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Final Rule Issued for TSCA eReporting

06 01 10 - 14:21 On January 6, 2010, the EPA issued a final rule to amend the Toxic Substances Control Act (TSCA) section 5 reporting regulations. The amendments establish electronic reporting requirements for TSCA section 5 submissions.  The final rule is effective as of April 6, 2010 and will establish requirements for using EPA's Central Data Exchange (CDX) to electronically submit premanufacture notices (PMNs) and other TSCA section 5 notices. EPA is also amending TSCA section 5 user fee regulations by adding a new User Fee Payment Identity Number field to the PMN form, to enable the Agency to match more easily a particular user fee with its notice submission.  Lastly, EPA is amending the PMN form by removing the Agent signature block field and thus the requirement for designated agents to sign the form.

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EPA is issuing these amendments to require manufacturers (including importers) and processors of TSCA chemical substances to use the Internet, through EPA's CDX, to submit TSCA section 5 notices and related documents to the Agency.  These include PMNs, Significant New Use Notices (SNUNs), Test Market Exemption Applications (TMEAs), Low Volume Exemption notices (LVEs), Low Exposure/Low Release Exemption (LoRex) notices, biotechnology notices for genetically modified microorganisms, Notices of Commencement of Manufacture or Import (NOCs) and other support documents (e.g., correspondence, requests for suspensions of the notice review period, amendments, and test data).

The requirement of CDX reporting will take place in 3 phases over a 2-year period.  During the first year following the effective date of this final rule, the Agency will allow submissions via CDX, optical disc (CD or DVD), and paper.  Regardless of the method of submission, EPA will require that all submissions be generated using the new electronic-PMN (e-PMN) software.  One year after the effective date of this final rule, paper submissions will no longer be accepted for any new notices and support documents (including NOCs), though optical discs may continue to be used.   Two years after the effective date of this final rule, optical discs will no longer be accepted, and all submitters must submit the notices and support documents via CDX.

EPA is also amending the TSCA section 5 User Fee regulations at 40 CFR 700.45 to add a new User Fee Payment Identity Number field to the PMN form.  This new field will enable the Agency to more easily match a particular user fee with its notice submission.  The second new information element on the amended PMN form will be optional and consist simply of the e-mail address for the Authorized Official (AO) submitting the notice listed on the "Submitter Identification" section on page 3 of the PMN form.  EPA is also removing the required Agent signature block field on page 2 of the form.