Protecting our way of life | EPA · Web viewOPPTS 870.2500/ OECD 404/ OECD 430/ OECD 431/ OECD 435/...

Send to Environmental Protection Authority preferably by email ([email protected]) or alternatively by post (Private Bag 63002, Wellington 6140) Payment must accompany application; see our fees and charges schedule for details.

DATA REQUIREMENTS Checklist and File Index for HS Applications

Please use this document for guidance on how to provide the filenames for the data included with your application and to confirm what you have provided. This completed document must be submitted along with the main application form for chemical pesticides containing a new active ingredient or for any application with supporting studies.

Applicants making an application for a substance other than a chemical pesticide that contains a new active ingredient (e.g. a new veterinary medicine, pure chemical, or biological pesticide), should consult with the EPA with respect to the data requirements needed to support such applications.

Name of the substance to be approved

Date

www.epa.govt.nz

mailto:[email protected]

2

Data Requirements – Index and Checklist

Guidelines

This document outlines the specific data requirements for approval of a chemical pesticide with a new

active ingredient. It is intended to be used as a checklist for 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. Recommendations for 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 informative manner.

Recommended filenames

Files should be named as follows:

Category_SectionRowNumber_Title_SubstanceType_UniqueIdentifier.pdf

Where: Category: Substance Type:

T – Toxicology studies; AI – Active ingredient

E – Ecotoxicology studies; F – Formulation

EF – Environmental Fate M – Metabolite

P – Physico-chemical studies

For example: T_3.1_Acute_oral_toxicity_AI_Study1.pdf

If multiple studies are supplied, unique identifiers (such as the laboratory study number OR company

study number) must be included at the end of the file name e.g.

T_3.2_Genotoxicity_in_vitro_F_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 organism name/type

used in the study.

If a substance has multiple active ingredients, or an active ingredient has multiple metabolites,

numbers can be used to differentiate these (e.g. AI1, AI2, M1, M2). Please ensure that you provide the

code names for the active ingredients, formulation and metabolites.

Conditionally required (CR) studies must be provided if they are already available. If CR studies are

not provided, these may be requested by the EPA.

Studies should be performed according to GLP (Good Laboratory 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, reports of these studies must also be provided to the EPA. Studies have to be

performed according to the most recent version of the guideline.

May 2019

3


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 information is not necessary. This

statement should have a logical and informative 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 information before considering

further testing. These data include physico-chemical properties, (Q)SAR, read-across, in vitro data,

animal studies, and human data. If you want us to read-across information from another (similar)

substance then you will need to justify why it is scientifically valid to read across the information. 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)SAR methods.

Reduction and refinement methods for in vivo testing are also encouraged to minimise the number of

animals used in testing.

Toxicological information 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 support your application, you will need to supply a Letter of Access1

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 for reports produced by other regulators such as an EU Draft Assessment Report

(DAR).

Before you conduct new tests to determine the hazardous properties of a substance, you should

assess all the information that is available for 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 corrosive substances at concentration/dose

levels that are known to cause corrosivity. Specific test strategies for skin and eye corrosion/irritation

testing are included in the EPA’s User Guide to Thresholds and Classifications under the HSNO Act

(www.epa.govt.nz/Publications/ER-UG-03-2.pdf). We encourage you to discuss the need to perform

supplementary studies with us before conducting the studies, so that the studies meet our needs. For

instance, we can discuss the parameters to be investigated and the objectives to be achieved (for

example, for products containing active ingredients or other components suspected of having

synergistic or additive toxicological effects).

1 Letter of Access (LoA) is a document, signed by the owner or owners of relevant data protected under the provisions of a Regulation, which states that these data may be used by the Authority for the purpose of the assessment of a product. In principle the LoA gives permission to refer to a certain study or set of studies, but it does not transfer ownership.

May 2019

http://www.epa.govt.nz/Publications/ER-UG-03-2.pdf

4


We expect applicants to provide a quantitative risk assessment (modelling) to support their application.

