DECREE NO. 3,945, OF September 28, 2001

Defines the composition of the Genetic Heritage Management Board and sets the standards for its functioning, upon the regulation of the arts. 10, 11, 12, 14, 15, 16, 18 and 19 of the Provisional Measure No. 2.186-16 of August 23, 2001, which has on access to genetic heritage, protection and access to the associated traditional knowledge, apportionment of benefits and access to technology and technology transfer for its conservation and use, and gives other arrangements.

THE PRESIDENT OF THE REPUBLIC, in the use of the assignments that confers it on art. 84, incisos IV and VI, paragraph (a) of the Constitution,

d and c r e t a:

Art. 1º This Decree defines the composition of the Board of Management of Genetic Heritage and sets the standards for its functioning, upon the regulation of the arts. 10, 11, 12, 14, 15, 16, 18 and 19 of the Provisional Measure No. 2.186-16 of August 23, 2001.

Art. 2º The Board of Management of Genetic Heritage is composed of a representative and respective deputy of the following organs and entities of the Federal Public Administration, who hold competence on the subject matters of the Interim Meas-tion No. 2.186-16, of 2001:

I-Ministry of the Environment;

II-Ministry of Science and Technology;

III-Ministry of Health;

IV-Ministry of Justice;

V-Ministry of Agriculture, Livestock, and Supply;

VI-Ministry of Defense;

VII-Ministry of Culture;

VIII-Ministry of Foreign Affairs;

IX-Ministry of Development, Industry and Foreign Trade;

X-Brazilian Institute of the Environment and Renewable Natural Resources-IBAMA;

XI-Institute of Research Gardens Botanical Garden of Rio de Janeiro;

XII-National Council for Scientific and Technological Development-CNPq;

XIII-National Institute of Amazonian Research-INPA;

XIV-Brazilian Company of Agrolivestock Research-Embrapa;

XV-Foundation Oswaldo Cruz-Fiocruz;

XVI- Institute Evandro Chagas;

XVII-National Foundation of the Indian-Funai;

XVIII-National Institute of Industrial Property-INPI;

XIX-Palmares Cultural Foundation.

§ 1º The Management Board will be chaired by the holder representative of the Ministry of the Environment and, in its impediments or departments, by the respective deputy.

§ 2º The members of the Management Board, holders and alternates, will be nominated by the legal representatives of the Ministries and the entities of the Federal Public Administration who make it up, and will be appointed in act of the Minister of State for the Environment.

§ 3º As functions of the members of the Management Board will not be remunerated and their exercise is considered to be relevant public service.

§ 4º The Management Board shall meet in ordinary character once a month and, extraordinarily, the at any time, upon convocation of its President, or of the absolute majority of its members, in this case by means of written document, accompanied by justified tariff.

§ 5º The periodicity referred to in § 4º may be amended by decision of the Management Board.

§ 6º The member who skips two straight meetings or three intercalates, without the corresponding substitutions by the alternate, will be removed from the Management Board.

§ 7º The Chairman of the Board of Management may invite experts to attend plenary or chamber-themed meeting to subsidize decision making.

Art. 3º Under the Interim Measure No. 2.186-16, from 2001, it competes with the Board of Management of Genetic Heritage, serviced its deliberative and normative nature:

I-coordinate the implementation of policies for the management of genetic heritage;

II-establish:

a) technical standards, pertinent to the management of genetic heritage;

b) criteria for access and remittance authorizations;

c) guidelines for elaboration of Genetic Heritage Utilization Contract and Benefits partition;

d) criteria for the creation of database for the record of information on traditional knowledge associated;

III- follow up, in articulation with federal bodies, or upon convenium with other institutions, the access and remittance activities of component of the genetic heritage component and access to traditional associated knowledge;

