The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation

Detalhes bibliográficos
Autor(a) principal: Soares Ferreira, Ismael
Data de Publicação: 2023
Outros Autores: Iorio Aranha, Márcio
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/1017
Resumo: Objective: to analyze the regulation of food of animal origin carried out by the Brazilian Health Surveillance Agency (Anvisa, in Portuguese) and the Ministry of Agriculture, Livestock and Food Supply (MAPA, in Portuguese) from the perspective of a process-oriented approach to regulation, with a specific emphasis on cases involving chemical substances in food of animal origin. Methods: this research conducted two case studies. The first case study examined Anvisa's normative acts regarding residues of veterinary drugs in food of animal origin. The second case study analyzed MAPA's decision to discontinue routine official analyses of water samples in the animal food industry. The research approach was qualitative, focusing on investigating the institutional and normative composition of Anvisa and MAPA from the perspective of a process-oriented approach to regulation. Results: the analysis revealed that Anvisa has successfully implemented mechanisms consistent with a process-oriented approach to regulation, including regulatory autonomy, functional stability of regulatory bodies, and administrative procedures to promote social participation. On the other hand, MAPA's institutional-legal environment exhibits less autonomy and formally adopted procedural elements consistent with a process-oriented approach to regulation since 2015. However, there is a concern that these elements might be eliminated when drafting internal regulations. Conclusion: the Brazilian regulatory model divides animal food regulation between two agencies, potentially resulting in decisions that overlook the public interest and social participation. This is evident in the normative production of MAPA, despite their formal adoption of good regulatory practices. Received: 11/04/23 | Accepted: 18/05/23
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spelling The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulationLa regulación de los alimentos de origen animal en Brasil a la luz de la teoría procesal administrativa de la regulaciónA regulação de alimentos de origem animal no Brasil à luz da teoria processual administrativa da regulaçãoAlimentos de Origen AnimalRegulaciónControl Social FormalRegulación y Fiscalización en SaludAgencia Nacional de Vigilancia SanitariaDerecho SanitarioAlimentos de Origem AnimalRegulaçãoControle Social FormalRegulação e Fiscalização em SaúdeAgência Nacional de Vigilância SanitáriaDireito SanitárioFoods of Animal OriginRegulationFormal Social ControlHealth Care Coordination and MonitoringBrazilian Health Surveillance AgencyHealth LawObjective: to analyze the regulation of food of animal origin carried out by the Brazilian Health Surveillance Agency (Anvisa, in Portuguese) and the Ministry of Agriculture, Livestock and Food Supply (MAPA, in Portuguese) from the perspective of a process-oriented approach to regulation, with a specific emphasis on cases involving chemical substances in food of animal origin. Methods: this research conducted two case studies. The first case study examined Anvisa's normative acts regarding residues of veterinary drugs in food of animal origin. The second case study analyzed MAPA's decision to discontinue routine official analyses of water samples in the animal food industry. The research approach was qualitative, focusing on investigating the institutional and normative composition of Anvisa and MAPA from the perspective of a process-oriented approach to regulation. Results: the analysis revealed that Anvisa has successfully implemented mechanisms consistent with a process-oriented approach to regulation, including regulatory autonomy, functional stability of regulatory bodies, and administrative procedures to promote social participation. On the other hand, MAPA's institutional-legal environment exhibits less autonomy and formally adopted procedural elements consistent with a process-oriented approach to regulation since 2015. However, there is a concern that these elements might be eliminated when drafting internal regulations. Conclusion: the Brazilian regulatory model divides animal food regulation between two agencies, potentially resulting in decisions that overlook the public interest and social participation. This is evident in the normative production of MAPA, despite their formal adoption of good regulatory practices. Received: 11/04/23 | Accepted: 18/05/23Objetivo: analizar la regulación de alimentos de origen animal realizada por la Agencia Nacional de Vigilancia Sanitaria (Anvisa) y por