Proposal for a Brazilian Centre on Alternative Test Methods

Last Updated: March 4, 2010

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Chantra Eskes¹*, Jadir Nunes², Octavio Presgrave³, Dermeval de Carvalho⁴, Ekaterina Rivera⁵, Thomas Hartung⁶, Sandra Coecke⁷, Philippe Masson⁸, Joachim Kreysa⁷ and Vanessa de Moura Sá-Rocha⁹

¹ Independent Consultant, Ispra, Italy; ² Brazilian Association of Cosmetology, São Paulo (SP), Brazil; ³ National Institute of Quality Control in Health (INCQS), Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro (RJ), Brazil; ⁴ Biotox, Ribeirão Preto, SP, Brazil; 5 Biological Science Institute, Federal University of Goiás, Brazil; ⁶ Johns Hopkins University, Baltimore, USA and University of Konstanz, Germany; ⁷ ECVAM, In Vitro Methods Unit, Institute for Health and Consumers Protection, European Commission Joint Research Centre, Ispra, Italy; ⁸ EVIC International, Paris, France; ⁹ Natura, Cajamar, SP, Brazil

* Corresponding author:
Chantra Eskes
eskesch@yahoo.com

The following article is a condensed version of an article published in ALTEX: Eskes, C., Sá-Rocha, V., Nunes, J., Presgrave, O., de Carvalho, D., Masson, P., et al. (2009). Draft Proposal for a Brazilian Centre on Alternative Test Methods. ALTEX. 26, 295-298. Available here.

Background

Several initiatives have taken place in Brazil to foster the creation of a center dedicated to alternatives to animal testing. These initiatives include the following:

In 2005, a meeting on alternative test methods for regulatory use named EMALT (Encontro sobre Métodos Alternativos ao Uso de Animais para Fins Regulatórios) was organized by the Brazilian National Institute of Quality Control in Health (Instituto Nacional de Controle e Qualidade Sanitária or INCQS). It comprised around a hundred participants from the Brazilian authorities and major stakeholders in the field of toxicological testing including representatives from the European Centre for the Validation of Alternative Methods (ECVAM). The aim of this meeting was to initiate discussions on the processes of funding, developing, and validating alternative methods in Brazil (Presgrave and Bhogal, 2005).
In 2008, a new law was adopted in Brazil regarding the use of animals for scientific purposes (law n.º 11.794). It establishes amongst other provisions the task to monitor and evaluate the introduction of alternative methods. However, the promotion and dissemination of information on existing alternative methods to the large Brazilian scientific community are not foreseen within such legislation.
In August 2008, Dr. Vanessa Sá-Rocha from Natura, an important Brazilian cosmetics company, organized a meeting among Brazilian regulatory authorities and major stakeholders including ECVAM, to foster discussions again on funding, developing, and validating alternative methods for toxicity testing in Brazil.
In November-December 2008, Dr. Jadir Nunes from the Brazilian Association of Cosmetology, together with Prof. Dermeval de Carvalho, presented a proposal to the Brazilian National Agency of Health Surveillance (Agência Nacional de Vigilância Sanitária or ANVISA) for the creation of a Centre for the Validation of Alternative Methods.
In December 2008, Dr. Octavio Presgrave from the INCQS published a scientific article on "The need for the Establishment of a Brazilian Centre for the Validation of Alternative Methods" (Presgrave, 2008).
In order to streamline the different activities undertaken, Dr. Chantra Eskes acted as a facilitator by establishing a new joint proposal, together with the Brazilian stakeholders currently involved, with the view of setting up a Brazilian Centre on Alternative Test Methods (BCATM; Eskes, et al., 2009). The proposal aims at favoring the development, validating and defining the criteria of acceptance of alternative test methods to be used and/or adapted to the Brazilian regulatory framework. It was proposed as a basis for finding consensus and progressing the initiatives in Brazil.
In May 2009, the BCATM joint proposal was submitted together with the previous initiatives to the ANVISA Brazilian Authority, requesting BCATM's creation. Additional support is also further being sought.

Need for a Brazilian Centre

Regulatory, commercial/industrial, scientific, ethical, national, and international needs would benefit from the creation in Brazil of a centre for the promotion of the 3Rs principles (replacement, reduction, and refinement), and for the validation of alternative test methods.