In the event that these data are not available, the EPA will use default values for the exposure

modelling.

May 2019

5


Endpoint & Test title

Tested “Substance”

A.I. - Active ingredient2

F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or

Conditionally Required (CR)

Recommended guideline(s)

Checklist Filename(s)

1. Identification

1A. Discussion of formation of impurities A.I. R OPPTS

830.1670 Data provided

EPA check

1B. Certified limits A.I. R OPPTS 830.1750

Data provided

EPA check

1C. Identity of the active substance A.I. R WHO/FAO 2010

Data provided

EPA check

2. Physical/chemical properties

2A. ColourA.I.

FR OPPTS


EPA check

2B. Physical stateA.I.

FR OPPTS


EPA check

2C. OdourA.I.

FR OPPTS


EPA check

2D. Self-heatingA.I.

FR A.15/A16/Test

N.4

Data provided

EPA check

2E. Flammability / Flash point

A.I. ROPPTS 830.6315/A.9/A.

Data provided

May 2019

6




A.I. - Active ingredient

F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




F 10/A.11/ A.12/ Test N.1

EPA check

2F. Explosive propertiesA.I.

FR

OPPTS 830.6316/A.14

Data provided

EPA check

2G. pHA.I.

FR

OECD 122/ OPPTS 830.7000/ CIPAC MT 75.3/ CIPAC MT 31/CIPAC MT 191

Data provided

EPA check

2H. Melting point A.I. ROECD 102/ OPPTS 830.7200

Data provided

EPA check

2I. Boiling point/boiling range A.I. R

OECD 103/ OPPTS 830.7220

Data provided

EPA check

2J. Density/relative density/bulk density

A.I.

F

ROPPTS 830.7300/ OECD 109/ CIPAC MT 186

Data provided

EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




2K. Dissociation constants in water A.I. R

OECD 112/ OPPTS 830.7370

Data provided

EPA check

2L. Partition coefficient (n-octanol/water), A.I. R

OECD 107/ OPPTS 830.7550/ OECD 117/ OPPTS 830.7570/ OECD 123

Data provided

EPA check

2M. Water solubility A.I. ROECD 105/ OPPTS 830.7840

Data provided

EPA check

2N. Vapour pressure A.I. ROECD 104/ OPPTS 830.7950

Data provided

EPA check

20. Corrosion characteristics F CR OPPTS


EPA check

2Q. Viscosity F CR OECD 114/ OPPTS 830.7100

Data provided

EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




2R. Solubility in organic solvents A.I. R CIPAC Method

MT 181 Data provided

EPA check

2S. Surface tension A.I. R OECD 115/Method A.5

Data provided

EPA check

2T. Oxidising propertiesA.I.

FR

A.17/ A.21/ Test O.1/: Test O.3/ Test O.2

Data provided

EPA check

2U. Particle size distribution

A.I.

FCR

OECD 110/ OPPTS 830.7520/ CIPAC MT 185/ CIPAC MT 187/ CIPAC MT 170/CIPAC MT 187

Data provided

EPA check

3. Toxicological studies3.1 Acute toxicity

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




3.1A. Acute oral toxicity3

A.I.

F

M

R

R

CR

OPPTS 870.1100/ OECD 401/ OECD 420/ OECD 423/ OECD 425

Data provided

EPA check

3.1B. Acute dermal toxicity

A.I.

F

M

R

R

CR

OPPTS 870.1200/ OECD 402

Data provided

EPA check

3.1C. Acute inhalation toxicity

A.I.

F

M

R

R

CR

OPPTS 870.1300/ OECD 403/ OECD 436

Data provided

EPA check

3.1D/ Acute skin irritation/corrosion

A.I.

