Comparison of Brazilian High- and Maximum-Containment Laboratories Biosafety and Biosecurity Regulations to Legal Frameworks in the United States and Other Countries: Gaps and Opportunities

André de Oliveira Mendonça; Kurt Allen Zuelke; Melissa M Kahl-Mcdonagh; Claudio Mafra

doi:10.1089/apb.2023.0005

Comparison of Brazilian High- and Maximum-Containment Laboratories Biosafety and Biosecurity Regulations to Legal Frameworks in the United States and Other Countries: Gaps and Opportunities

Appl Biosaf. 2024 Mar 1;29(1):45-56. doi: 10.1089/apb.2023.0005. Epub 2024 Feb 28.

Authors

André de Oliveira Mendonça¹, Kurt Allen Zuelke², Melissa M Kahl-Mcdonagh², Claudio Mafra³

Affiliations

¹ National Veterinary Laboratory-LFDA/SP-Ministry of Agriculture (MAPA), Campinas, SP, Brazil.
² Texas A&M Global Health Research Complex (GHRC), College Station, TX, USA.
³ Department of Biochemistry and Molecular Biology, University of Viçosa (UFV), Viçosa, MG, Brazil.

PMID: 38434103
PMCID: PMC10902269 (available on 2025-03-01)
DOI: 10.1089/apb.2023.0005

Abstract

Introduction: Although the United States and other countries have implemented comprehensive legislation, regulations, and policies to support biosafety and biosecurity of high- and maximum-containment laboratories, Brazil's legislation has notable gaps and inconsistencies.

Objective: To evaluate the Brazilian approach to ensuring nationwide biosafety and biosecurity oversight and governance of high- and maximum-containment laboratories.

Methods: A systematic gap analysis was conducted to compare Brazilian biosafety and biosecurity legislation, regulations, and policies with their international counterparts, with a particular focus on the oversight and governance of high- and maximum-containment laboratories.

Results: We found that Brazilian biosafety and biosecurity legislation, regulations, and policies have relevant gaps. Governance and regulatory oversight of Brazil's high- and maximum-containment laboratories are decentralized with variable levels of adherence to commonly accepted global biosafety and biosecurity compliance standards. These findings represent a limitation not only to governance but also to the preparedness to face current and future challenges related to emergent infectious diseases in Brazil. Enhancing the Brazilian legal framework on laboratory biosafety and biosecurity is necessary and urgent. Reviewing the lessons learned and regulations applied in the United States and other international frameworks helped identify potential areas for improving Brazil's ability to inventory and manage its diverse biocontainment laboratory capabilities and assure these valuable resources align with national needs and priorities.

Conclusion: The Brazilian government has an opportunity to revise and improve upon a national set of legislation, regulations, and policies for its high- and maximum-containment laboratories, taking advantage of legislation and guidelines published by other countries.

Keywords: biological select agents and toxins program; high- and maximum-containment laboratories; laboratory biosafety; laboratory biosecurity; policies; regulation.