Testing of Certain High Production Volume Chemicals

EPA is proposing a test rule under section 4(a)(1)(B) of the Toxic Substances Control Act (TSCA) to require manufacturers (including importers) and processors of certain high production volume (HPV) chemical substances to conduct testing for acute toxicity; repeat dose toxicity; developmental and reproductive toxicity; genetic toxicity (gene mutations and chromosomal aberrations); ecotoxicity (in fish, Daphnia, and algae) and environmental fate (including five tests for physical chemical properties and biodegradation). EPA has preliminarily determined that each of the 37 chemical substances included in this proposed rule is produced in substantial quantities and that there is substantial human exposure to each of them. Moreover, EPA believes that there are insufficient data to reasonably determine or predict the effects on health or the environment of the manufacture, distribution in commerce, processing, use, or disposal of the chemicals, or any combination of these activities. EPA has concluded that this proposed testing program is needed and appropriate for developing such data. Data developed under this proposed rule will provide critical information about the environmental fate and potential hazards associated with these chemicals which, when combined with information about exposure and uses, will allow the Agency and others to evaluate potential health and environmental risks and take appropriate follow up action. Persons who export or intend to export any chemical substance included in the final rule based on this proposed rule would be subject to the export notification requirements in TSCA section 12(b)(1) and at 40 CFR part 707, subpart D. EPA has also taken steps, as described in this document, to consider animal welfare and to provide instructions on ways to reduce or in some cases eliminate animal testing, while at the same time ensuring that the public health is protected.