• 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.
• EPA allows commercial establishments to assume responsibility for submitting substantial risk information obtained by individual employees and officials.
• 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.

Section 8(e) of the Toxic Substances Control Act (TSCA) requires U.S. chemical manufacturers (including importers), processors, and distributors to notify the Environmental Protection Agency (EPA) immediately of information that reasonably supports the conclusion that their substances or mixtures present a substantial risk of injury to health or the environment. 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.

Section 8(e) continues to be an important and useful tool for early warning and identification of potential substantial risk situations allowing EPA and others to focus their limited resources on chemicals or mixtures of highest concern. The submission of section 8(e) information makes it possible for the agency and others to learn quickly about potential new chemical hazards/risks posed by exposure to chemical substances, to conduct more complete assessments and, if needed, to take effective action to eliminate or reduce such risks in a timely manner.

Specifically, section 8(e) of TSCA states, “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.”

What is substantial risk?

EPA’s TSCA section 8(e) guidance (in the June 3, 2003, Federal Register 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.

Who is required to report?

Section 8(e) of TSCA requires manufacturers (including importers), processors, and distributors of chemicals to notify the 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 TSCA section 23) to report the information directly to EPA.

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 EPA. 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 the agency.

It should be noted that trade associations and industry consortia can submit substantial risk notification on behalf of member companies covered under the reporting requirement.

Voluntary submissions

EPA welcomes human health and environmental risk-related information submitted by persons not covered by the TSCA section 8(e) reporting requirement. The agency 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.

Sometimes FYIs are also 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.