IV-deliberate on:

a) access authorization and sample shipment of component of the genetic heritage component, upon prior annuence of its holder;

b) access to knowledge traditional associate, upon prior annuence of its holder;

c) special access and sample remittance of component sample of the genetic heritage, with term of up to two years, renewable for equal periods, the national public or private institution that exerts research and development activity in the biological and related areas, and the national, public or private university;

d) special access to knowledge traditional associate, with term of up to two years, renewable for equal periods, the national public or private institution that exerts research and development activity in the biological and related areas, and the national, public university or private;

e) accreditation of national public institution of research and development, or of federal public institution of management, to authorize another national, public or private institution, which exerts activity of research and development in the biological and related areas, to access component sample of the genetic heritage and associated traditional knowledge, and well as well to remit component sample of genetic heritage to national institution, public or private, or for institution based abroad;

f) accreditation of national public institution to be faithful component depository of component of genetic heritage;

g) describe of institutions for the failure to comply with the provisions of the Provisional Measure No. 2.186-16, of 2001, and of this Decree;

V-giving annuence to the Contracts of Use of Genetic Heritage and of the Repartition of Benefits as to the compliance with the requirements set out in the Provisional Measure No. 2.186-16, 2001;

VI-promoting debates and public consultations on the topics of which it treats the Interim Measment No. 2.186-16, 2001;

VII- function as a higher resource instance in relation to the decision of accredited institution and of the acts arising from the application of the Interim Measment No. 2.186-16, of 2001;

VIII-approve its internal regiment.

Single paragraph. The Board of Management of Genetic Heritage will exercise its competence under the devices of the Convention on Biological Diversity, of the Interim Measree No. 2.186-16, of 2001, and of this Decree.

Art. 4º The deliberations of the Board of Management will be taken by an absolute majority of its members.

Single paragraph. It is up to the President of the Management Board the voting tie vote.

Art. 5º Of the Board of Management's deliberations rests with the Plenary, whose decision will be taken by two-thirds of its members.

Paragraph single. The deliberations of the Plenary of the Management Board that decide the interposed resources.

Art. 6º In the deliberations in proceedings involving the direct participation of the Ministry or of the represented entity in the Management Board, the respective member shall not be entitled to vote.

Art. 7º It is established, in the structure of the Ministry of the Environment, the Department of Genetic Heritage, which will exercise the function of the Executive Secretariat of the Management Board, and shall have the following assignments, among others:

I-implement the deliberations of the Management Board;

II-promote the instruction and the stepping stone of the processes to be submitted to the Deliberation of the Board of Management;

III-supporting accredited institutions;

IV-issue, according to deliberation of the Management Board and in its name, Access Authorization and sample Remitterance of component of the existing genetic heritage in the national territory, on the continental shelf and in the exclusive economic zone, as well as Authorization of Access to associated traditional knowledge;

V-issue, according to Deliberation of the Management Board and on its behalf, Special Access and Shipment Authorization of component of the genetic heritage component, and Authorization of Access to traditional associate knowledge, with term of up to two years, renewable by equal periods, the national public or private institution that exerts research and development activity in the biological and related areas and the national, public or private university;

VI-follow-up, in articulation with the too many federal bodies, the access and remittance activities of component of the genetic heritage component and access to associated traditional knowledge;

VII-promote, according to deliberation of the Board of Management and in his name, the accreditation of national public institution of research and development, or federal public institution of management, to authorize national, public or private institution, to access component sample of the genetic heritage and of associate traditional knowledge, and well thus to send component sample of the genetic heritage to the national, public or private institution, or to the institution based abroad, respected the requirements of the art. 19 of the Interim Measure No. 2.186-16, of 2001;

VIII-promoting, according to deliberation by the Management Board and on its behalf, the national public institution accreditation to be faithful component depository of component of genetic heritage;

IX-describe institutions, in accordance with deliberation of the Management Board and on its behalf, by the discompliance of the provisions of the Interim Measment No. 2.186-16, of 2001, and of this Decree;

