptor or donor.

I- mutagenesis;

II- formation and use of somatic cells from an animal hybridome;

III-cell fusion, including protoplasm fusion, of plant cells, which can
be produced through traditional culture techniques;

IV- self-cloning of non-pathogenic organisms when processed in a natural
fashion.

Art.6 The following activities related to GMOs and GMO derivatives are
forbidden:

I-any genetic manipulation of living organisms or *in vitro* handling of
natural or recombinant DNA/RNA carried out outside the standards
provided for in this Law;

II- genetic manipulation of human germ cells;

III- *in vivo* intervention in human genetic material, except for
required diagnostic, prevention or treatment procedures for diseases or
defects, as previously approved by the National Biosafety Commission -
CTNBio and relevant registration and inspection agencies; in cases of
clinical research approval by the National Commission for Ethics in
Research - Conep -of the Ministry of Health National Health Council is
required;

IV- production, storage or manipulation of human embryos intended to be
used as available biological material;

V *in vivo* intervention in the genetic material of animals, except for
cases in which such intervention constitutes a significant advance in
scientific research and in technological development, according to
ethical principles such as the principle of responsibility and the
principle of prudence, and as previously approved by CTNBio;

VI- release or disposal into the environment of GMOs and their
derivatives in violation of standards set by CTNBio and registration and
inspection agencies and entities, and as provided for by the regulation
of this Law;

VII- supplying products without proper information to users as to
release criteria and technical requirements applicable to biosafety
maintenance;

VIII- project implementation without previous registration of the GMO
research institution and its technician in charge and CIBio;

IX- environmental release of any GMO and GMO derivatives without CNTBio
approval or licensing from the responsible environmental agency or
entity as published in the Federal Official Journal;

X- operation of laboratories, vivaria, greenhouses and trial stations
that manipulate GMOs and their derivatives without proper observation of
the standards provided for in this law and biosafety legislation;

XI-absence of adequate activities related to investigation of accidents
occurred in the course of research and projects in genetic engineering
or failure to submit the accident report to the relevant authority
within a maximum of five days from occurrence;

XII- project implementation without recording project progress and
follow-up;

XIII- failure to promptly notify CTNbio and public health and
environmental authorities about accidents that may result in
dissemination of GMO and their derivatives;

XIV- absence of the necessary means to provide communication to CTNBio
and health, environmental and plant and animal health protection
authorities, the public, and institution or company employees on
potential risks and actions to be taken in the occurrence of hazards.

CHAPTER II

NATIONAL BIOSAFETY COUNCIL - CNBS

Art.7. It is hereby established the National Biosafety Council - CNBS, a
counseling body to the President to formulate and implement the National
Biosafety Policy --PNB. CNBS shall set the principles and guidelines for
administrative action by relevant federal agencies and entities, provide
appraisal, if necessary, as a body of last resort on aspects involving
the convenience and opportuneness of requests for authorization of
activities involving construction, cultivation, production,
manipulation, transport, transfer, commercialization, import, export,
storage, research, consumption, release or disposal of GMO and their
derivatives.

Sole paragraph. CNBS´s decisions as a body of last resort on aspects
involving the convenience and opportuneness of activities shall require
previous favorable opinion by CTNBio and relevant registration and
inspection agencies and entities, as well as determination by the
President or request from any of its members.

Art.8.CNBS comprises the following members:

I- Minister and Chief of Staff for the Presidency who will be the chair;

II-Secretary for Government Communication and Strategic Management of
the Office of the President;

III-Minister of Science and Technology;

IV-Minister of Agrarian Development;

V-Minister of Agriculture;

VI-Minister of Justice;

VII-Minister of Health;

VIII-Special Minister for Food Security and Combating Hunger;

IX-Minister of the Environment;

X-Minister of Foreign Relations;

XI-Minister of Development, Industry and Trade; and

XII-Special Secretariat of Aquaculture and Fisheries.

§1 CNBS shall meet any time when summoned by the Minister and Chief of
Staff for the Presidency, or by request of four of its member, and shall
issue decisions as resolutions.

§2 CNBS may invite representatives from other agencies or public and
private entities to participate in the meetings.

CHAPTER III

NATIONAL BIOSAFETY COMMISSION - CTNBio

Art.9 CTNBio is a collegial, consultative and deliberative body within
the Ministry of Science and Technology that supplies technical support
and counsel to the Federal Government in the formulation, updating and
implementation of the national biosafey policy (PNB) for GMOs and their
derivatives, as well as establishment of safety standards and technical
opinion on protection of human, animal and plant health and the
environment in activities that involve construction, cultivation,
production, manipulation, transport, transfer, commercialization,
import, export, storage, research, consumption, release or disposal of
GMO and their derivatives.

