9-Misc: USDA update of biotech issues in Brazil
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-------------------------------- GENET-news --------------------------------
TITLE: Update of Biotech Issues in Brazil
SOURCE: US Department of Agriculture, Foreign Agricultural Service
GAIN Report #BR1623
DATE: November 7, 2001
------------------ archive: http://www.gene.ch/genet.html ------------------
Global Agriculture Information Network
Voluntary Report - public distribution
GAIN Report #BR1623
Update of Biotech Issues in Brazil
Approved by: William W. Westman, Agricultural Counselor
U.S. Embassy Prepared by: Joao F. Silva, Agricultural Specialist
Report Highlights: Commercial production and trade of genetically modified
organisms (GMOs) in Brazil remains prohibited pending a final decision by
the Brazilian Federal Court whether the Federal Government has the
authority to approve the commercial release of these products. The
Government of Brazil issued a Decree establishing a labeling requirement
and tolerance limits for packaged food products containing GMOs to be
effective December 31, 2001. However, the issue is not completely resolved
because the National Congress continues to debate more stringent labeling
Includes PSD changes: No Includes
Trade Matrix: No Unscheduled
Report Brasilia [BR1], BR
TABLE OF CONTENTS EXECUTIVE SUMMARY ...................... Page 1 of 7
THE COURT BATTLE OVER RRS ................................ Page 1 of 7
NEW DIRECTIVE ON GMO FOOD LABELING ....................... Page 2 of 7
THE CONGRESSIONAL DEBATE ON GENETICALLY MODIFIED ORGANISMS Page 2 of 7
PUBLIC PERCEPTION ........................................ Page 3 of 7
ANNEX .................................................... Page 4 of 7
Translation of Decree Number3,871 (labeling) ............. Page 4 of 7
Abbreviations/Glossary ................................... Page 6 of 7
Commercial production and trade of genetically modified organisms (GMOs) in
Brazil remains prohibited, pending a final decision by the Regional Federal
Court (TRF) on the Round Up Ready Soybean (RRS) court case. This legal, or
"white" moratorium, has placed a hold on the sale of RRS seeds for the 2001/
02 soybean crop (planted October/November of 2001, and harvested March/
April 2002). Nationwide controversy on the issue continues among the
GovernmentŐs executive, judiciary, and legislative branches, the scientific
community, and consumer groups, notably the Consumer Protection Institute
(IDEC) and Greenpeace. The federal government issued Decree Number 3,871,
establishing a labeling requirement and tolerance limits for packaged food
products containing genetically modified organisms, which will enter into
force on December 31, 2001. In addition to this court battle, the National
Congress is expected to release, by mid-November, a final report on the
issue, which combines 18 draft bills that have been introduced during the
past four years.
Note: This report updates GAIN Report Number BR 1601, dated January 17,
THE COURT BATTLE OVER RRS
The Provisional Measure (MP) Number 2,137 issued by the President of
Brazil, and published on December 28, 2000 in BrazilŐs Federal Register
(Diario Oficial), took effect immediately, but the MP has not been approved
by the National Congress. The MP 2,137 redefined the role of the National
Technical Commission on Biosafety (CTNBio) by providing the Commission with
the authority to evaluate and authorize the production and sale of GMOs in
Brazil. MP 2,137 was the federal governmentŐs response to the rule issued
by the Regional Federal Court (TRF) in Brasilia, which upheld the decision
of federal judge Prudente declaring unconstitutional clause XIV of Article
Two of Law 1,752/95 during MonsantoŐs appeal of its court case. As result,
PrudenteŐs decision established that CTNBio did not have the authority to
waive environmental impact studies and reports (EIA-RIMA) for RRS seeds.
The Brazilian Consumer Protection Institute (IDEC) and Greenpeace of Brazil
filed an injunction against MP 2,137 and obtained a favorable ruling issued
by the 14 th Circuit of the Regional Federal Court (TRF). This rule is
still in place, but a surprising rule issued by Judge Joao B. Moreira, of
the 5 th Circuit of the TRF, changed provisions of the previous rule by
authorizing CTNBio to evaluate the biosafety of cultivars that receive the
gene, resistant to insects, which is derived from the bacteria Bacillus
thurigienis (Bt). However, Judge Moreira maintained the section of the rule
which prohibited sale of genetically modified seeds resistant to
agricultural chemicals (pesticides/herbicides) that were not covered by a
special temporary registration (RET) issued by the Ministry of Agriculture,
Livestock, and Food Supply (MAPA). The RET is based on Decree Number 98,816/
90. Although a RET for RRS seeds from MAPA is required, the other two
Ministries involved (Health and Environment) have not yet ruled on RRS
seeds for toxicity and environmental impact.
