The U.S. Environmental Protection Agency (EPA) issued on August 16, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. More information is available at http://www.epa.gov/cdr/. Set forth below are key components of the CDR Rule, how reporting will change from prior IUR reporting, and potential issues.
For the 2012 reporting period, companies must report if they manufacture or import a volume of a chemical substance on the TSCA Inventory during the principal reporting year (i.e., 2011) that meets or exceeds 25,000 pounds per site during that year and is not otherwise exempt.
A potentially surprising inclusion in the list of parties required to report are distribution centers that serve "portable manufacturing units." EPA has expressed its view that units that engage in chemical reactions via portable manufacturing units must report under the CDR Rule if they meet the reporting threshold. In the August 2010 proposed rulemaking, EPA provided examples of what may constitute a portable manufacturing unit — including building or road construction projects that use tanks to produce calcium hydroxide slurry and agricultural units that remotely produce ammonium hydroxide for land use.
Chemical substances subject to reporting have not changed under the CDR Rule from prior IUR rules. Reportable chemicals are those listed in the TSCA Master Inventory File at the beginning of an applicable submission period, unless the chemical substance is specifically excluded. The exemptions from reporting also have not changed except for very limited circumstances.
The 2012 submission period, during which 2011 manufacturing, processing and use information and 2010 production volume information should be reported, is scheduled to run from February 1, 2012, to June 30, 2012. Subsequent recurring submission periods will be from June 1 to September 30 at four-year intervals, beginning in 2016. This means EPA has switched the reporting frequency back to every four years from every five years.
Starting with the 2012 reporting period, EPA is replacing the "readily obtainable" standard used for the reporting of processing and use information with the "known to or reasonably ascertainable by" standard. The new reporting standard is more rigorous, as it is now defined to include "all information in a person's possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know."
Manufacturing-related information required to be reported for the principal reporting year, subject to the relevant reporting threshold, includes the volume of chemical used on site; volumes directly exported; and volumes recycled, remanufactured, reprocessed, or reused.
Processing- and use-related information to be reported includes, for 2011, that on all reportable chemical substances manufactured at 100,000 pounds or more per site, unless otherwise exempted. This means EPA is amending the rule to reduce the reporting threshold for processing and use information to 100,000 from 300,000 pounds per chemical substance for the 2012 reporting period.
Claims for confidentiality for chemical and site identity previously required substantiation but, starting with the 2012 reporting period, companies must provide upfront substantiation for each processing and use data element claimed as confidential business information (CBI) if the submitter has reason to believe release of the information would reveal trade secrets, or confidential commercial or financial information. Of particular interest, in the final rule EPA "cautions submitters that they may be subject to criminal penalties under 18 U.S.C. Section 1001 if they knowingly and willfully make a false statement in connection with the assertion of a CBI claim."
EPA intends to conduct a webinar to demonstrate e-CDRweb as all reporting must be done electronically. More information is available at http://www.epa.gov/iur/pubs/guidance/aboutsub.html.
The new rule is long (63 pages) and complicated. It warrants a careful read as there are many issues that could impact reporting obligations.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at Lbergeson@putman.net.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.