THIS IS TO CERTIFY THAT I, BUNNY GUSTAVE PERSIJN, OFFICIAL PUBLIC TRANSLATOR, DULY COMMISSIONED AND QUALIFIED ACCORDING TO THE OFFICIAL GAZETTE OF SEPTEMBER 20, 1972 – No. 8447 -, HAVE RECEIVED AND TRANSLATED TO THE BEST OF MY KNOWLEDGE AND BELIEF A DOCUMENT WITH THE FOLLOWING CONTENTS :

Ministry of Science and Technology

MINISTRY OF SCIENCE AND TECHNOLOGY

Executive Office

NATIONAL TECHNICAL BIO-SAFETY COMMISSION – CTNBio

PRIOR CONCLUSIVE TECHNICAL OPINION No. 530/2005

File No.: 01200.001690/2003-81

Applicant: Associação Avícola de Pernambuco – AVIPE

CNPJ: 00.404.394/0001-43

Address: Rua Rio de Janeiro, 22, Torrões, Recife, PE.

Subject: Request to Import Transgenic Corn

Prior Extract: 29/2003 Published in the D.O.U. 114, Section 3, page 5 of June 16, 2003

Meeting: 14th Extraordinary Meeting

Decision: Approved

CTNBio, upon reviewing the process requesting a Prior Conclusive Technical Opinion for the importation and commercialization of genetically modified corn for use in animal rations, has decided for its APPROVAL, and hereby authorizes the importation of the product according to the terms of this opinion.

AVIPE – Associação Avícola do Estado de Pernambuco, requests CTNBio to issue a Prior Conclusive Technical Opinion for the importation and commercialization of genetically modified corn for use in animal rations. The applicant requests authorization to import 400,000 (four hundred thousand) tons of genetically modified corn from Argentina, isolated or mixed, with genes CrylAB, CrylAC and Cry9C, which are insect resistant; pat and bar, which impart tolerance to the herbicide ammonium glufosinate; and mEPSPS, which grants tolerance to the herbicide glifosate. The product is to be imported monthly, in lots of 40,000 (forty thousand) tons, for distribution to chicken farmers in the states of Paraiba and Pernambuco, according to the provisions of Communiqué 113 of CTNBio and Technical Note ASBio/DDIV-MAPA.  

Communication 113 

The Chairperson of the National Technical Commission – CTNBio, using the legal power attributed to him and in response to the request from the Ministry of Agriculture and Food Supply – MA, based on paragraph 1, art. 8 of Law 8.974/95, informs that the said Commission, at an extraordinary meeting held during the period June 28-30, 2000, reviewed the said request and expressed its opinion in the form of Prior Conclusive Technical Opinion, as a result of the following administrative process: 

I – File No.: 01200.001874/2000-07

Communication: Official Letter DPC 33/2000

Interested Party: Ministry of Agriculture and Food Supply, Office of Agricultural and Animal Husbandry Protection

Subject: Request for a Conclusive Technical Opinion on the safety of genetically modified corn as animal feed.

Summary: The Ministry of Agriculture and Food Supply requested, through the process identified above, that the CTNBio issue on an urgent basis, as a result of the reduced corn crop in Brazil, a Conclusive Technical Opinion on the safety as animal feed of hybrid events of genetically modified corn kernels available for commercialization in the world market. This Conclusive Technical Opinion will enable the Ministry of Agriculture and Food Supply to decide on the importation of genetically modified corn kernels for use as animal ration. It is the legal incumbency of the supervisory agencies under the Ministry of Agriculture and Food Supply, within the realm of its competence and in accordance with the CTNBio´s Conclusive Technical Opinion, as provided by art. 7 of Law 8.974/95, "the issuance of authorization for entry into the country of any product containing GMOs or derivatives thereof." Furthermore, paragraph 1, art. 8 of the said Law provides that "products containing GMOs originating in other countries and to be used for commercialization or manufacturing may only be introduced in Brazil following the conclusive opinion of CTNBio and the authorization of the competent supervisory agency, taking into consideration technical opinions issued by other countries, when available."

