FFDCA | FIFRA | TSCA
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:
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |