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FFDCA | FIFRA | TSCA

The EPA (United States Environmental Protection Agency) provides final test guidelines that are generally intended to meet all testing requirements under TSCA (Toxic Substances Control Act), FIFRA (Federal Insecticide, Fungicide and Rodenticide Act) and FFDCA (Federal Food, Drug, and Cosmetic Act) in order to determine if a chemical substance may pose a risk to human health or the environment. They are intended for use in the testing of pesticides and toxic substances, and the development of test data for submission to the EPA.

Final test guidelines are organized by series number as follows:

  • 830 - Product Properties Test Guidelines
  • 835 - Fate, Transport and Transformation Test Guidelines
  • 840 - Spray Drift Test Guidelines
  • 850 - Ecological Effects Test Guidelines
  • 870 - Health Effects Test Guidelines
  • 880 - Biochemicals Test Guidelines
  • 885 - Microbial Pesticide Test Guidelines
  • 890 - Endocrine Disruptor Screening Program Test Guidelines

TSCA Section 4(h)(2)(C) requires EPA to develop a list of particular alternative test methods or strategies that do not require new vertebrate animal testing and are scientifically reliable and relevant. LAUS can support you with the following New Approach Methodologies (NAMs) presented in that list:

Source

Title

Information Gathered

OECD TG 431

In Vitro Skin Corrosion: Reconstructed Human Epidermis (Rhe) Test Method

Evaluates corrosivity (human skin as source)

OECD 435

In Vitro Membrane Barrier Test Method for Skin Corrosion

Evaluates corrosion using a synthetic membrane

OECD TG 437

Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage

Evaluates eye irritation / corrosivity in bovine eyes

OECD TG 439

In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Evaluates irritation (human skin as source)

OECD TG 442C

In Chemico Skin Sensitisation: Assays addressing the Adverse Outcome Pathway key event on covalent binding to proteins

No animal or human cells used, evaluates simple binding of a chemical to a synthetic peptide

OECD TG 442D

In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method

Skin sensitization evaluated – human cells used

OECD TG 442E

In Vitro Skin Sensitisation: In Vitro Skin Sensitisation assays addressing the Key Event on activation of dendritic cells on the Adverse Outcome Pathway for Skin Sensitisation

Skin sensitization evaluated – human cells used

OECD TG 476

In Vitro Mammalian Cell Gene Mutation

Tests using the Hprt and xprt genes Evaluates gene mutations in either human or rodent cells

OECD TG 487

In Vitro Mammalian Cell Micronucleus Test

Evaluates chromosomal effects in either human or rodent cells

OECD TG 490

In Vitro Mammalian Cell Gene Mutation

Tests Using the Thymidine Kinase Gene Evaluates gene mutations in either human or rodent cells

OECD TG 492

Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage

Evaluates eye irritation with reconstructed human cells (either eye or skin)

LAUS could also support you with the performance of other tests:

Series 830 - Product Properties Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
Group B— Physical/Chemical Properties Test Guidelines.
830.6302 Color none 63-2 none 712-C-96-019
830.6303 Physical State none 63-3 none 712-C-96-020
830.6304 Odor none 63-4 none 712-C-96-021
830.6313 Stability to Normal and Elevated Temperatures, Metals, and Metal Ions none 63-13 none 712-C-96-022
830.6314 Oxidation/Reduction: Chemical Incompatibility none 63-14 none 712-C-96-023
830.6315 Flammability none 63-15 none 712-C-96-024
830.6316 Explodability none 63-16 none 712-C-96-025
830.6317 Storage Stability none 63-17 113 712-C-96-026
830.6319 Miscibility none 63-19 none 712-C-96-027
830.6320 Corrosion Characteristics none 63-20 none 712-C-96-028
830.6321 Dielectric Breakdown Voltage none 63-21 none 712-C-96-029
830.7000 pH 796,1450 63-12 none 712-C-96-030
830.7050 UV/Visible Absorption 796,1050 none 101 712-C-96-031
830.7100 Viscosity none 63-18 114 712-C-96-032
830.7200 Melting Point/Melting Range 796,1300 63-5 102 712-C-96-033
830.7220 Boiling Point/Boiling Range 796,1220 63-6 103 712-C-96-034
830.7300 Density/Relative Density/Bulk Density 796,1150 63-7 109 712-C-96-035
830.7370 Dissociation Constants in Water 796,1370 63-10 112 712-C-96-036
830.7520 Particle Size, Fiber Length, and Diameter Distribution 796,1520 none 110 712-C-96-037
830.7550 Partition Coefficient (n-octanol/water), Shake Flask Method 796,1550 63-11 107 712-C-96-038
830.7560 Partition Coefficient (n-octanol/water), Generator Column Method 796,1720 63-11 none 712-C-96-039
830.7570 Partition Coefficient (n-octanol/water), Estimation by Liquid Chromatography 796,1570 63-11 117 712-C-96-040
830.7840 Water Solubility: Column Elution Method; Shake Flask Method 796,1840 63-8 105 712-C-96-041
830.7860 Water Solubility, Generator Column Method 796,1860 63-8 none 712-C-96-042
830.7950 Vapor Pressure 796,1950 63-9 104 712-C-96-043

 