F

M

R

R

CR

OPPTS 870.2500/ OECD 404/ OECD 430/ OECD 431/ OECD 435/ OECD 439

Data provided

EPA check

3 To address animal welfare concerns, the OECD Guidance Document on Considerations for Waiving or Bridging of Mammalian Acute Toxicity Tests (Series on Testing & Assessment No. 237) should be taken into account when considering testing for acute toxicity, skin and eye irritation/corrosion and skin sensitisation. Justification should be provided for all waivers. https://www.oecd.org/env/ehs/testing/mono%202016%2032.pdf

May 2019

https://www.oecd.org/env/ehs/testing/mono%202016%2032.pdf

10





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




3.1E. Acute eye irritation

A.I.

F

M

R

R

CR

OPPTS 870.2400/ OECD 405/ OECD 437/ OECD 438/ OECD 491/ OECD 492

Data provided

EPA check

3.1F. Skin sensitization

A.I.

F

M

R

R

CR

OPPTS 798.4100/ OECD 406/ OECD 429/ OECD 442A/ OECD 442B/ OECD 442C/ OECD 442D

Data provided

EPA check

3.2 Genotoxicity

3.2A. In vitro studiesA.I.

M

R

CR

OPPTS 870.5100/ OECD 471/OECD 487/ OPPTS 870.5300/ OECD 476/ OECD 490

Data provided

EPA check

3.2B. In vivo studies in somatic cells

A.I. R OPPTS 870.5395/

Data provided

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




M CR

OECD 474/ OPPTS 870.5385

OECD 475/ OECD 488/ OECD 489

EPA check

3.2C. In vivo studies in germ cells

A.I.

F

M

CR

OPPTS 870.5380/ OECD 483/ OECD 478

Data provided

EPA check

3.3 Short term toxicity

3.3A. Repeated dose 28-day toxicity study in rodents

A.I.

F

M

CR

OPPTS 870.3050/ OECD 407/ OPPTS 870.3200/ OECD 410/ OECD 412

Data provided

EPA check

3.3B. Repeated dose 90-day oral toxicity study in rodents

A.I.

M

R

CR

OPPTS 870.3100/ OPPTS 712-C-98-199/ OECD 408

Data provided

EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




3.3C. Repeated dose 90-day oral toxicity study in non-rodents

A.I.

M

R

CR

OPPTS 870.3150/ OECD 409

Data provided

EPA check

3.3D. Repeated dose 90-day inhalation toxicity study in rodents

A.I.

MCR

OPPTS 870.3465/ OECD 413

Data provided

EPA check

3.3E. Repeated dose 90-day dermal toxicity study in rodents

A.I.

MCR

OPPTS 870.3250/ OECD 411

Data provided

EPA check

3.4 Reproductive and developmental toxicity

3.4A. Reproduction/ Developmental Toxicity Screening Test

A.I.

MCR

OPPTS 870.3550/ OECD 421

Data provided

EPA check

3.4B. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test

A.I.

MCR

OPPTS 870.3650/ OECD 422

Data provided

EPA check

3.4C. Prenatal Developmental Toxicity Study

A.I.

M

R

CR

OPPTS 870.3700/ OECD 414

Data provided

EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




3.4D. One-Generation Reproduction Toxicity Study

A.I.

M

R

CROECD 415

Data provided

EPA check

3.4E. Two-Generation Reproduction Toxicity

A.I.

M

R

CROECD 416

Data provided

EPA check

3.5 Long term toxicity and carcinogenicity

3.5A. Chronic Toxicity/carcinogenicity

A.I.

M

R

CR

OPPTS 870.4200/ OECD 451/ OPPTS 870.4100/ OECD 452/ OPPTS 870.4300/ OECD 453

Data provided

EPA check

3.6 Neurotoxicity

3.6A. Neurotoxicity studies in rodents

A.I.

MCR

OPPTS 870.6200/ OECD 424

Data provided

EPA check

3.6B. Delayed polyneuropathy studies

A.I.

M

CR OPPTS 835.6100/ OECD 418/

Data provided

EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




OPPTS 835.6100/ OECD 419

3.7 Absorption, distribution, metabolism and excretion

3.7A. Toxicokinetics A.I. CROPPTS 870.7485/ OECD 417

Data provided

EPA check

3.7B. Dermal absorption

A.I.

