This text does not substitute the original publishe d in the Federal Official Gazette 
 COMISSÃO TÉCNICA NACIONAL 
DE BIOSSEGURANÇA 
[National Technical Biosafety Committee] 
 
NORMATIVE RESOLUTION No. 5, of March 12, 2008 
 
 
         The  Comissão Técnica Nacional de Biossegurança – CTNBi o  [National Technical Biosafety 
Committee], pursuant to its legal and regulatory du ties, in compliance with the provisions of 
subsection II, article 14 of Law No. 11105, dated M arch 24, 2005, hereby resolves: 
 
         CHAPTER I 
 
         PRELIMINARY AND GENERAL PROVISIONS 
        
Article 1. The commercial release of Genetically Mo dified Organisms - GMO and its 
derivates shall comply with the rules set forth in this Normative Resolution, as well as the 
authorization in written issued by the CTNBio, in c ompliance with all conditions imposed in the 
aforementioned authorization. 
 
         Sole Paragraph. The CTNBio authorization d oes not exempt the applicant from complying 
with other legal obligations in the country applica ble to the subject matter of the application. 
 
         Article 2. That derivative which GMO has b een approved by the CTNBio shall not be 
submitted to assessment and issuance of technical o pinion by this latter. 
 
         Article 3. The GMO with the same genetic c onstruction as that used in GMO of the same 
specie with technical opinion favorable to the comm ercial release in Brazil, shall be submitted to 
simplified analysis, aiming at its release, at the CTNBio's discretion. 
 
         Article 4. At the CTNBio's discretion, sub ject to consultation, the assessment and issuance 
of a new technical opinion may be dismissed for GMO s that comprise more than one event, 
combined by means of classic genetic breeding and w hich have already been previously 
approved for commercial release by CTNBio. 
 
         Article 5. It shall not be included in the  category of GMO derivate the pure substance, 
chemically defined, obtained by means of biologic p rocess and which do not contain GMO, 
heterologous protein or recombinant DNA. 
 
         Sole Paragraph. The pure protein, chemical ly defined, shall not be considered heterologous 
protein, even if produced from GMOs. 
 
         Article 6. For the purpose of this Normati ve Resolution it shall be considered: 
          I - risk assessment: combination of proce dures or methods, by means of which it is 
assessed, case by case, the potential effects of th e commercial release of the GMO and its 
derivates on the environment and the human and anim al health.  
         II - organism: every biologic entity able to reproduce or transfer genetic material, includin g 
virus and other classes that may be known;   
         III - Genetically Modified Organism - GMO:  the organism whose which genetic material - 
DNA/RNA has been modified by any genetic engineerin g technique; 
         IV - GMO derivate: product obtained from a  GMO and which has no autonomous capacity 
of replication or which does not have a viable form  of GMO; 
         V - applicant: Any legal entity with a Bio safety Quality Certificate - CQB that proposes to 
carry out commercial release, in compliance with th is Normative Resolution; 
         VI - legally responsible person: an indivi dual responsible for the development of the 
commercial release, pursuant to CTNBio's rules. This text does not substitute the original publishe d in the Federal Official Gazette 
          VII - post-commercial release monitoring: a set of processes to monitor the effects of the 
commercial release of the GMO and its derivates on the environment and on human and animal 
health; 
         VIII - risk: probability of occurrence of adverse effect. 
 
         Article 7. The authorization for commercia l release of a GMO or derivate maybe suspended 
or revoked by the CTNBio, at any time, in case adve rse effects on the environment or on human 
and animal health are detected, provenly arising fr om the results of the post-commercial release 
monitoring or before proof of new scientific knowle dge. 
 
         Article 8. The legally responsible person of the applicant entity and the CIBio shall be in 
charge of ensuring the full compliance with of this  Normative Resolution. 
  
        Article 9. Whenever a commercial release of  a GMO and its derivates is authorized, the 
applicant’s legally responsible person must communi cate any non-compliance with the conditions 
established in the CTNBio's technical decision.  This text does not substitute the original publishe d in the Federal Official Gazette 
          CHAPTER II 
 
         THE PROPOSAL 
 
         Article 10. The applicant shall, after CIB io’s approval, submit the proposal to the CTNBio, 
along with: 
         I – application for commercial release dat ed and signed by the legally responsible person; 
         II – copy of CIBio’s technical opinion on the proposal; 
         III – statement on the accuracy of the inf ormation provided signed by the legally responsible  
person; 
         IV – executive summary, including the abst ract of the proposal; 
         V – information related to the GMO, pursua nt to the Annex II of this Normative Resolution; 
         VI – risk assessment to human and animal h ealth, in compliance with the Annex III of this 
Normative Resolution; 
         VII – risk assessment to the environment, in compliance with the Annex IV of this Normative 
Resolution; 
         VIII – monitoring plan in compliance with the Annex I of this Normative Resolution. 
         Sole Paragraph. The proposal shall be subm itted in Portuguese, together with twenty 
printed copies and one digital copy. 
 