Series 835 - Fate, Transport and Transformation Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
835.0001 Principles and Strategies Related to Biodegradation Testing of Organic Chemicals under the Toxic Substances Control Act (TSCA) none none none 712-C-08-008
Group A—Laboratory Transport Test Guidelines.
835.1110 Activated Sludge Sorption Isotherm none none none 712-C-98-298
835.1230 Adsorption/Desorption (Batch Equilibrium) none 163-1 106 712-C-08-009
Group B—Laboratory Abiotic Transformation Test Guidelines.
835.2120 Hydrolysis [SUPERSEDES 835.2110] none 161-1 111 712-C-08-012
835.2130 Hydrolysis as a Function of pH and Temperature 796,3510 none none 712-C-98-059
Group C—Laboratory Biological Transformation Test Guidelines.
835.3100 Aerobic Aquatic Biodegradation 796,3100 none none 712-C-98-075
835.3110 Ready Biodegradability 796.3180,
796.3200,
796.3220,
796.3240,
796.3260		 none 301 712-C-98-076
835.3140 Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test) [SUPERSEDES 835.3120] none none 310 712-C-08-001
835.3170 Shake Flask Die-Away Test none none none 712-C-98-297
835.3200 Zahn-Wellens/EMPA Test 796,3360 none 302B 712-C-98-084
835.3210 Modified SCAS Test 796,3340 none 302A 712-C-98-085
835.3215 Inherent Biodegradability - Concawe Test none none none 712-C-08-003
835.3240 Simulation Test—Aerobic Sewage Treatment: A. Activated Sludge Units none none 303 712-C-08-004
835.3400 Anaerobic Biodegradability of Organic Chemicals 796,3140 none none 712-C-98-090
835.3420 Anaerobic Biodegradability of Organic Compounds in Digested Sludge: By Measurement of Gas Production none none 311 712-C-08-007

 

Series 840 - Spray Drift Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
840.1100 Spray Droplet Size Spectrum none 201-1 none 712-C-98-055

 

Series 850 - Ecological Effects Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
Group A—Aquatic and Sediment-Dwelling Fauna, Aquatic Microcosm and Field Testing Test Guidelines.
850.1010 Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids   72-2 202 712-C-16-013
850.1075 Freshwater and Saltwater Fish Acute Toxicity Test   72-1,
72-3		 203 712-C-16-007
850.1300 Daphnid Chronic Toxicity Test   72-4 211 712-C-16-005
850.1400 Fish Early Life Stage Toxicity Test   72-4 210 712-C-16-008
850.1735 Spiked Whole Sediment 10-Day Toxicity Test, Freshwater Invertebrates       712-C-16-002
850.1740 Spiked Whole Sediment 10-Day Toxicity Test, Saltwater Invertebrates       712-C-16-001
Group C—Terrestrial Beneficial Insects, Invertebrates, and Soil and Wastewater Microorganisms Test Guidelines.
850.3020 Honey Bee Acute Contact Toxicity Test none 141-1 none 712-C-12-019
850.3030 Honey Bee Toxicity of Residues on Foliage none 141-2 none 712-C-12-018
850.3100 Earthworm Subchronic Toxicity Test 795,1500 none none 712-C-12-016
850.3200 Soil Microbial Community Toxicity Test 797,3700 none none 712-C-12-015
850.3300 Modified Activated Sludge, Respiration Inhibition Test 795,1700 none none 712-C-12-014
Group D—Terrestrial and Aquatic Plants, Cyanobacteria, and Terrestrial Soil Core Microcosm Test Guidelines.
850.4000 Background and Special Considerations- Tests with Terrestrial and Aquatic Plants, Cyanobacteria, and Terrestrial Soil-Core Microcosms none 120-1 none 712-C-12-013
850.4400 Aquatic Plant Toxicity Test Using Lemna spp. 797,1160 122-2,
123-2		 none 712-C-12-008
850.4500 Algal Toxicity 797,1050 122-2,
123-2		 201 712-C-12-006
850.4550 Cyanobacteria (Anabaena flos-aquae) Toxicity 797,1050 122-2,
123-2		 201 712-C-12-005

 

Series 870 - Health Effects Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
870.5100 Bacterial Reverse Mutation Test 798.5100,
798.5265		 84-2 471 712-C-98-247
870.5300 In vitro Mammalian Cell Gene Mutation Test 798,5300 84-2 476 712-C-98-221
870.5375 In Vitro Mammalian Chromosome Aberration Test 798,5375 84-2 473 712-C-98-223

 

Series 880 - Biochemicals Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
Group A—Product Analysis Test Guidelines.
880.1100 Product Identity and Composition none 151-10 none 712-C-96-273

 

Series 885 - Microbial Pesticide Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
Group A—Product Analysis Test Guidelines.
885.1100 Product Identity none 151A-10 none 712-C-96-273
Group D—Nontarget Organism and Environmental Expression Test Guidelines.
885.4200 Freshwater Fish Testing, Tier I none 154A-19 none 712-C-96-332
885.4240 Freshwater Aquatic Invertebrate Testing, Tier I none 154A-20 none 712-C-96-333
885.4380 Honey Bee Testing, Tier I none 154A-24 none 712-C-96-337
885.4650 Aquatic Invertebrate Range Testing, Tier III none 154A-27 none 712-C-96-343
885.4700 Fish Life Cycle Studies, Tier III none 154A-28 none 712-C-96-344
885.4750 Aquatic Ecosystem Test none 154A-29 none 712-C-96-345

 

Series 890 - Endocrine Disruptor Screening Program Test Guidelines
OCSPP / OPPTS
Guideline No.		 Guideline Names Other Reference Numbers EPA Pub Number
OPPT OPP OECD
Group A—EDSP Tier 1 Test Guidelines.
890.1350 Fish Short-term Reproduction none none 299 740-C-09-007

 

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