Basic Knowlegde of Agricultural Chemicals
3. Registration system for agricultural chemicals
(1) Registration system for agricultural chemicals
The entire process from manufacturing, importing to selling, utilizing agricultural chemicals is strictly regulated in accordance with the Agricultural Chemicals Regulation Law, to ensure the safety of these chemicals (Historically, the regulations focused on selling, but the revision in December 2002 added manufacturing, importing and utilizing regulations). The registration system plays a central role in these regulations, in which only the agricultural chemicals registered by the nation (the Ministry of Agriculture, Forestry and Fisheries) are permitted, with some exceptions, to be manufactured, imported, and sold.
(2) Procedures for registration
Manufacturers and importers of agricultural chemicals must apply for registration via the Incorporated Administrative Agency Food and Agricultural Materials Inspection Center to the Minister of Agriculture, Forestry, and Fisheries, accompanied by the materials to confirm the quality and safety of the relevant agricultural chemicals. This includes various test results concerning the efficacy against diseases and pests, negative effect on crops, toxicity to humans, and residue in crops, etc. It takes approximately 10 years and several billion yen to develop a new agricultural chemical (Fig. 3).
Figure 3. Procedures for development & research of a new agricultural chemical (Data from Japan Crop Protection Association)
Agricultural chemicals are used in crops for food, and consideration must also be given to their effect on the environment. Sufficient tests should be conducted to ensure the safety of these chemicals and organisms.
(3) Scheme of Evaluation
In response to the application, the Ministry of Agriculture, Forestry and Fisheries directs the Incorporated Administrative Agency Food and Agricultural Materials Inspection Center to evaluate whether the relevant agricultural chemical is suitable for registration. Food and Agricultural Materials Inspection Center , Agricultural Chemicals Inspection Station conducts thorough evaluations with regard to the test results submitted, on efficacy, toxicity, and crop and soil residual properties, and then reports the results to the Ministry of Agriculture, Forestry and Fisheries. This is done to ensure that they are of proper quality and that they are correctly and safely used. From these results, the Ministry then decides whether the relevant agricultural chemical should be registered (Fig. 4).
Figure 4. Flowchart of registration system
(4) Items for Evaluation
Food and Agricultural Materials Inspection Center conducts evaluations on efficacy, phytotoxicity, safety, and quality of the agricultural chemical.
A Evaluation of efficacy
This evaluation is conducted to examine whether the relevant agricultural chemical is effective for controlling diseases, pests, and weeds, when used in accordance with the methods specified in the application form.
B Evaluation of phytotoxicity
This evaluation is conducted to ensure that the agricultural chemical does not have harmful effect on the target or the surrounding crops, when used in accordance with the methods specified in the application form.
C Evaluation of safety
This evaluation is conducted concerning the safety of producers, consumer exposure by chemical-added agricultural products, and environment exposure.
In order to confirm the safety for these, the applicant is required to conduct a number of studies on toxicity, residues, effects on the environment and other items, in reliable study institutions. Food and Agricultural Materials Inspection Center evaluates the results submitted, and comprehensively estimates the effects of the agricultural chemicals on humans and the environment.
Human and livestock toxicity studies are divided into 2 main branches, acute and chronic. Acute toxicity studies examine the toxicity when a large amount of agricultural chemical is ingested in a short period of time, that is, mainly the effects on users. Chronic toxicity studies examine the toxicity when a small amount of agricultural chemical is ingested for a long period of time, that is, the effects on consumers of chemical-added agricultural products.
A list of the study results to be submitted is shown below (Table 3).
- (1) Study results of efficacy
- Study results of efficacy on the indicated diseases and pests
(For agents used to promote or inhibit the physiology of field crops and other products, study results of efficacy on the relevant crops and products shall be submitted.)
- Study results of efficacy on the indicated diseases and pests
- (2) Study results of phytotoxicity
- A Phytotoxicity on the applied crops
- B Phytotoxicity on the surrounding crops
- C Phytotoxicity on the succeeding crops
- (3) Study results of toxicity
- Acute toxicity studies
- A Acute oral toxicity study
- B Acute dermal toxicity study
- C Acute inhalation toxicity study
- D Skin irritation study
- E Eye irritation study
- F Skin sensitization study
- G Acute neurotoxicity study
- H Acute delayed neurotoxicity study
- Study on mid-and long-term effects
- I 90-day repeated oral toxicity study
- J 21-day repeated dermal toxicity study
- K 90-day repeated inhalation toxicity study
- L Repeated oral neurotoxicity study
- M 28-day repeated dose delayed neurotoxicity study
- N 1-year Repeated oral toxicity study
- O Carcinogenicity study
- P Reproduction toxicity study
- Q Teratogenicity study
- R Mutagenicity study
- Studies that are informative in considering the treatment of acute intoxication
- S Pharmacology study
- Studies that are informative in understanding agricultural chemical metabolic pathway in animals and plants and the structure of metabolites
- T Studies of metabolic fate in animals
- U Study of plant metabolism
- Studies of environmental effects
- V Study of soil metabolism
- W Study of water metabolism
- X Study of effects on aquatic organisms
- Y Study of effects on beneficial organisms other than aquatic organisms
- Z Study of physical characteristics, stability and degradability for active ingredients
- AA Study of derivation of predicted environmental concentration
- Acute toxicity studies
- (4) Residue studies
- A Study of residue in crops
- B Study of residue in soil
D Standards to withhold registration
The Agricultural Chemicals Regulation Law proclaims that the standards shall be established by the nation from the standpoint of preventing residue in crops and soil, harm to humans, livestock, and aquatic organisms due to water pollution, and that the nation shall confirm for each application that the relevant agricultural chemical does not exceed the standards.
These standards are called "Standards for withholding registration,” because the registration is withheld if the agricultural chemical is decided, as a result of examination, to exceed the standards. These are established and notified by the Minister of the Environment. As for the standards of the residue in crops, food standards (the Maximum Residue Level), which is in accordance with the Food Sanitation Law, serves as the standards for withholding registration (Fig. 5).
Figure 5. The Maximum Residue Level, the standards for withholding of agricultural chemicals registration, and the Standards for Agricultural Chemical Use
