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When and how to submit a substantial risk notice
  • There is no required collection instrument or reporting form on which section 8(e) information must be submitted to EPA.
  • Submissions may be filed using EPA’s electronic Central Data Exchange (CDX).

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

  • Emergency Incidents of Environmental Contamination, which should be reported immediately by telephone to the National Response Center at (800) 424-8802 or to the EPA Administrator or EPA Regional Administrator, and
  • 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 or federal or state regulatory agency, as described in section VII (c) through (f) of the section 8(e) guidance. See page 33139 of the June 3, 2003, Federal Register, and look for section VII (Information Which Need Not Be Reported).

There is no required collection instrument or reporting form on which section 8(e) information must be submitted to EPA; however, the section 8(e) policy statement requires all respondents to ensure that a written section 8(e) notice:

  • Is sent to EPA by a method verifying the agency’s receipt;
  • States that it is being submitted under section 8(e) of TSCA;
  • Contains the name, address, job title, phone number, and signature of the person reporting, and the name and address of the establishment with which the person is associated;
  • Identifies the chemical substance(s) or mixture including, if known, the Chemical Abstracts Service (CAS) Registry Number(s);
  • Summarizes adverse health/environmental effects being reported including a description of the nature and extent of the risk; and
  • Contains the specific source/summary of the supporting data.

Submitters of Substantial Risk Notifications pursuant to TSCA section 8(e) and voluntary “For Your Information” (FYI) submissions have the option to file electronically, rather than by paper. These submissions may be filed using EPA’s electronic document submission system, the Central Data Exchange (CDX).

EPA encourages stakeholders to use CDX to send TSCA section 8(e) notices, versus submitting them by paper. However, EPA will continue to send paper letters acknowledging receipt of notices that were submitted by paper.

The steps to reporting electronically are as follows:

  1. Register to use EPA’s agency-wide CDX portal for submitting information in a secure manner.
  2. Once registered and in CDX, select the Chemical Safety and Pesticide Programs (CSPP) section.
  3. From this section, access the Chemical Information Submission System (CISS), a web-based TSCA reporting tool.
  4. 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; and
  • Enables data, reports, and other information to be submitted easily as PDF attachments or in other electronic formats, such as XML.

In order to facilitate the efficiency in communications and cost savings in submissions and correspondence for both EPA and respondents, EPA has incorporated the following data elements into the reporting tool:

  • Submission Type — Identifies the submission, including the type of submission and whether it is the initial submission, a follow-up, or a final report.
  • Summary of Attachment — Allows the respondent to provide a summary or abstract of the attached study or report, any internal company tracking number, an EPA tracking number, and an indication of the number of studies submitted.
  • Chemical Identification — Identifies the chemical(s) addressed in the submission.
  • Title of Attachment — Identifies the title of the attached study or report.
  • Indexing Terms — Allows the respondent to identify the proper terms to use for indexing purposes, which facilitates the search and retrieval of the information.
  • Submitter Information — Identifies the submitter and/or technical contact, including name, title, company, mailing address, phone, and email address.
  • Comments — Allows the submitter to provide any additional comments, so as to avoid the need for or use of a separate cover letter.

EPA is also now able to electronically acknowledge receipt of substantial risk notices submitted via the CDX. The communication service 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.