On December 4, 2013, the U.S. Environmental Protection Agency (EPA) issued a final rule entailing the use of electronic reporting for certain reporting requirements under the Toxic Substances Control Act (TSCA), effective March 4, 2014. This article summarizes the final rule.
TSCA gives the EPA broad authority to regulate the manufacture (including import) and processing of chemical substances. TSCA allows the EPA to require these manufacturers and processors to generate and submit data and information to the agency. For example, under TSCA Section 4, the EPA can compel data to determine whether the manufacture, distribution in commerce, processing, use or disposal of such chemicals or mixtures presents an “unreasonable risk” of injury to health or the environment. Under TSCA Section 8, the EPA can compel the submission of data, including information that’s necessary to evaluate the potential adverse human-health and environmental effects from exposure to identified chemical substances, mixtures or categories (TSCA Section 8(a)), or submit lists or copies of ongoing and completed unpublished health and safety studies concerning identified chemical substances, mixtures or categories (TSCA Section 8(d)). Under TSCA Section 5(a)(1), chemical manufacturers must notify the EPA at least 90 days before manufacturing a new chemical substance for commercial purposes, and before manufacturing or processing the chemical substance for any use that the EPA has determined to be a “significant new use” under TSCA Section 5(a)(2).
Historically, the EPA has accepted these data submissions through non-electronic means. Not surprisingly, managing these data has proven to be difficult and costly. According to the EPA, the final rule is part of broader government efforts to move to modern, electronic methods of information gathering. The EPA’s Chemical Information Submission System (CISS) web-based reporting tool and e-PMN software enable data transmittal via the Central Data Exchange (CDX) — the EPA’s electronic data portal, and reduce errors.
Under the final rule, the EPA extends TSCA Section 5 electronic reporting requirements to Notices of Commencement (NOC) and support documents (e.g., correspondence, amendments and test data) relating to TSCA Section 5 notices submitted to the EPA prior to April 6, 2010 — the effective date of the TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations.
Effective March 4, the EPA will only accept information subject to these rules when documents are submitted through the CDX and the CISS tool. However, TSCA Section 5 submissions must be submitted using the e-PMN software downloaded from the CDX website. Data, reports and other information not submitted in this manner won’t be considered to have met the filing requirements of those rules. The final rule also amends regulations pertinent to TSCA Section 4 test rules and enforceable consent agreements. Documents required under TSCA Section 4 must be submitted electronically. In addition, any company that manufactures, imports or processes a chemical substance under 40 C.F.R. Part 766 must test that chemical substance immediately for the presence of halogenated dibenzodioxins/halogenated dibenzofurans (HDD/HDF), and submit all test data to the EPA.
Electronic reporting requirements also apply to Form 7710-35, Manufacturer’s Report — Preliminary Assessment Information. In addition, electronic reporting requirements apply to Form 7710-51, Dioxins/Furans Report Form, and the submission of documents under the TSCA Section 8(d) Health and Safety Data Reporting Rule and the Dibenzo-Para-Dioxins/Dibenzofurans Rule at 40 C.F.R. Part 766.
The EPA also requires submission of allegations of significant adverse reactions to dibenzo-para-dioxins/dibenzofurans, pursuant to 40 C.F.R. Part 717. Because the EPA hasn’t received many allegations of significant adverse reactions, it’s not implementing a mechanism for electronic submission of these allegations at this time. Persons subject to these requirements must continue to submit paper copies to the EPA.
The EPA properly notes that submitting documents electronically saves time and money, and reduces errors. While there may be some initial computer issues to address, particularly by first-time submitters, the EPA does a good job of responding to requests for help and eliminating computer glitches. The final rule is a positive development and will help industry and the EPA manage documents better and more efficiently.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).