Environmental Radar: REsp No. 1,840,012 – STJ reaffirms the binding nature of CTNBio’s opinion for environmental licensing of GMOs

In the context of the judgment of Special Appeal No. 1,840,012/PR, the 2nd Panel of the Superior Court of Justice (“STJ”) recognized, by majority, the binding nature of the prior conclusive technical opinion of the National Technical Commission on Biosafety (“CTNBio”) regarding the risk assessment and the need for environmental licensing of activities involving Genetically Modified Organisms (“GMOs”), even under the former Federal Law No. 8,974/1995[1].

The Underlying Action

The Special Appeal originated from an annulment action filed against the Brazilian Institute for the Environment and Renewable Natural Resources (“IBAMA”, Brazilian Environmental Agency), due to the issuance of an infraction notice and an embargo order, motivated by the conduct of research activities with GMOs without the Operating License for Research Area (“LOAP”), a requirement set forth in Resolution No. 305/2002 of the National Council for the Environment (“CONAMA”)[2].

The 1st level judge ruled in favor of the annulment action, understanding that the planting and research activities would be exempt from licensing, on the grounds that CTNBio’s technical opinion binds the other bodies of the Administration regarding the biosafety aspects of GMOs and that, once the potential for environmental impact had been dismissed by the Commission in the specific case, it would not be for IBAMA to require environmental licensing.

The understanding was initially upheld by the Federal Regional Court of the 4th Region (“TRF-4”) on appeal, but subsequently reversed in the judgment of motions for clarification with modifying effects, filed by IBAMA and the Federal Public Prosecutor’s Office.

In the TRF-4’s reanalysis, it was noted that, unlike the current Biosafety Law, which grants CTNBio competence to deliberate “as a final and definitive instance” on the need for licensing (Art. 16, § 3[3]), the prior legislation preserved the competences of the oversight bodies to establish additional requirements (Art. 7, § 1[4]). Thus, from the publication of CONAMA Resolution No. 305/2002 until the entry into force of Federal Law No. 11,105/2005, the LOAP would be required for activities involving GMOs.

The STJ’s Decision

By majority vote, the 2nd Panel granted the special appeal filed by the sanctioned company, to reinstate the first-instance judgment that had annulled the administrative acts.

Dissenting were Justice Maria Thereza de Assis Moura (Rapporteur) and Justice Francisco Falcão, who followed the TRF-4’s understanding that, during the period of Federal Law No. 8,974/1995, CTNBio’s opinion had a merely advisory character and did not condition the administrative process of environmental licensing.

However, the understanding of Justices Afrânio Vilela (justice writing for the court), Marco Aurélio Bellizze, and Teodoro Silva Santos prevailed, recognizing:

(i)    CTNBio’s technical competence: Already under Federal Law No. 8,974/1995, CTNBio held competence to issue a prior conclusive technical opinion on the biosafety aspects of the GMO and, as established by the Federal Supreme Court (“STF”) in the judgment of ADI No. 3,526, the Commission is a qualified instance to conduct the study of the GMO, including from an environmental perspective;

(ii)   The binding nature of the opinion: CTNBio’s prior conclusive technical opinion binds the other bodies of the Administration with regard to the biosafety aspects of the GMO, including as to the need for environmental licensing. The environmental agency may not diverge from this conclusion, under penalty of an undue reassessment of a technical matter already decided by the body with specific legal attribution;

(iii) The prerequisites of environmental licensing: Environmental licensing must apply to activities that are effectively or potentially polluting or capable of causing environmental degradation. In the absence of such conditions, pursuant to CTNBio’s technical opinion, the requirement of a license is not legitimate;

(iv) The restrictive interpretation of CONAMA Resolution No. 305/2002: The Resolution must be interpreted in accordance with the governing legislation. As an infra-legal act, it may not expand the instances requiring licensing when the prerequisite of the existence of an effectively or potentially polluting activity is absent.

Based on these premises, considering that the sanction was imposed exclusively due to the lack of environmental licensing, “in a reduced area, without attribution of other environmental impacts”, the STJ declared null and void the infraction notice and the embargo order issued by IBAMA.

Outlook

The decision is relevant in reaffirming CTNBio’s technical competence, even under the former Federal Law No. 8,974/1995, whose wording was less explicit regarding the binding nature of its opinions in the context of environmental licensing.

By recognizing that already under the prior legislation CTNBio held the final word on the need for licensing, the STJ confers legal certainty to activities carried out during the period between the publication of CONAMA Resolution No. 305/2002 and the entry into force of Law No. 11,105/2005, limiting the sanctioning activity of environmental agencies in such cases.

From a practical standpoint, companies and institutions that conducted research with GMOs during that period, supported by a favorable opinion from CTNBio, now have case-law support to challenge sanctions based exclusively on the absence of a LOAP.

[1]Federal Law No. 8,974/1995 was the first Brazilian statute to establish safety and oversight rules for the use of genetic engineering and the release of GMOs into the environment, as well as to create CTNBio. Federal Law No. 8,974/1995 was repealed by Federal Law No. 11,105/2005.

[2]CONAMA Resolution No. 305/2002 provides for Environmental Licensing, Environmental Impact Studies, and Environmental Impact Reports for activities and projects involving Genetically Modified Organisms and their derivatives.

[3]Art. 16. It shall be incumbent upon the registration and oversight bodies and entities of the Ministry of Health, the Ministry of Agriculture, Livestock and Supply, and the Ministry of the Environment, and the Special Secretariat for Aquaculture and Fisheries of the Presidency of the Republic, among other attributions, within the scope of their competences, subject to the technical decision of CTNBio, the deliberations of the CNBS, and the mechanisms established in this Law and its regulations: (…) § 3. CTNBio shall deliberate, as a final and definitive instance, on cases in which the activity is potentially or effectively capable of causing environmental degradation, as well as on the need for environmental licensing.

[4]Art. 7. It shall be incumbent upon the oversight bodies of the Ministry of Health, the Ministry of Agriculture and Supply, and the Ministry of the Environment, within the scope of their respective competences, subject to the prior conclusive technical opinion of CTNBio and the mechanisms established in the regulations of this Law: (…) § 1. The prior conclusive technical opinion of CTNBio is binding upon the other bodies of the administration with regard to the biosafety aspects of the GMO analyzed thereby, preserving the competences of the oversight bodies to establish additional requirements and procedures specific to their respective areas of legal competence.