Reporting a TSCA Chemical Substantial Risk Notice

On this page:

• Overview
  • Read TSCA section 8(e) Frequent Questions.
• Who Must Report Substantial Risk Notifications to EPA under TSCA section 8(e)?
• What Types of Substantial Risk Notifications are Reportable under TSCA section 8(e)?
• How Soon do I have to Submit a Substantial Risk Notifications after I Obtain New Information?
• How do I File Substantial Risk Notifications and FYI Submissions under TSCA section 8(e)
• What is a “For Your Information (FYI)” submission?
• If I am Not a Chemical Manufacturer, Importer, Processor or Distributor, Can I Still Submit a Substantial Risk Notifications?

Overview

Section 8(e) of the Toxic Substances Control Act (TSCA) requires that EPA be immediately notified when substances or mixtures present a substantial risk of injury to health or the environment.

TSCA section 8(e) states that ‘‘Any person who manufactures, [imports,] 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 [EPA] Administrator of such information unless such person has actual knowledge that the Administrator has been adequately informed of such information.’’ 15 U.S.C. 2607(e).

EPA’s guidance states that Substantial Risk Notifications under TSCA section 8(e) should be submitted within 30 calendar days of obtaining substantial risk information.

In addition, EPA established a classification system to distinguish voluntary “For Your Information” (FYI) submissions from Substantial Risk Notifications submitted formally to EPA under TSCA section 8(e), discussed above. The FYI classification was created by EPA to capture chemical risk submissions by persons or organizations not subject to the TSCA section 8(e) reporting requirements.

Read TSCA section 8(e) requiring substantial risk notifications to EPA (15 U.S.C. 2607(e)).

Read EPA’s guidance documents on Substantial Risk Notifications.

Read TSCA section 8(e) Frequent Questions.

View substantial risk notifications submitted to EPA in ChemView or CDAT

Who Must Report to EPA under TSCA section 8(e)?

Section 8(e) of TSCA requires manufacturers (including importers), processors, and distributors of chemicals to notify EPA immediately of information that reasonably supports the conclusion that their substances or mixtures present a substantial risk of injury to health of the environment.

TSCA section 8(e) does not provide exemptions for small businesses, small production or importation volumes, or commercial activities such as manufacture for export only or research and development.

EPA allows commercial establishments to assume responsibility for submitting substantial risk information obtained by individual employees and officials. EPA's TSCA section 8(e) policy statement explains that individual officers/employees are viewed as having discharged their individual TSCA section 8(e) responsibilities once they notify a designated supervisor or official in full about pertinent information, provided the employing entity has an established, internally publicized and affirmatively implemented procedure governing such Substantial Risk Notifications. The Agency's TSCA section 8(e) policy statement specifies that such procedures, at a minimum, must:

• specify the information that must be reported;
• indicate how the reports are to be prepared and submitted internally;
• note the Federal civil and criminal penalties for failure to report substantial risk information; and
• provide a mechanism for the timely notification of officers and employees who submitted reports about the disposition of those reports. Such notification should inform the reporting employee/officer as to whether or not the information was submitted to EPA, and if not, inform the employee or officer of their protected right (under section 23 of TSCA) to report the information directly to EPA.

Read EPA’s policy statement and other guidance documents on TSCA section 8(e).

It is important to note that, those employees and officers who are responsible for actual management of the organization's TSCA section 8(e) reporting obligations retain personal civil and/or criminal liability for ensuring that substantial risk information is submitted to the Agency. In the absence of established internal procedures, all employees and officers retain their individual responsibilities and liabilities for ensuring that substantial risk information is reported to EPA.

What Types of Substantial Risk Notifications are Reportable under TSCA section 8(e)?

EPA’s TSCA section 8(e) Guidance (68 FR 33129) states that a "substantial risk of injury to health or the environment" is

• A risk of considerable concern because of the seriousness of the effect, and
• The fact or probability of its occurrence.

These two criteria are differentially weighted for different types of effects. Certain human health effects are so serious that relatively little weight is given to exposure. The mere fact that the implicated chemical is in commerce constitutes sufficient evidence of exposure. In contrast, the remaining human health effects as well as environmental effects must involve or be accompanied by the potential for significant levels of exposure.

How Soon do I have to Submit a Substantial Risk Notifications after I Obtain New Information?

Under TSCA section 8(e), persons covered under the reporting requirement should report the new information to EPA within 30 calendar days of obtaining it. The exceptions are:

1. Emergency Incidents of Environmental Contamination, which should be reported immediately by telephone to the National Response Center (1-800-424-8802) or to the EPA Administrator or Regional Administrator, and
2. Non-emergency Incidents of Environmental Contamination, which should be reported to EPA under TSCA within 90 calendar days of obtaining it, unless reported within 90 days to another EPA office, federal or state regulatory agency, as described in Section VII (c) through (f) of the section 8(e) Guidance - 68 FR 33139 "Information which need to be reported".