Sole paragraph. CTNBio shall exert its jurisdiction by monitoring
technical progress and development in biosafety, biotechnology,
bioethics and related areas, aiming at protection of human, animal and
plant life and health and the environment.

Art.10. CTNBio comprises incumbent members and deputies nominated by the
Minister of Science an Technology forming a body of twenty-six Brazilian
citizens of widely recognized expertise and outstanding professional
activity in areas such as biology, molecular biology, immunology,
ecology, bioethics, genetic, virology, entomology, public health, labor
safety and health, biochemistry, pharmacology, animal and plant
pathology, microbiology, toxicology, biotechnology or biosafety:

I- ten specialists of well-known technical and scientific expertise and
full professional activity representing scientific societies, two
members being nominated by CNBS for each of the following areas: human
health, animal health, plant health, environment and social science;

II- one representative of each of the following bodies nominated by the
relevant authority:

a\) Ministry of Science and Technology;

b\) Ministry of Health;

c\) Ministry of Environment;

d\) Ministry of Agrarian Development;

e\) Ministry of Agriculture;

f\) Ministry of Development, Industry and Trade;

g\) Special Secretariat of Aquaculture and Fisheries;

h\) Special Ministry for Food Security and Combating Hunger;

III - a representative of legally established institution in the area of
consumer protection;

IV - a representative of legally established institution in the
biotechnology business sector;

V - a representative of legally established institution in the area of
health;

VI - a representative of legally established environment protection
institution;

VII - a representative of legally established institution in the area of
bioethics;

VIII - a representative of legally established institution in the
agribusiness sector;

IX - a representative of legally established family farming protection
institution;

X - a representative of legally established workers' protection
institution.

§1 Each incumbent member shall have a deputy that will participate in
activities in case of incumbent member impossibility to participate.

§2 This Law will define the operating aspects of CTNBio and the
nomination procedures of CTNBio members, mentioned in subsection I and
subsections III to X.

§3 CTNBio members must be guided by the strict observation of ethical
and professional concepts, and shall abstain from deliberations that
would meet their professional or personal interests, under penalty of
loosing their mandate, as defined by the regulation.

§4 Quorum for CTNBio deliberations shall be 17 favorable votes.

§5 Quorum for CTNBio meetings shall be 17 members, including,
necessarily, the presence of at least one representative of each area
mentioned in subsection I of this article.

§6 When necessary, bodies and entities of the Administration may request
their participation in CTNBio meetings in order to address subjects of
their special interest.

§7 Exceptionally, members of the scientific community, the public sector
and the civil society may be invited to attend the meetings, with the
rights of voice, but no rights to vote.

§8 The Minister of Science and Technology will appoint the chairman of
the Committee, from a list made by the Committee, for a two-year
mandate, renewable for up to two consecutive periods.

Art. 11 CTNBio will constitute sectoral and permanent subcommissions on
human health, animal, plant and environment, besides extraordinary
subcommissions intended for previous analysis of themes to be submitted
to the plenary of the Commission.

§1. Both incumbent members and deputies take part in the sectoral
subcommissions, and are in charge of distributing the proceedings for
analysis.

§2. Operation and coordination of sectoral subcommissions shall be set
in the CTNBio bylaws.

Art.12.CTNBio has the authority to:

I- provide consultative technical support and counsel to CNBS in
formulation of PNB for GMOs and their derivatives;

II- set up, according to its jurisdiction, risk assessment and
monitoring criteria for GMOs and their derivatives;

III- conduct risk assessments, on a per-case basis, for activities and
projects involving GMOs and their derivatives submitted to its analyses;

IV -- follow-up development and scientific progress in biosafety of GMOs
and their derivatives;

V- establish contacts with national and international institutions
engaged in GMO biosafety;

VI - set up standards for activities and projects related to GMOs and
their derivatives;

VII --propose studies and research in the field of GMO and GMO
derivative biosafety;

VIII --establish operation mechanisms for Internal Biosafety Commissions
within institutions involved in education, scientific research,
technological development and industrial production related to GMOs and
their derivatives;

X- issue opinions on quality assurance in biosafety in respect to the
Specific Business License set forth in art. 14, II, for development of
activities involving GMOs and their derivatives in laboratories,
institutions or companies;

