MoA Promulgates 2 Rules for Pesticide Labs

MoA Promulgates 2 Rules for Pesticide LabsOn 31 Aug 2017, China MoA issued Announcement 2570 of 2017, releasing two supporting rules for the management of pesticide testing facility: “Rules for the Accreditation on Testing Facility for Pesticide Registration” and “Good Laboratory Practice for the Experimentation of Pesticide Registration”.
 
The regulatory study scope is classified into 5 major categories: product chemistry, efficacy, toxicology, residue and environmental impact and testing facility should apply for the accreditation separately. The accreditation consists of data review and on-site inspection. ICAMA will firstly check the application materials and on-site inspections are organized by the MoA.
 

Product ChemistryEfficacyToxicologyResidueEnvironmental Impact
Full-component test;
Physical chemical properties;
Product quality / storage stability test;
Agricultural and forestry uses:

  • insecticide
  • fungicide
  • herbicide
  • PGR
  • rodenticide field

Hygienic uses(non-crop use):

  • hygienic insecticide
  • rodenticide
  • termite control
  • stored-grain pest control
  • mollusk control
Acute toxicity:

  • oral
  • dermal
  • inhale
  • eye irritation
  • skin irritation
  • skin sensitization

Repeated dosage:

  • sub-acute/chronic oral
  • sub-acute/chronic dermal
  • sub-acute/chronic inhale
  • chronic toxicological study

Specific toxicity:

  • neurotoxicity (acute and delayed)
  • endocrine disruption
  • mutagenicity
  • reproductive toxicity
  • teratogenicity

Metabolism and kinetics
Microbial pathogenicity:

  • acute oral
  • acute inhale
  • acute injection
  • cell culture

Exposure dose quantitation:

  • household insecticide
  • Occupational exposure of pesticide applicator
Metabolism:

  • metabolism in plant
  • metabolism in animal;

Residue in crop:

  • Indoor;
  • field;

Processed agricultural product;

Ecotoxicology
Type A (Short term effect on non-target organism): Avian oral, avian feeding, acute toxicity to fish, Daphnia magna immobilization, algae growth inhibition, Lemna growth inhibition, M. spicatum toxicity, acute oral toxicity to bee, acute contact toxicity to bee, silkworm toxicity, acute toxicity to parasite, acute toxicity predator, acute toxicity to earthworm, effect on soil microbe;
Type B (long term effect study): avian reproduction, fish early-life toxicity, Daphnia magna reproduction, fish bioaccumulation, bee larval development, chronic toxicity to silkworm, earthworm reproduction;
 Type C (simulation): fish lifecycle study,  aquatic ecosystem simulation study(meso-cosmos), bee semi-field study;
 Type D (microbial pesticide): toxicity to avian, toxicity to bee, toxicity to silkworm, toxicity to fish, toxicity to Daphnia manga, proliferation study;
Environmental fate
Type A: hydrolysis, photolysis in water, photolysis in soil surface, soil absorption(batch balancing method), soil leaching, soil absorption(HPLC), method validation test for the determination of pesticide in water; method validation test for the determination of pesticide in soil
Type B: Aerobic metabolism in soil, anaerobic metabolism in soil, Aerobic metabolism in water-sediment system
 

MoA followed the OECD’s GLP principles during development of “Good Laboratory Practice for the Experimentation of Pesticide Registration”. MoA will conduct supervision and investigation of organizations and personnel, quality assurance system and conditions within the laboratory according to the requirements of this regulation.

China has not yet joined the OECD’s MAD (mutual acceptance of data) system and study reports from a China MoA-accredited GLP lab will not be recognized as a GLP report by the receiving/regulatory authority from the destination country while the reports from an overseas OECD GLP lab are accepted by MoA. To expand the acceptance agreements, China has accelerated MAD negotiations with other countries such as the United State and Egypt, etc. In the “Administrative Measures for the Registration of Pesticide”, it is stipulated that MoA will accept product chemistry and toxicity study reports obtained from overseas GLP-compliant laboratories from a country which has mutual or multilateral agreement on data acceptance with China. Meanwhile, MoA is discussing the proposed schedule for rejecting the overseas GLP report from a country/organization which has not yet reached MAD agreement with China.

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