Risk and Reaction: Reporting and Recordkeeping Under TSCA

Posted on 9/10/2013 by Anthony R. Cardno

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)]
TSCA Reporting Recordkeeping
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.
Contaminated Water 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.

Tags: EPA, reporting and recordkeeping, TSCA

Find a Post

Compliance Archives

Lion - Quotes

I chose Lion's online webinar because it is simple, effective, and easily accessible.

Jeremy Bost

Environmental Health & Safety Technician

The instructor made the class very enjoyable and catered to the needs of our group.

Sarah Baker


Our instructor was very dynamic and kept everyone's interest. Hazmat shipping can be a dry, complicated topic but I was engaged the entire time.

Kimberly Arnao

Senior Director of EH&S

Lion's training was by far the best online RCRA training I've ever taken. It was challenging and the layout was great!

Paul Harbison

Hazardous Waste Professional

My experience with Lion classes has always been good. Lion Technology always covers the EPA requirements I must follow.

Steven Erlandson

Environmental Coordinator

Given the choice, I would do all coursework this way. In-person courses go very fast without the opportunity to pause or repeat anything.

Ellen Pelton

Chemical Laboratory Manager

Lion is easily and consistently the best option for compliance training. I've learned new information from every instructor I've had.

Rachel Mathis

EHS Specialist

Best instructor ever! I was going to take my DOT training w/a different provider, but based on this presentation, I will also be doing my DOT training w/Lion!

Donna Moot

Hazardous Waste Professional

Lion Technology workshops are amazing!! You always learn so much, and the instructors are fantastic.

Dorothy Rurak

Environmental Specialist

This training broke down the regulations in an easy-to-understand manner and made them less overwhelming. I now feel I have the knowledge to make more informed decisions.

Amanda Oswald

Shipping Professional

Download Our Latest Whitepaper

Get to know the top 5 changes to OSHA’s revised GHS Hazard Communication Standard at 29 CFR 1910.1200 and how the updates impacts employee safety at your facility.

Latest Whitepaper

By submitting your phone number, you agree to receive recurring marketing and training text messages. Consent to receive text messages is not required for any purchases. Text STOP at any time to cancel. Message and data rates may apply. View our Terms & Conditions and Privacy Policy.