National Council to Control Animal
Experimentation (CONCEA) and
Alternative methods: How and When?
José Mauro Granjeiro, PhDCouncil to Control Animal Experimentation (Concea)Coordinator
National Institute of Metrology, Quality and Technology - Life Science Applied Metrology DirectoryDeputy Director / Senior Research
Fluminense Federal UniversityAdjunct Professor
Main points
• Brazilian Legislation
• Law 11,794/2008
• CONCEA structure
• Normative Resolution 17 and 18
• Actual scenario
• Challenges
Brazilian Federal Constitution 1988
Article 225, § 1st
all have the right to an ecologically balanced environment, which is
an asset of common use and essential to a healthy quality of life,
and both the Government and the community shall have the duty to defend and preserve it for present and future generations.
VII - protect the fauna and the flora, with
prohibition, in the manner prescribed by law,
of all practices which represent a risk to their
ecological function, cause the extinction of
species or subject animals to cruelty.
Law Nº 9,605/1998.
• Art. 32. Practice abuse, abuse, injure or
mutilate wild, domestic or domesticated,
native or exotic animals
– Penalty - detention of three months to one year
and fine.
– § 1. The same penalties who performs painful or cruel experiments on live animals, even for
educational or scientific purposes, when there
are alternative resources.
The CONCEA is the Brazilian legal
authority responsible to regulate
the use of animals in teaching
and scientific activities
(Law 11,794 / 2008)
Aims
• To discipline the humanitarian and ethical use of
animals with the purpose of teaching, research and
technological development
• To coin Legal Security in relation to the use of animals.
• Legitimate implementation of policies related to the
Control of Animal Experimentation (Ex. Policies
alternative methods).
• Define and make known the penalties for infractions.
• Transparency to societyhttp://www.planalto.gov.br/ccivil_03/_ato2007-2010/2008/lei/l11794.htm
http://www1.jus.com.br/doutrina/texto.asp?id=2026
Sergio Arouca
Law 11,794/2008
• Regulamentation of Art. 225, § 1st. subsections VII
(Brazilian Federal Constitution);
– Creates the National Council to Control Animal
Experimentation – CONCEA
– Establishes procedures for the scientific and teaching use
of animals
– Organizes a "National System" of Animal Experimentation
(CIUCA)
Decree Nº 6.899, 15/07/2009
• Define the composition of the National Council on
Animal Experimentation - CONCEA
– establishes rules for their operation,
– The executive-secretary,
– Creates the Register of Institutions Conducting Animal
Experimentation (CIUCA - Cadastro das Instituições de Uso
Científico de Animais)
Council Members (28)
Minister of Science, Technology and InnovationPresident of Concea
• Ministry of:
a) Science, Technology and
Innovation (Coordinator)
b) Health
c) Education
d) Environment
e) Agriculture, Livestock and
Food Supply
• National Council for Scientific
and Technological
Development
• Council of Rectors of
Universities
• Brazilian Academy of Science
• Brazilian Society for the
Advancement of Science
• Federation of Societies for
Experimental Biology
• Brazilian Society of Science in
Laboratory Animals
• Pharmaceutical Industries
2 representatives (+2 deputy) Societies for the protection of animals
Roadmap
RegulationRegister (CIUCA)
Licensing
Surveillance
Monitoring the
implementation of
Alternative Methods
Permanent chambers
CONCEA
Scientific Research
Teaching LivestockAlternative Methods
Legislation and Dissemination
Normative Resolutions and Guides• Up to 21 Normative Resolutions
– Regulamentação and procedures
• Guides
– Brazilian Code for the Care and Use of Animals for
Scientific and Teaching Purposes - DBCA
– Guide for Euthanasia
– Guide with Minimum criteria for animal facility and
procedures
• Rodents and lagomorphs
• Non-human primates (IN PUBLIC CONSULT until may 25th),
– Dogs and Cats, Birds, Bovine, Horse, Fish, Reptile,
Swine
Decree Nº 6.899, 15/07/2009• Article. 2o consider:
– Alternative methods: internationally validated
and accepted procedures which guarantee
similar and reproducible results to achieve, as far
as possible, the same objective of substituted
procedures by methodologies that:
• Don’t use animals;
• Use animal species of lower order;
• Use less animals;
• Use ex vivo systems; or
• Promote refinement;
15
Replacement
Reduction
Refinement
Recognition of validate alternative
methods
• Normative Resolution 17:
– Established the process for acceptance of
validated alternative methods
Validation Process
RENAMA
BraCVAM
Candidate Assay
BraCVAM Recommendation
Pear Review (scientific
committee)
Accepted?
NoYes CONCEA Decision
(Regulatory Acceptance; Public
Consultation)
External Validation
Accepted?
BraCVAM
No
Yes
Validated and with regulatory acceptance
Method
Official Institutions
Coordination
Publication as
Concea'
Resolution
(enforcement)
Proposed system
under discussion:
validation and
regulatory
acceptance
Normative Resolution 181) Skin irritation and corrosion
• OECD TG 430
• OECD TG 431
• OECD TG 435
• OECD TG 439
2) Ocular irritation and corrosion
• OECD TG 437
• OECD TG 438
• OECD TG 460
3) Phototoxicity
• OECD TG 432
4) Skin Absorption
• OECD TG 428
5) Skin sensitisation
• OECD TG 429
• OECD TG 442A e 442B
6) Acute toxicity
•OECD TG 420
•OECD TG 423
•OECD TG 425
•OECD GD
7) Genotoxicity
•OECD TG 48718
Actual scenario
• Need of human resources and infrastructure
– GLP recognized facilities in Brazil (31 / 2014)
• One for in vitro tests;
• Seven for animal tests;
• Up to 5 years after recognition of alternative
test to prohibit the use of animal;
Challenges• RENAMA – Brazilian Network on Alternative
Methods
– First round
• 5 labs – intercomparison – problems…
– Not following the protocol
– Cells (senescence / mycoplasma)
– Second round
• 3 private labs – service for cosmetic companies
– preliminarily analysis - problems…
• Legal Aspect (commercial use
of human cells
except blood)
• IPS as alternative!!
• Human cell
providers
We must be part of the scientific evolution
of toxicology of 21st Century
Thank you
• More information
– www.inmetro.gov.br
– www.renama.org.br
– José Mauro Granjeiro
• [email protected] - [email protected]
• Bioengineering, Life Sciences Applied Metrology
• +55 21 2145 3221
• +55 21 98702 3433
• http://scholar.google.com.br/citations?user=5peGDJgAAAAJ&hl=pt-BR
• http://www.researcherid.com/rid/D-8289-2012