         Article 11. After the receipt of the propo sal for commercial release, the CTNBio Executive 
Office shall inform the applicant if the documentat ion is complete within a thirty-day term 
maximum. 
 
         Article 12. The commercial release proposa l filed at the CTNBio Executive Office shall have 
its previous abstract published in the Federal Offi cial Gazette after registered and duly 
documented. 
 
         Article 13. The CTNBio shall carry out the  public consultation of the proposal for commercial  
release, for  30 days from  the publication of the previous abstract in the Federal Official Gazette. 
In this sense, the relevant information shall be av ailable in the SIB, in the CTNBio portal and at its  
Executive Office. 
 
         Article 14. The CTNBio may carry out a pub lic hearing required by one of its members of by 
a party provenly interested in the subject matter o f the decision and approved by absolute 
majority, assuring the participation of the civil s ociety. 
 
         §1 CTNBio shall publish in the Federal Off icial Gazette, in the SIB and in its electronic 
webpage, no less than thirty (30) days in advance, the call notice for the public hearing, including 
in such notice the subject matter, date, and time a nd venue where the public hearing will be held. 
         §2 The public hearing shall be coordinated  by the President of CTNBio who, after exposure 
of the subject matter of the hearing, will open the  discussions with those interested present. 
         §3 After the conclusion of the public hear ing, the manifests, opinions, suggestion and 
documents shall be available to those interested at  the CTNBio Executive Office.  
         §4 For the purposes of this article, an in terested party shall be the applicant of the proces s 
or legal entity, which corporate purpose is related  to the areas set forth in the main clause and in 
subsections III, VII and VIII of article 3 of the C TNBio internal proceedings.  
         §5 After holding the public hearing, CTNBi o shall include the relevant biosafety subject 
matter in its meeting agenda, with the objective of  discussing and considering the remarks and 
questions received. 
 
         Article 15. The proposal shall be assessed  by all the CTNBio Permanent Sectorial Sub-
commissions, which may request technical opinions f rom ad hoc consultants, whenever needed. 
 This text does not substitute the original publishe d in the Federal Official Gazette 
          Sole Paragraph. It shall be simultaneously  guaranteed, a ninety-(90)-day term to each one 
of the sub-commissions for analysis and preparation  of the reports, and such term may be 
extended, for an equal period, maximum, as per CTNB io plenary decision. 
 
         Article 16. CTNBio may require supplementa ry information and if it become necessary to 
submit new documents, the applicant shall respond w ithin a ninety-(90)-day term maximum, as of 
the date of receipt of the mail send to it, subject  to filing of the process. 
 
         Sole Paragraph. The counting of the term s et forth in the article 14 hereof shall be 
adjourned during the compliance with the  diligence s. 
 
         Article 17. The reporters of the technical  opinions of the sub-commissions and of the 
plenary shall consider, besides the applicants’ rep orts, the existing scientific literature, as well a s 
studies and other documents filed in public hearing s or in the CTNBio, on prior to fifteen days 
after the public hearing is held, including the occ asional opposing vote, pursuant to article 34 of 
CTNBio By-laws. 
 
         Article 18. After the publication of the f avorable technical decision on the biosafety of the  
proposal for commercial release of GMO and its deri vates, CTNBio shall send copy of the 
process, within ten (10) business days, to the regi stration and inspection agencies and entities, 
for the accomplishment of their duties. 
 
 
 
 
         
CHAPTER III 
 
         RISK ASSESSMENT 
 
         Article 19. The risk assessment, as define d in article 4, subsection I, hereof, shall identif y 
and assess the potential adverse effects of the GMO  and its derivates on human and animal 
health, on the environment and on vegetables, keepi ng the transparency, the scientific method 
and the precautionary principle. 
 