Decision: The events of genetically modified corn, object of this Conclusive Technical Opinion, were classified in accordance with the phenotypical characteristics of the genetic modifications listed below:

Resistance to insects:

• Anti-lepidopterus toxin – cry1a(b) codifying gene
• Anti-lepidopterus toxin – cry1a(c) codifying gene
• Anti-lepidopterus toxin – cry9(c) codifying gene

Resistance to herbicides:

• Ammonium glufosinate deactivating enzyme – phosphinotricin acetyl transferase codifying genes (pat/bar)
• Gliphosate deactivating enzyme – 5-enolpiruvil-schiquimate-3phosphate-syntase codifying gene (mEPSPS)

The exam included the evaluation of food safety of events that accumulate on corn kernels, independently or in combination, the expression products of the genes mentioned. Analyses were based on Normative Instruction No. 3 (Norms for the Planned Release in the Environment of Genetically Modified Organisms), referring exclusively to the food safety aspects listed in Section L, which deals with genetically modified organisms consumed as food. That Section provides the necessary requisites sufficient to justify this Conclusive Technical Opinion. Those scientific analyses, also based on technical opinions of countries that authorized the commercial use of those products in their territories, enable the following conclusions:  

1. phosphinotricin acetyl transferase: genetically modified corns that accumulate in their kernels the expression products of pat/bar genes are similar in their chemical composition to non-transgenic corns. All events analyzed that express pat proved non-allergenic. The aminoacid sequences of the enzyme bear no similarity or identity with known alergens and toxins. The enzyme is highly labile to thermal and acid treatment, as well as to human and animal digestive fluids. Independently of the level of the protein accumulated on the of the genetically modified corns there is no evidence that the protein produces acute or allergenic toxic effects. 

2. 5-enolpiruvil-schiquimate-3-phosphate-syntase (mEPSPS): genetically modified corns that accumulate in their kernels the expression products of the mepsps gene are equivalent in the chemical composition to non-transgenic corns. The mEPSPS protein was the object of analysis by the CTNBio as to its allergenicity and digestibility. There is no evidence that the protein produces acute or allergenic toxic effects.

3. Bt-cry1a(b), cry1a(c), and cry9(c) toxins: genetically modified corns that accumulate in their kernels the expression products of the cry1a(b), cry1a(c), and cry9(c) genes are equivalent in the chemical composition to non-transgenic corns. Cry1a(b), cry1a(c), and cry9(c) proteins were obejct of analysis by the CTNBio as to their allergenicity and toxicity. There is no evidence that the protein produces acute or allergenic toxic effects. Additionally, Instruction 134 of June 1995 by the Health Surveillance Secretariat of the Ministry of Health, which provides guidance as to Syllabus B-01 Bacillus thurigiensis as a Class IV biological insecticide for farm use on different crops, including corn, classifies it as without restrictions for a maximum residues limit and safety intervals, in the case of formulae containing maximum concentrations of B. thurigiensis of 1,200 international toxic units per mg.   

In view of the above evidence, CTNBio´s Conclusive Technical Opinion is as follows: 

1. There is no indication that genetically modified corn kernels, commercialized worldwide, and the object of this opinion, have damaging effects when used as feed in animal rations. 

2. The unloading of genetically modified corn kernels, object of this opinion, must be carried out at units located in ports or border posts where there are International Agricultural Surveillance of the Ministry of Agriculture and Food Supply, following practices of careful contention including in those cases of sporadic and temporary storage at those locations. Transportation must be done in vehicles especially adapted to carry kernels and/or in other units that ensure careful contention, so as to prevent the dispersion of genetically modified corn kernels in the environment. 

3. Unloading, storage and transportation and processing of genetically modified corn kernels in ration processing and production units must be carried out under careful contention, as provided by national bio-safety legislation and in CTNBio´s specific Normative Instructions.

4. Only those derivative products that do not contain viable forms of genetically modified corn kernels and obtained after processing may be used to feed cattle.

5. The discarding of genetically modified corn kernels must be done in accordance with the provisions of Normative Instruction No. 17.

