EPA Revises TSCA Section 5 PMN and SNUN Electronic Reporting Requirements
On January 6, 2010, the U.S. Environmental Protection Agency (EPA) promulgated a final rule amending the electronic reporting requirements under Section 5 of the Toxic Substances Control Act (TSCA) (available online). According to EPA, the amendments are intended to streamline and reduce the administrative costs and burdens of TSCA Section 5 notifications for both industry and EPA by establishing standards and requirements for the use of EPA’s Central Data Exchange (CDX) to encrypt and submit electronically premanufacture notices (PMN) and other TSCA Section 5 notices and support documents to EPA. The final rule also amends TSCA Section 5 user fee regulations by adding a new User Fee Payment Identity Number field to the PMN form, which EPA states will enable it to match more easily a particular user fee with its notice submission. Lastly, EPA is amending the PMN form by removing the Ag ent signature block field, and thus the requirement for designated agents to sign the form. The final rule is effective April 6, 2010.
As discussed below, EPA’s decision to issue the final rule requiring electronic PMN reporting telegraphs EPA’s probable interest in requiring electronic reporting of Inventory Update Rule (e-IUR) information. EPA is expected to propose IUR modifications shortly. The most recent Regulatory Agenda outlines several significant potential modifications, including electronic reporting (available online).
Overview of Final Rule
The amendments 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 EPA. These documents include PMNs, Significant New Use Notices (SNUN), Test Market Exemption Applications (TMEA), Low Volume Exemption (LVE) notices, Low Exposure/Low Release Exemption (LoRex) notices, biotechnology notices for genetically modified microorganisms, Notices of Commencement of Manufacture or Import (NOC), and other support documents (e.g., correspondence, requests for suspensions of the notice review period, amendments, and test data). EPA is introducing CDX reporting of Section 5 notices in three phases over a two-year period. On or before April 6, 2011, EPA will allow submissions via CDX, optical disc (CD or DVD), and paper. Regardless of the method of submission, all submissions must be generated using the new electr onic-PMN (e-PMN) software. After April 6, 2011, EPA will no longer accept paper submissions for any new notices and support documents (including NOCs), though optical discs may continue to be used. After April 6, 2012, EPA will no longer accept optical discs, and all submitters must submit the notices and support documents electronically via CDX. According to EPA, the phased approach will allow submitters to gain experience in using the e-PMN software and the submission delivery system.
To submit documents electronically to EPA, submitters must register with CDX and be approved by EPA. Two types of submitters may register with CDX for e-PMN: Authorized Officials and Support Registrants. More information on the registration process and how to submit notices via CDX is available online. More information on how to use the e-PMN software is available in EPA’s e-PMN Submission Software question and answer document, available online.
EPA intends to hold a webinar on the CDX registration process for anyone interested in learning how to register with CDX to submit TSCA Section 5 notices electronically to EPA. According to EPA, the webinar will be held January 21, 2010. EPA asks interested participants to check its New Chemicals Program website online for information on the date and time. EPA states that it will hold additional webinars on the e-PMN process, and that it will post information on the additional webinars on its New Chemicals Program website, as it becomes available.
EPA has expressed its interest in requiring IUR information to be submitted electronically. Not everyone is enamored with the idea, however, and smaller business interests in particular have pushed backed. Several factors make it probable that EPA’s proposed revisions to IUR reporting expected to be issued soon will require electronic reporting of IUR information: EPA’s expressed commitment to the Government Paperwork Elimination Act (GPEA), which requires federal agencies to provide for the option of electronic maintenance, submission, or disclosure of information, where practicable as a substitute for paper; the federal government’s broader efforts to modernize methods of information gathering; and, with its promulgation of the e-PMN rule, EPA has established a precedent for requiring electronic reporting of Confidential Business Information, thus opening the door for such a requirement under e-IUR.
* * * * *
We hope this information is helpful. As always, please call if you have any questions.