| TOP |
| 6th Report of Market Access Ombudsman Council (March 16, 2000) |
1. Complainant: U.S. Embassy
2. Ministry concerned: Ministry of Labor
3. Complaint:
Glutalaldehyde (hereafter referred to as GA), used in hospitals as a disinfectant, was deemed an "existing chemical substances with strong mutagenic properties" under the Industrial Safety and Health Law in October 1998. However, this determination was probably made only on the basis of in vitro test results.
In the United States and Europe, on the other hand, tests made to check for mutagenic properties in GA do not conclude that GA has mutagenic properties only on the basis of in vitro testing; a comprehensive judgment is made using both in vitro and in vivo testing, after which it has been found that mutagenic properties are not a concern.
Accordingly, from the viewpoint of international harmonization of testing methods, test results from foreign countries regarding the mutagenic properties of GA should be accepted and this should be deemed not a concern.
Note: In vitro testing: the chemical substance being tested is added to cells which are cultured and checked for chromosomal abnormalities. In vivo testing: rats or other living organisms are injected with the chemical substance being tested and their cells are checked for chromosomal abnormalities.
4. Corresponding Policy of the Ministries concerned:
In its hazard-assessment testing system, the Ministry of Labor focuses on carcinogenic properties. Tests for mutagenic properties using microorganisms (in vitro) and for chromosomal abnormalities using cell cultures (in vitro) based on Article 57-4 of the Industrial Safety and Health Law are conducted to screen substances for carcinogenic properties. The results of these two hazard-assessment tests determine the presence or absence of mutagenic properties.
As a result, substances evaluated as mutagenic properties are identified as such in announcement from the Director-General of Labor Standards Bureau of the ministry, in order to protect workers from damage for their health, and guidance concerning manufacturing and handling methods is given. Similar announcement has already been carried out for over 100 such substances with the guidance to protect workers from damage for their health. The ministry believes that in vitro testing alone is sufficient for evaluation results of tests for mutagenic properties.
However, since these tests are carried out to screen substances for carcinogenic properties, this issue will be considered separately when it is clear that the substance in question does not have carcinogenic properties.
(Further developments)
In the light of the Ministry of Labor's policies, the complainant submitted documentation to the ministry in November 1999 showing that GA has no carcinogenic properties.
The ministry subsequently replied that since the data submitted did not clearly indicate that testing had been carried out at testing facilities conforming to OECD-GLP standards and conducted in accordance with OECD test guidelines, it was not appropriate to evaluate whether GA had carcinogenic properties or not on this basis and that further documents were required to certify this.
The complainant is currently readying the documents requested by the ministry.
(For reference)
The OECD (Organization for Economic Cooperation and Development) has drawn up OECD test guidelines and OECD-GLP (Good Laboratory Practice), and upon the OECD's recommendation that they be adopted by member countries, the Ministry of Labor amended the relevant laws in May 1988 to mandate that hazard-assessment testing of new chemical substances be carried out according to OECD test guidelines and that such testing of the substances in question be carried out at testing facilities conforming with GLP standards.