When we talk about the Toxic Substances Control Act (TSCA), we often talk about the inventory reports chemical manufacturers, processors, and distributors must submit to the EPA. In addition to requiring these inventory reports, TSCA also includes reporting and recordkeeping standards for two specially identified situations: Companies must report to the EPA on any “substantial risk” a chemical substance or mixture poses to humans or the environment and must keep records of “significant adverse reactions” experienced due to chemical exposure.
Reporting of Substantial Risk
“Any person who manufactures, processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of such information” unless the person can be sure the EPA is already aware of such information. [TSCA §8(e)]
The manufacturer’s responsibility to report chemicals that pose a “substantial risk” to human health or the environment was created by Congress in the TSCA statute. The U.S. EPA was not required to create, and has not created, any regulations implementing this requirement. However, over the years, the EPA has issued a series of policy statements, guidance documents, and interpretations to help regulated entities comply with this statutory requirement.
For example, in 2003, the U.S. EPA stated that it considers “substantial risks” to include:
- Human health effects (evidence of cancer, birth defects, mutagenicity, prolonged incapacitation, inability to use a normal bodily function);
- Environmental effects (changes in population density, behavior, growth, survival); and
- Emergency incidents of environmental contamination that seriously threatens human health or threatens non-human populations with large-scale or ecologically significant destruction.
Under TSCA Substantive risk information must be submitted to the EPA within 30 working days of acquisition of the information. Reports must include the job title, name, address, and phone number of the reporter; the name and address of the establishment with which the reporter is associated; identification of the chemical substance; a summary of the risks being reported; and the specific source of the information along with supporting technical data, if available. Reports of emergency incidents of environmental contamination must be made by phone to the appropriate EPA regional office immediately and followed up in writing within 30 days. [68 FR 33129, June 2, 2003
Records of Adverse Reactions
Distinct from the statutory requirement to report “substantial risks” are regulatory requirements to record significant “adverse reactions.” Manufacturers and processors of chemical substances (as defined in 40 CFR 717.5) must collect and retain information on allegations of the following:
- Reactions to human health, including long-lasting or irreversible damage, partial or complete bodily impairment (reproductive, neurological, or blood disorders), group or individual impairment at time of exposure; or
- Reactions to the environment, including gradual or sudden changes in species distribution, abnormal death rate (fish kills, etc.), reduction in species’ reproductive success, reduction in agricultural productivity, and long-lasting or irreversible contamination.
Allegations may come in any form, written (signed by the alleger) or oral (transcribed into written form), and from any source (employees, customers, neighbors, other organizations).
Records of allegations of significant adverse reactions related to the health of employees must be kept for 30 years. All other records of allegations must be kept for five years. However, there is no requirement for reporting this information to the EPA, unless an EPA inspector asks to see records of allegations. [40 CFR 717.5]
By collecting information about the hazards posed by chemical substances manufactured, imported, processed, or distributed in the U.S., the EPA evaluates the risks these chemical pose and looks for ways to prevent harm to human health and the environment.
Make sure you are meeting all of your reporting and recordkeeping responsibilities at the live, instructor-led TSCA Reporting and Recordkeeping Webinar
on October 17. Learn what you must collect, report, and keep on file to keep your facility in compliance with the latest regulations.