Test guidelines for regulatory assessment of pesticides and other chemicals in China

Transcription

1 2014 International Symposium and Autumn Meeting of the KSPS Test guidelines for regulatory assessment of pesticides and other chemicals in China D r. Cai L e i m i n g ( Z A A S, C H I N A ) M r. C h e n T i e c h u n ( I C A M A, C H I N A ) 2 8 O c t o b e r

2 Outline Test Guidelines used for Pesticide Assessment Legislation background Dossier requirement Test guidelines Test Guidelines used for New Chemical Assessment Legislation background Dossier requirement Test guidelines 2

3 Test Guidelines used for Pesticide Assessment 3

4 Legislation Background Regulatory System Main Authority: Ministry of Agriculture (MOA) Regulatory Systems: Registration System Production License System Market Supervision System Application System

5 Legislation Background Legal Framework Regulation on Pesticide Administration (RPA) issued by State Council in 1997, and revised in 2001 and 2003 The Implementation Measures of Regulations on Pesticide Administration (IMRPA) issued by MOA in July,1999 and revised in 2002 and 2007

6 Legislation Background Registration System Data Requirements of Pesticide Registration first issued in 1982 and revised in 1988, 1992, 2001 and 2007 Registration board: The Evaluation and Adjudication Board of Pesticide Registration (EABPR) ICAMA assumes the detailed affairs of pesticide registration authorized by MOA

7 Dossier requirements Basic Technical Data Required for Registration Chemistry Efficacy Residue Toxicology Environmental fate and eco-tox Labeling

8 Test Guidelines 1 Physical Chemical Properties-- Guidance on the Determination of Physico-chemical Properties of Pesticides (NY/T ) Test Guidelines Code No. Reference Part 1: ph NY/T EPA OPPTS Part 2: Acidity and Alkalinity NY/T CIPAC MT191 Part 3: Appearance NY/T EPA OPPTS , 6303, 6304 Part 4:Technical Material Stability NY/T EPA OPPTS Part 5: Ultraviolet / Visibility Absorption NY/T EPA OPPTS Part 6:Explodability NY/T EPA OPPTS Part 7:Photo-transformation in Water NY/T EPA OPPTS Part 8:Partition Coefficient (n-octanol/water) NY/T OECD107,117 Part 9:Hydrolysis NY/T OECD111 Part 10:Oxidation/Reduction: Incompatibility Chemical NY/T EPA OPPTS Part 11:Flash Point NY/T EC A.9 8

9 Test Guidelines 1 Physical Chemical Properties-- Guidance on the Determination of Physico-chemical Properties of Pesticides (NY/T )(cont.) Test Guidelines Code No. Reference Part 12:Fire Point NY/T ASTM 92-05a Part 13:Miscibility with Hydrocarbon Oil NY/T EPA OPPTS Part 14:Saturated Vapour Pressure NY/T OECD104 Part 15:Flammability of Solids NY/T EC A.11 Part 16:Corrosion Characteristics to Packaging Material NY/T EPA OPPTS Part 17:Density NY/T OECD109 Part 18:Specific Optical Rotation NY/T GB/T Part 19:Boiling Point NY/T OECD103 Part 20:Melting Point NY/T OECD102 Part 21:Viscosity NY/T OECD114 Part 22:Solubility NY/T OECD105 9

10 Test Guidelines 2 Toxicological Test Methods of Pesticides for Registration (GB ) published as National Standard in 1995 and effected in guidelines, including acute toxicity (6), subchronic /subacute toxicity (4), accumulation toxicity(1),genetoxicity (in vitro and in vivo,5), teratogenicity, reproduction toxicity, chronic/carcinogencity(3), delayed neuron toxicity, and toxic kinetics. 10

11 Toxicological Test Guidelines of Pesticides for Registration draft National Standards will be published 28 guidelines Test Guidelines 2 11

12 Toxicological Test guidelines Test Guidelines Code No. of Pesticides Reference for Part Registration(draft) 1: General Principles Part 2: Acute Oral Toxicity Test - Horn s method Part 3: Acute Oral Toxicity Test -Up-and-Down- Procedure Test Guidelines 2 Part 4: Acute Oral Toxicity Test-Miller and Taninter s Method GB GB GB GB OECD Guidelines Sec. 4; EPA OPPTS 870 GB OECD 425 EPA OPPTS Part 5: Acute Dermal Toxicity Test Part 6: Acute Inhalation Toxicity Tes Part 7: Dermal Irritation/Corrosion Test Part 8: Acute Eye Irritation/Corrosion Test Part 9: Skin Sensitisation Test Part 10: Short-term Repeated Dose 28-Day Oral Toxicity Study Part 11: Short-term Repeated Dose 28-day Dermal Toxicity Study GB GB GB GB GB GB GB OECD 402; EPA OPPTS OECD 403; EPA OPPTS OECD 404; EPA OPPTS OECD 405 OECD 406 OECD 407; EPA OPPTS OECD 410; EPA OPPTS

13 Test guidelines Code No. Reference Toxicological Test Guidelines of Pesticides for Part Registration(draft)(cont.) 12: Short-term Repeated Dose 28-day OECD 412 Inhalation Toxicity Study Part 13: Subchronic Toxicity Study Part 14: Bacterial Reverse Mutation Test Part 15: In Vivo Mammalian Erythrocyte Micronucleus Test Part 16: In Vivo Mammalian Bone Marrow Cell Chromosome Aberration Test Part 17: Mammalian Spermatogonial/Spermatocyte Chromosome Aberration Test Part 18: Rodent Dominant Lethal Test Part 19: In Vitro Mammalian Cells Chromosome Aberration Test Part 20: In Vitro Mammalian Cell Gene Mutation Test Part 21: Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in Vivo Part 22: DNA Damage and Repair/Unscheduled DNA Synthesis in Mammalian Cells in Vitro Test Guidelines 2 GB GB GB GB GB GB GB GB GB GB GB OECD 408,409; EPA OPPTS ,3465 OECD 471; EPA OPPTS OECD 474;EPA OPPTS OECD 475,; EPA OPPTS OECD 483;EPA OPPTS OECD 478; EPA OPPTS OECD 473; EPA OPPTS OECD 476; EPA OPPTS OECD OECD 482,;EPA OPPTS

14 Test Guidelines 2 Toxicological Test Guidelines of Pesticides for Registration(draft)(cont.) Test guidelines Code No. Reference Part 23: Teratogenicity Part 24: Two generation Reproduction Toxicity Study Part 25: Acute Delayed Neurotoxicity Test Part 26: Chronic Toxicity Study Part 27: Carcinogenicity Study Part 28: Combined Chronic Toxicity/Carcinogenicity Study Part 29: Metabolism and Toxicokinetics Test GB GB GB GB GB GB GB OECD 414; EPA OPPTS OECD 416; EPA OPPTS OECD 418 OECD 452; EPA OPPTS OECD 451, EPA OPPTS OECD 453, EPA OPPTS OECD 417, EPA OPPTS

15 Test Guidelines 3 Environmental fate and ecological effects Guidelines on environmental safety assessment for chemical pesticides (National Standard, ) 8 guidelines on environmental fate 13 guidelines on ecological effects 15

16 Test Guidelines 3 Guidelines on environmental safety assessment for chemical pesticides Part 1 Soil Transformation Part 12 Fish Acute Toxicity Test Part 2 Hydrolysis Part 13 Daphnia sp., Acute Immobilisation Test Part 3 Photo-transformation Part 14 Alga Growth Inhibition Test Part 4 Absorption in Soil Part 15 Earthworm Acute Toxicity Test Part 5 Leaching in Soil Part 16 Soil Micro-organism Toxicity Test Part 6 Volatility Part 17 Trichogramma Toxicity Test Part 7 Bioconcentration Test Part 18 Amphibian Toxicity Test Part 8 Transformation in Water- Sediment Systems Part 10 Effects on Non-target Plants Part 9 Avian Toxicity Test Part 20 Livestock Short-term Diatery Toxicity Test Part 10 Honeybee Acute Toxicity Test Part 21 Crustacean Toxicity Test Part 11 Silkworm Toxicity Test

17 Test Guidelines 3 Aquatic Spp. Zebrafish (Danio rerio) Japanese Medaka(Oryzias latipes) Cyprinoid fish(cyprinus carpio) Daphnia Sp.(Daphnia magna) Green alga (Desmodesmus subspicatus) Xenopus(Xenopus laevis)

18 Test Guidelines 3 Terrestrial Spp. Japanese Quail (Coturnix coturnix japonica) Honey Bees (Apis mellifera) Earthworm (Eisenia foelide) Trichogramma (Trichogramma L) Silkworm (Bombyx mori) Livestock(cattle sheep) Plants

19 Test Guidelines 4 Residue Chemistry Guideline on pesticide residue trials NY/T References OECD Section 5 FAO, Guidelines on Producing Pesticide Residues Data from Supervised Trials. Rome, 1990 USEPA, Residue Chemistry Test Guidelines OPPTS Crop Field Trials,

20 Test Guidelines used for New Chemical Assessment 20

21 Legislation Background Regulatory System Authority: Ministry of Environmental Protection (MEP) Regulations Regulation on Environmental Management of New Chemical Substances (Decree No.17 of SEPA, effected in 2003) revised as Regulation on Environmental Management of New Chemical Substances (Decree No.7 of MEP, effected on 15 th Oct 2010 )

22 Framework of the revised Regulation Chapter 2 Notification Procedures (11 articles) Chapter 1 General provisions (8 articles) Chapter 3 MEP Decree No.7 Registration (9 articles) Chapter 6 Supplementary provisions (3 articles) Chapter 4 Chapter 5 Legal Responsibilities (7 articles) Tracking control (14 articles) 22

23 Dossier Requirements Notification Types Normal notification Level I: 1t notified quantity < 10t Level II: 10t notified quantity < 100t Level III: 100t notified quantity < 1000t Level IV: notified quantity 1000t Simplified notification Basic circumstance: notified quantity < 1t Specific circumstances Record notification Scientific research, notified quantity < 0.1t Imported for conducting eco-toxicity tests of new chemicals within Chinese territory by using Chinese target organism

24 Dossier Requirements for Normal Notification Risk Assessment Report Physical-chemical, toxicological and ecotoxicological properties test report and qualification certificate of the testing agency Classifications and labels Material Safety Data Sheet (MSDS).

25 Testing guidelines of chemicals SEPA Standards Guidelines for the Testing of Chemicals (HJ/T ), revised in 2013 including 186 test methods. Including: Physico-chemical properties, Effects on Biotic systems, Degradation and accumulation, and Health effects. Basically consistent guidelines. the Guidelines have provided a set of methods for China s testing facilities to conduct the test of chemicals. with OECD, ISO and USEPA

26 Effect on biotic systems (HJ/T ) 201 Toxicity of algae growth inhibition 210 Toxicity test of fish early-stage living 202 Acute toxicity of daphnia 211 Daphnia magna reproduction test 203 Acute toxicity of fish 212 Short-term toxicity test of fish embryoyolk sac absorption day prolonged toxicity of fish 213 Honeybees acute oral toxicity test 205 Toxicity test of bird feed daily limit 214 Honeybees acute contact toxicity test 206 Bird reproduction test 215 Larval fish growth test 207 Acute toxicity of earthworms Terrestrial plant growth test Toxicity of respiration inhibition of activated sludge Toxicity of respiration inhibition of activated sludge Soil microbe: nitrogen transformation test Soil microbe: carbon transformation test Test of seed sprouting and root extension Test of seed sprouting and root extension

27 Degradation and Accumulation (HJ/T ) 301 Ready bio-degradation 302C Renovated MITI test (II) 301A DOC subduction test 303A Simulation test --- aerobic sewage treatment: coupling elements test 301B CO 2 evolution test 304A Inherent soil capacity of bio-degradation 301C Renovated MITI test (I) 305 Running water fish test 301D Closed bottle method test 305A Continuous static fish test 301E 301F 302A Renovated OECD selection test Test of respiration measurement method Renovated test of semicontinual activated sludge 305B Semi-static fish test 305C Test of fish bio-accumulation 305D Static fish test 302B Zahn-Wellens Test 399 Absorption and accumulation test

28 Effect on biotic systems(national Standards) GB/T Chemical algae growth inhibition test OECD 201 GB/T Chemical test of daphnia acute activity inhibition OECD 202 GB/T Chemical 14-day test of fish prolonged toxicity OECD204 GB/T Chemical toxicity test of bird feed daily limit OECD205 GB/T Chemical bird reproduction test OECD206 GB/T Chemical earthworm acute toxicity test OECD207 GB/T Chemical respiration inhibition test of activated sludge OECD209 GB/T Chemical toxicity test of fish early-stage living OECD210 GB/T Chemical daphnia magna reproduction test OECD211 GB/T Chemical - short-term toxicity test of fish embryoyolk sac absorption OECD212 GB/T Chemical larval fish growth test OECD215 GB/T Chemical honeybees acute oval toxicity test OECD213 GB/T Chemical honeybees acute contact toxicity test OECD214

29 Degradation and Accumulation (National Standards) GB/T bio-degradation CO 2 evolution test OECD 301B GB/T fast bio-degradation renovated MITI test (II) OECD 302C GB/T Simulation test of aerobic sewage treatment: activated sludge element method OECD 303 GB/T GB/T GB/T GB/T Accelerated bio-degradation DOC subduction test Accelerated bio-degradation renovated MITI test (I) Accelerated bio-degradation closed bottle method test Inherent bio-degradation renovated test of semi-continual activated sludge OECD 301A OECD 301C OECD 301D OECD 302A

30 Degradation and Accumulation (National Standards) GB/T GB/T Accelerated degradation renovated OECD selection test Accelerated bio-degradation respiration measurement method test OECD 301E OECD 301F GB/T Inherent bio-degradation Zahn-Wellens Test OECD 302B GB/T Seawater bio-degradation shake-flask method test OECD 306 GB/T Seawater bio-degradation closed bottle method test OEC D306 GB/T Bio-accumulation semi-static fish test OECD 305B GB/T Bio-accumulation running water fish test OECD 305

31 Conclusions Keep our test guidelines consistent with international level Keep to perfect our test methods system Keep in touch with international experts Many works need to do in compliance with MAD

32 Welcome to Hangzhou!

33 THANKS 감사합니다. 蔡磊明中华人民共和国浙江省浙江省农业科学院 Cai Leiming Zhejiang Institute of Agricultural Science, Zhejiang Province, P. R. China 陈铁春中华人民共和国农业部 农药检定所 Chen Tiechun Institute for the Control of Agrochemicals, MOA, P. R. China