3rd Report of the Market Access Ombudsman Council (March 18, 1996)

1-(4) International Harmonization for Veterinary Drug Residue Standards in Edible Meats

1. Complainant: Tokyo Chamber of Commerce and Industry

2. Ministry concerned: Ministry of Health and Welfare

3. Background Information:

Under the Food Sanitation Law of Japan, the Minister of Health and Welfare, from the viewpoint of public health, may establish standards of foods for sale. It is prohibited to sell or import food products that do not conform to the standards. Of the veterinary drug used in the production of livestock and cultivated fish, antibiotics and synthetic antibacterial agent must be kept out of meat, poultry meat, and fish and shellfish for fear of affecting the health of the people who consume food products containing these chemicals.

An international organization (Joint FAO/WHO Food Standards Programme Codex Alimentarius Commission) is currently advancing the establishment of international standards (Codex Alimentarius) for veterinary drug remaining in food products. As of July 1995, the Commission made recommendations on international standards for fifteen substances.

As for foreign countries, the United States has standards on the residue values for approximately 80 substances in animal medicine, including antibiotics, synthetic antibacterial agent, hormones and anthelmintics. EU plans to establish residue standards for all substances used as veterinary drugs in EU by the end of 1996. At present, EU has residue standards on 40 substances.

Because scientific evaluations have recently been established both in Japan and abroad on the effect of consuming food products containing antibiotics and synthetic antibacterial agent on the health (i.e. establishment of evaluation techniques and accumulation of testing data), it has become possible to establish the safety standards of some substances in food products that would have no effect on the health when consumed (including effects on the bacteria in the digestive tubes). The ministry concerned claims that it will introduce the principles of MRL (maximum residue level) that the EU and Codex Alimentarius Commission adopted, and successively set MRLs for those substances for which international standards have been established and the data for safety evaluation are available. In December 1995, the ministry concerned set MRLs for six substances. The ministry concerned will continue to establish MRLs for each substance for which the data necessary for safety evaluation will become available.

As for Naicarbazin, which has been pointed out by the complainant, the United States sets its MRLs in poultry of 4.00 ppm. However, no residue standard level has been set in Japan, EU, or Codex Alimentarius Commission.

4. Complaint:

The following complaint was raised.

In Japan, absolutely no chemical residue is permitted in edible meats, which is quite different from the international standard that allows residue of approximately 0.1 ppm (depending on the chemical). For example, whereas the domestic tolerance for Naicarbazin (antibacterial agent) in poultry is 0.03 ppm, or detection limit, the tolerance standard of the FSIS (an institution under the U.S. Department of Agriculture) is 4.00 ppm, i.e. more than 100 times the domestic standard. Therefore, the Japanese standard should be alleviated to bring it in line with the international standard. The ministry concerned claims that it will not immediately set a MRLs because the safety of Naicarbazin has yet to be evaluated by an international institution. However, Japan should set its own standard level. In addition, an inspection certificate should be accepted in lieu of conducting a domestic inspection for poultry imported from Brazil.

5. Results of Deliberation:

The ministry concerned claims that the data required for evaluating the safety of Naicarbazin, an example of the problems, are not available around the world and so it cannot immediately establish the residue standard level. However, no major problem has occurred in the United States for approximately 20 years, which should serve as sufficient safety data.

It is clear that Japan is lagging behind the United States and EU in the establishment of MRLs, so it is expected by the rest of the world to take a more active approach. Consequently, the ministry concerned should take the actions listed the below.

The ministry concerned recognizes that the domestic inspection of Naicarbazin, which is mandated for the import of poultry from Brazil, may be omitted if a residue prevention measure including appropriate inspection in Brazil, is taken. The discussion with the Brazilian government is under way.

(1) The ministry concerned plans to clarify the deliberation schedule at the Food Safety Council for MRLs for which international standards have been already established and bring the standards in line with the international standards as soon as possible. In this case, the ministry concerned should clarify and announce what veterinary drugs it plans to set MRLs for and when these standards will be established. In addition, when the standard setting work at the international institution reaches a certain stage, Japan should also begin to prepare for establishing MRLs for veterinary drugs and establish the standards as soon as possible.

(2) As for veterinary drugs for which no international standards have been set, the ministry concerned should collect data, consult the Food Safety Council, including on the feasibility of accepting the standard levels of the United States, EU, etc., and advance the establishment of domestic MRLs at an early date.

In addition, for substances for which there is a great need to establish MRLs, the ministry concerned should contribute to the establishment of international standards by submitting to the international institution data on safety and other means.

(3) The ministry concerned should further expedite the deliberation by the Food Safety Council on the establishment of MRLs for veterinary drugs in food products.

(4) In establishing MRL for each veterinary drug, the ministry concerned should prepare a priority list based on requests from within Japan and abroad and announce the list as well as the standard establishment schedule during fiscal year 1996.

Government decision (March 26, 1996)

1-(4) International Harmonization for Veterinary Drug Residue Standards in Edible Meats

(1) The deliberation schedule at the Food Safety Council for MRLs (maximum residue levels), for which international standards have been already established, will be clarified and the standards will be brought in line with the international standards as soon as possible. In this case, the ministry concerned will clarify and announce what veterinary drugs it plans to set MRLs for and when these standards will be established. In addition, when the standard setting work at the international institution reaches a certain stage, preparations for establishing MRLs for veterinary drugs will be undertaken and the standards will be established as soon as possible.

(2) As for veterinary drugs for which no international standards have been set, the ministry concerned will collect data, consult the Food Safety Council, including on the feasibility of accepting the standard levels of the United States, EU, etc., and advance the establishment of domestic MRLs at an early date.
In addition, for substances for which there is a great need to establish MRLs, contributions will be made to the establishment of international standards by submitting to the international institution data on safety and other means.

(3) The deliberation by the Food Safety Council on the establishment of MRLs for veterinary drugs in food products will be further expedited.

(4) In establishing MRL for each veterinary drug, a priority list will be prepared based on requests from within Japan and abroad and will be announced during fiscal year 1996 together with the standard establishment schedule.

Follow-up (May 12, 1997)

1-(4) International Harmonization for Veterinary Drug Residue Standards in Edible Meats

(1) There are 12 substances for which the Codex Alimentarius Commission has recommended that international standards (Codex standards) for MRL in food products be established. In addition to oxytetracycline and five other substances for which standards have already be established in Japan (December 1995, implemented July 1996), standards for sulfadimitine and four other substances will be set in March 1997 (scheduled to be implemented in October 1997).

(2) Regarding Japan's contribution by collecting data on safety and helping establish international standards for substances for which there is a great need to establish MRL, Japanese committee members will continue to collect a broad range of data and provide information on safety to the Joint FAO/WHO Expert Committee for Food Additives (JECFA) which evaluates toxicity.

(3) Where establishment of MRL for veterinary drugs in food products is concerned, the work of the Food Safety Council will be streamlined and deliberations will be expedited by having sub-committees conduct specialized evaluations (on toxicity and drug tolerance).

(4) A priority list for the establishment of MRL for individual veterinary drugs was released in March 1997. It listed five substances, including moxydectin, for which the establishment of standards will be deliberated immediately, and others (azaperone and 13 others) for which the establishment of standards will be deliberated, after providing of the necessary data.