Common questions on environmental data for pesticide registration

Time:2019-07-24 Source:CNCIC
According to the requirements of pesticide registration, the common questions of environmental data are as follows:
Validity of test data
1. Test reports shall be issued by qualified institutes for pesticide registration declared by the Ministry of Agriculture (MOA) or by an overseas laboratory which has signed a mutual recognition agreement with relevant department of Chinese government. However, the half-field trail of bees, final residue test of mulberry leaves, acute and chronic test of silkworms should be completed in China.
2. Environmental risk assessment report can be completed by enterprise or the relevant companies entrusted by the enterprise.
3. Test sample shall be sealed by provincial institute for the control of agrochemicals, and the sealed No. shall be indicated in the prominent position in reports; test shall be completed within the validity period of the sample. If the sample is expired, it should be resealed or enterprise provides sufficient evidence to prove the qualification of the product.
Expansion registration
1. For registered product which was in accordance with the old data requirements, if some new risk point exists when the scope of use is increased, environmental information should be supplied. Otherwise, no need to supply relative test data. Chemical pesticides expanded for registration involve new scope of use, environmental risk assessment report should be submitted; biochemical, botanical, and microbial pesticides can be submitted without risk assessments, but relevant environmental documents should be submitted according to the new requirements.
2. If registration on the minor crops is not an expansion of application scope, the data should be complying with the requirements of the field crops, otherwise, there is no need to submit environmental risk assessment.
Environmental test
1. According to the requirements, “the results of TC tests indicate that one of the three organisms of fish, daphnia and algae is sensitive, then the formulation only needs to select sensitive species for testing”, the results here should be the data of TC, but not the query information.
2. If there is no need to register the TK, according to the registration requirements, all the tests of the TK should be completed with formulation.
3. In principle, the auxiliaries used in the formulation should not significantly increase the toxicity; toxicity of the formulation should be close to or lower than TC. When the toxicity of the formulation (calculated as active ingredient) is 100 times higher than TC (or authoritative data) or the toxicity level is increased by more than two grades (except for active ingredient content ≤1%), it would not pass the environmental review.
Environment risk assessment
1.  For products in the form of salt, due to the strong water solubility of salt, theoretically, the fate of the salt and acid in the environment should be different, but if the salt can be proved quickly metabolized to acid in the environment, then the acid data can also be used in risk assessment.
2.  For the aquatic ecological risk assessment, DT50 of the water-sediment system can be used to replace the DT50 of water if the half-life of the water layer dissipation cannot be obtained.
3.  For aquatic ecosystem, when 60% of the scenarios’ RQ<1 and the remaining 40% RQ<10, the risk to the aquatic ecosystem is considered acceptable.
4.  When effect assessment is analyzed by SSD model, the species of vertebrate needs to be increased to 5, and the invertebrate and primary producer need to be increased to 8.
5.  If the crop is not listed in the environmental risk assessment model, crops with similar factors such as plant height, root length and leaf area index can be alternative; or all crops should be evaluated.
6.  Generally, risk assessment would match the relative environmental tests. However, in special cases, such as granules, seed treatment agents with systemic active ingredient, may not be tested for toxicity for bees, but risk assessment for bees should be submitted.
7.  For bees, considering whether the crop is a honey source or pollen source plant, and whether the time of administration overlaps with the flowering period of the plant.
8.  Risk assessment of groundwater, is concerned with related metabolites, both major and minor, soil aerobic metabolites are generally considered for dry fields, metabolites of aerobic, anaerobic and water-sediment systems are generally considered for paddy fields. For the risk assessment of soil organisms, the main metabolites are concerned, which is generally aerobic metabolism of the soil. Risk assessment of soil organisms for rice is not required currently.
9.  In principle, registration of pyraclostrobin, chlorfenapyr, triphenylacetate, fluridazine, hexaflumuron, triflumuron, flubenzuron, chlorbenzuron, flubenzuron, pyrethroids on rice is not acceptable, except for product with acceptable risk after assessment.