el Ministerio de Agricultura, Ganadería y Abastecimiento (MAPA, en portugués) en la perspectiva de la teoría procesal administrativa de la regulación, así como normativa casos sobre sustancias químicas en alimentos de origen animal. Metodología: se realizaron dos estudios de caso – uno sobre los actos normativos de Anvisa sobre residuos de medicamentos veterinarios en alimentos de origen animal; y otro sobre la decisión del MAPA de poner fin a los análisis oficiales de muestras de agua en las industrias de alimentos para animales de forma rutinaria – basado en un enfoque cualitativo de la composición institucional y normativa de Anvisa y MAPA, en la perspectiva de la regulación administrativa de la teoría procesal. Resultados: Anvisa ha adoptado mecanismos consistentes con la teoría procesal administrativa de la regulación, como la autonomía, la estabilidad funcional de los agentes reguladores y la participación social. Respecto al MAPA, su ámbito institucional tiene menor autonomía y ha adoptado formalmente, desde 2015, elementos procedimentales compatibles con dicha teoría, pero que pueden ser desestimados durante la producción normativa interna. Conclusión: el modelo regulatorio brasileño, que divide la regulación de los alimentos de origen animal entre dos órganos, puede generar decisiones que no toman en cuenta el interés público y la participación social, lo que se puede ver en la producción normativa del MAPA, incluso con la adopción formal de buenas prácticas regulatorias. Recepción: 11/04/23 | Aceptación: 18/05/23Objetivo: analisar a regulação de alimentos de origem animal realizada pela Agência Nacional de Vigilância Sanitária (Anvisa) e pelo Ministério da Agricultura, Pecuária e Abastecimento (MAPA) sob a perspectiva da teoria processual administrativa da regulação, bem como casos normativos sobre substâncias químicas em alimentos de origem animal. Metodologia: foram realizados dois estudos de caso – um sobre os atos normativos da Anvisa sobre resíduos de medicamentos veterinários em alimentos de origem animal; e outro sobre a decisão do MAPA pelo fim das análises oficiais de amostras de água em indústrias de alimentos de origem animal de forma rotineira – a partir de uma abordagem qualitativa da composição institucional e normativa da Anvisa e do MAPA, sob a ótica da teoria processual administrativa da regulação. Resultados: a Anvisa tem adotado mecanismos condizentes com a teoria processual administrativa da regulação, como autonomia, estabilidade funcional dos agentes reguladores e participação social. Em relação ao MAPA, seu ambiente institucional detém menor autonomia e tem formalmente adotado, desde 2015, elementos processuais compatíveis com tal teoria, mas que podem ser desconsiderados durante a produção normativa interna. Conclusão: o modelo regulatório brasileiro, que divide a regulação dos alimentos de origem animal entre dois órgãos, pode gerar decisões que não levam em conta o interesse público e a participação social, o que pode ser percebido na produção normativa do MAPA, mesmo com a adoção formal de boas práticas regulatórias. Submissão: 11/04/23 | Aprovação: 18/05/23Fundação Oswaldo Cruz Brasília2023-09-20info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontextotextoinfo:eu-repo/semantics/otherapplication/pdfhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/101710.17566/ciads.v12i3.1017Iberoamerican Journal of Health Law; Vol. 12 No. 3 (2023): (JUL./SEPT. 2023); 146-165Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 12 Núm. 3 (2023): (JUL./SEPT. 2023); 146-165Cadernos Ibero-Americanos de Direito Sanitário; v. 12 n. 3 (2023): (JUL./SET. 2023); 146-1652358-18242317-839610.17566/ciads.v12i3reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/1017/1136Copyright (c) 2023 Ismael Soares Ferreira, Márcio Iorio Aranha (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessSoares Ferreira, IsmaelIorio Aranha, MárcioIorio Aranha, MárcioIorio Aranha, Márcio2023-11-17T14:03:54Zoai:ojs.cadernos.prodisa.fiocruz.br:article/1017Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2023-11-17T14:03:54Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
La regulación de los alimentos de origen animal en Brasil a la luz de la teoría procesal administrativa de la regulación
A regulação de alimentos de origem animal no Brasil à luz da teoria processual administrativa da regulação
title The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
spellingShingle The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
Soares Ferreira, Ismael
Alimentos de Origen Animal
Regulación
Control Social Formal
Regulación y Fiscalización en Salud
Agencia Nacional de Vigilancia Sanitaria
Derecho Sanitario
Alimentos de Origem Animal
Regulação
Controle Social Formal