The important point in JudgeŐs Moreira decision in favor of CTNBio is that
he was the first judge to use MP 2,137/00 as the basis to support his
decision. Judge MoreiraŐs opinion could support the GovernmentŐs approval
of RRS seeds for commercial sales. A final ruling on this case is expected
by mid December 2001.
NEW DIRECTIVE ON GMO FOOD LABELING
Brazilian President Cardoso signed Decree Number 3,871 on July 18, 2001
(published on July 19, 2001 in BrazilŐs Federal Register (Diario Oficial)
which established a four-percent tolerance limit in packaged food products
containing genetically modified organisms. This Decree applies to all
genetically modified packaged food products that have received final
technical approval from CTNBio. This Decree also creates an Inter-
ministerial Commission to analyze and review the provisions of the Decree
and the methodology to detect the presence of genetically modified
organisms. The Decree does not enter into force until December 31, 2001.
The Public Prosecution Service (MP) and the Brazilian Institute of Consumer
Defense (IDEC) filed an injunction against Decree 3,781/01 alleging that
the four-percent tolerance is contrary to the Brazilian Consumer Code (law
Number 8,078/90), principally Article 6, item III, of such Law. Judge Isa
P. Costa of the 13 th Circuit of the Federal Justice Court in Brasilia
denied the request for an injunction requested by the MP and IDEC.
However, the labeling controversy is far from being resolved because the
Brazilian Congress continues to debate the issue. This may explain why the
Brazilian government has not notified the WTO regarding Decree Number 3,781/
01. The other explanation is that, since the regulation does not enter into
force until the end of the year, the government has time to notify the WTO
before December 31, 2001.
THE CONGRESSIONAL DEBATE ON GENETICALLY MODIFIED ORGANISMS
The Brazilian House of Representatives in the National Congress has been
debating the GMO issue in Brazil for the past 4 years without reaching a
consensus. However, the Special Commission of the House on GMOs is expected
to release by mid-November 2001, a final report based on public hearings
conducted by the Commission.
This report is based on the draft bill Number 2,905 of 1997, the first law
to be introduced in the House about the issue, which establishes conditions
for marketing GMOs in Brazil. The final report is expected to include 18
other draft bills related to the issue that were introduced in the House
during these past four years.
There is another draft of Legislative Decree Number 1,089 of 2001 which is
being considered separately by members of the House to suspend the
provisions of Decree 3,871/01 issued by President Cardoso on food labeling.
In addition to the House, there are three other draft bills in the Senate:
a) PLS 118/99 (mandatory labeling of GMO products), b) PLS216/99 (which
prohibits production and sale of GMOs in Brazil for five years, and c) PLS
271/00 (which suspends production and sale of GMOs in Brazil until 2004).
Finally, there are two Constitutional Amendments in the National Congress
related to GMOs: a) 159/99 (by which farms that produce GMO crops can be
expropriated for purposes of Agrarian Reform), and 237/00 (which authorizes
the Federal Government to regulate GMO products, thus preventing Brazilian
states from creating their own laws and regulations).
Because of the Presidential elections in 2002, it is uncertain whether
these bills will actually become laws in the National Congress, because the
GMO issue in Brazil is not only emotional, but increasingly ideological.
For example, the Landless Movement in Brazil (MST) has destroyed research
fields of RRS because of their antagonism against multinational companies.
These groups also allege that biotechnology will be damaging to small
farmers because of increased dependence on this technology and the high
cost of GMO seed.
At the request of Greenpeace of Brazil, the most important opinion survey
institute in Brazil (IBOPE), conducted a national survey, from July 18-24,
2001, about the public acceptance of GMOs in Brazil. The results of the
survey indicate that 74 percent of the Brazilian population prefers
conventional food products rather than those produced with GMOs because
they donŐt have sufficient information about the possible health risks and
environmental impact. Also, 67 percent of the people interviewed believe
that planting of GMO crops should be prohibited.
