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

MAIN HISTORIC ASPECTS

Brazilian Legislation

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

HOW and WHEN???

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

• jmgranjeiro@inmetro.gov.br - jmgranjeiro@gmail.com

• 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