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EPA Requires E-Submission of TSCA Filings

Date: Jan 06, 2010

On January 6, 2010, EPA announced the phase-in of electronic reporting requirements for certain TSCA filings. (75 Fed. Reg. 773). Documents subject to the new requirements include:

  • Premanufacture Notices (PMNs)
  • Significant New Use Notices (SNUNs)
  • Low Volume Exemption (LVE) notices
  • Low Exposure/Low Release Exemption (LoRex) notices
  • Biotechnology notices for genetically modified microorganisms, including Microbial Commercial Activity Notices (MCANs), TSCA Experimental Release Applications (TERAs), Test Market Exemption Applications (TMEAs), and Tier I or Tier II Exemption Requests
  • Notices of Commencement of Manufacture or Import (NOCs)
  • Other support documents (e.g., correspondence, requests for suspensions of the notice review period, amendments, and test data)

EPA will be phasing in the electronic reporting requirements over a two-year period. Between April 6, 2010, and April 5, 2011, EPA will accept electronic submission through EPA's Central Data Exchange (CDX), as well as submissions via CD, DVD, and paper. Between April 6, 2011, and April 5, 2012, EPA will only accept submission via CD and DVD, and electronic submissions via CDX. Starting on April 6, 2012, all documents must be submitted electronically through CDX.

It is important to note that, beginning April 6, 2010, regardless of how the document is submitted, the document must be generated using the electronic-PMN (e-PMN) software. The e-PMN software can be accessed at http://cdx.epa.gov/epa_home.asp. If a document contains information claimed as Confidential Business Information (CBI), the e-PMN software will facilitate the creation of both CBI and non-CBI versions of the document. For additional guidance on the e-PMN software and the CDX system, see http://epa.gov/oppt/newchems/epmn/epmn-index.htm.

The requirements can be summarized as follows:

  • April 6, 2010 – April 5, 2011
        - Use e-PMN software to generate form.
        - Submit form via CD/DVD or paper, or electronically through CDX.
  • April 6, 2011 – April 5, 2012
        - Use e-PMN software to generate form.
        - Submit form via CD/DVD, or electronically through CDX.
  • Starting April 6, 2012
        - Use e-PMN software to generate form.
        - Submit form ONLY electronically through CDX.

Changes to PMN Form

EPA is also making three changes to the PMN form itself. First, EPA is adding a new required field on the PMN form for the User Fee Payment Identity Number. This number may be a check number, a wire transfer number, or a "Pay.gov" transaction number used to electronically transmit the required user fee. EPA will also include a new optional field for the e-mail address of the Authorized Official who is listed on the Submitter Identification section on page 3 of the PMN form. Finally, EPA is removing the Agent signature block field on page 2, which means that Agents no longer need to sign PMN forms. Note that if a PMN is submitted by an Agent of the manufacturer or importer, the Authorized Official of the manufacturer or importer must still sign the PMN form, and the Agent's name and contact information must still be included on page 3 of the form.

Keller and Heckman Webinar to Cover New Reporting Requirements

These new electronic reporting requirements and changes to the PMN form will be among the many topics addressed during Keller and Heckman's upcoming TSCA Fundamentals Webinar series, which will be held on January 27, February 3, and February 10. The details of these new electronic reporting requirements will be covered during the January 27 session. Click here to register for the webinar series, or visit the following link: http://online.krm.com/iebms/reg/reg_p1_form.aspx?oc=10&ct=0010661SER&eventid=16420.