- Who must report to EPA under TSCA 8(e)?
- What types of notices are reportable under TSCA 8(e)?
- Where do I submit TSCA 8(e) notices?
- How soon do I have to submit a TSCA 8(e) notice after I obtain new information?
- If I am not a chemical manufacturer, importer, processor or distributor, can I still submit a TSCA 8(e) notice?
Who must report to EPA under TSCA 8(e)?For the purposes of 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 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, 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 Section 8(e).
Despite these limitations in coverage, EPA has received numerous 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 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 8(e), such notices are designated as “For Your Information” (FYI) submissions, the voluntary adjunct to TSCA 8(e). 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 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 notices. 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 Section 8(e) policy statement explains that individual officers/employees are viewed as having discharged their individual 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 notices. The Agency's 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.
The Agency believes that the above procedures serve to ensure prompt and appropriate processing and consideration of pertinent information by persons subject to 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 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.
What types of notices are reportable under TSCA 8(e)?The June 3, 2003 TSCA 8(e) Guidance (68FR33129) 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.
Where do I submit TSCA 8(e) notices?Information on how to submit your TSCA Section 8(e) and FYI submissions can be found here.
How soon do I have to submit TSCA 8(e) notices?
Under Section 8(e) of TSCA, anyone subject to the reporting requirement should submit information to EPA within 30 calendar days of obtaining it. The information may be toxicity and/or exposure data and need not be complete or definitive. Limited studies (e.g., range-finding studies), preliminary results and draft reports may constitute sufficient evidence for Section 8(e) reporting. Information that has been published or submitted to EPA under other authorities is exempt from Section 8(e) reporting.
How many days do I have to submit a Section 8(e) report?
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 - 68FR33139 "Information which need to be reported".
Please see our Contact Us page for information on how to submit your TSCA Section 8(e) submissions.