According to the survey, 31 percent of the people interviewed knew about
GMOS, and 91 percent defended specific labeling for GMOs. People living in
the South and Southeast regions of Brazil were more aware of GMOs than
those Brazilians living in the Northeast, Center-West and Northern regions
of the country.
Greenpeace is using the results of this survey to increase public awareness
of its campaign of "Brazil free of GMOs". The Brazilian biotech companies
recently founded the "Biotechnology Information Council" (CIB, in
Portuguese). The purpose of CIB is to produce and release reliable
scientific information on GMOs to the general public.
There is no reliable survey of Brazilian farmersŐ perceptions of GMOs.
However, most leaders of farm organizations support the approval of GMOs in
Brazil to remain competitive with Argentine and American farmers. Trade
analysts estimate 2.0 million hectares will be planted with GMO crops
during the 2001/02 marketing year, mostly in the South and Southeast
regions of the country.
Most traders of agricultural products in Brazil advocate the planting of
both GMOs and non-GMOs in Brazil. According to some trade analysts, there
is a difference in price of US$20 per metric ton in the world market in
favor of Brazilian soybean meal compared its Argentine counterpart. Most
Brazilian traders, however, are against "Identity Preservation" (IP)
because this would increase the cost of Brazilian beans and could erode
BrazilŐs competitive position in the world market. Currently, the Ministry
of Agriculture, Livestock, and Food Supply (MAPA) declares that planting of
GMOs is prohibited in Brazil, and this information has satisfied import
requirements in the European Union. However, traders have been alerted they
must meet more stringent certification standards in the European and
Chinese markets in 2002.
The greater interest in traceability has increased investments in
inspection and certification laboratories to test for Non-GMO products. One
of the companies has increased the frequency of DNA samples from soybean
shipments to 130 samples per month because of increased traces of GMOs
produced in Southern Brazil.
Translation of Decree Number 3,871 (labeling)
Decree Number 3,871 of July 18, 2001 Published in the Diario Oficial on
July 19, 2001
Regulates the labeling of packaged foods that have been or are produced
with genetically modified organisms, and provides other measures.
The President of the Republic, under the authority conferred upon him by
article 84, item IV, of the Constitution.
Article One. Packaged foods for human consumption, that contain or will be
produced with genetically modified organisms, with a content above a 4
(four) percent limit for the product, must be labeled to provide this
information, without prejudice, to comply with the regulations on biosafety
and the regulations applied to foods in general or other supplemental rules
of the respective regulatory and inspection agencies.
Paragraph One. With reference to Article One, the labeling must show one of
the following statements: "(type of product) genetically modified" or
"contains (type of ingredient) genetically modified".
Paragraph Two. The information on the label must be in the Portuguese
language, with characters of size and format that make them clear and
Paragraph Three. For the purpose of this Decree, the limit foreseen in
Article One establishes the tolerance level for the unintentional presence
of genetically modified organisms, in terms of percentage by weight or
volume, in one lot of the same product obtained by conventional techniques.
Paragraph Four. For foods consisting of more than one ingredient, the
levels of tolerance established will be applied to each one of the
ingredients considered separately in the composition of the food.
Article Two. This Decree applies to all products genetically modified that
have received final technical approval from the National Technical
Commission on Biosafety (CTNBio), relative to the safety of the genetically
modified organism, for commercial purposes, as well as the respective
authorization for sale by the responsible agency.
Article Three. Creation of Interministerial Commission with the legal
responsibility to propose the review, complementing and updating the
dispositions of this Decree, as well as the methodology to detect the
presence of genetically modified organisms, taking into consideration the
most recent scientific and technological procedures.
Paragraph One. The Commission will be composed of representatives of the
Ministries of Justice, Agriculture and Food Supply, Development, Industry
and Foreign Trade, Health, and Science and Technology, nominated by the
respective heads of each Ministry, and approved by the Minister of Science
Paragraph Two. The Presidency and the Secretariat of the Commission will be
determined by a rotation system among the Ministries named above for a
period of 12 (twelve) months, beginning with the Ministry of Justice,
through the Department of Consumer Protection and Defense (DPDC), Office of
Economic Law (SDE).
