The Ministry of Health, Labour and Welfare (MHLW) is going to implement a so-called "positive list system"- a system to prohibit the distribution of foods that contain agricultural chemicals above a certain level if maximum residue limits (MRLs) have not been established. The agricultural chemicals include pesticides, veterinary drugs and feed additives. This activity is based on the revised Food Sanitation Law published in May 2003. The system will take effect within three years after the publication of the revised law.

The MHLW proposed the first draft of the provisional MRLs in October 2003. It aims to protect public health as well as to avoid unnecessary disruption in food trade when the Japanese positive list system takes effect. The provisional MRLs will be established for chemicals that are domestically authorized under the Agricultural Chemical Control Law, and chemicals for which Codex MRLs or other MRLs are established based on scientific evaluations. The first draft shows the provisional MRLs for 647 agricultural chemicals. As of July 2004, MRLs for 242 pesticides and 30 veterinary drugs are enforced according to the provision in the Article 11, Paragraph 1 of the Food Sanitation Law and the analytical methods for the chemicals are published by the MHLW. In addition the MHLW published an analytical method for multi pesticide residues in 1997.

The National Institute of Health and Sciences (NIHS) has been working to develop analytical methods for the proposed MRLs since fiscal year 2003 in collaboration with official laboratories of local governments and laboratories registered under the Food Sanitation Law. The NIHS plans to continue the project through fiscal year 2005. The NIHS reports a part of the result of the activities in fiscal year 2003 as attached. The NIHS will report further the results from the activity when it is available.

Please note that the analytical method in the attachment is still under consideration. The MHLW will announce the finalized method when the positive list system takes effect.

If you have any questions and comments on this, please contact the following point. Please note that MHLW would not be able to respond to the comments and questions individually under some circumstance.

Attachment

Summary

Regarding the provisional MRLs for pesticides, veterinary drugs and feed additives in the Japanese Positive List System, the following points are examined.

a.

Pesticides (1) Analytical method with GC/MS for multi-residues in crops (2) Analytical method with GC/MS for multi-residues in animal products (3) Analytical method with LC/MS and LC/MS/MS for multi-residues in crops (4) Analytical method for individual residues which cannot be detected in the multi residue method (5) New application with the current official methods under the Food Sanitation Law (6) Documentation of analytical methods for Registration Withholding Limits and other standards

b.

Veterinary Drugs and Feed Additives (1) Analytical methods with HPLC, LC/MS and LC/MS/MS for multi-residues in animal products (2) New application with the current official methods under the Food Sanitation Law (3) Documentation of analytical methods for veterinary drugs domestically used and other standards for veterinary drugs such as Codex Alimentarius (4) Analytical method for individual residues which cannot be detected in the multi residue method (5) Standardization of the analytical methods

Working Plan

a.	Pesticides Fiscal Year 2003   (1), (2) and (4)-(6) in the above for about 240 substances in crops and about 70 substances in animal products Fiscal Year 2004   (1)-(6) for about 250 substances in crops     and about 110 substances in animal products Fiscal Year 2005   Not Determined
b.	Veterinary Drugs and Feed Additives Fiscal Year 2003   (1)-(4) in the above for about 80 substances Fiscal Year 2004   (1)-(5) for about 140 substances Fiscal Year 2005   Not Determined

Results

a.

Pesticides The result from a part of (1) and (2) under "a. pesticide" in the summary are reported. (1) The multi-residues analytical method given in the annex 1(PDF:13KB) was examined for around 120 pesticides in fiscal year 2003. It has been found that the method is applicable for about 90 substances given in the annex 2(PDF:11KB) as the result from add-recovery tests in brown rice, soy bean, potato, spinach, cabbage, apple, and orange. However it is assumed that the method may not be applicable in some crops, MRLs and detection limits. And this method is not applicable for XMC, Isoxathion, Ethion, Endosulfan, Tetradifon, Triazimefon, Propargite, Profenofos, Methidathion(DMTP) in tea excepted powdered green tea. (2) The multi-residues analytical method given in the annex 3(PDF:14KB) was examined in fiscal year 2003. It has been found that the method is applicable for about 60 substances given in the annex 4(PDF:11KB). However it is assumed that the method may not be applicable in some animal products, MRLs and detection limits.

b.

Veterinary Drugs and Feed Additives The Provisional MRLs for 225 veterinary drugs and feed additives shows in the first draft.   The multi-residues analytical methods with HPLC given in the annex 5 and 6(PDF:28KB) were examined for around 90 veterinary drugs in fiscal year 2003. And analytical methods for individual or group residues were examined when the substances are unable to be detected by the multi-residues analytical methods. It has been found that the methods are applicable for about 80 substances given in the annex 7(PDF:18KB).   The multi-residues analytical methods with HPLC will be examined for around 55 veterinary drugs in fiscal year 2004. In 145 veterinary drugs 60 veterinary drugs which standards are not currently available in Japan and 30 substances that are categorized in pesticides are excluded from the project. In addition the method developed in 2003 will be validated.