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Reviewing New Chemicals under the Toxic Substances Control Act (TSCA)

How to Submit via e-PMN

Warning

Do not e-mail any Confidential Business Information (CBI) to EPA. EPA's e-mail system is not secured to protect CBI.

On this page you will find:

Overview

The e-PMN software enables manufacturers (including importers) of TSCA chemical substances to use the Internet, through EPA's CDX, to submit TSCA section 5 notices to the Agency. These notices include:

  • Premanufacture Notices (PMNs)
  • Bona Fide notices
  • Biotechnology Notices for genetically modified microorganisms
  • Notices of Commencement of Manufacture (including Import) (NOCs)
  • Support documents for section 5 notices (e.g., correspondence, requests for suspensions of the notice review period, amendments, letters of withdrawal, Transfer of Ownership, and test data)
  • Alternative Control Measures for Significant New Use Rules (SNURs)

The PMN form should also be used to submit:

  • Significant New Use Notices (SNUNs)
  • Test Market Exemption applications (TMEAs)
  • Low Volume Exemption (LVE) notices and modifications
  • Low Exposure/Low Release (LoREX) exemption notices and modifications
  • Mock PMNs

In order to submit documents electronically to EPA, fill out PMN forms using the e-PMN software and submit through the Central Data Exchange (CDX). To access CDX, you must pre-register with CDX and be approved by EPA. In order to access and use the new e-PMN software, all users must register with CDX for the CSPP program service ("CSPP: Submissions for Chemical Safety and Pesticides Programs").

If you have technical issues or problems regarding the e-PMN software or CDX registration, please contact the CDX Help Desk at helpdesk@epacdx.net or 888-890-1995. International callers who wish to contact the Help Desk should call 970-494-5500. If you have programmatic questions, please contact Kathryn Schechter at 202-564-8589 or e-mail Schechter.Kathryn@epa.gov.

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Questions about Registration and Software Definitions

Who is a Primary Authorized Official and what can a Primary Authorized Official submit?

An Authorized Official is a person in a company legally responsible for the data in the notice. Generally this would be the person who signs the certification page. A Primary Authorized Official may submit any section 5 document via CDX to EPA. This includes section 5 Notices (PMN, SNUN, LVE, TMEA, LoREX, Modifications to LVE and LoREX, Biotechnology, Bona Fide, NOC and Letters of Support) and support documents to the section 5 Notices (amendments, test data, and correspondence). Note: Only Authorized Officials may submit section 5 Notices.

A Primary Authorized Official can also assign persons to work on their behalf (Agents/Consultants and Support persons); see below.

Who is a Secondary Authorized Official and what can a Secondary Authorized Official submit?

A Secondary Authorized Official is a person in a company legally responsible for the data in the notice who will be submitting information in a joint submission or Letter of Support. Generally this would be the person who signs the certification page. A Secondary Authorized Official may submit joint submissions or Letters of Support to any section 5 document via CDX to EPA. This includes section 5 Notices (PMN, SNUN, LVE, TMEA, LoREX, Modifications to LVE and LoREX, Biotechnology, and Bona Fide). Note: Only Authorized Officials may submit section 5 Notices.

A Secondary Authorized Official can also assign persons to work on their behalf (Agents/Consultants and Support persons); see below.

Who is a Primary Agent/Consultant and what can a Primary Agent/Consult submit?

A Primary Agent/Consultant is a person not of the submitting company who wishes to create section 5 notices on behalf of the Authorized Official. These persons will also be able to submit amendments to the original notice and be able to submit supporting documentation (test data and other correspondence).

Note: Only Authorized Officials may submit the original section 5 Notices.

Who is a Secondary Agent/Consultant and what can a Secondary Agent/Consult submit?

A Secondary Agent/Consultant is a person not of the submitting company who wishes to create joint submissions or Letters of Support on behalf of the Secondary Authorized Official. These persons will also be able to submit amendments to the original joint submission/Letter of Support.

Note: Only Authorized Officials may submit the original section 5 Notices.

Who is a Primary Support Registrant and what can a Primary Support Registrant submit?

A Primary Support Registrant is a person designated by an Authorized Official to edit e-PMN documents on behalf of an Authorized Official. The Support Registrant can be another person from the Authorized Official's company or can be a person from outside the company.

A Support Registrant may not submit any documents.

Who is a Secondary Support Registrant and what can a Secondary Support Registrant submit?

A Secondary Support Registrant is a person designated by a Secondary Authorized Official to edit joint submissions or Letter of Support documents on behalf of an Authorized Official. The Support Registrant can be another person from the Authorized Official's company or can be person from outside the company.

A Support Registrant may not submit any documents.

e-PMN webinars

To assist submitters with new features of its electronic, web-based system for receiving TSCA section 5 submission forms and support documents, EPA will hold a webinar on September 30, 2015 from 1-4 p.m.

View webinar presentation materials.

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Previous version of e-PMN Software Download (eTSCA)

Although the eTSCA software can no longer be used to submit directly/electronically via CDX, in order to reconcile with notices that were sent previously using the eTSCA software, here are instructions to assist in submitting support documents for such notices. The instructions include:

How to open the eTSCA files

eTSCA files can be draft files, finalized files or Copy of Record files.  These files have one of the following file extensions: pmn_tsca, noc_tsca, sup_tsca, or biotech_tsca. To open any of these files, first add the file extension “.zip” to the filename then open with any unzip program.

How to upload the eTSCA file into the new e-PMN software

Create a new Premanufacture form in the new e-PMN software.  Select the “Upload XML” button on the bottom left of the application and then select “Upload Archive file”.  Select the eTSCA file to upload (xxx.pmn_tsca).

Once the XML within the eTSCA file has been imported, upload any necessary attachments. Lastly, check the system validation to ensure that there are no errors; also, check the pdf for missing information.

How to make amendments for eTSCA original notices

Since it is no longer possible to make changes within an eTSCA notice, you can amend a the notice by submitting in a support document using the new e-PMN software that includes a narrative in “Section V. text/description of changes” and/or an attachment to designate amendments to the eTSCA notice.

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