Federal Decree N. 8,772 was published on May 12, 2016 in the Official Gazette and regulates Federal Law No. 13.123, of May 20, 2015, which calls for access to genetic resources*, protection and access to traditional knowledge** and the sharing of benefits for conservation and sustainable use of biodiversity.

The activities that are expressly subject to the requirements of Law No. 13,123/2015 and of Decree No. 8,772/2016 are: (i) access to genetic resources or traditional knowledge; (ii) remittance abroad of samples of genetic resources; (iii) the economic exploitation of finished products or reproductive material originating from access to genetic resources or traditional knowledge performed after the effectiveness of the Law No. 13,123/2015.

Access to genetic resources or to traditional knowledge, which was preformed before June 30, 2000, as well as the economic exploitation of finished products or their reproductive material are not subject to the obligations set forth in Law No. 13,123/2015 and Decree No. 8,772/2016

This Regulation ensures the right for indigenous people, traditional communities and traditional farmers who perform or have traditional knowledge to participate in decision-making in respect to access to traditional knowledge and access to its corresponding shared benefits.

Access to traditional knowledge of identified origin is subject to prior informed consent. Said consent must respect the traditional ways of the organization and representation of indigenous peoples, traditional communities or traditional farmers and their respective community protocol, when it is applicable.

The Regulation defines the following directives for obtaining prior informed consent: (i) clarifications to indigenous peoples, traditional communities or traditional farmers about: the social, cultural and environmental impacts resulting from the activity performed; the rights and the liabilities of each part of the performance of the activity and in its results; and the right of indigenous peoples, traditional communities and traditional farmers to refuse access to the traditional knowledge; (ii) participation of indigenous peoples, traditional communities or traditional farmers in the definition of shared benefit modalities resulting from economic exploitation and (iii) the respect of indigenous peoples, traditional communities and traditional farmers right to refuse access to traditional knowledge during the process of prior consent.

Please note that demonstration of prior informed consent must be formalized in an understandable language to indigenous peoples, traditional communities or traditional farmers and must contain: (i) a description of the history of the process for obtaining prior informed consent; (ii) a description of the traditional ways of organization and representation of indigenous peoples, traditional communities or traditional farmers; (iii) the research purpose, as well as its methodology, duration, budget, potential benefits and a description of the project’s financial resources; (iv) the intended use of the traditional knowledge; and (v) the geographic area covered by the project and the indigenous peoples, traditional communities or traditional farmers involved.

In relation to liabilities, the regulation provides for some specific administrative infractions, which can be punished with warning, fine, temporary suspension of rights, embargo of activities, partial interdiction or total suspension of the activity, or the suspension or cancellation of certification or authorization.

The fine that will be imposed by the official authority, for each infraction, and, for each person involved, can vary from BRL 10,000.00 to BRL 10,000,000.00.

The official agencies able to monitor and verify the existence of administrative infractions are: (i) IBAMA; (ii) the Brazilian Naval Command and (iii) the Ministry of Agriculture, Livestock and Supply. If the infraction involves traditional knowledge, the official agencies of protection of indigenous peoples, traditional communities and traditional farmers will support the actions of IBAMA.

* Genetic resources are defined in this context as “genetic information belonging to vegetation, animals, microbes or other natural species, including substances derived from the metabolism of these living beings.”

** Traditional knowledge is defined in this context as the “information or practice of indigenous peoples, traditional communities and traditional agriculture concerning the properties or direct or indirect uses of genetic resources.”