TSCA: New Requirements for Submitting Section 5 Notices Take Effect in January 2016
The U.S. Environmental Protection Agency (EPA) recently reminded stakeholders that new requirements for submitting Toxic Substances Control Act (TSCA) Section 5 notices and support documents will take effect on January 19, 2016. EPA issued a direct final rule on July 20, 2015, amending the TSCA Section 5 electronic reporting regulations. Submitters will be required to use the new Chemical Safety and Pesticide Programs (CSPP) data flow, referred to as the new version of the electronic premanufacture notice (e-PMN) software or the “Thin Client” in EPA’s Central Data Exchange (CDX) to submit TSCA Section 5 notices and supporting documents electronically. The CSPP data flow replaces the eTSCA software that submitters would download and use to prepare and submit premanufacture notices (PMN). In addition, for the first time, submitters will also be required to use EPA’s e-PMN software and CDX to submit “bona fide intents to manufacture” electronically. EPA encourages submitters who are not already registered for CDX to register for CDX and for the updated e-PMN data flow “as soon as possible.” EPA will transition completely to the Thin Client software on January 19, 2016. Until then, submitters may use either the new version of the e-PMN software (Thin Client), or the previous version of the e-PMN software (Thick Client).
EPA’s main e-PMN website states that the e-PMN software enables manufacturers, including importers, of TSCA chemical substances to use the Internet, through CDX, to submit TSCA Section 5 notices to EPA. These notices include:
- PMNs and exemption notices;
- Bona fide notices;
- Biotechnology notices for genetically modified microorganisms;
- Notices of commencement of manufacture (including import) (NOC);
- 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); and
- Alternative control measures for significant new use rules (SNUR).
EPA states that the PMN form should also be used to submit:
- Significant new use notices (SNUN);
- Test market exemption applications (TMEA);
- Low volume exemption (LVE) notices and modifications;
- Low exposure/low release (LoREX) exemption notices and modifications; and
- Mock PMNs.
To submit documents electronically to EPA, users should complete the PMN or other pertinent forms using the online e-PMN software and submit them to EPA using CDX. To access CDX, users must pre-register and be approved by EPA. To access and use the new e-PMN software (Thin Client), all users must register with CDX for the CSPP service (“CSPP: Submissions for Chemical Safety and Pesticides Programs”). Six types of submitters may register with CDX (Thin Client):
- Primary authorized officials;
- Primary agents/consultants;
- Primary supports;
- Secondary authorized officials;
- Secondary agents/consultants; and
- Secondary supports.
Guidance documents and sample forms for CDX registration and the new e-PMN software (Thin Client) are available online. EPA posted questions about registration and software definitions, and presentation materials from its September 30, 2015, e-PMN webinar.
While change is never easy, transitioning to the new electronic only platform for Section 5 notices has many upsides. By shifting to an entirely online system hosted in EPA’s secure network, submitters will avoid the many challenges of recent years associated with downloading the “Thick Client” software, including firewalls and software incompatibility, such as problems with Java versioning. Any internet connected computer is used to logging into CDX and working on a PMN file. The ability to upload and transmit notices and supporting documents is convenient and efficient. Most would agree that the CDX system is reliable and relatively user-friendly, particularly once you get the hang of it. EPA’s response to inquiries is fast and helpful. The new Thin Client has new features that increase efficiency, including the ability to upload data from xml files, and links to EPA’s Substance Registry System (SRS) and Facility Registry System (FRS).
The new system also acknowledges the reality that the Primary Authorized Official (AO) who signs a TSCA submission often is not the party that actually develops the technical submission. Accordingly, the revised Thin Client process allows the Primary AO’s delegate (the Primary Agent/Consultant) to begin and prepare the submission for the AO’s review and submission, as well as monitor and manage submitted documents on the AO’s behalf after the initial submission.
As some revisions to a company’s current CDX registrations may be required to use the Thin Client, companies planning TSCA Section 5 submissions may wish to take steps now before the January 19, 2016, end of the transition period to avoid procedural delays later.
Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) are developing in-depth guidance and detailed instructions on how to register for the CSPP work flow, which roles to register for, how to manage organizations in CDX, and how to sponsor an agent/consultant.