Electronic Reporting Requirements for Certain Information under the Toxic Substances Control Act
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- Final Rule
- Notice for the Electronic Reporting Option for Substantial Risk Notifications and “For Your Information” (FYI) Submissions
- How To Report Electronically
- Data Requirements Subject to the Final Rule
On December 4, 2013 EPA finalized a rule to require electronic reporting of certain information submitted to the Agency under the Toxic Substances Control Act (TSCA) sections 4, 5, 8(a) and 8(d). The final rule follows two previous rules requiring similar electronic reporting of information submitted to EPA (for TSCA Chemical Data Reporting and for Pre-Manufacture Notifications), and is intended to save time, improve data quality and increase efficiency.
Specifically, the final rule requires electronic submission of data and other information for:
- TSCA section 4 test rules,
- TSCA section 5 Notices of Commencement of Manufacture or Import ("NOCs") and support documents relating to section 5 Notices sent to EPA before April 6, 2010,
- TSCA section 8(a) Preliminary Assessment Information Rule (PAIR) submissions, and
- TSCA section 8(d) health and safety studies.
Notice for the Electronic Reporting Option for Substantial Risk Notifications and “For Your Information” (FYI) Submissions
TSCA Section 8(e) requires U.S. chemical manufacturers, importers, processors, and distributors to notify EPA immediately of information that reasonably supports the conclusion that their substances or mixtures presents 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. 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. As of March 19, 2014, submitters of Substantial Risk Notifications and “For Your Information” reports under TSCA Section 8(e) can utilize electronic reporting.
How To Report Electronically
Under the final rule, submitters are required to:
- First register to use EPA's agency wide Chemical Data Exchange (CDX) portal for submitting information in a secure manner.
- Once registered and in CDX, users will select the Chemical Safety and Pesticide Programs (CSPP) portion of the site.
- From this area of the site, users will access a Web-based TSCA reporting tool, called the Chemical Information Submission System (CISS), which will be brought on-line shortly before the December 2013 webinars.
- Data submissions pursuant to TSCA sections 4 and 8 will be available under the CISS reporting tool.
Note: Users who have previously registered with CDX to submit data under TSCA section 5 or for the Toxics Release Inventory TRI-ME Program are able to add "Submission for Chemical Safety and Pesticide Program (CSPP)" to their current registration.
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
Data Requirements Subject to the Final Rule
Under the final rule, electronic reporting is required for the following information:
Section 4 Test Rules
- Study plans
- Study results
- Letters of intent to conduct testing
- Extension requests
- Modification requests
- Exemption requests
- Hearing requests
- Dioxins/Furans Report Form (PDF)(9 pp., 409 KB) (required after submission of a positive test result under 40 CFR 766 Dioxins/Furans)
Section 4 Enforceable Consent Agreements (ECAs)
- Study plans
- Modification of study plans
- Modification of test schedules
Section 5 Notices of Commencement of Manufacture or Import ("NOCs") and support documents relating to TSCA section 5 Notices sent to EPA before April 6, 2010
- Test data
Section 8(a) Preliminary Assessment Information
- Manufacturer's Report Sample Form 7710-35 (PDF) (12 pp., 282 KB)
Section 8(d) Health and Safety Studies
- Full study reports
- Ongoing studies
- Initiated studies
- Robust summaries
- Studies previously sent to other federal agencies without confidentiality claims
- Requests for extension of time
- Requests for withdrawal of a chemical from a rule
CDX Registration Process
- CDX CSPP Registration User Guide (PDF) (226 pp., 7.0 MB)
CSPP User Guides
- Section 4 Test Rules and Enforceable Consent Agreements
- Primary Authorized Official User Guide (PDF) (166 pp., 6.9 MB)
- Primary Support User Guide (PDF) (154 pp., 5.9 MB)
- Section 8 (a) Preliminary Assessment Information
- Primary Authorized Official User Guide (PDF) (66 pp., 2.76 MB)
- Primary Support User Guide (PDF) (51 pp., 1.9 MB)
- Section 8 (d) Health and Safety Studies
- Primary Authorized Official User Guide (PDF) (100 pp., 3.95 MB)
- Primary Support User Guide (PDF) (83 pp., 3.16 MB)
- Section 5 Electronic Reporting
CSPP Webinar Materials
December 5, 2012, EPA presented a webinar of on the enhanced CDX registration website and process. See the slide presentation (PDF) (56 pp., 2.8 MB)
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@example.com or 888-890-1995.
- For general questions on TSCA reporting, contact the TSCA hotline at 202-554-1404 or e-mail firstname.lastname@example.org. 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 Katherine Sleasman at 202-564-7716 or e-mail email@example.com.