         Article 20. It shall be included in the re spective commercial release proposals, the 
information required in Annexes I, II, III and IV o f this Normative Resolution, duly supported by 
scientific reports of the results achieved during t he planned environmental releases or from other 
studies, without prejudice to other pieces of infor mation deemed relevant by the CTNBio. 
         § 1 Having any doubt about the answer prov ided to one of the questions stated in the 
annexes of this Normative Resolution, the nature of  the doubt shall be clarified. 
         § 2 The existence of risk related to comme rcial release shall be declared, making explicit 
the prevention and mitigation measures. 
 
         Article 21. Those cases not considered for  in this Normative Resolution shall be settled by 
the CTNBio. 
 
         Article 22. Companies that have filed thei r commercial release requests with CTNBio before 
this Normative Resolution came into force shall sub mit, within sixty (60) days from its publication, 
supplementary information or new data it deems nece ssary, so as to adapt its request to the 
conditions set forth in this Normative Resolution, and a new filing request shall not be deemed 
necessary.  
 
         Sole paragraph. If the sixty (60)-day term  is not enough for occasional supplementation of 
such information, the applicant shall request addit ional deadline to CTNBio with its due 
justifications.  This text does not substitute the original publishe d in the Federal Official Gazette 
  
         Article 23. CTNBio's Normative Instruction  No. 20, of December 20, 2001, is revoked.  
 
         Article 24. This Normative Resolution shal l come into force as of the date of its publication . 
 
WALTER COLLI 
President of CTNBio 
 
 
ANNEX I 
 
POST-COMMERCIAL RELEASE MONITORING 
 
         1. The applicant shall submit to CTNBio, f or evaluation and approval, a post-commercial 
release monitoring plan which shall be analyzed cas e by case. 
         2. The applicant shall submit the monitori ng plan along with the commercial release request 
and shall have a period of thirty (30) days to adju st its monitoring plan proposal for CTNBio’s 
appraisal and approval after the publication of fav orable technical decision for commercial use. 
         3. The monitoring shall be carried out by the applicant aiming at following the effects 
deriving from the commercial release of the GMO and  derivates onto the environment and human 
and animal health. 
         4. The monitoring shall be carried out in strict compliance with the precautionary principle,  
transparence and scientific independence. 
         5. The monitoring shall have as guideline the use of international acknowledged scientific 
methodology and the use of experimental designs app ropriate to the inferences to be made.  
         6. The monitoring plan, once approved, sha ll be sent by CTNBio to the registration and 
monitoring agencies and entities for acknowledgemen t and follow-up. 
         7. The applicant shall submit an annual re port for a period of at least five (5) years on the  
post-commercial release monitoring and a final repo rt after the end of the monitoring, which shall 
be forwarded to the inspection agencies.  
 
 
  
ANNEX II 
 
GMO-RELATED INFORMATION 
 
         Inform: 
         1. Identification of the genetic transform ation event, objective and use of GMO and its 
derivates; 
         2. Taxonomic classification, from the fami ly to the most detailed level of the organism to be  
released, including, when appropriate, subspecies, cultivar, pathovar, lineage and serotype;  
         3. Introduced genes, organisms of origin a nd their specific functions; 
         4. Vector used and its spectrum of hosts;  
         5. Genetic map used in the transformation process (transgene/vector), indicating the 
regions that specify function - promoters, cis regu latory elements, selection marker genes and 
origin of replication;  
         6. Summary of the constructions used to ob tain the GMO; 
         7. Risk classification of the Genetically Modified Organism in compliance with Normative 
Resolution No. 2, of November 27, 2006; 
         8. Methods used to obtain the genetic modi fication;  
         9. Molecular characterization of the inser t into the receptor organism, providing information  
related to: (1) number of copies inserted; (2) loca lization of the insert into the genome, when 
applicable; (3) gene flanking sequences; (4) nucleo tide sequence of transgene insert in the GMO, 
indicating the regulatory elements - promoters, cis  regulatory elements, poliadenilation sites, 
introns and exons and region where transcription en ds; This text does not substitute the original publishe d in the Federal Official Gazette 
          10. The expression product from the insert ed gene in the receptor organism, described in 
details;  
         11. General and specific GMO detection tec hniques, presenting corresponding 
methodology; 
         12. Inserted genes’ genetic inheritance pr ofile  
         13. Description of pleiotropic and epistat ic effects of the inserted genes, when noticed;  
         14. Degree of genotypic stability, specify ing the methodology used and number of assessed 
generations; 
         15. Existence of interactions with adverse  effects, when two or more genes are inserted in 
the same GMO by DNA recombining techniques and thei r possible consequences;  
         16. Genetic modifications into the GMO tha t may alter its reproduction, survival, 
dissemination or capacity of transference of insert ed genes to other organisms;  
 
