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Reporting Requirements

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

For the purposes of TSCA Section 8(e), the term "person" includes the following: any natural person, corporation, firm, company, sole proprietorship, joint venture, partnership, association, or any other business entity, any state or political subdivision of a state government, any municipality, any interstate body, and any department or agency of the Federal Government.

Such "persons" are subject to TSCA Section 8(e) only to the extent they are engaged in commercial activities involving manufacture, importation, processing or distribution of chemical substances or mixtures under the jurisdiction of the Toxic Substances Control Act. Labor unions, trade associations, contract testing laboratories and agencies of the Federal Government are not typically involved in such commercial activities.

Under TSCA Section 8(e), there are no exemptions for small businesses, small production or importation volumes, or commercial activities such as manufacture for export only or research and development. However, TSCA Section 8(e) does not require a subject person to submit information about a chemical substance or mixture that the person does not manufacture, import, process or distribute commercially. Further, a person who obtains substantial risk information about a chemical or mixture that the person did at one time, but does not any longer, manufacture, import, process or distribute in commerce, is not required to submit the information under TSCA Section 8(e).

Despite these limitations in coverage, EPA has received numerous TSCA Section 8(e) submissions from respondents who obtained otherwise reportable Section 8(e) information but for some technical reason were not required to submit the information to EPA under TSCA Section 8(e). Such information can be highly useful to EPA and the public for assessing potential risks and for considering appropriate actions to reduce or eliminate health and environmental risks. If not submitted under TSCA Section 8(e), such notices are designated as “For Your Information” (FYI) submissions. Because these notices demonstrate and reflect a submitter’s product stewardship, EPA welcomes and encourages them. EPA also asks submitters to be mindful of TSCA Section 8(e) reporting criteria and to consider the FYI alternative whenever those criteria do not apply.

EPA asks that persons subject to TSCA Section 8(e) reporting consider all pertinent information for submission to EPA, while at the same time minimizing unnecessary or ill-considered Substantial Risk Notifications. The Agency believes these objectives may be served best by allowing commercial establishments to assume responsibility for submitting substantial risk information that is obtained by individual employees and officials. Accordingly, 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:

The Agency believes that the above procedures serve to ensure prompt and appropriate processing and consideration of pertinent information by persons subject to TSCA Section 8(e) of TSCA. It is important to note, however, that despite the establishment of such procedures, 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 such established internal procedures, all employees and officers retain their individual responsibilities and liabilities for ensuring that substantial risk information is reported to EPA.

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

The June 3, 2003 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 Option

Submitters of Substantial Risk Notifications pursuant to TSCA Section 8(e) and voluntary “For Your Information” (FYI) submissions now have the option to file electronically, rather than by paper. The March 17, 2014 Federal Register Notice announces that these submissions may now be filed using EPA’s electronic document submission system, the Central Data Exchange (CDX). The Notice follows three previous rules requiring similar electronic reporting of information submitted to EPA (for TSCA Chemical Data Reporting, Pre-Manufacture Notifications, and TSCA sections 8 and 4) intended to save time, improve data quality and increase efficiency.

How to Report Electronically?

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:

How to Report Paper Submissions?

Send paper submissions to the addresses below:

Substantial Risk Notifications:

TSCA Confidential Business Information Center (7407M)
WJC East; Room 6428; Attn: Section 8(e)
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

Courier Deliveries:
1201 Constitution Avenue, NW
WJC East; Room 6428
Washington, DC 20004-3302

FYI Submissions:

TSCA Confidential Business Information Center (7407M)
WCJ East; Room 6428; Attn: FYI
U.S. Environmental Protection Agency
1200 Pennsylvania Avenue, NW
Washington, DC 20460-0001

Courier Deliveries:
1201 Constitution Avenue, NW
WCJ East; Room 6428
Washington, DC 20004-3302

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Resources

CDX Registration Process

CSPP User Guides

CSPP Webinar Materials

September 18, 2012, , EPA presented a webinar of the TSCA section 8(a) and FYI reporting. See the slide presentation (PDF). (67 pp., 3.81 MB.) About PDF)

September 20, 2012, EPA presented a webinar on TSCA Section 8(d) and 8(e). See the slide presentation (PDF). (78 pp., 5.17 MB)

For Help with CDX and the CISS Reporting Tool:

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

Trade associations and industry consortia can submit substantial risk notification in 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.

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