DATA REQUIREMENTS Checklist and File Index for HS Applications

Transcription

1 DATA EQUIEENTS and ile Index f HS Applications Send to Environmental Protection Authity preferably by (HSApplications@epa.govt.nz) alternatively by post (Private Bag 63002, Wellington 6140) Payment must accompany application; see our fees and charges schedule f details. Please use this document f guidance on how to provide the filenames f the data included with your application and to confirm what you have provided. This completed document must be submitted along with the main application fm f chemical pesticides containing a new active ingredient f any application with suppting studies. Applicants making an application f a substance other than a chemical pesticide that contains a new active ingredient (e.g. a new veterinary medicine, pure chemical, biological pesticide), should consult with the EPA with respect to the data requirements needed to suppt such applications. Name of the substance to be approved Date

2 2 Data equirements Index and Guidelines This document outlines the specific data requirements f approval of a chemical pesticide with a new active ingredient. It is intended to be used as a checklist f applicants to confirm that all data have been provided, and to serve as an index which EPA staff can use to readily identify studies in the supplied dossier. ecommendations f how files should be named are made below, however if you choose to use your own naming system, you must ensure that files are named in a systematic, logical and infmative manner. ecommended filenames iles should be named as follows: Categy_SectionowNumber_Title_SubstanceType_UniqueIdentifier.pdf Where: Categy: T Toxicology studies; E Ecotoxicology studies; E Environmental ate P Physico-chemical studies example: T_3.1_Acute_al_toxicity_AI_Study1.pdf Substance Type: AI Active ingredient mulation etabolite If multiple studies are supplied, unique identifiers (such as the labaty study number O company study number) must be included at the end of the file name e.g. T_3.2_Genotoxicity_in_vitro bacteria.pdf To increase process efficiency, after a single unique identifier is selected, please ensure naming consistency throughout all files you may also want to include in the file name the ganism name/type used in the study. If a substance has multiple active ingredients, an active ingredient has multiple metabolites, numbers can be used to differentiate these (e.g. AI1, AI2, 1, 2). Please ensure that you provide the code names f the active ingredients, fmulation and metabolites. required () studies must be provided if they are already available. If studies are not provided, these may be requested by the EPA. Studies should be perfmed accding to GLP (Good Labaty Practice). Non-GLP studies will be evaluated on a case by case basis. Not all studies and available guidelines are listed below. When studies have been conducted with other test methods, repts of these studies must also be provided to the EPA. Studies have to be perfmed accding to the most recent version of the guideline.

3 3 Data equirements Index and General notes Please note that new studies may not be the only way of meeting the data requirements, but all endpoints that are indicated as required must be addressed. If you consider that a study is not required then you must provide a statement to justify why the infmation is not necessary. This statement should have a logical and infmative file name. EPA policy is to minimise the use of animals in mammalian toxicology studies wherever technically and scientifically feasible. You should gather and evaluate all available infmation befe considering further testing. These data include physico-chemical properties, (Q)SA, read-across, in vitro data, animal studies, and human data. If you want us to read-across infmation from another (similar) substance then you will need to justify why it is scientifically valid to read across the infmation. Tests on vertebrate animals should be undertaken only where no other validated methods are available. Alternative methods to be considered include in vitro methods and in silico/(q)sa methods. eduction and refinement methods f in vivo testing are also encouraged to minimise the number of animals used in testing. Toxicological infmation can be obtained from unpublished studies, databases and publications such as books, scientific journals, criteria documents, monographs and other publications. If you do not own the data that you want to use to suppt your application, you will need to supply a Letter of Access 1 signed by the owner of the data so that we can use the data to assess your product. You may need a letter of access f repts produced by other regulats such as an EU Draft Assessment ept (DA). Befe you conduct new tests to determine the hazardous properties of a substance, you should assess all the infmation that is available f that substance. You should also consider the possible effects of components on the toxic potential of the total mixture. You should avoid conducting new in vivo testing with crosive substances at concentration/dose levels that are known to cause crosivity. Specific test strategies f skin and eye crosion/irritation testing are included in the EPA s User Guide to Thresholds and Classifications under the HSNO Act ( We encourage you to discuss the need to perfm supplementary studies with us befe conducting the studies, so that the studies meet our needs. instance, we can discuss the parameters to be investigated and the objectives to be achieved (f example, f products containing active ingredients other components suspected of having synergistic additive toxicological effects). 1 Letter of Access (LoA) is a document, signed by the owner owners of relevant data protected under the provisions of a egulation, which states that these data may be used by the Authity f the purpose of the assessment of a product. In principle the LoA gives permission to refer to a certain study set of studies, but it does not transfer ownership.

