STF once again analyzes ADI against provisions of the Biosafety Law

Today, the virtual plenary trial of Direct Unconstitutionality Action 3526 resumed. In it, there are questions about several articles of Law 11.105/2005 (biosafety). If there is no request for review or referral to the physical plenary, the conclusion of the case must occur by the end of the 21st. The initial petition was presented on June 20, 2005.

In the action, the then Attorney General of the Republic, Claudio Fonteles, requests a declaration of unconstitutionality of section VI of art. 6th; of art. 10; of items IV, VIII, X and §§ 1st, 2nd, 3rd, 4th, 5th and 6th of art. 14; of §1°, item I and §§ 2°, 3°, 4°, 5°, 6° and 7° of art. 16; and arts. 30, 34, 35, 36, 37 and 39 of the Biosafety Law.

The questioned devices have the following wording:

Art. 6 It is prohibited:

(...)

VI - release of GMOs or their derivatives into the environment, within the scope of research activities, without a favorable technical decision from CTNBio and, in cases of commercial release, without a favorable technical opinion from CTNBio, or without licensing from the body or entity responsible environmental responsibility, when the C T B i considers the activity as potentially causing environmental degradation, or without the approval of the National Biosafety Council - CNBS, when the process has been invoked by it, in accordance with this Law and its regulations;

Art. 10. CTNBio, part of the Ministry of Science and Technology, is a multidisciplinary collegiate body of consultative and deliberative nature, to provide technical and advisory support to the Federal Government in the formulation, updating and implementation of the GNP of GMOs and their derivatives, as well such as the establishment of technical safety standards and technical opinions regarding the authorization of activities involving research and commercial use of GMOs and their derivatives, based on the assessment of their zoophytosanitary risk to human health and the environment.

Single paragraph. CTNBio must monitor technical and scientific development and progress in the areas of biosafety, biotechnology, bioethics and the like, with the aim of increasing its capacity to protect human health, animals and plants and the environment.

Art. 14. CTNBio is responsible for:

(...)

IV- carry out risk assessment analysis, case by case, regarding activities and projects involving GMOs and their derivatives;

(...)

VIII- authorize, register and monitor research activities with GMOs or GMO derivatives, in accordance with current legislation;

(...)

XX- identify activities and products resulting from the use of GMOs and their derivatives that potentially cause environmental degradation or that may cause risks to human health;

(...)

§ 1° Regarding the biosafety aspects of the GMO and its derivatives, the CTNBio's technical decision binds the other bodies and entities of the administration.

§ 2° In cases of commercial use, among other technical aspects of their analysis, the registration and inspection bodies, in the exercise of their duties in the event of a request by CTNBio, will observe, regarding the biosafety aspects of the GMO and its derivatives, the CTNBio's technical decision.

§ 3° In case of a favorable technical decision on biosafety within the scope of the research activity, CTNBio will forward the respective process to the bodies and entities referred to in art. I6 of this Law, to exercise its powers.

§ 4 CTNBio's technical decision must contain a summary of its technical basis, explain the safety measures and restrictions on the use of GMOs and their derivatives and consider the particularities of the different regions of the country, with the aim of guiding and subsidizing the bodies and registration and inspection entities, referred to in art. 16 of this Law, in the exercise of its powers.

§ 5° The derivative whose GMO has already been approved by it will not be subject to analysis and issuance of a technical opinion by CTMBio.

§ 6. Individuals or legal entities involved in any of the phases of the agricultural production process, commercialization or transportation of a genetically modified product that have obtained authorization for commercial use are exempt from presenting the CQB and establishing a CTBio, unless otherwise decided by the CTNBio.