F

M

R

R

CR

OECD 428/ OECD 427

Data provided

EPA check

3.7D. The screening and testing of potential endocrine disrupters

A.I.

MCR

OECD 455/ OECD 457/ OECD 493

Data provided

EPA check

4. Exposure monitoring4.1 Applicator exposure monitoring

4.1A. Dermal exposure - outdoor F R OPPTS


EPA check

4.1B. Dermal exposure - indoor F R OPPTS


EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




4.1C. Inhalation exposure - outdoor F R OPPTS


EPA check

4.1D. Inhalation exposure - indoor F R OPPTS


EPA check

4.1E. Biological monitoring F CR OPPTS


EPA check

4.2 Post-application exposure monitoring

4.2A. Foliar Dislodgeable Residue Dissipation

F R OPPTS 875.2100

Data provided

EPA check

4.2B. Soil Residue Dissipation F CR OPPTS


EPA check

4.2C. Dermal Exposure F R OPPTS 875.2400

Data provided

EPA check

4.2D. Inhalation Exposure F CR OPPTS


EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




4.2E. Biological monitoring F CR OPPTS


EPA check

4.3 Bystander exposure

4.3A. Dermal Exposure F R Data provided

EPA check

4.3B. Inhalation Exposure F R

Data provided

EPA check

4.3C. Oral Exposure F R Data provided

EPA check

5. Transport in environmental media5.1 Mobility in soil

5.1A. Adsorption/desorption batch equilibrium

A.I.

M

R

CR

OECD 106/ OPPTS 835.1230

Data provided

EPA check

5.1B. Leaching studies in soil column

A.I.

M

CROECD 312/ OPPTS 835.1240

Data provided

EPA check

5.1C. Lysimeter studies A.I. CR OECD Series on Testing an

Data provided

May 2019

17





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




M

Assessment No. 22. Guidance Document for the Performance of Out-door Monolith Lysimeter Studies (2000).

EPA check

5.1D. Field leaching studies

A.I.

MCR

Data provided

EPA check

5.2 Abiotic degradation

5.2A. Hydrolysis as function of pH A.I. R

OECD 111/ OPPTS 835.2120

Data provided

EPA check

5.2B. Photodegradation in water (photolysis) A.I. R

OECD 316/ OPPTS 835.2240

Data provided

EPA check

5.2C. Photodegradation on soil (photolysis) A.I. R OPPTS


EPA check

5.2D. Photodegradation in air A.I. CR OPPTS


EPA check

May 2019

18





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




5.3 Biological degradation

5.3.1 Biodegradation in water

5.3.1A. Ready biodegradability A.I. R

OECD 301/ OECD 310/ OPPTS 835.3110/ OPPTS 835.3140

Data provided

EPA check

5.3.1B. Aerobic mineralization in surface water – simulation biodegradation test

A.I.

MCR

OECD 309/ OPPTS 835.3190

Data provided

EPA check

5.3.1C. Biodegradability in sea water A.I. CR

OECD 306/ OPPTS 835.3160

Data provided

EPA check

5.3.1D. Aerobic aquatic metabolism

A.I.

MR

OECD 308/ OPPTS 835.4300

Data provided

EPA check

5.3.1E. Anaerobic aquatic metabolism

A.I.

MCR

OECD 308/ OPPTS 835.4400

Data provided

EPA check

May 2019

19





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




5.3.1F. Aquatic (sediment) field dissipation

A.I.

MCR OPPTS


EPA check

5.3.2 Biodegradation in soil

5.3.2A. Inherent biodegradation in soil

A.I.

M

R

CR

OECD 304A/ OPPTS 835.3300

Data provided

EPA check

5.3.2B. Aerobic soil metabolism

A.I.

M CR

OECD 307/ OPPTS 835.4100/ ISO 10381-6:2009

Data provided

EPA check

5.3.2C. Anaerobic soil metabolism

A.I.