4 4 Data equirements Index and We expect applicants to provide a quantitative risk assessment (modelling) to suppt their application. In the event that these data are not available, the EPA will use default values f the exposure modelling.

5 5 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 1. Identification 1A. Discussion of fmation of impurities B. Certified limits C. Identity of the active substance WHO/AO Physical/chemical properties 2A. Colour B. Physical state C. Odour Please identify whether it is the Pure AI (PAI) the Technical AI (TAI)

6 6 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 2D. Self-heating A.15/A16/Test N.4 2E. lammability / lash point /A.9/A.1 0/A.11/ A.12/ Test N.1 2. Explosive properties /A.14 2G. ph OECD 122/ / CIPAC T 75.3/ CIPAC T 31/CIPAC T 191 2H. elting point OECD 102/ I. Boiling point/boiling range OECD 103/

7 7 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 2J. Density/relative density/bulk density / OECD 109/ CIPAC T 186 2K. Dissociation constants in water OECD 112/ L. Partition coefficient (n-octanol/water), OECD 107/ / OECD 117/ / OECD Water solubility 2N. Vapour pressure OECD 105/ OECD 104/ Crosion characteristics

8 8 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 2Q. Viscosity OECD 114/ Solubility in ganic solvents CIPAC ethod T 181 2S. Surface tension OECD 115/ethod A.5 2T. Oxidising properties A.17/ A.21/ Test O.1/: Test O.3/ Test O.2 2U. Particle size distribution OECD 110/ / CIPAC T 185/ CIPAC T 187/ CIPAC T 170/CIPAC T 187

9 9 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 3. Toxicological studies 3.1 Acute toxicity 3.1A. Acute al toxicity / OECD 401/ OECD 420/ OECD 423/ OECD B. Acute dermal toxicity / OECD C. Acute inhalation toxicity / OECD 403/ OECD To address animal welfare concerns, the OECD Guidance Document on Considerations f Waiving Bridging of ammalian Acute Toxicity Tests (Series on Testing & Assessment No. 237) should be taken into account when considering testing f acute toxicity, skin and eye irritation/crosion and skin sensitisation. Justification should be provided f all waivers.

10 10 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 3.1D/ Acute skin irritation/crosion / OECD 404/ OECD 430/ OECD 431/ OECD 435/ OECD E. Acute eye irritation / OECD 405/ OECD 437/ OECD 438/ OECD 491/ OECD Skin sensitization / OECD 406/ OECD 429/ OECD 442A/ OECD 442B/ OECD 442C/ OECD 442D 3.2 Genotoxicity 3.2A. In vitro studies / OECD 471/OECD 487/ / OECD 476/ OECD 490

11 11 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 3.2B. In vivo studies in somatic cells / OECD 474/ OECD 475/ OECD 488/ OECD C. In vivo studies in germ cells / OECD 483/ OECD Sht term toxicity 3.3A. epeated dose 28- day toxicity study in rodents / OECD 407/ / OECD 410/ OECD B. epeated dose 90- day al toxicity study in rodents / 712-C / OECD 408

12 12 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 3.3C. epeated dose 90- day al toxicity study in non-rodents / OECD D. epeated dose 90- day inhalation toxicity study in rodents / OECD E. epeated dose 90- day dermal toxicity study in rodents / OECD eproductive and developmental toxicity 3.4A. eproduction/ Developmental Toxicity Screening Test / OECD B. Combined epeated Dose Toxicity Study with the eproduction/developme ntal Toxicity Screening Test / OECD 422

13 13 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 3.4C. Prenatal Developmental Toxicity Study / OECD D. One-Generation eproduction Toxicity Study OECD E. Two-Generation eproduction Toxicity OECD Long term toxicity and carcinogenicity 3.5A. Chronic Toxicity/carcinogenicity / OECD 451/ / OECD 452/ / OECD Neurotoxicity 3.6A. Neurotoxicity studies in rodents / OECD 424

14 14 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 3.6B. Delayed polyneuropathy studies / OECD 418/ / OECD Absption, distribution, metabolism and excretion 3.7A. Toxicokinetics / OECD B. Dermal absption OECD 428/ OECD D. The screening and testing of potential endocrine disrupters OECD 455/ OECD 457/ OECD Exposure moniting 4.1 Applicat exposure moniting 4.1A. Dermal exposure - outdo B. Dermal exposure -

15 15 equired () - Active ecommended (,, ) equired - mulation () - etabolite indo Data equirements Index and ilename(s) 4.1C. Inhalation exposure - outdo D. Inhalation exposure - indo E. Biological moniting Post-application exposure moniting 4.2A. oliar Dislodgeable esidue Dissipation B. Soil esidue Dissipation C. Dermal Exposure D. Inhalation Exposure

16 16 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 4.2E. Biological moniting Bystander exposure 4.3A. Dermal Exposure 4.3B. Inhalation Exposure 4.3C. Oral Exposure 5. Transpt in environmental media 5.1 obility in soil 5.1A. Adsption/desption batch equilibrium OECD 106/ B. Leaching studies in soil column OECD 312/ C. Lysimeter studies OECD 22

17 17 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 5.1D. ield leaching studies 5.2 Abiotic degradation 5.2A. Hydrolysis as function of ph OECD 111/ B. Photodegradation in water (photolysis) OECD 316/ C. Photodegradation on soil (photolysis) D. Photodegradation in air Biological degradation Biodegradation in water 5.3.1A. eady biodegradability OECD 301/ OECD 310/

18 18 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) / B. Aerobic mineralization in surface water simulation biodegradation test OECD 309/ C. Biodegradability in sea water OECD 306/ D. Aerobic aquatic metabolism OECD 308/ E. Anaerobic aquatic metabolism OECD 308/ Aquatic (sediment) field dissipation Biodegradation in soil 5.3.2A. Inherent OECD 304A/

19 19 equired () - Active ecommended (,, ) equired - mulation () - etabolite biodegradation in soil Data equirements Index and ilename(s) 5.3.2B. Aerobic soil metabolism OECD 307/ / ISO : C. Anaerobic soil metabolism OECD 307/ D. ate of degradation in soil Based on the results of the above mentioned studies 5.3.2E. Terrestrial field dissipation estry dissipation G. Combination and tank mixes (USEPA)

20 20 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) Bioconcentration/Bioaccumulation studies 5.3.3A. Bioaccumulation in ish OECD B. Bioaccumulation in Terrestrial Oligochaetes OECD C. Bioaccumulation in Sediment-dwelling Benthic Oligochaetes OECD Volatility from soil 5.4A. Labaty volatility B. ield volatility Ecotoxicological studies 6.1 Aquatic ecotoxicity Sht-term studies 6.1.1A. ish acute toxicity test, freshwater and marine OECD 203/

21 21 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) B. ish acute toxicity mitigated by humic acid C. ish Embryo Acute Toxicity (ET) Test OECD D. Aquatic invertebrate acute toxicity (freshwater daphnids) / OECD E. Gammarid acute toxicity test Oyster acute toxicity test (shell deposition) G. ysid acute toxicity test

22 22 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.1.1H. Penaeid acute toxicity test I. Bivalve acute toxicity test (embryo larval) J. reshwater alga and cyanobacteria growth inhibition OECD 201/ / K. Aquatic plant toxicity test using Lemna spp OECD 221/ Long term studies 6.1.2A. ish life cycle toxicity OECD 210/ / / OECD

23 23 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 212/ OECD 215/ OECD B. Daphnia magna reproduction test OECD 211/ C. ysid chronic toxicity test D. Effects on aquatic macrophytes AST E / OECD 239/ OECD 238/ Other aquatic studies 6.1.3A. Generic freshwater microcosm test, labaty B. Site-specific aquatic microcosm test, labaty

