Minutes of Env. Data Requirement Workshop
Date: May 24, 2017
Time: 9:00 - 12:00
Venue: 8th conference room, no.5 building, Yongan hotel.
A No.5 Nongzhanguan bei road, Chaoyang district, Beijing.
Host by: ICAMA
Participants:
Company | Representation |
ICAMA | Deputy Chief Agronomist: Mr. JIANG Hui (joined the meeting later) Director of Env Division: Mr. WANG Shoushan(only a short period) Deputy Director of Env. Division: Dr. YUAN Shankui (chaired the meeting) Env. Division: Mr. Zhou Yanming |
CLC | Yaping Liu ( CLC ) Xiao Mei Zhang (BASF) Dr. Li Zhaoqiang (CERA, SYN) Dr. Haytham Shbaita (CERA, BASF) |
Experts and CROs | Prof. LI Chongjiu(University of Agriculture) Dr. SHAN Zhengjun(NIES) Dr . WU (Zhejiang CAAS) Dr. Chen Lang(Shenyang Safety Evaluation Centre) Dr. TANG Baohua (Xishan Zhongke) Dr. ZHANG Hongtao (Fuoshan Safety Evaluation Centre) Prof. ZHANG Xing(Northwest University of Agriculture) |
CAPDA | 1 representative |
Local ICAs | Representative from Beijing, Zhejiang, Guangdong, Guangxi, Hunan |
Industry | Domestic Industrial representatives from Noposion and Guanxi Tianyuan |
Minutes:
New data requirements:
-- Will be issued in the form of announce by MoA at a later point of time.
-- Framework of new requirements is based on different types of pesticide instead of registration types & application of pesticide in current status.( e.g. chemical, biochemical, microbial etc. ).
-- For repacking ,no data will be required.
-- TC data of public health pesticide and rodenticide will be not written down into the context of data requirements, but will be as the note of data requirements' attachment.
-- 3 registration types of TC: new, equivalent, non-equivalent.
Registration types of formulation: new formulation, new formulation type, new content, new ready-mixture, unregistered application scope, unregistered application method, me-too ( same scope and method ), me-too ( different scope and method ), metoo ( same scope and method ), me-too ( different scope and method ) etc.
Draft new Env. data requirement:
-- Materials: the materials were shared during the meeting, and had to be returned back after the meeting finished. Different types of pesticide are classified along with a table ( like chemical incl. TC & formulation, bio-chemical incl. TC & formulation, microbial incl. TK & formulation etc.) , which is described in the materials listed the test item in first column and a following explanation/introduction/trigger for per test item in second column.
-- ICAMA shall have a separated table indicating which studies can be accepted from global GLP data and which studies need to be done in China.
Key changes of draft new Env. data requirements:
Chemicals:
Efate data
- Volatility test is not required because the model input parameter only needs vapor pressure.
- The column leaching test is incorporated into the ad test: conduct ads/dis test first and if the compound is very low absorbing conditionally a column leaching test is required.
- The original soil residue test is replaced by the TFD and water body dissipation study (no guidance available on the latter).
- The analytical method and validation for soil and water samples are separated from the residue study becoming new env data requirements.
- Some small changes for example BCF test is NOT needed if the LogPow < 3 or DT50 is <5 days at different buffer solutions (hydrolysis)
Ecotox data
- More chronic tests are required. Bird repro test is required, which was originally required for rodenticide.
- Fish ELS test is required for ai (unconditional) and FLCT test is conditionally required.
- Daphnia repro test, bee larval development test and silkworm chronic test are required only for IGR ai.
- Amphibian acute test is not required, but Amphibia metamorphy test is required with the condition that developmental toxicity or teratogenicity in results of fish ELS test and FLCT test.
- Aquatic plant test is newly required for herbicide ai, non-target plant test is revoked.
- NTA test for predator is required in addition to the test on parasitic NTA.
- Earthworm repro test is conditionally required. Carnivore indirect poison id required for rodenticide.
-- Public health formulation applied indoor use: Silkworm tests are waived.
-- Others: briefly introduced the changes of data requirement for biopesticides, microbial pesticides and botanical pesticides.
Participants' key comments:
-- Structure of the date requirement: it was suggested to make it clearer and organized, e.g. core data, higher tier, waivers separately listed etc, It was also suggested that compounds with “special” properties need special requirements.
--It was also raised at the workshop that the risk vs. benefit needs to be considered when reviewing applications. Science should be the base when addressing specific issues. Should not be too rigid in the decision-making process.
--Risk assessment report is newly required for applicator, most of participants were worried that enterprises do not have the ability to set up the report.
CERA comments:
--The anaerobic soil metabolism test. Due to limited value in risk assessment restrict to 1 soil and paddy field.
--For the soil adsorption/desorption & column leaching test: Update the information and discussion that is going around the OECD 106,further information will be provided also on other testing methods for low sorbing compounds.
--Bird short term feeding test: OECD is not requiring this test due to limited scientific value, kindly ask ICAM A to reconsider, supporting information will be provided.
--Chronic test: Suggested to set up clear guidance on when commonly conditional chronic test are triggered.
--Species required: Indicator species are commonly used worldwide covering local species due to commonly higher sensitivity. Furthermore hatching experience and statistical interpretation is given with established indicator species: further supporting information will be provided.
Croplife China
June 7, 2017