6. Accidental releases of genetically modified corn kernels in the environment must be immediately communicated to the CTNBio and to the authorities responsible for agricultural, environmental and health surveillance.

7. Importers, transporters and processors of genetically modified corn kernels dealt with in the Conclusive Technical Opinion are accountable for ensuring the safety of transporting and discarding the product, preventing the their inadvertent release in the environment, in accordance with the provisions of art. 23 of Law 8.974/95. 

Under the competence established in art. 1 D of Law 8.974/95, the Commission concluded that the request is in accordance with CTNBio´s norms and the pertinent legislation aimed at ensuring the biosafety of the environment, agriculture, and human and animal health.

Technical basis:

Brazil´s Northeastern region has been supplied with corn imported from Argentina, in addition to the Federal Government´s Food Supply Program. Reasons for importing the product are the reduction in the national corn crop and cost reduction, for logistic reasons.

Starting in June 2000, the Office of the Federal Public Attorney requested Federal Justice to prohibit the unloading of transgenic corn from 7 ships coming from Argentina, which were later released by court decision (170,000 tons). The judicial authorization has been obtained since based on the conclusive technical opinion of CTNBio (Communication 113 of June 30, 2000), which recommended the use of transgenic corn as animal feed, while establishing a series of demands related to the unloading, transportation, storage and processing.

Nevertheless, the Office of the Federal Public Attorney has been insisting on the application, in the State of Pernambuco, of the decision of the 6th Federal Court, Brasilia Judicial Section, on Public Civil action No. 1998.34.00.027682-0, demanding studies on environmental impact and labeling. 

Opinion GM-032 of the Federal General Attorney´s Office, which is part of Process No. 001.006775/01-78, emanating from the Ministry of Science and Technology on June 18, 2002 and published in the Union´s Oficial Gazette No. 149/02 of August 5, 2002, whcih was approved by His Excellency the President of the Republic on the same day, says in its Indent 7 that should the CTNBio "state that there is no risk to human, animal and plant life and health, as well as to the environment, resulting from activities and projects involving GMOs," any further administrative procedure is unnecessary and even vetoed if aimed at investigating the absence or re-evaluating that potential risk in any of the areas in which any other Public Administration agencies or bodies have jurisdiction.

At its 63rd ordinary meeting, held on October 23, 2002, the CTNBio, following an ample debate of the subject, concluded that there was no new scientific fact whatsoever that would justify a review of the events of genetically modified corn approved for the exclusive purpose of use as animal feed.  

During the long period of time between the AVIPE request and its analysis (May 2003 to March 2005), new transgenic events of corn were introduced in the world market. In the case of Argentina, there was authorization for the planting and commercialization of the transgenic event of MON NK603 corn containing gene CP4-EPSPS that confers tolerance to gliphosphate. Gene CP4-EPSPS has a long history of use in other species of transgenic plants (soybeans, cotton) and is naturally present in foods derived from plants and microorganisms.

Furthermore, during that period, the Bayer Company, holder of the transgenic corn event that contains gene Cry9(c) requested its cancellation in the world market.

In view of the above, we hereby authorize the importation of genetically modified corn from Argentina (320,000 tons), excluding event Cry9(c) and including event NK603, for use exclusively in animal ration, as requested by Associação Avícola de Pernambuco, provided that the bio-safety required by CTNBio’s Communiqué 113/00 are complied with, in addition to the specific requirements and/or additional procedures adopted by the area of competence of the supervisory agency, namely, the Ministry of Agriculture, Animal Husbandry and Supply – MAPA, Technical Note ASBio/DDIV No. 07/2003.

Any further requests of the same nature that involve the same events contained in this prior conclusive technical opinion are hereby exempted from a new evaluation by the CTNBio.

That GMO must be used only for the purpose specified in the prior conclusive technical opinion.

Provided that the recommendations and the bio-safety measures contained herein, the activity is not potentially a significant cause of environmental degradation or harmful to human health. 

Jorge Almeida Guimarães

Chairperson - CTNBio

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