How Do I File Substantial Risk Notifications and FYI Submissions under TSCA section 8(e)?

Electronic Reporting Requirement

Substantial Risk Notifications pursuant to TSCA section 8(e) that include Confidential Business Information (CBI) claims must be submitted electronically via Central Data Exchange (CDX) using the appropriate section 8(e) reporting application. Voluntary “For Your Information” (FYI) submissions should be filed using the appropriate FYI reporting tool in CDX.

Note: TSCA places limits on the ability of information submitters to retain Confidential Business Information (CBI) claims on health and safety data and health and safety studies. Learn more about substantiating CBI claims and TSCA section 8(e) Substantial Risk Notices.

Read additional guidance on substantial risk notifications.

How to Report Electronically?

• First, register to use EPA's agency-wide Central Data Exchange (CDX) portal for submitting information in a secure manner.
• Once registered and in CDX, select the Chemical Safety and Pesticide Programs (CSPP) section.
• From this section, you can access the Chemical Information Submission System (CISS), a web-based TSCA reporting tool.
• Data submissions pursuant to TSCA sections 8 and FYI are available under the CISS reporting tool.

This reporting tool is compatible with Windows, Mac, Linux, and UNIX based computers, and uses "Extensible Markup Language" (XML) specifications for efficient data transmission across the Internet.

The CISS Web reporting tool has several important features:

• Provides user-friendly navigation
• Works with CDX to secure online communication
• Creates a completed Portable Document Format (PDF) for review prior to submission
• Enables data, reports and other information to be submitted easily as PDF attachments or in other electronic formats, such as XML

CDX Electronic Communication for TSCA Substantial Risk Notices

EPA is now able to electronically acknowledge receipt of substantial risk notices submitted via the Central Data Exchange (CDX). The communication service began in September 2017 and is similar to how some electronic banking messaging systems work. It will deliver a secure message to the authorized official's (AO) CDX account, and will deliver a second generic message to the AO's email account, stating a communication has been delivered to their CDX account. The email will also provide directions for retrieving the communication from CDX.

If you have any questions regarding this service, please call the CDX Helpdesk at 1-888-890-1995.

Resources

CDX Registration Process

CSPP CDX Registration Guide

CSPP User Guides

• TSCA section 8(e)
  • Primary Authorized Official User Guide (PDF)
  • Primary Support User Guide (PDF)
• FYIs
  • For Your Information (FYI) User Guide–Primary Authorized Official (PDF)
  • Primary Support User Guide (PDF)

CSPP Webinar Materials

September 18, 2012, EPA presented a webinar of the TSCA section 8(a) and FYI reporting. See the slide presentation (PDF).

September 20, 2012, EPA presented a webinar on TSCA section 8(d) and 8(e). See the slide presentation (PDF).

For Help with CDX and the CISS Reporting Tool:

• If you have technical issues or problems regarding the CISS reporting tool or CDX registration, please contact the CDX Help Desk at [email protected] or 888-890-1995.
• For general questions on TSCA reporting, contact the TSCA hotline at 202-554-1404 or e-mail [email protected]. International callers who wish to contact the Help Desk should call 970-494-5500.
• If you have programmatic questions about EPA's TSCA e-reporting requirements, please contact Toni Krasnic at 202-564-0984 or e-mail [email protected].

What is a “For Your Information (FYI)” Submission?

The “For Your Information” (FYI) submission classification system was established by EPA to distinguish these voluntary submissions from “substantial risk” notifications submitted formally to EPA under TSCA section 8(e), a mandatory reporting provision of TSCA, discussed above. The FYI classification was created by EPA to capture submissions by persons or organizations not subject to the reporting requirements.

Since 1977, EPA has received FYI submissions covering a wide variety of chemical substances and mixtures from chemical companies, trade associations, unions, public interest groups, civic associations, private citizens, academic institutions, state and other federal agencies as well as similar organizations and agencies in foreign countries. These substantial risk notices contain information on human exposure, epidemiology, toxicity test results, monitoring studies, environmental fate, and other information that may be pertinent to risk assessment.

Sometimes FYIs are submitted when a manufacturer, importer, or processor is not sure its information supports a conclusion of substantial risk. Often they are submitted when a person or company not required to submit, nevertheless, would like to bring risk information on a chemical to EPA’s attention. Chemical companies, trade associations, public interest groups and academic institutions are among those who submit FYIs.

If I am Not a Chemical Manufacturer, Importer, Processor or Distributor, Can I still Submit Substantial Risk Notifications?

Trade associations and industry consortia can submit substantial risk notification on behalf of member companies covered under the reporting requirement. Also, EPA welcomes human health and environmental risk-related information submitted by persons not covered by the TSCA section 8(e) reporting requirement. EPA designates such submissions as voluntary “For Your Information” (FYI) submissions.