X- establish biosafety requirements for the authorization of operation
for laboratories, institutions or companies that will develop activities
related to GMOs and their derivatives;

XI -- establish the biosafety level to be applied to GMOs and their
uses, and the respective safety measures and procedures for GM and GMO
derivative use, according to standards set forth in the regulation of
this Law;

XII- classify GMOs according to risk classes in accordance with criteria
established in the regulation of this Law;

XIII-issue preliminary and conclusive technical opinions, on a
case-by-case basis, regarding the activities, consumption or release of
GMO and GMO derivatives, including their classification pursuant to risk
degree and biosafety level requirements, as well as the safety measures
required and restrictions for use, forwarding it to the relevant
registration and inspection agencies and entities;

XIV- issue normative resolutions on issues within its jurisdiction;

XV-give technical support to the relevant agencies in investigating
accidents and illnesses, identified during projects and activities
applying DNA/RNA recombinant techniques.

XVI-give technical support to inspection agencies and entities in the
exercise of their duties related to GMOs and GMO derivatives;

XVII-publish in the Federal Official Journal the requests preceding the
analyses and the opinions on the proceedings under its consideration,
and give full publicity, through the Biosafety Information System (SIB),
to its agenda, on-going proceedings, annual reports, minutes of meetings
and any other non-confidential information of commercial interest,
pointed out by the applicant and deemed so by CTNBio;

XVIII-identify, in order to give subsidies to the agencies and entities
set forth in art. 14, the activities and products originating from GMOs
and GMO derivatives that potentially cause significant damage to the
environment and may cause risks to human health;

XIX-provide additional information to the technical opinion, at request
of registration and inspection agencies and entities, in order to
clarify specific issues concerning GMOs and GMO derivatives;

XX-reconsider its decisions, at its own discretion or at request of CNBS
or any registration and inspection agencies and entities, based in new
scientific facts or knowledge deemed as relevant to GMO or GMO
derivative biosafety, at the time and manner set forth in the bylaws;

XXI-present a bylaw proposal to the Minister of Science and Technology.

§1 CTNBio technical and conclusive opinion binds, if unfavorable, the
other administration agencies and entities pursuant to GMO and GMO
derivative biosafety aspects under its consideration.

§2 By issuing an opinion favorable to its continuation, CTNBio will
forward the corresponding proceeding to the agencies and entities set
forth in art. 14 herein, for possible registration and licensing under
the applicable law.

§3 As part of the discovery procedure, CTNBio must request to
registration and inspection agencies and entities a term of reference
with biosafety requirements for assessment of GMOs and GMO derivatives.

§4 CTNBio's conclusive technical opinion must provide a summary of its
technical rationale and document compliance with the terms of reference,
highlighting the safety measures and restrictions for use of GMOs and
GMO derivatives in the light of the particularities of each region in
the country, in order to guide and give subsidies to registration and
inspection agencies and entities in the exercise of their duties.

§ 5 Derivatives whose GMO has been approved by CTNBio will not be
submitted to CTNBio analysis and technical opinion.

§ 6 Individual or legal entities participating in any phases of crop
production, commercialization or transport of GMOs that were granted a
favorable, conclusive and preliminary technical opinion by CTNBio and a
favorable commercialization decision issued by the agencies and entities
set forth in art. 14 herein are waived from presenting the Specific
Business License set forth in subsection IX of this article.

Art.13 CTNBio may conduct public hearings, which are compulsory for
commercial clearance requests.

CHAPTER V

REGISTRATION AND INSPECTION AGENCIES AND ENTITIES

Art. 14 Registration and inspection agencies and entities from the
Ministries of Health, Agriculture, Environment and the Special
Secretariat of Aquaculture and Fisheries, according to CTNBio technical
opinion, CNBS deliberations and the mechanisms established during
regulation of this Law must perform, among other competencies:

I--registration, authorization, licensing, inspection and monitoring of
the activities and projects related to research and technological
development, production and manipulation of GMOs and GMO derivatives;

II- issue of Specific Business License for laboratories, institutions or
companies intending to develop activities related to GMOs and GMO
derivatives;

III- issue of registration and authorization or licensing for
commercialization of products containing GMOs or GMO derivatives
intended for human and animal consumption, plant use or release into the
environment;

IV- issue of authorization/licensing required for any product containing
GMO and GMO derivatives entering the country;

V-keep the SIB posted with update information on the institutions and
technicians in charge of activities and projects related to GMOs and GMO
derivatives in the national territory;

VI-forward granted registrations and authorizations to the Federal
Official Journal and SIB for publication;

VII-apply the penalties set forth in this Law;

VIII-issue temporary authorization for field trials with GMOs and GMO
derivatives;

IX-submit to CTNBio term of reference with biosafety requirements for
biosafety assessment of GMOs and GMO derivatives and

X-assess the need of monitoring and risk management of derivatives
accordingly to subsections I, II, III and IX.

