EPA Issues Final Chemical Data Reporting Rule
On August 16, 2011, the United States Environmental Protection Agency (USEPA) issued its final rule on chemical reporting which will apply to the next reporting period running from February 1, 2012 through June 30, 2012. Adopted pursuant to section 8(a) of the Toxic Substances Control Act (TSCA), the rule increases the type and amount of information USEPA will collect on commercial chemicals from chemical manufacturers, including importers, allowing USEPA to better identify and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the TSCA Chemical Substance Inventory (TSCA Inventory).
The new rule, referred to as the Chemical Data Reporting Rule (CDR), amends and renames the existing Inventory Update Rule. The rule requires more frequent reporting of critical information on chemicals and requires the submission of new and updated information relating to potential chemical exposures, current production volume, manufacturing site-related data, and processing and use-related data for a larger number of chemicals. Instead of reporting every five years, the reporting period returns to a four year cycle.
Among the changes required under the new rule, manufacturers, including importers, must:
- Report if the production volume of a chemical substance meets or exceeds the 25,000 lb threshold during the principal reporting year (i.e., calendar year 2011).
- Report processing and use information of all reportable chemical substances manufactured (including imported) at 100,000 lb or more, unless otherwise exempted
- Provide upfront substantiation for data claimed as confidential business information. Submitters cannot claim those data elements as confidential when they are identified as “not known to or reasonably ascertainable by.”
- Submit their reporting electronically via e-CDRweb, EPA’s electronic reporting tool.
The new rule also modified reporting thresholds, updated definitions, revised industrial classifications and modified situations in which confidentiality may be claimed. Guidance documents are available on-line.
Although electronic reporting for the 2012 CDR is not yet available, EPA will be hosting an instructional webinar to demonstrate e-CDRweb on September 23, 2011. Those interested will be able to test the tool during the following week, although the test version will not be usable for actual 2012 submissions.
Additional requirements will be phased in for the 2016 reporting period. These include:
- A reporting requirement if, in any calendar year since the last principal reporting year, a chemical substance was manufactured (including imported) at a site in production volumes of 25,000 lb or greater.
- A requirement to report the production volume for each of the years since the last principal reporting year.
- The reporting threshold for processing and use information will be reduced to 25,000 lb.
- The reporting threshold will be 2,500 lb for certain chemical substances that are the subject of a proposed or promulgated TSCA rule under section 5(a)(2)(Significant New Use Rule), section 5(b)(4) (Chemical of Concern List), or section 6 (unreasonable risk finding), an order issued under TSCA section 5(e) or 5 (f), or the subject of relief granted under a civil action under TSCA section 5 or 7.
EPA expects the new electronic reporting requirement and limits on confidentiality claims will strengthen the agency’s chemical management program and increase the transparency of critical information on chemicals.