Regulação e Fiscalização em Saúde
Agência Nacional de Vigilância Sanitária
Direito Sanitário
Foods of Animal Origin
Regulation
Formal Social Control
Health Care Coordination and Monitoring
Brazilian Health Surveillance Agency
Health Law
title_short The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
title_full The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
title_fullStr The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
title_full_unstemmed The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
title_sort The regulation of animal-source foods in Brazil in the light of a process-oriented approach to regulation
author Soares Ferreira, Ismael
author_facet Soares Ferreira, Ismael
Iorio Aranha, Márcio
author_role author
author2 Iorio Aranha, Márcio
author2_role author
dc.contributor.author.fl_str_mv Soares Ferreira, Ismael
Iorio Aranha, Márcio
Iorio Aranha, Márcio
Iorio Aranha, Márcio
dc.subject.por.fl_str_mv Alimentos de Origen Animal
Regulación
Control Social Formal
Regulación y Fiscalización en Salud
Agencia Nacional de Vigilancia Sanitaria
Derecho Sanitario
Alimentos de Origem Animal
Regulação
Controle Social Formal
Regulação e Fiscalização em Saúde
Agência Nacional de Vigilância Sanitária
Direito Sanitário
Foods of Animal Origin
Regulation
Formal Social Control
Health Care Coordination and Monitoring
Brazilian Health Surveillance Agency
Health Law
topic Alimentos de Origen Animal
Regulación
Control Social Formal
Regulación y Fiscalización en Salud
Agencia Nacional de Vigilancia Sanitaria
Derecho Sanitario
Alimentos de Origem Animal
Regulação
Controle Social Formal
Regulação e Fiscalização em Saúde
Agência Nacional de Vigilância Sanitária
Direito Sanitário
Foods of Animal Origin
Regulation
Formal Social Control
Health Care Coordination and Monitoring
Brazilian Health Surveillance Agency
Health Law
description Objective: to analyze the regulation of food of animal origin carried out by the Brazilian Health Surveillance Agency (Anvisa, in Portuguese) and the Ministry of Agriculture, Livestock and Food Supply (MAPA, in Portuguese) from the perspective of a process-oriented approach to regulation, with a specific emphasis on cases involving chemical substances in food of animal origin. Methods: this research conducted two case studies. The first case study examined Anvisa's normative acts regarding residues of veterinary drugs in food of animal origin. The second case study analyzed MAPA's decision to discontinue routine official analyses of water samples in the animal food industry. The research approach was qualitative, focusing on investigating the institutional and normative composition of Anvisa and MAPA from the perspective of a process-oriented approach to regulation. Results: the analysis revealed that Anvisa has successfully implemented mechanisms consistent with a process-oriented approach to regulation, including regulatory autonomy, functional stability of regulatory bodies, and administrative procedures to promote social participation. On the other hand, MAPA's institutional-legal environment exhibits less autonomy and formally adopted procedural elements consistent with a process-oriented approach to regulation since 2015. However, there is a concern that these elements might be eliminated when drafting internal regulations. Conclusion: the Brazilian regulatory model divides animal food regulation between two agencies, potentially resulting in decisions that overlook the public interest and social participation. This is evident in the normative production of MAPA, despite their formal adoption of good regulatory practices. Received: 11/04/23 | Accepted: 18/05/23
publishDate 2023
dc.date.none.fl_str_mv 2023-09-20
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
texto
texto
info:eu-repo/semantics/other
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/1017
10.17566/ciads.v12i3.1017
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/1017
identifier_str_mv 10.17566/ciads.v12i3.1017
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/1017/1136
dc.rights.driver.fl_str_mv Copyright (c) 2023 Ismael Soares Ferreira, Márcio Iorio Aranha (Autor)
https://creativecommons.org/licenses/by/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2023 Ismael Soares Ferreira, Márcio Iorio Aranha (Autor)
https://creativecommons.org/licenses/by/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 12 No. 3 (2023): (JUL./SEPT. 2023); 146-165
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 12 Núm. 3 (2023): (JUL./SEPT. 2023); 146-165
Cadernos Ibero-Americanos de Direito Sanitário; v. 12 n. 3 (2023): (JUL./SET. 2023); 146-165
2358-1824
2317-8396
10.17566/ciads.v12i3
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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