 
 
ANNEX III 
 
HUMAN AND ANIMAL HEALTH RISK ASSESSMENT 
 
(A) Organisms consumed as food 
 
Inform: 
         1. The background of the use in food, in B razil and in other countries of the parental or 
donor organism, indicating the consumption level, t he processing previous to consumption and 
animal species feeding from these organisms; 
         2. Possible effects on human and animal fo od chain by ingesting the GMO and their 
derivatives; 
         3. Difference in the chemical and nutritio nal composition between food derived from 
genetically modified vegetables and non-modified ve getables, in natura, or after processing, and 
the occurrence of substantial equivalence between t he GMO and its parental organism;  
         4. Changes on animal performance, when fed  with genetically modified organisms or any of 
its parts, in natura, or after processing, even pro viding the results of the nutritional assessment on  
experimental animals for two generations, indicatin g the species used in the tests, length of 
experiments, physiologic and morphologic variations  observed in relation to the control-groups 
and nutritional quality alterations, if applicable;  
         5. Stability to digestion and to industria l processing of the protein specified by the transg ene 
based on physic-chemical properties;  
         6. The possible deleterious effects of the  GMO in pregnant animals and their teratogenetic 
potential; 
         7. The conclusions of the immunologic and histological analyses of relevant tissues, 
especially from the digestive tract; 
         8. The Ability of the GMO to produce toxin s or metabolites that cause adverse conditions to 
consumers, either animal or human ones, reporting e xperimental evidences;  
         9. Toxicological and pharmacological asses sment carried out in experimental animals, 
describing results; 
         10. Similarity of the GMO expression produ cts with know allergens, reporting on possible 
allergic reactions identified after GMO ingestion i n the assessment carried out in experimental 
animals, describing the results. 
         
(B) Microorganisms used as vaccine 
 
Inform: 
         1. Disease to be controlled with the use o f vaccine and host species, indicating organs 
colonized by the vaccine, if alive, and the parenta l organism host species, from which the vaccine 
was created;  This text does not substitute the original publishe d in the Federal Official Gazette 
          2. Immunity level and length produced in t he host species after vaccination with the GMO, 
informing how long one can detect the GMO in vaccin ated animals or in their excrements, 
providing experimental evidence;  
         3. Possible dissemination of vaccinal orga nism of vaccinated animals to other unvaccinated 
ones or to other species, including human beings, i nforming the mechanisms and frequency of 
such event with experimental data; 
         4. Details, if applicable, of host suscept ibility to the vaccinal organism affected by the 
general state (for instance, immunosuppression or c oncomitance of other disease) or by 
medicative treatment or others;  
         5. Experimental evidence that the vaccinal  organism genetic material was entirely or 
partially integrated to the genome of the vaccinate d host cells;  
         6. Possibility of a viral vaccine to retur n to its wild condition by recombination or 
complementation with other intracellular viruses, p roviding experimental results if such 
phenomenon takes place;  
         7. Possible deleterious effects of vaccine s in pregnant animals and their teratogenetic 
potential, describing the efficiency and innocuousn ess tests carried out;  
         8. Possible interferences of the vaccinal organism in the efficiency of other vaccination or in 
subsequent immunizations against other diseases. 
 