MCR

OECD 307/ OPPTS 835.4200

Data provided

EPA check

5.3.2D. Rate of degradation in soil

A.I.

M

R

CR

Based on the results of the above mentioned studies

Data provided

EPA check

5.3.2E. Terrestrial field dissipation

A.I.

MCR OPPTS


EPA check

May 2019

20





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




5.3.2F. Forestry dissipation

A.I.

MCR OPPTS


EPA check

5.3.2G. Combination and tank mixes (USEPA)

F CR OPPTS 835.6400

Data provided

EPA check

5.3.3 Bioconcentration/Bioaccumulation studies

5.3.3A. Bioaccumulation in Fish A.I. CR

OECD 305 / OCSPP 850.1730

Data provided

EPA check

5.3.3B. Bioaccumulation in Terrestrial Oligochaetes

A.I.

FCR OECD 317

Data provided

EPA check

5.3.3C. Bioaccumulation in Sediment-dwelling Benthic Oligochaetes

A.I.

FCR OECD 315

Data provided

EPA check

5.4 Volatility from soil

5.4A. Laboratory volatility

A.I.

MCR OPPTS


EPA check

May 2019

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F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




5.4B. Field volatilityA.I.

MCR OPPTS


EPA check

6. Ecotoxicological studies

6.1 Aquatic ecotoxicity

6.1.1 Short-term studies

6.1.1A. Fish acute toxicity test, freshwater and marine

A.I.

F

M

R

CR

OECD 203 / OCSPP 850.1075

Data provided

EPA check

6.1.1B. Fish acute toxicity mitigated by humic acid

A.I.

MCR OPPTS

850.1085 (draft) Data provided

EPA check

6.1.1C. Fish Embryo Acute Toxicity (FET) Test

A.I.

MCR OECD 236

Data provided

EPA check

6.1.1D. Aquatic invertebrate acute toxicity (freshwater daphnids)

A.I.

F

M

R

R

CR

OECD 202 / OCSPP 850.1010

Data provided

EPA check

6.1.1E. Gammarid acute A.I. CR OCSPP Data provided

May 2019

22





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




toxicity testF

M850.1020 EPA check

6.1.1F. Oyster acute toxicity test (shell deposition)

A.I.

F

M

CR OCSPP 850.1025

Data provided

EPA check

6.1.1G. Mysid acute toxicity test

A.I.

F

M

CR OCSPP 850.1035

Data provided

EPA check

6.1.1H. Penaeid acute toxicity test

A.I.

F

M

CR OCSPP 850.1045

Data provided

EPA check

6.1.1I. Bivalve acute toxicity test (embryo larval)

A.I.

F

M

CR OCSPP 850.1055

Data provided

EPA check

6.1.1J. Freshwater alga and cyanobacteria growth inhibition

A.I.

F

M

R

R

CR

OECD 201 / OCSPP 850.4500 / OCSPP 850.4550

Data provided

EPA check

May 2019

23





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.1.1K. Aquatic plant toxicity test using Lemna spp

A.I.

F

M

CROECD 221 / OCSPP 850.4400

Data provided

EPA check

6.1.2 Long term studies

6.1.2A. Fish life cycle toxicity

A.I.

M

R

CR

OECD 210 / OCSPP 850.1400 / OPPTS 850.1500 (draft) / OECD 212 / OECD 215 / OECD 229

Data provided

EPA check

6.1.2B. Daphnia magna reproduction test

A.I.

M

R

CR

OECD 211 / OCSPP 850.1300

Data provided

EPA check

6.1.2C. Mysid chronic toxicity test

A.I.

MCR OPPTS

850.1350 (draft) Data provided

EPA check

6.1.2D. Effects on aquatic macrophytes

A.I.

M

CRASTM E1913-04 / OECD 239 / OECD 238 / OCSPP

Data provided

EPA check

May 2019

24





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




850.4450

6.1.3 Other aquatic studies

6.1.3A. Generic freshwater microcosm test, laboratory

A.I.

