TSCA 5(e) Exposure-Based Policy: Testing
Below is listed the basic TSCA section 5(e) exposure-based testing typically triggered by meeting human or environmental exposure criteria. Note that, where applicable, both OPPTS Harmonized Test Guidelines and OECD Test Guidelines are listed, but PMN submitters should consult those web sites for the latest versions of the guidelines. EPA strongly encourages you, before performing any testing, to consult with the Agency concerning selecting a protocol or developing the information. Published test guidelines provide general guidance for development of test protocols, but are not themselves acceptable protocols. Test data should also be developed according to TSCA Good Laboratory Practice Standards (GLPS) at 40 CFR Part 792 (48 FR 53922; November 29, 1983) and through the use of methodologies generally accepted at the time the study is initiated. Failure to obtain protocol approval or follow GLPS could result in data insufficient to permit a reasoned evaluation of the effects of the substance. Any test data submitted should include protocols, raw data, and results.
For those PMN substances that meet human exposure criteria and warrant testing as determined by EPA, chemical manufacturers may be asked to perform some or all of the following health "core" tests on the PMN substance:
Bacterial reverse mutation (formerly "Ames") test (OPPTS 870.5100/OECD 471)
Mammalian erythrocyte micronucleus (intraperitoneal route) (OPPTS 870.5395/OECD 474)
Repeated dose 28-day oral toxicity in rodents (OPPTS 870.3050 or OECD 407)
Acute oral toxicity (OPPTS 870.1100/OECD 401, or OECD 425 ["Acute Oral Toxicity: Up-and-Down Procedure"])
For those PMNs expected to be produced in annual quantities greater than one million pounds (approximately 454,000 kilograms), and for which high exposures to workers or exposure to any consumers or the general population is expected, additional higher-tiered testing may be warranted at higher production and exposures. In these cases, EPA may also request the "Prenatal Developmental Toxicity" test (OPPTS 870.3700; oral route, one species), OECD 421 ("Reproduction/Developmental Toxicity Screening Test") or OECD 422 (combined OECD 407 (28-day study) and OECD 421).
Environmental Toxicity Testing
For those PMN substances that meet the substantial environmental release criterion and warrant testing as determined by EPA, chemical manufacturers may be asked to perform some or all of the following environmental "core" tests on the PMN substance if the chemical is expected to be acutely toxic:
Algal toxicity (OPPTS 850.5400/OECD 201 ("Alga, Growth Inhibition Test"))
Aquatic invertebrate acute toxicity, freshwater daphnids (OPPTS 850.1010/OECD 202 ("Daphnia sp. Acute Immobilisation Test and Reproduction Test"))
Fish acute toxicity (OPPTS 850.1075/OECD 203)
If the chemical is expected to be chronically toxic, then chronic toxicity tests of aquatic organisms will be recommended.
Environmental Fate Testing
For those PMN substances that meet the drinking water, ground water, total release to environment media, or total release to surface water exposure-based policy criteria and warrant testing as determined by EPA, chemical manufacturers may be asked to perform some or all of the following environmental fate testing, depending upon predicted solubility and which of the above criteria are met.
Water solubility - OPPTS 830.7840 or 835.7860; OECD 105
Fate in wastewater treatment - Porous Pot test (OPPTS 835.3220); or Semi-Continuous Activated Sludge test (OPPTS 835.3210; OECD 302A); or Modified Zahn-Wellens/EMPA test (OPPTS 835.3200; OECD 302B); or Activated Sludge Sorption Isotherm test (OPPTS 835.1110)
Aerobic biodegradation - Ready Biodegradability test (OPPTS 835.3110; OECD 301A-F); or Sealed Vessel CO2 Production test (OPPTS 835.3120)
Anaerobic biodegradation - Anaerobic Biodegradability of Organic Chemicals (OPPTS 835.3400)
Soil biodegradation - OPPTS 835.3300; OECD 304A
Photolysis (photodegradation ) - OPPTS 835.2210
Hydrolysis as a function of pH (stability in water) - OPPTS 835.2110 or 835.2130, or OECD 111