07/06/11

Brazil Joins OECD Agreement To Share Data

Brazil recently joined the OECD Agreement on mutual acceptance of chemical data. The country is the fifth non OECD member country to join the agreement.

Mutual Acceptance of data

The Council of the OECD can adopt legal instruments such as, in the area of chemicals, the decision regarding the mutual acceptance of data (MAD, Decision of 1981[1]). This decision, which is binding on member countries, provides "that data generated in the testing of chemicals in an OECD Member country in accordance with OECD Test Guidelines and OECD Principles of Good Laboratory Practice shall be accepted in other Member countries for purposes of assessment and other uses relating to the protection of man and the environment".

In order to carry out the MAD decision, the OECD adopted:

Guidelines for the testing of chemicals. These contain methods that the member countries have to follow.
Principles for good laboratory practice (GLP). The compliance with the GLP is ensuring by laboratories established in the member countries.

To fully implement this system, the member countries have to pass national procedures for monitoring compliance. The national authority which will be in charge of monitoring compliance will exchange information on compliance and also supply information regarding the procedures of its country.

In 1997 the Council issued a further Decision concerning the Adherence of non-Member Countries to the Council Acts related to the Mutual Acceptance of Data in the Assessment of Chemicals.

This has allowed Brazil to lodge a request to adhere to the MAD agreements in 1998, and become a provisional member in 2007, and an effective one on 9 May 2011. So far Brazil's participation is limited to pesticides, industrial chemicals and biocides. The next step in its participation will be a review of its involvement in the field of medical products.

Implementation in Brazil

In Brazil, the organism connected to the GLP is the National Institute of Metrology, Standardization and Industrial Quality (INMETRO), an executive agency of the Brazilian Ministry of Development, Industry and Foreign Trade.

In the framework of Inmetro, there are several responsible organs:

• Cgcre/inmetro: General Coordination for Accreditation of Inmetro is the authority in charge of the compliance monitoring for the GLP within the institute.
• Dicla: The Laboratory Accreditation Division is in charge of the activities related to the monitoring and recognition of the test facilities in accordance with the GLP Principles.

The interest of third countries for joining the MAD scheme reveals the efficiency of these agreements, as well as the benefits that countries which become members can gain from their membership. In addition of an obvious economic gain, a harmonization of the different national legislations may allow increased safety, reduces animal testing, and eliminates non-tariff trade barriers.

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