F

M

CR OPPTS 850.1900 (draft)

Data provided

EPA check

6.1.3B. Site-specific aquatic microcosm test, laboratory

A.I.

F

M


Data provided

EPA check

6.1.3C. Field testing for aquatic organisms

A.I.

F

M


Data provided

EPA check

6.1.3D. Aquatic food chain transfer

A.I.

F

M


Data provided

EPA check

6.2 Sediment ecotoxicity

6.2A. Sediment-water Chironomid toxicity using spiked sediment

A.I.

F

CROECD 218 / OCSPP 850.1735 /

Data provided

EPA check

May 2019

25





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




M OPPTS 850.1790 (draft)

6.2B. Sediment-water Chironomid toxicity using spiked water

A.I.

F

M

CR OECD 219 Data provided

EPA check

6.2C. Sediment-water Chironomid life-cycle toxicity test using spike water or spiked sediment

A.I.

F

M


EPA check

6.2D. Whole sediment acute toxicity invertebrates, marine

A.I.

F

M

CR OCSPP 850.1740

Data provided

EPA check

6.2E. Tadpole/sediment subchronic toxicity test

A.I.

F

M


Data provided

EPA check

6.3 Soil ecotoxicity

6.3.1 Earthworms and other invertebrates

May 2019

26





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.3.1A. Earthworm acute test

A.I

F

M


EPA check

6.3.1B. Earthworm subchronic toxicity test

A.I

F

M

CR OCSPP 850.3100

Data provided

EPA check

6.3.1C. Earthworm reproduction test (Eisenia fetida/Eisenia andrei)

A.I.

M

R

CROECD 222

Data provided

EPA check

6.3.1D. Earthworm – field studies

A.I.

F

M

CR ISO 11268-3: 2014 Part 3.

Data provided

EPA check

6.3.1E. Enchytraeid reproduction test

A.I.

F

M


EPA check

6.3.1F. Predatory mite (Hypolaspis [Geolaelaps] aculeifer) reproduction test in soil

A.I.

F

M


EPA check

May 2019

27





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.3.1G. Collembolan reproduction test in soil

A.I.

F

M


EPA check

6.3.1H. Determination of development toxicity of a test chemical to Dipteran dune flies

A.I.

F

M


EPA check

6.3.2 Microorganisms

6.3.2A. Soil microorganism: nitrogen transformation test

A.I.

F

M

R

CR

CR

OECD 216 / OCSPP 850.3200

Data provided

EPA check

6.3.2B. Soil microorganism: carbon transformation test

A.I.

F

M

CROECD 217 / OCSPP 850.3200

Data provided

EPA check

6.3.2C. Soil microbial community toxicity test

A.I.

F

M

CR OCSPP 850.3200

Data provided

EPA check

6.3.3 Plants

May 2019

28





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.3.3A. Seedling emergence

A.I.

F

M

CR

R

CR

OECD 208 / OCSPP 850.4100

Data provided

EPA check

6.3.3B. Terrestrial plant vegetative vigour

A.I.

F

M

CR

R

CR

OECD 227 / OPPTS 850.4150

Data provided

EPA check

6.3.3C. Seed germination, root elongation

A.I.

F

M

CR OPPTS 850.4200

Data provided

EPA check

6.3.3D. Early seedling growth

A.I.

F

M

CR OCSPP 850.4230

Data provided

EPA check

6.3.3E. Rhizobium-legume toxicity

A.I.

F

M

CR OCSPP 850.4600

Data provided

EPA check

6.3.3F. Plant uptake and translocation test

A.I.

F

CR OCSPP 850.4800

Data provided

EPA check

May 2019

29





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




M

6.3.3G. Terrestrial plants field study

A.I.

F

M

CR OCSPP 850.4300

Data provided

EPA check

6.3.4 Other soil tests

6.3.4A. Terrestrials soil-core microcosm test

A.I.