X-register the Genetic Heritage Utilization Contracts and the Benefits Breakdown, after the Management Board's annuence;

XI-release list of exchange species facilitated constants of agreements international, including on food security, of which the Country is a signatory, in accordance with § 2º of the art. 19 of the Provisional Measure No. 2.186-16, of 2001;

XII-create and maintain:

a) enrollment of ex situcollections, as predicted in art. 18 of the Provisional Measure No. 2.186-16, of 2001;

b) database for the registration of information obtained during the component collection of the genetic heritage component;

c) data base concerning the Access and Shipment Permits of component of the genetic heritage component and access to associated traditional knowledge, to the Material Transfer Terms and the Genetic Heritage Utilization and Breakdown Contracts of Benefits;

XIII-disclose, periodically, list of Access and Shipping Authorizations, of the Material Transfer Terms and of the Genetic Heritage Utilization Contracts and of the Benefits Breakdown.

Art. 8º For obtaining access authorization and sample shipment of component of the genetic heritage and access to traditional knowledge associated with the national, public or private institution, which exerts activity of research and development in the biological and related areas, of which they treat the "a" and "b" points of the inciso IV of the art. 11 of the Provisional Measure No. 2.186-16, 2001, should forward request to the Management Board or the accredited institution, answering at least the following requirements:

I-proving your performance in research and development in the biological and related areas;

II-technical qualification for performance of sample collection and shipment activities of component of the Genetic Heritage component or for access to the associated traditional knowledge;

III-structure available for the component handling of component of the Genetic Heritage;

IV-research project that describes the sample collection activity of the component of the Genetic Heritage or of access to associated traditional knowledge, including information on the intended use;

V-prior annuence for admission to the areas to be sampled by the collection expedition, in the form set out in § § 8º and 9º of the art. 16 of the Provisional Measure No. 2.186-16, of 2001;

VI-fate of the samples of the components of the genetic heritage to be accessed.

Single paragraph. The research project referred to in the inciso IV of this article should contain:

I-history, justification, definition of the objectives, methods and results expected from the sample or the information to be accessed;

II-detailed itinerary in the National Territory, indicating the predicted dates for the beginning and termination of the activity;

III-discrimination of the type of material or information to be accessed and approximate quantification of samples to be obtained;

IV-indication of the sources of funding, of the respective amounts and division of the responsibilities of each party;

V-curriculum vitae of the researchers and technicians involved, case are not available on the lattes platform, maintained by the CNPq.

Art. 9º For obtaining special access and sample shipment authorization of genetic heritage component and access to knowledge traditional associate the national, public or private institution, which exerts research and development activity in the biological and related areas, of which they treat the "c" and "d" points of the inciso IV of the art. 11 of the Provisional Measure No. 2.186-16, 2001, should forward request to the Board of Management, attending at least the following requirements:

I-proving its performance in research and development in the areas biological and related;

II-technical qualification for performance of the component sample collection and remittance activities of the Genetic Heritage component;

III-structure available for the sample handling of component of the Genetic Heritage;

IV-portfolio of the projects developed by the institution, highlighting those that will be benefited by the requested authorization, including information on the intended use;

V-prior annuence for ingress in the areas to be sampled by the collection expeditions in the form set out in § 11 of the art. 16 of the Provisional Measure No. 2.186-16, of 2001;

VI-fate of the genetic material to be accessed and indication of the technical staff and the infrastructure available to manage the Material Transfer Terms to be signed prior to shipment of sample to another national, public or private institution, or based abroad and the respective Genetic Heritage Utilization and Benefits Utilization Contracts, when it is the case.

Single paragraph. The research projects included in the portfolio referred to in the inciso IV of this article, directly benefitted by the solicitation, should contain:

I-history, justification, definition of the objectives, methods and results expected from the sample or the information to be accessed;

II-detailed itinerary in the National Territory, indicating the expected dates for the commencement and termination of the activity, to be forwarded to the Management Board;

III-discrimination of the type of material or information to be accessed and approximate quantification of samples to be obtained;

IV-indication of the sources of funding, of the respective amounts and division of the responsibilities of each party;

V-curriculum vitae of the researchers and technicians involved, if they are not available on the lattes platform, maintained by the CNPq.