 
ANNEX IV 
 
ENVIRONMENT RISK ASSESSMENT 
 
(A) PLANTS 
 
Inform: 
         1. Area of natural occurrence of the GMO p arental organism, its ancestors and wild 
relatives – origin and genetic diversity centers – and ancestral or wild relative species, existing in  
some Brazilian ecosystem of the same genera of the non-modified parental species.  
         2. Cultivation and use of parental organis m background in terms of safety to the 
environment, for human and animal consumption, info rming the possibility of introgressive 
hybridization with sexually compatible species and possible selective advantage of the transgene;  
         3. Possible effects on relevant indicator organisms (symbionts, predators, pollinators, 
parasites or competitors to the GMO) in ecosystems where one intends to carry out its cultivation, 
in comparison to the GMO parental organism in a con ventional production system; 
         4. Dispersion ability of the GMO propagati on and reproduction structures besides the 
cultivation areas and the mechanisms of its dispers ion in the air, water and soil, providing 
information on the pollen viability and indicating potential pollination agents and their geographic 
distribution in Brazil;  
         5. Possibility of forming long term reprod uction structures in the parental organism; 
         6. Frequency in which the crossing of the GMO parental organism occurs, within the same 
species and with sexually compatible species, listi ng the assessed species, the techniques used 
and the resulting effects;  
         7. Resulting effects of horizontal transfe rence to soil microbiota, if applicable;  
         8. Negative and positive effects impacts t o target and non-target organisms that may occur 
with the release of GMOs, listing the assessed spec ies, the reasons for the choice and the 
techniques used to demonstrate the impacts; 
         9. Modifications in the plant ability to a dd substances or remove them from the soil, due to 
the introduction of new traits, describing possible  physical and chemical alterations in the soil and 
contamination of adjacent water bodies resulting fr om interactions with the GMO, comparatively 
to the conventional systems.  
         10. Possible modification of the GM plant biodegradability, in comparison to the parental 
genotype;  
         11. Possible resistance to chemical agents  caused by the introduced traits;  This text does not substitute the original publishe d in the Federal Official Gazette 
          12. Historic of the use of the GMO and cou ntries in which its commercialization and planting 
has been authorized or denied, presenting, in such case, commercial post-release monitoring or 
study data, if available; 
         13. Changes in the GMO capacity to survive  on environments different form those in which 
the parental organism is found, caused by new intro duced traits.  
 
(B) MICROORGANISMS 
 
Inform: 
         1. The possibility of such GMO to produce spores and be resistant to desiccation. 
         2. Sterilizing and antimicrobial agents th at act against GMOs and their mutagenic capacity 
to the GMO;  
         3. The possible effects of GMOs on water, air and soil quality; 
         4. Survival and dispersion of the GMO in w ater, air and soil;  
 
 
(C) MICROORGANISMS ASSOCIATED TO ANIMALS 
 
         These issues refer to microorganisms assoc iated to animals. The aspects referred to herein 
shall also take into account the ecological interac tions and the host animal behavior, which could 
cause environmental impact.  
 
Inform: 
         1. Host animal species and historic of the  use of the parental organism; 
         2. GMO capacity to colonize other animals at any level, including feral populations and the 
possible effects in plants, non-host animals and th e environment;  
         3. Traits granted by the GMO to the host s pecies, reporting the secondary effects that may 
arise from the new trait granted to the host; 
         4. Possible alterations in the host’s comp etitive advantage or reproductive adaptability;  
         5. Secondary effects of GMO release in the  host and if the transgene can be transferred. In 
case of horizontal transference to another microorg anism or to the host’s cells, report the results 
resulting from the transference; 
         6. How long the GMO can last in the enviro nment and factors that affect its survival after 
excreted by host animal.  
 
(D)MICROORGANISMS ASSOCIATED TO PLANTS 
 
         These issues are related to microorganisms  associated to plants and microorganisms that 
can be applied to modify the environment. 
 
Inform: 
         1. Plant species to which GMO is associate d. 
         Describe the interaction specificity and i ndicate the spectrum of other host species with 
which the GMO may interact; 
         2. Use of parental organism in agriculture , if applicable; 
         3. The GMO effect on the associated vegeta l species, including possible secondary effects, 
including monitoring ways of such effects; 
         4. The GMO effect on the distribution and abundance of associated plant species and on 
other species with which the GMO may interact; 
         5. Interactions and effects caused by the GMO to organisms in soil benefic to plants and 
found in cultivation areas, reporting how often suc h events occur;  
         6. Possible effects resulting from the exc hange, if applicable, of GMO genetic material with 
phytopathogens.  
 
(E) ORGANISMS USED FOR BIOLOGIC CONTROL  
 This text does not substitute the original publishe d in the Federal Official Gazette 
 Inform: 
         1. The target species of biologic control and the GMO direct effects over it compared to the 
effects over the parental organism; 
         2. Spectrum of organisms susceptible to th e GMO and the susceptibility of non-target 
organisms to the GMO, describing the criteria emplo yed in the choice of the assessed organisms; 
         3. Ways in which GMOs disperse from one in dividual to another one and factors that affect 
such dispersion;  
         4. Secondary effects that may occur in pre dators, preys, competitors, and parasites of the 
target species; 
         5. Metabolites produced by the GMO that ma y cause direct or indirect deleterious effects to 
other species by means of concentration in the food  chain;  
         6. Resulting effects of horizontal transfe rence to another organism, if applicable; 
         7. Possible genetic modifications that may  occur in target organism populations as a result 
of the GMO use. 
 