F

M

CR OCSPP 850.4900

Data provided

EPA check

6.4 Terrestrial vertebrates

6.4A. Avian acute oral toxicity test (non-dietary)

A.I

F

M

R

CR

CR

OECD 223 / OCSPP 850.2100

Data provided

EPA check

6.4B. Avian reproduction test

A.I.

F

R

CR

OECD 206 / OCSPP 850.2300

Data provided

EPA check

6.4C. Field testing for terrestrial wildlife

A.I.

FCR OCSPP


EPA check

May 2019

30





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.5 Terrestrial invertebrates – bees and other beneficial arthropods

6.5.1 Effects on bees

6.5.1A. Honey bee acute oral toxicity

A.I

F

M

R

CR

CR

OECD 213 Data provided

EPA check

6.5.1B. Honey bee acute contact toxicity

A.I

F

M

R

CR

CR

OECD 214 / OCSPP 850.3020

Data provided

EPA check

6.5.1C. Honey bee toxicity of residues on foliage

A.I.

F

M

CR OCSPP 850.3030

Data provided

EPA check

6.5.1D. Honey bee larval toxicity test, single exposure

A.I

F

M

R

CR

CR

OECD 237 Data provided

EPA check

6.5.1E. Honeybee brood feeding test

A.I.

F

CR OECD Series No.75

Data provided

EPA check

May 2019

31





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




M

6.5.1F. Chronic toxicity to bees

A.I.

F

M

R

CR

CR

No validated guideline available

Data provided

EPA check

6.5.1G. Sub-lethal effects

A.I.

F

M

CRNo validated guideline available

Data provided

EPA check

6.5.1H. Cage and tunnel tests

A.I.

F

M

CR OECD 75 / EPPO 170

Data provided

EPA check

6.5.1I. Field tests with honeybees

A.I.

F

M

CR EPPO 170 Data provided

EPA check

6.5.1J. Field testing for pollinators

A.I.

F

M

CR OCSPP 850.3040

Data provided

EPA check

6.5.2 Effects on other beneficial arthropods

May 2019

32





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.5.2A. Standard laboratory testing for non-target arthropods testing with Aphidius rhopalosiphi and Typhlodromus pyri

A.I

F

M

CR

R

CR

M.P. Candolfi, S. Blümel, R. Forster et al. (2000)4:

Data provided

EPA check

6.5.2B. Extended laboratory testing for non-target arthropods, aged residue studies with non-target arthropods

A.I.

F

M

CR

M.P. Candolfi, S. Blümel, R. Forster et al. (2000) 4/ Mead-Briggs, M.A., Moll, M., Grimm, et al (2010)5.

Data provided

EPA check

6.5.2C. Semi-field studies with non-target arthropods

A.I.

F

M

CR

M.P. Candolfi, S. Blümel, R. Forster et al. (2000)6

Data provided

EPA check

6.5.2D. Field studies with non-target arthropods

A.I.

F

M

CR

M.P. Candolfi, S. Blümel, R. Forster et al. (2000)6

Data provided

EPA check

6.6 Other concerns

4 Guidelines to evaluate side- effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92- 9067-129-7.5 An extended laboratory test for evaluating the effects of plant protection products on the parasitic wasp, Aphidius rhopalosiphi (Hymenoptera, Braconidae). BioControl 55:329-338.6 Guidelines to evaluate side- effects of plant protection products to non-target arthropods. IOBC, BART and EPPO Joint Initiative. ISBN: 92- 9067-129-7.

May 2019

33





F - Formulation

M - Metabolite

Code name

(A.I., F, M)

Required (R) or




6.6A. Endocrine disrupting properties

A.I.

F

M

CR

OECD 229/ OECD 231/ OECD 234/ OECD 240/ OECD 24/OCSPP 890.2100

Data provided

EPA check

May 2019

Protecting our way of life | EPA · Web viewOPPTS 870.2500/ OECD 404/ OECD 430/ OECD 431/ OECD 435/...

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Transcript of Protecting our way of life | EPA · Web viewOPPTS 870.2500/ OECD 404/ OECD 430/ OECD 431/ OECD 435/...