§1 Licensing, registration, authorization and inspection agencies and
entities provided for in this article must observe biosafety aspects
concerning GMOs and GMO derivatives set forth in CTNBio preliminary
conclusive technical opinion.

§ 2  in case of disagreement with CTNBio's technical opinion,
registration and inspection agencies and entities may request a review
provided that science-based rationale is given under subsection XX of
article 11.

§ 3 The applicants for the authorization of activities provided for in
this Law must require the consideration of CTNBio, which will forward a
conclusive technical opinion to the agencies and entities set forth in
this article within the time frame set in regulation and, when is the
case, observing the CNBS decision.

§ 4 After favorable CTNBio opinion:

I- the Ministry of Agriculture must issue authorizations and
registrations, inspect products and activities related to GMOs and GMO
derivatives intended for animal use, agriculture, livestock,
agribusiness and related activities, according to the legislation in
force and the provisions in this Law;

II- the competent agency of the Ministry of Health must issue
authorizations, registrations and inspect products and activities
related to GMOs and GMO derivatives intended for human consumption,
pharmacological use and household and public sanitation purposes, among
other uses, according to the legislation in force and the provisions in
this Law;

III- the competent agency of the Ministry of Environment must issue
authorizations, registrations and licenses, besides inspecting products
and activities related to GMOs and GMO derivatives intended for release
into the ecosystems, according to the legislation in force and the
provisions in this Law;

IV-the Special Secretariat of Aquaculture and Fisheries must issue the
authorizations and registrations provided for in this article, related
to GMOs and GMO derivatives intended for fishery and aquaculture
purposes, according to the legislation in force and the provisions in
this Law;.

§ 5 Registration and inspection agencies and entities are granted
unlimited access to all information contained in applications submitted
to CTNBio.

CHAPTER VI

THE INTERNAL BIOSAFETY COMMISSION - CIBio

Art.15 Each institution applying genetic engineering techniques and
methods or using GMOs and GMO derivatives must implement a CIBio and
appoint one technician in charge of each specific project.

Art.16 The CIBio, within the institution where it was constituted, must:

I- keep workers and other members of the community that might be
affected by the activity posted on all health and safety issues and
procedures required in case of accidents;

II- implement preventive and inspection programs to assure that the
facilities under its responsibility are in compliance with biosafety
standards and rules defined by CTNBio and the regulation of this Law;

III-forward to CTNBio the documentation to be defined in the regulation
of this Law, intended for analysis, registration or authorization of the
competent body, when applicable:

IV-monitor each activity or on-going project regarding GMOs and GMO
derivatives;

V-notify CTNBio, registration and inspection agencies and entities and
labor organizations of the risks people are exposed, as well as any
accidents or incidents that may cause dissemination of biological
agents;

VI- investigate the occurrence of accidents and illnesses possibly
related to GMOs and GMO derivatives, forwarding its conclusions and
provisions to CTNBio.

CHAPTER VII

THE BIOSAFETY INFORMATION SYSTEM - SIB

Art.17 It is hereby established, within the scope of the Ministry of
Science and Technology, the Biosafety Information System - SIB, an
information management system for the analysis, authorization,
registration, monitoring and follow-up of activities related to GMOs and
GMO derivatives.

§1 Legal, regulatory and administrative provisions that change,
complement or produce any effects on biosafety legislation regarding
GMOs and GMO derivatives must be published in the SIB concurrently to
the date these provisions come into force.

§2 Registration and inspection agencies and entities must feed the SIB
with information related to the activities mentioned herein, processed
within the scope of their competencies.

CHAPTER VIII

CIVIL AND ADMINISTRATIVE LIABILITIES

Art.18 Without prejudice to the application of penalties provided for in
this Law, people held responsible for damage to the environment will be
jointly liable to compensation or full indemnification, regardless of
fault.

Art.19 Administrative infringement is understood as every action or
inaction that violates the rules provided for in this Law and other
relevant legal provisions.

