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Send to Environmental Protection Authority preferably by email (HSApplications@epa.govt.nz) 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
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
Data Requirements – Index and Checklist
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
4
Data Requirements – Index and Checklist
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
Data Requirements – Index and Checklist
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
830.6302 Data provided
EPA check
2B. Physical stateA.I.
FR OPPTS
830.6303 Data provided
EPA check
2C. OdourA.I.
FR OPPTS
830.6304 Data provided
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
7
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
830.6320 Data provided
EPA check
2Q. Viscosity F CR OECD 114/ OPPTS 830.7100
Data provided
EPA check
May 2019
8
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
May 2019
9
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
10
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
11
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
12
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
13
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
14
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
875.1100 Data provided
EPA check
4.1B. Dermal exposure - indoor F R OPPTS
875.1200 Data provided
EPA check
May 2019
15
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
4.1C. Inhalation exposure - outdoor F R OPPTS
875.1300 Data provided
EPA check
4.1D. Inhalation exposure - indoor F R OPPTS
875.1300 Data provided
EPA check
4.1E. Biological monitoring F CR OPPTS
875.1500 Data provided
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
875.2200 Data provided
EPA check
4.2C. Dermal Exposure F R OPPTS 875.2400
Data provided
EPA check
4.2D. Inhalation Exposure F CR OPPTS
875.2500 Data provided
EPA check
May 2019
16
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
4.2E. Biological monitoring F CR OPPTS
875.2600 Data provided
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
835.2410 Data provided
EPA check
5.2D. Photodegradation in air A.I. CR OPPTS
835.2370 Data provided
EPA check
May 2019
18
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
5.3.1F. Aquatic (sediment) field dissipation
A.I.
MCR OPPTS
835.6200 Data provided
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
835.6100 Data provided
EPA check
May 2019
20
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
5.3.2F. Forestry dissipation
A.I.
MCR OPPTS
835.6300 Data provided
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
835.1410 Data provided
EPA check
May 2019
21
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
5.4B. Field volatilityA.I.
MCR OPPTS
835.8100 Data provided
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
CR OPPTS 850.1925 (draft)
Data provided
EPA check
6.1.3C. Field testing for aquatic organisms
A.I.
F
M
CR OPPTS 850.1950 (draft)
Data provided
EPA check
6.1.3D. Aquatic food chain transfer
A.I.
F
M
CR OPPTS 850.1850 (draft)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
CR OECD 233 Data provided
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
CR OPPTS 850.1800 (draft)
Data provided
EPA check
6.3 Soil ecotoxicity
6.3.1 Earthworms and other invertebrates
May 2019
26
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
6.3.1A. Earthworm acute test
A.I
F
M
CR OECD 207 Data provided
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
CR OECD 220 Data provided
EPA check
6.3.1F. Predatory mite (Hypolaspis [Geolaelaps] aculeifer) reproduction test in soil
A.I.
F
M
CR OECD 226 Data provided
EPA check
May 2019
27
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
6.3.1G. Collembolan reproduction test in soil
A.I.
F
M
CR OECD 232 Data provided
EPA check
6.3.1H. Determination of development toxicity of a test chemical to Dipteran dune flies
A.I.
F
M
CR OECD 228 Data provided
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
850.2500 Data provided
EPA check
May 2019
30
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
Data Requirements – Index and Checklist
Endpoint & Test title
Tested “Substance”
A.I. - Active ingredient
F - Formulation
M - Metabolite
Code name
(A.I., F, M)
Required (R) or
Conditionally Required (CR)
Recommended guideline(s)
Checklist Filename(s)
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
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