Art. 16. The registration and inspection 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 duties, will be responsible for field of its competences, observing the technical decision of CTBio, the deliberations of the CNBS and the mechanisms established in this Law and its regulation

§ 1° After a favorable statement from CTNBio, or CIBS, in the event of a recall or appeal, it will be possible, as a result of specific analysis and pertinent decision:

III - the competent body of the Ministry of the Environment issues authorizations and registrations and inspects products and activities involving GMOs and their derivatives to be released into natural ecosystems, in accordance with the legislation in force and in accordance with the regulations of this Law, as well as the licensing, in cases where CTNBio decides, in accordance with this Law, that the GMO is potentially causing significant degradation of the environment;

§ 2°- Only the provisions of items l and II of art. 8 and the caput of art. 10 of Law No. 6.938, of August 31, 1981, in cases where CTNBio decides that the GMO is potentially causing significant degradation of the environment.

§ 3 - CTNBio deliberates, in the last and final instance, on the cases in which the activity is potentially or actually causing environmental degradation, as well as on the need for environmental licensing.

§ 4 The issuance of records, authorizations and environmental licensing referred to in this Law must occur within a maximum period of 120 (one hundred and twenty) days.

§ 5° The counting of the period provided for in § 4° of this article will be suspended, for up to 180 (one hundred and eighty) days, during the preparation, by the applicant, of the necessary studies or clarifications.

§ 6 - The authorizations and registrations referred to in this article will be linked to the corresponding CTNBio technical decision, with technical requirements that go beyond the conditions established in that decision being prohibited, in aspects related to biosafety.

§ 7º In case of divergence regarding CTNBio's technical decision on the commercial release of GMOs and derivatives, the registration and inspection bodies and entities, within the scope of their competences, may present an appeal to the CNBS, within a period of up to 30 (thirty) days, counting from the date of publication of CTNBio's technical decision.

Art. 30. GMOs that have obtained a technical decision from CTNBio in favor of their commercial release until the entry into force of this Law may be registered and commercialized, unless otherwise stated by the CNBS, within 60 (sixty) days, counting from the date publication of this Law. (...)

Art. 34. Provisional registrations granted under the aegis of Law No. 10.814, of December 15, 2003, are validated and become permanent.

Art. 35. The production and commercialization of seeds of genetically modified soybean cultivars tolerant to glyphosate registered in the National Cultivar Registry - RNC of the Ministry of Agriculture, Livestock and Supply are authorized.

Art. 36. The planting of genetically modified soybeans tolerant to glyphosate, reserved by rural producers for their own use, in the 2004/2005 harvest is authorized, with the commercialization of the production as seed being prohibited.

Single paragraph. The Executive Branch may extend the authorization referred to in the caput of this article.

So far, eight ministers have voted. Your understandings:

• Nunes Marques (rapporteur): is not aware of the action regarding the allegations of unconstitutionality of arts. 30, 34, 35, 36, 37 and 39; recognizes and judges the action unfounded, declaring constitutional: item IV of art. 6th; art. 10; section IV, VIII, XX and §§ 1st, 2nd, 3rd, 4th, 5th, and 6th of art. 14; § 1, item III and §§ 2, 3, 4, 5, 6, and 7 of art. 16.

• Edson Fachin: partially recognizes and, in the known part, judges the request, declaring arts unconstitutional. 6th, VI; 10; 14, IV, VIII, XX and §§ 1st, 2nd, 3rd, 4th, 5th and 6th; 16, § 1st, III and §§ 2nd, 3rd, 4th, 5th, 6th and 7th; 30; 34; 35; 36; and 37.

• Gilmar Mendes, Dias Toffoli, Luiz Fux e Roberto Barroso: declared the loss of the object of the direct action in relation to art. 36 of Law 11.105/2005; As for the other provisions, the requests are dismissed as unfounded.

• Carmen Lúcia e Rosa Weber: accompany minister Edson Fachin.

Minister Alexandre de Moraes had requested a view of the files, which he returned to continue the analysis. His voting content is not yet known.

UPDATE (22/08/2023): Alexandre de Moraes, Cristiano Zanin e André Mendonça accompanied Gilmar Mendes. Therefore, the action was dismissed. This means that the questioned devices were declared constitutional.

The initial petition for ADI 3526 can be read at the link below.