Jan. 9, 2008
The Japanese agrochemical industry has expressed concern at the prospect of significant cost increases from government proposals to change registration data requirements. The Japanese Ministry of Agriculture, test facility officials and the Japan Crop Protection Association (JCPA) are discussing the draft changes, which include an increase in data on maximum residue levels (MRLs).
In a bid to harmonise the current field trial system for crop residues, the government plans to introduce the internationally recognised GLP system as a replacement for the Japanese "official trial" system. Currently, the registration procedure requires two sets of field trial data conducted by a government body and two chemical analyses, one carried out by an official laboratory and one by a private laboratory. The proposals would require eight sets of crop residue studies and one chemical analysis. The system would be opened up to allow private companies to conduct the trials and tests.
While the industry does not object to the introduction of GLP, members of the JCPA regard the cost implications as a "serious problem". Concerns have also been raised about possible deficiencies in testing facilities, including adequate capacity to cope with the extra trials. Discussions are focusing on the scale of the extra trials needed. Government officials point out that the new system would accept data that has been produced in other countries. The regulatory authorities hope to conclude the discussions as soon as possible to enable early implementation of the changes.
Efficacy trials are also currently conducted under the official trial system. It is envisaged that the conduct of these studies will also be opened to private companies that have suitable facilities to maintain data confidentiality. Currently, six two-year trials are required for each crop/pest registration.
The other proposed change under discussion relates to additional data on MRLs in fish. Under the current system, residue data for fish are required only for pesticides with a bioconcentration factor of above 5,000. However, the Ministry wants to extend this data requirement to all pesticides, including those for non-crop use. The change reflects the introduction in 2006 of the Japanese -positive list" for MRLs for specific pesticides in food.
The Ministry plans to bring the fish residue data requirements into force for new registrations in April 2008. For existing registrations, it proposes that approval holders should submit a fish residue study by the end of 2008.