Paragraph Three. Participation in the Commission, as collaborators, will
include professionals and representatives of the public agencies and
entities whose functions are related to the issues of importance to them.
Paragraph Four. The Commission will adopt a work plan that allows the
participation of the public through public consultations or other measures
that take into consideration the main interest groups involved.
Paragraph Five. The Commission will be installed within a maximum of 60
(sixty) days, beginning on the date of the publication of this Decree.
Article Four. The Ministries represented in the Commission, and in their
respective areas of influence, will be responsible for the review and
control of information furnished by consumers.
Article Five. This Decree will enter into force on December 31, 2001.
Brasilia, July 18, 2001; 180 th of the Independence and 113 th of the
FERNANDO HENRIQUE CARDOSO (President)
Jose Gregori (Minister of Justice)
Marcus Vinicius Pratini de Moraes (Minister of Agriculture and Food Supply)
Jose Serra (Minister of Health)
Benjamim Benzaquen Sicsu (Acting Minister of the Development, Industry and
Ronaldo Mota Sardenberg (Minister of Science and Technology)
ABIA - Brazilian Association of Food Industries, based in Sao Paulo.
ANVISA - Agency for Sanitary Surveillance, Ministry of Health.
CIB - Conselho de Informacoes de Biotecnologia (Biotechnology Information
Council). Non-profit private organization formed by major multinational
biotech companies, Brazilian Association of Seed Producers, Brazilian
cooperatives, and the Rural Brazilian Society.
CTNBio - National Technical Commission on Biosafety, created by Law 8,974
of January 5, 1995 which provides the legal framework and sets the
standards and means of production, importation, manipulation,
transportation, marketing, and consumption of genetically modified
organisms. Presidential Decree Number 1,752 of December 20, 1995 also
provides the regulatory framework under which CTNBio operates. In addition,
Provisional Measure 2,137 of December 28, 2000 added and altered some
clauses of Law 8,974/95 to clearly define the role of CTNBIO, which is
under the authority of the Ministry of Science and Technology.
DJ - Decisao Judicial. Sentence. Final Decision Rule.
DO - Diario Oficial. Official Gazette (BrazilŐs equivalent of the United
States Federal Register). Any law or regulation to become effective in
Brazil must be published in the Diario Oficial.
EC - Emenda Constitucional (Constitutional Amendment).
EIA-RIMA - Environmental Impact Study and Report of the Impact on the
GMOs - Genetically Modified Organisms
IDEC - Brazilian Consumer Protection Institute, based in Sao Paulo.
IP - Preservacao de Identidade (Identity Preservation)
Liminar - Injunction. Temporary Restraining Order. Writ.
MP - Medida Provisoria. Provisional Measure. It is an act by the President,
under the powers and privileges granted to him by the Brazilian
Constitution . It has the power of a law, until Congress gives final
approval, and then, becomes a law.
MPF - Ministerio Publico Federal - Public Prosecution Service. Independent
federal body with the primary role of providing citizens with a secure
means to fight in the courts when the law is violated, or there is abuse of
MAPA - Ministry of Agriculture, Livestock, and Food Supply
MCT - Ministry of Science and Technology
MMA - Ministry of the Environment
MST - Movimento dos Trabalhadores Sem-Terra (Landless Workers Movement)
Parecer - Opinion. Judgment. View. Legal Opinion
PC - Parecer Conclusivo - Conclusive View.
Portaria - Directive (Administrative rule)
Procurador da Republica - Attorney General
Promotor - Prosecuting Attorney; Public Prosecutor
RET - Special Temporary Registration. RET is issued by the Ministry of
Agriculture, Livestock, and Food Supply (MAPA) for agricultural chemicals
(pesticides/herbicide), based on Decree Number 98,816/90. A company
(Brazilian or foreign) that needs to register a pesticide or herbicide in
Brazil files a request with the MAPA, which sends the request to the
Ministry of Health (for their opinion on toxicity), and to the Ministry of
Environment (for their opinion on environmental impact). The request, then
returns to MAPA for final approval and issuance of the final registry
TFR - Federal Court of Appeals
TRF - Regional Federal Court
STF - Supreme Court
STJ - Supreme Court of Justice
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