April 6, 2012, Effective Date for TSCA Section 5 CDX Submissions
Bergeson & Campbell, P.C. (B&C) wishes to remind the firm’s clients and friends that effective April 6, 2012, the U.S. Environmental Protection Agency (EPA) requires all chemical manufacturers or importers that submit a Toxic Substances Control Act (TSCA) Pre-manufacture Notice (PMN), a Microbial Commercial Activities Notification (MCAN) or other biotechnology notice for genetically modified microorganisms, a Notice of Commencement of Manufacture or Import (NOC), Significant New Use Notice (SNUN), an exemption application, or related support documents, must do so electronically through EPA’s Central Data Exchange (CDX), an Internet portal, using EPA’s electronic PMN (e-PMN) software (which is the same software for all submission types). EPA no longer accepts the historic submission method of a paper copy or the more recent CD-ROM submission.
EPA already uses CDX for several other reporting requirements, including most recently the TSCA Chemical Data Reporting rule. If a user already is registered with CDX, the registration can be modified to add the e-PMN component. If, however, a user does not yet have a CDX registration, the registration and set-up process may take several weeks or more, so it is important to begin the registration process immediately if a submitter is not already registered. In addition, while downloading the software should be straightforward, consultation with your computer support staff is advisable. There may be difficulties in setting up CDX access in the typical corporate IT environment.
B&C and its consulting affiliate, The Acta Group, L.L.C. (Acta) are pleased to assist with TSCA submissions. We offer a range of TSCA submission development services, including working with clients to clarify chemical identity in coordination with the Chemical Abstracts Service (CAS) Inventory Expert Service (IES), assessing structure activity relationships and the applicability of chemical analogs, developing human exposure and environmental release estimates as well as narrative explanations, preparing pollution prevention benefits discussions, and reviewing study reports as appropriate. B&C can prepare and forward files to our clients for their submission through EPA’s CDX in their capacity as “Authorized Officials.” B&C also can submit supporting information directly to EPA as a “Support Registrant,” after the initial submission has been made. Supporting information may include submission amendments, revisions, test data, review period extensions, and other correspondence. Given how EPA has structured its e-submission process, however, the original e-submission must be made from the submitter’s (manufacturer’s/importer’s, also known as the Authorized Official’s) computer, which is why the submitter must register directly with CDX and download the encrypted software.