Provisional Translation

OTO No. 660 Classification MAFF-(8)
MOE-(2)
Date of Acceptance March 6, 2003 Ministry/Agency Receiving Complaint Cabinet Office
Responsible Ministries Ministry of Agriculture, Forestry and Fisheries, Ministry of Environment Related Laws Agricultural Chemicals Regulation Law
Complainant Domestic firm Exporting Countries China
Subject Designation of Chinese agricultural materials as special agricultural chemicals
Description of Complaint 1. In December 2002, the Agricultural Chemicals Regulation Law (1948 Law No. 82) was revised to prohibit any party from manufacturing, processing or importing agricultural chemicals other than those designated by the Minister of Agriculture, Forestry and Fisheries, and the Minister of Environment as special agricultural chemicals that do no harm to agricultural products, humans, livestock and aquatic animals and plants, based on their raw materials, unless they receive a registration number from the Minister of Agriculture, Forestry and Fisheries (Article 2). The revised law also bans anyone from using agricultural chemicals other than the specially designated ones and those with appropriate labeling including registration numbers (Article 11).

2. As public comments were solicited on the designation of the special agricultural chemicals, the complainant submitted a comment calling for designating the complainant's Chinese agricultural material as a special agricultural chemical. Since any response of the ministries in charge of the matter to this comment has been left unknown and since the March 10 date for the implementation of the revised law is approaching, the complainant makes the following requests.

3. According to newspaper and other reports, only baking soda, vinegar and regional natural pest enemies like ladybirds will be designated as special agricultural chemicals.
However, the complainant doubts the advisability of these being designated as special agricultural chemicals since farmers have reported problems including the adverse impact of massive ladybird use on the residential environment, the adverse impact of vinegar on soil-creating microbes (chain effects) and the soil aggregation with baking soda (affecting plant growth).
The complainant asks the ministries to concretely specify the standards that the Agricultural Material Council has used to select them as special agricultural chemicals.

4. On the other hand, the No.1, No.2 and No.3 Chinese agricultural materials that the complainant imports from China have been certified by an accredited Japanese Agriculture Standard certification organization, as materials for production of organic agricultural products as provided in the JAS Law. Regarding uses and purposes of the complainant's Chinese agricultural materials, the organization's MT-0007 JAS certificate for materials and the like certifies (1) No.1 as helpful in preventing pests, (2) No.2 as helpful in preventing diseases and (3) No.3 as helpful in improving soil and invigorating microbes. Their safety and usefulness have been certified.
Furthermore, two research laboratories in their analysis reports, have confirmed the safety of the complainant's Chinese agricultural material. Chinese patent No. 4074 clearly indicates that it is effective in preventing and eliminating bacterial pathogens and pests.

5. Therefore, the complainant wants the ministries to promptly designate No.1 as a special agricultural chemical useful for preventing and eliminating pests, No.2 as a special agricultural chemical useful for preventing and eliminating bacterial pathogens and No.3 as a special agricultural chemical useful for improving soil.

Details of Measures The ministries have replied as follows:
1. As the Agricultural Chemicals Regulation Law was revised to ban the manufacturing, import and use of non-registered agricultural chemicals, the special agricultural chemicals system was introduced to avoid excessive regulations that could require the registration of all pesticides and natural pest enemies that are used by farming households and have no safety problems. The Ministry of Agriculture, Forestry and Fisheries asked the Agricultural Material Council to have its committee of academic experts consider what should be designated as special agricultural chemicals, based on a survey as conducted by the ministry.

2. The committee first excluded those that are not agricultural chemicals and considered whether to give the special agricultural chemicals designation to those that have an evident efficacy as agricultural chemicals and have no safety problems. As a result, candidates for the designation included bacteria-killing baking soda and vinegar whose main components have been proven to have efficacy through the agricultural chemicals registration, as well as natural pest enemy insects. The reasons for selecting these candidates follow:
(1) Baking soda and vinegar dispersed on farm products are considered to be safe to humans, livestock, agricultural products, aquatic animals and plants, etc. because they are used as food.
(2) Although natural pest enemies from outside one region could kill existing ones in the region to affect the local ecological system, those collected in the vicinity of the region are considered to be safe to humans, livestock, agricultural products, aquatic animals and plants, etc.
Based on these reasons, the committee recommended the ministries to designate baking soda, vinegar and natural pest enemy insects since their efficacy and safety were considered to have been confirmed.

3. The designation of the Chinese agricultural materials in question has been withheld because there has been no objective information demonstrating their efficacy. Since materials that can be used for "preventing and eliminating harmful animals and plants on farms" as provided in the JAS for organic farm products do not include the Chinese agricultural materials in question, the JAS certificate for materials and the like, as provided in the complaint, cannot be admitted as a document to confirm that the materials in question can be used for preventing and eliminating pests and diseases. The certificate's descriptions of uses and purposes cannot be admitted as objective information demonstrating efficacy.

4. While the complaint cites the analysis of agricultural chemicals in the agricultural materials in question to claim the safety of the materials, raw materials must be individually proven to be safe to humans, livestock, agricultural products, aquatic animals and plants, etc. before the designation. The absence of chemicals in the materials in question cannot lead the ministries to judge that the safety of the materials is evident.

5. As for those whose designation as special agricultural chemicals has been withheld, the ministries are willing to consider guidelines on efficacy and safety conditions based on views of experts. Building on the consideration of these guidelines, the ministries are planning to decide whether they could be designated as special agricultural chemicals.

6. It is inappropriate to give the special agricultural chemicals designation to individual products (goods) that are made from plural raw materials for the following reasons:
(1) If the designation were to be given on a product-by-product basis, all products including those made by farmers on their own, whose raw materials, components and manufacturing methods differ, would have to be examined for the designation.
(2) If the designation were to be given on a product-by-product basis, manufacturers could change specifications of products to allow sales and use of products that are different from designated ones.
(3) The U.S. minimum list pesticide system subjects substances (raw materials), instead of individual products, to the designation.
Therefore, the ministries base the special agricultural chemicals designation on the consideration of the efficacy and safety for individual raw materials.

Classification of Processing Cc Directions  
Remarks A written reply was made on March 17, 2003.

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