Art. 10. For the accreditation of national public institution of research and development or of federal public institution of management to authorize another national, public or private institution, that exercises research and development activity in the areas biological and related purposes, to access and remit component sample of the genetic heritage and to access traditional associated knowledge of which treat items 1 and 2 of the "e" of the inciso IV of the art. 11, of the Provisional Measure No. 2.186-16, of 2001, the Management Board should receive solicitation that will meet at least the following requirements:

I-proving its performance in research and development in the biological areas and related to or in the area of management;

II-list of the activities and projects in development related to the actions of which it treats the Interim Measase No. 2.186-16, of 2001;

III-available infrastructure and technical team to act:

a) in the application and issuance analysis, to third parties, of authorization from:

1. access to the component sample of the existing genetic heritage under in situ conditions on the national territory, on the continental shelf and in the exclusive economic zone, upon prior annuence of their holders;

2. access to associated traditional knowledge, upon prior annuence of their holders;

3. sample shipment of component of the genetic heritage component to national, public or private institution, or to institution based abroad;

b) in the follow up, in articulation with federal bodies, or upon convenium with other institutions, from the component sample access and remittance activities of the genetic heritage and access to associated traditional knowledge;

c) in the creation and maintenance of:

1. ex situ collections enrollment, as provided for in the art. 18 of the Provisional Measure No. 2.186-16, of 2001;

2. data base for record of information obtained during the component sample collection of the genetic heritage;

3. database relating to Access and Shipment Authorizations, the Material Transfer Terms and the Genetic Heritage Utilization and Benefits Reduction Contracts;

d) in the release of list of Authorizations of Access and Shipping, of the Material Transfer Terms and Utilization Contracts of Genetic Heritage and Benefits Breakdown;

e) in the follow-up and implementation of the Material Transfer Terms and of the Genetic Heritage Utilization Contracts and the Repartition of Benefits regarding the processes by it authorized;

f) in the preparation and forwarding, to the Board of Management, of annual report of the activities carried out and copy of the databases to the Executive Secretariat of the Board of Management.

Art. 11. For the accreditation of national public institution of research and development as faithful component depository of component of the Genetic Heritage of which it treats the "f" of the inciso IV of the art. 11, of the Provisional Measure No. 2.186-16, of 2001, the Management Board should receive solicitation that will meet at least the following requirements:

I-proving its performance in research and development in the biological areas and related;

II-indication of the available infrastructure and capacity for conservation, under ex situ conditions, of samples of components of the Genetic Heritage;

III-proving the capacity of the team technical responsible for the conservation activities;

IV-description of the methodology and material employed for the conservation of species on which the institution will take responsibility in the quality of trusty trustee;

V-indication of the budget availability for maintenance of the collections.

Art. 12. The component collection activity of the genetic heritage and access to associated traditional knowledge, which contributes to the advancement of knowledge and that is not associated with bioprospecting, when it involves the participation of legal person foreign, will be authorized by the CNPq, observed the determinations of the Interim Measment No. 2.186-16, of 2001, and the prevailing legislation.

Single paragraph. The authorization provided in the caput of this article will observe the technical standards set out by the Management Board, which will exercise supervision of these activities.

Art. 13. The Rules of Procedure of the Board of Management of Genetic Heritage will have at least the form of its acting, the means of registration of its deliberations and the archiving of its acts.

Art. 14. This Decree comes into force on the date of its publication.

Brasilia, September 28, 2001; 180º of Independence and 113º of the Republic.

FERNANDO HENRIQUE CARDOSO

Johaness Eck

José Serra

Carlos Américo Pacheco

José Sarney Filho