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National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro, PhD Council to Control Animal Experimentation (Concea) Coordinator National Institute of Metrology, Quality and Technology - Life Science Applied Metrology Directory Deputy Director / Senior Research Fluminense Federal University Adjunct Professor
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National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

Dec 13, 2018

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Page 1: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 2: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

Main points

• Brazilian Legislation

• Law 11,794/2008

• CONCEA structure

• Normative Resolution 17 and 18

• Actual scenario

• Challenges

Page 3: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

MAIN HISTORIC ASPECTS

Brazilian Legislation

Page 4: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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.

Page 5: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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.

Page 6: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

The CONCEA is the Brazilian legal

authority responsible to regulate

the use of animals in teaching

and scientific activities

(Law 11,794 / 2008)

Page 7: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 8: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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)

Page 9: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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)

Page 10: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 11: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

Roadmap

RegulationRegister (CIUCA)

Licensing

Surveillance

Monitoring the

implementation of

Alternative Methods

Page 12: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

Permanent chambers

CONCEA

Scientific Research

Teaching LivestockAlternative Methods

Legislation and Dissemination

Page 13: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

HOW and WHEN???

Page 14: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 15: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 16: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

Recognition of validate alternative

methods

• Normative Resolution 17:

– Established the process for acceptance of

validated alternative methods

Page 17: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 18: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 19: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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;

Page 20: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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

Page 21: National Council to Control Animal Experimentation (CONCEA ... · National Council to Control Animal Experimentation (CONCEA) and Alternative methods: How and When? José Mauro Granjeiro,

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