Sole paragraph. Penalties for administrative infringements will be
imposed according to this Law, regardless of the precautionary action
demanding seizure of products, suspension of sales licensing and embargo
of activities, with the following sanctions:

I-warning;

II-fine;

III-seizure of GMOs and GMO derivatives;

IV-suspension of sales of GMOs and GMO derivatives;

V-embargo on the activity;

VI-partial or full quarantine of establishment, activity or business;

VII-suspension of registration, license or authorization;

VIII-cancellation of registration, license or authorization;

IX-removal or restriction on federal tax support and tax relief;

X-removal or suspension of credit lines available at federal credit
institutions;

XI-intervention in the establishment;

XII-five-year prohibition of contracts signed with the Administration.

Art.20 Registration and inspection agencies and entities shall define
the applicable criteria and amounts, in order to apply fines that vary
from R\$ 2,000.00 (two thousand reais) to R\$ 1,500,000.00 (one million
and five thousand reais), accordingly to the seriousness of the
infringement.

§ 1 Fines are cumulative and may be added to the other sanctions set
forth in this article.

§2 In case of recidivism, fines will double.

§3 In case of continuing infringement, characterized by continuation of
action or inaction after punishment, the corresponding penalty will be
applied daily until its cause ceases, without prejudice to immediate
suspension of the activity or quarantine of laboratory, institution or
company in charge.

§ 4 Fine collection resources will be allocated to federal laboratories
in charge of bioengineered food analysis, to registration and inspection
agencies and entities that had issued the fine and to CTNBio.

Art.21 Fines set forth in this Law will be applied by registration and
inspection agencies and entities of the Ministries of Agriculture,
Health, Environment and the Special Secretariat of Aquaculture and
Fisheries, according to their corresponding competencies.

§ 1 Inspection agencies and entities of the Administration may sign
agreements with States, the Federal District and Municipalities for the
inspection activities set forth in this Law, and may transfer to them
the revenues originating from fine collection.

§ 2 The inspecting authority will send CTNBio a copy of the notice of
violation.

§ 3 When violation constitutes a crime, misdemeanor or damage to the
Public Treasury or to consumers, the inspecting authority will represent
to the competent body in order to ascertain criminal and administrative
liabilities.

CHAPTER IX

FINAL AND TEMPORARY PROVISIONS

Art. 22 Food and food products intended for human or animal consumption
containing or being produced from genetically modified products must
display all relevant information on their labels, pursuant to the
regulation, without prejudice to compliance with the labeling
legislation in force.

§1 The information mentioned in this article must also be included in
the invoice, so that the product or ingredient will be accompanied by
such information at all stages of the productive chain.

§ 2 A regulation may establish a minimum quantity of GMOs that is waived
compliance with the provisions in this article.

Art.23 CTNBio shall review its normative decisions within a time frame
of 120 days in order to promote its adequacy for the provisions of this
Law.

Art.24 Institutions developing activities ruled by this Law on the date
of its publication must comply with its provisions within the time frame
of 120 days from the date the ruling decree was published, and present a
detailed report on the existing products and GMO on-going researches or
projects.

Art.25 CTNBio will count on an executive secretariat, and the Ministry
of Science and Technology shall provide it with technical and
administrative support.

Art.26.Art. 13 of Law n[o]{.underline} 8.974, of January 5, 1995, is
hereby in force added by the following subsection:

VI- construction, cultivation, production, transportation, transfer,
commercialization, import, export or storage of genetically modified
organism or GMO derivative, without authorization or in disagreement
with legal or regulatory determination.

Penalty - one to three years of confinement." (NR)

Art.27 Description of Code 20, Appendix VIII of Law n[o]{.underline}
6.938, of August 31, 1981, is hereby in force and will read as follows:

Code 20, Description: forestry; economical exploitation of wood or loose
wood and forest byproducts; importation or exportation of Brazilian wild
flora and fauna specimens; breeding and economical exploitation of the
exotic and wild fauna; use of natural genetic assets, exploitation of
live aquatic resources; introduction of exotic species, except for
genetic improvement of plants and agricultural purposes; introduction of
genetically modified species previously identified by the registration
and inspection agency or entity of the Ministry of Environment as
potentially harmful to the environment; use of the biological diversity
by the biotechnology in activities previously identified by the
registration and inspection agency and entity of the Ministry of
Environment as potentially harmful to the environment."

Art.28 This Law will be regulated within 90 days from the date of its
publication.

Art.29 This Law comes into force on the date of its publication.

Art.30 Law no. 8.974, of January 5, 1995, except art.13, and Provisional
Measure no. 2,191-9, of August 23, 2001 are hereby revoked.

OFFICE OF THE PRESIDENCY OF THE REPUBLIC