24 24 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.1.3C. ield testing f aquatic ganisms D. Aquatic food chain transfer Sediment ecotoxicity 6.2A. Sediment-water Chironomid toxicity using spiked sediment OECD 218/ / B. Sediment-water Chironomid toxicity using spiked water OECD C. Sediment-water Chironomid life-cycle toxicity test using spike water spiked sediment OECD D. Whole sediment acute toxicity

25 25 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) invertebrates, marine 6.2E. Tadpole/sediment subchronic toxicity test Soil ecotoxicity Earthwms and other invertebrates 6.3.1A. Earthwm acute test A.I OECD B. Earthwm subchronic toxicity test A.I C. Earthwm reproduction test (Eisenia fetida/eisenia andrei) OECD D. Earthwm field studies ISO : 2014 Part 3.

26 26 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.3.1E. Enchytraeid reproduction test OECD Predaty mite (Hypolaspis [Geolaelaps] aculeifer) reproduction test in soil OECD G. Collembolan reproduction test in soil OECD H. Determination of development toxicity of a test chemical to Dipteran dune flies OECD icroganisms 6.3.2A. Soil microganism: nitrogen and carbon transfmation test OECD 216/ OECD 217/

27 27 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.3.2B. Soil microbial community toxicity test Plants 6.3.3A. Seedling emergence / / OECD B. Terrestrial plant vegetative vigour / / OECD C. Seed germination, root elongation D. Early seedling growth

28 28 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.3.3E. hizobiumlegume toxicity Plant uptake and translocation test G. Terrestrial plants field study Other soil tests 6.3.4A. Terrestrials soilce microcosm test Terrestrial vertebrates 6.4A. Avian acute al toxicity test (non-dietary) A.I / OECD 223

29 29 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.4B. Avian dietary toxicity test A.I / OECD C. Avian reproduction test / OECD D. Wild mammal acute toxicity E. ield testing f terrestrial wildlife Terrestrial invertebrates bees and other beneficial arthropods Effects on bees 6.5.1A. Honey bee acute al toxicity A.I OECD B. Honey bee acute contact toxicity A.I OECD 214/

30 30 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.5.1C. Honey bee toxicity of residues on foliage D. Honey bee larval toxicity test, single exposure A.I OECD E. Honeybee brood feeding test OECD Series No Chronic toxicity to bees No validated guideline available 6.5.1G. Sub-lethal effects No validated guideline available 6.5.1H. Cage and tunnel tests OECD 75/ EPPO 170

31 31 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s) 6.5.1I. ield tests with honeybees EPPO J. ield testing f pollinats OCSPP Effects on other beneficial arthropods 6.5.2A. Standard labaty testing f nontarget arthropods testing with Aphidius rhopalosiphi and Typhlodramus pyri A.I.P. Candolfi, S. Blümel,. ster et al. (2000) 4 : 6.5.2B. Extended labaty testing f nontarget arthropods, aged residue studies with non-.p. Candolfi, S. Blümel,. ster et al. 4 Guidelines to evaluate side- effects of plant protection products to non-target arthropods. IOBC, BAT and EPPO Joint Initiative. ISBN:

32 32 - Active - mulation - etabolite (,, ) equired () equired () ecommended target arthropods (2000) 4 / ead- Briggs,.A., oll,., Grimm, et al (2010) 5. Data equirements Index and ilename(s) 6.5.2C. Semi-field studies with non-target arthropods.p. Candolfi, S. Blümel,. ster et al. (2000) D. ield studies with non-target arthropods.p. Candolfi, S. Blümel,. ster et al. (2000) Other concerns 6.6A. Endocrine disrupting properties OECD 229/ OECD 231/ OECD 234/ OECD 240/ OECD 24/OCSPP 5 An extended labaty test f evaluating the effects of plant protection products on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae). BioControl 55: Guidelines to evaluate side- effects of plant protection products to non-target arthropods. IOBC, BAT and EPPO Joint Initiative. ISBN:

33 33 Data equirements Index and - Active - mulation - etabolite (,, ) equired () equired () ecommended ilename(s)