NEW! Japan’s Ministry of Health, Labor and Welfare (MHLW) Implements New Regulations

1 May 2006

Similar to U.S. regulations regarding residues of agricultural chemicals in food

Schering-Plough Animal Health

556 Morris Avenue
Summit, New Jersey 07901
(908) 473-3336
Luis Fernandez, Senior Product Manager
Swine Business Unit

Dear Valued Customer:

As you may be aware, Japan will implement new regulations on May 29, 2006 for residues of agricultural chemicals in food. Japan’s Ministry of Health, Labor and Welfare (MHLW) is adopting a regulation similar to that used in the United States, featuring a "positive list" with maximum residue limits (MRL) for specific residues. Veterinary residues exceeding these MRLs or residues exceeding the default tolerance of the "uniform limit" (0.01 ppm) in meat and poultry products for which there is no MRL, cannot be marketed in Japan and could be rejected at the port after implementation of the new regulation. A few agriculture chemicals will be regulated with a "no residue" standard.

The MRLs for veterinary drugs may vary widely between Europe, Japan and the U.S. (Click here) Therefore, a U.S.-based producer of animal-derived food must be cautious when using U.S. approved drugs in animals that may be exported. Producers or anyone using these materials must understand that the U.S. regulatory procedures for both establishing withdrawal periods for veterinary drugs and testing for violative residues may be different from those used in Japan and other countries.

Japan and the U.S. may not test the same tissues. MRLs (or tolerances) in the U.S. have historically been established for only one tissue (i.e., the marker tissue). As international trade has become more important, many regulatory agencies and the Codex Alimentarius are establishing MRLs for multiple tissues. If Japan tests tissues other than the U.S. marker tissue, then the U.S. withdrawal periods may not be predictive of test results for those other tissues.
Information is available for only four tissues. The U.S. Food and Drug Administration requires manufacturers to develop residue depletion data on four edible tissues: muscle, liver, kidney and fat. For most U.S. products, there will be no or limited information available relative to residue depletion in by-products or other tissues. If Japan tests by-products or tissues other than the U.S. marker tissue, the U.S. withdrawal periods may not be predictive of test results for those other tissues.
Japan and the U.S. may not test for the same residue. In formulating practices, producers should ensure that the residue for which Japan is testing is the same residue for which the U.S. MRL is established. Products often have multiple metabolites, and Japan’s testing for a metabolite, which is different from that for which testing is conducted in the U.S., may cause the U.S. information to not be predictive of test results.
Japanese and U.S. analytical methods may differ. Information relative to the U.S. withdrawal period and tissue depletion is only valid if the analytical method used in the Japanese import testing program is the same as the U.S. method used to generate this information.
Product formulations may differ. A withdrawal period is generally formulation dependent. Therefore, a recommended withdrawal period for one formulation may not be applicable to another manufacturer’s product, even though it may contain the same active ingredient or be the same dosage form.
Sampling of injection sites. In the U.S., injection sites are not utilized to determine withdrawal times or tissue depletions. Residue levels may be higher at injection sites. If Japan should happen to test an injection site, residue levels may be above the MRL level, even after the approved U.S. withdrawal period.

I hope the above background information is useful in understanding the pending MRL regulatory program in Japan. We have attached a table that includes MRLs and withdrawal times for products approved in the U.S. and sold by Schering-Plough Animal Health Corporation. As you will note, there may be significant differences between what Japan utilizes as a guideline for safe residue levels and what is used in the United States. This is similar to the situation that occurred in the mid 1990s with chlortetracycline.

Meat that is produced in the U.S. and destined for Japan should follow the most conservative withdrawal time listed to ensure that will satisfy both U.S. and Japanese law. This information is intended as a guide, and does not replace the need for a comprehensive plan to avoid having violative residues in meat produced for U.S. consumption or in exports of meat products to Japan.

You are encouraged to speak with one of our technical services veterinarians listed below for more information and to further discuss the information.

SWINE:
Dr. Doug Hutchinson 800-962-1269 (Ext. 8172)
Dr. Robyn Fleck 800-962-1269 (Ext. 8406)
Dr. Chun Zhou 800-962-1260 (Ext. 8140)

Schering-Plough Animal Health (SPAH) has provided this information as a service to our customers and has attempted to convey accurate information. SPAH does not represent, imply, guarantee, warrant or assume any legal liability or responsibility for the accuracy or completeness of information contained in the attached table relating to the Japan MRLs, and urges you to contact the Japan Ministry of Health, Labor and Welfare for the most complete, accurate and up-to-date information on MRLs. SPAH shall have absolutely no liability in connection with any residues in meat products exported to Japan.

Very truly yours,

Fernando Riaza, DVM
VP Global Swine Business

Luis R. Fernandez, DVM
Sr. Marketing Manager

Greg Lage
Sales Manager

Robyn Fleck, DVM
Technical Services

Chun Zhou, DVM, PhD
Technical Services

Doug Hutchinson, DVM
Technical Services