In the field of regulatory toxicological testing and hazard assessment, several alternatives to animal testing have already been adopted internationally within the Organisation for Economic Cooperation and Development (OECD) Test Guidelines program (e.g., OECD TG 430 to 432, 437, and 438). Several countries/regions have established bodies that focus on the promotion and validation of alternative methods to animal testing, such as ECVAM (Europe/EU), the Interagency Coordinating Committee on the Validation of Alternative Methods or ICCVAM (United States), and the Japanese Center for the Validation of Alternative Methods or JaCVAM (Japan). Other countries, including China, Korea, and India, are establishing similar bodies. The creation of a Brazilian Centre on Alternative Test Methods, and its presence in the national and international arena, represents a requisite to: 1) harmonizing Brazilian standards in the field of alternative methods to animal testing, and whenever applicable its accordance to the internationally agreed guidelines and principles; 2) promoting Brazilian regulatory and commercial requirements in the field of scientific and toxicological testing; and 3) fostering Brazilian communication with international bodies.

Alternative test methods are generally used within industry for screening, efficacy testing, and/or preclinical testing purposes. Brazil is one of the world's largest economies, and has vast natural resources for the potential discovery and exploitation of novel natural ingredients. Relevant alternative methods may be used to reduce the time needed for screening of new ingredients, decrease its costs as well as the number of animals required with the traditional tests. Alternative methods are already recognized as having the potential to be mechanistically more relevant for predicting some human health effects than traditional animal tests, given, for example, the species differences related to differences in metabolism or so-called biotransformation (Coecke, et al., 2006).

Furthermore, recent European legislation calls for the use of non-animal testing. The European Cosmetics Directive has established a marketing ban which entered into force in March 2009 on cosmetic products containing ingredients that have been tested on animals, and since 2004 on finished cosmetic products tested on animals. In addition, the European regulation on chemicals (REACH) requires toxicological information on around 30,000 existing chemicals. As a base-testing requirement for raw materials marketed in volumes greater than10 tonnes/year, information coming from non-animal testing is required. In order for Brazilian industries to strengthen their international market position and benefit from about 500 million European consumers, the promotion and validation of alternative methods will be essential.

The participation of Brazilian academic scientists and other researchers could lead to the development and validation of alternative methods to animal testing which are more readily accessible and less costly for Brazilian needs compared to methods coming from foreign countries. It could also lead to the development of a new market based on novel in vitro technologies, similarly to what is currently occurring in Europe and in the USA.
The Brazilian Centre on Alternative Test Methods would serve as a focal point for information, discussions, and training to the Brazilian scientific community coming from academia and industry, as well as to regulators, in order to favor a harmonized and common understanding of the principles of the 3Rs, of the validation of alternative test methods, and of the various applications alternative methods can have for basic research, industrial testing, and regulatory testing requirements. In addition, a Brazilian Centre would favor the development and validation of alternative test methods to be used and/or adapted to the Brazilian regulatory framework, as well as defining the criteria for their acceptance.

Proposed Activities of a Brazilian Centre

The role of the Brazilian Centre on Alternative Test Methods (BCATM) is to bridge the needs of different stakeholders in Brazil for alternative test methods by offering the following services:

Providing up-to-date information on alternatives to animal testing (the 3Rs principles, standards of internationally agreed requirements, and validated and available alternatives to animal testing) to Brazilian scientists and regulators through a centralized website, database, and publications;
Communicating and networking of interested parties through seminars and workshops;
Identifying current regulatory and non-regulatory needs of available alternatives;
Training and educating on the 3Rs principles, on the principles of validation, and on validated alternative methods;
Participating in and coordinating Brazilian and international validation of alternative methods.

The above proposed activities and a structure for the BCATM have been described in greater detail in the full ALTEX article (Eskes et al., 2009).

The Way Forward for Alternative Methods in Brazil

The creation of a Brazilian Centre on Alternative Test Methods as proposed here could widely benefit the scientific and regulatory applications of alternative methods in Brazil. The development of new industries around the cutting edge biotechnologies could enhance economic development. Having "local" alternative methods available could reduce the time and costs of required testing for new ingredients. Addressing international testing requirements such as recent EU legislation would promote Brazil's participation in international commerce.

The BCATM would be a resource to Brazil scientists and regulators for harmonized education, training, information, consultation, and the coordination of national and international efforts.

Acknowledgement

The authors wish to acknowledge Dr. Sherry Ward for her support and editorial work.

References

Author Biography