(F) ORGANISMS FOR BIOREMEDIATION  
 
Inform: 
         1. Bioremediation target substratum and GM O effect on such substratum, when compared 
to the effect in the parental organism, as well as necessary additional measures to the process 
efficiency;  
         2. Substances that may be metabolized by t he GMO and may not be metabolized by the 
parental organism; 
         3. Possible deleterious effects of the GMO  or of its metabolites directly over other 
organisms or indirectly by means of the food chain concentration; 
         4. Mechanisms involved in the GMO dispersi on and possible consequences to the 
environment, describing the measures used to mitiga te occasional undesired dispersions.  
 
(G) VERTEBRATES (EXCLUDING FISH) 
 
Inform:  
         1. Environmental effects or about the well -being of animals deriving from the GMO release 
and the probabilities for such intercurrence;  
         2. Changes in other species characteristic s caused by genetic modifications, providing 
details about them, if applicable; 
         3. Possible effects of the modified charac teristics expression on the behavior, physiology 
and reproduction of the animal, providing details d eriving from sample-animals data;  
         4. Existence of feral populations of the e xperimental species in Brazil and environmental, 
agricultural or sanitary damage cause by such exist ence; 
         5. Experimental data related to the crossi ng between the GMO and feral animals kept in 
captivity;  
         6. The effect of the new genetic material introduction on the distribution and abundance of 
feral populations or on their ability to cause agri cultural and environmental problems, as well as to 
contribute to the dissemination of infectious disea ses;  
         7. The effect of the new genetic material introduction on the gene set of feral species, 
including changes in the distribution of such feral  populations or on their ability to cause 
agricultural or environmental problems, as well as to disseminate infectious diseases; 
         8. Management procedures and environmental  factors requested for the best expression of 
the new trait, providing data to support the respon se;  
         9. Possibility of the GMO to cross with na tive species in Brazil; 
         10. Possibility of the new trait to increa se the species ability to establish feral populatio ns.  
 
(H) FISH AND OTHER WATER LIVING ORGANISMS  
 
Inform: This text does not substitute the original publishe d in the Federal Official Gazette 
          1. New metabolites or toxins produced by t he GMO that may have a damaging effect on 
parasites or predators; 
         2. Possible adverse effects, different fro m those expected  that may result from the GMO 
release, including its interaction with the ecosyst em in the place where the release occurs;  
         3. Effects on other traits of such organis m resulting from the genetic modification; 
         4. Possible transference of modified genet ic material to other species, by means of non-
conventional reproductive mechanisms, and, if appli cable, provide details and describe such 
effects; 
         5. About the existence of natural populati on of the parental organism in the country – 
including rivers, lakes, dams, or costal waters, de scribing possible problems caused by such 
populations to other organisms, providing details a bout them;  
         6. Possible contribution of such modified trait to the ability of such species to colonize wa ter 
habitats in the country, in case there are no natur al populations of such parental organism in 
Brazil; 
         7. Occasional experimental studies on the phenotypical expression of the modified genetic 
material in natural occurrence organisms (for examp le, the crossing of the GMO with wild 
animals, or animals raised in captivity);  
         8. Possibility of the new genetic material  to integrate the natural population gene set;  
         9. Mechanisms adopted to prevent the dispe rsion of GMOs to other ecosystems. 
 
(I) INVERTEBRATES 
 
Inform: 
         1. GMO effect on food chain;  
         2. Possible production of new toxins or me tabolites by the GMO that is able to cause 
deleterious effects in their parasites or predators ; 
         3. Possible adverse effects of such releas e in the local ecosystem; 
         4. Register of natural populations of the parental organism in Brazil, and, if applicable, 
inform their effects, either positive or negative, to agriculture, the environment and to public 
health;  
         5. Possibility of the transgene to be tran smitted to other species, by means of non-
conventional reproductive mechanisms, and, if appli cable, provide details on the transfer 
mechanisms by listing the species; 
         6. Eventual experimental study on the phen otypical expression of the transgene in 
crossings of modified families with wild organisms.  If so, detail the results;  
         7. Distribution and abundance of natural p opulation changes by the possible integration of 
the transgene to the gene set of such populations, informing the possible effect of such change; 
         8. Mechanisms to be adopted to prevent the  dispersion of GMOs to other environments.