The U.S. Environmental Protection Agency (EPA) announced on August 2, 2011, the final Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) Rule, previously referred to as the Inventory Update Reporting (IUR) Modifications Rule. The CDR is intended to enable EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the TSCA Chemical Substance Inventory (TSCA Inventory). This includes current information on chemical substance production volumes, manufacturing sites, and how the chemical substances are used. According to EPA, this information helps it determine whether humans or the environment potentially are exposed to reported chemical substances in ways that could prove harmful. EPA will publish submitted CDR data that are not confidential business information (CBI). The final CDR Rule amends the previous IUR Rule to require submission of information that EPA believes will better address its and the public's information needs, improve the usability and reliability of the reported data, and ensure that data are available in a timely manner. EPA is requiring electronic reporting of CDR information and modifying reporting requirements, including certain circumstances that trigger reporting, the specific data to be reported, the reporting standard for processing and use information, and CBI reporting procedures. The CDR Rule establishes the upcoming submission period, which will be from February 1, 2012, to June 30, 2012, and which will include submission of production information from 2010 and production, processing, and use information from 2011. The CDR Rule will be effective 30 days after publication in the Federal Register. More information is available online.
Set forth below are some of the key components of the CDR Rule, how reporting will change from prior IUR reporting, and potential issues with these changes. We are preparing an in-depth analysis of these issues and will distribute it separately to our clients and friends list-serve.
According to a fact sheet available online, the name change from IUR to CDR "is intended to better reflect the distinction between the next data collection (which includes exposure-related data) and the TSCA Inventory itself (which only involves chemical identification information)." EPA states that identifying the next data collection as "CDR" will make it easier for the public to understand what information is available to them through the data collection effort. EPA reportedly modified the IUR Rule to meet four primary goals: to tailor the information collected to meet better EPA's general information needs; to increase its ability to provide effective public access to the information; to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and to improve the usefulness of the information reported.
Who Is Required to Report?
EPA states that entities may be affected by the CDR Rule if they manufacture (including manufacture as a byproduct or import) for commercial purposes, chemical substances listed on the TSCA Inventory and produced in volumes of 25,000 pounds (lbs) or more at a site during the principal reporting year (i.e., calendar year 2011). Potentially affected entities may include, but are not limited to:
One issue that could have a significant impact on certain industries concerns EPA's definitions of and interpretative guidance statements on "manufacture" and "byproduct." EPA states that it is providing "additional information on byproduct reporting" because "the scope of the CDR obligation to report byproducts is not well understood by industry." EPA is careful not to note that the reason this issue is not clear to industry is because EPA's explanations over the years have lacked clarity and certainly formality in that the reporting policy has been fragmentary and unstructured. In particular, EPA states in the CDR that "[c]hemical substances that are byproducts of the manufacture, processing, use, or disposal of another chemical substance or mixture, like any other manufactured chemical substances, are subject to CDR reporting if they are listed on the TSCA Inventory, are not otherwise excluded from reporting, and their manufacturer is not specifically exempted from CDR reporting requirements." EPA's guidance and interpretation of "byproducts" raises many issues, including possible notice issues, and it is by no means clear whether certain byproducts should be listed on the TSCA Inventory and/or subject to CDR reporting, and whether EPA has interpreted such terms consistently and in a way countenanced by TSCA.
When Is Reporting Required?
The 2012 submission period, during which 2011 manufacturing, processing, and use and 2010 production volume information would be reported, is scheduled to occur 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.
What Will Change for 2012?
Under the final CDR Rule, manufacturers (including importers) are:
Manufacturing-related information required to be reported, subject to the relevant reporting threshold, includes:
Processing and use-related information required to be reported includes:
The new "known to or reasonably ascertainable by" standard should be reviewed carefully, including the hypothetical examples provided by EPA to illustrate the anticipated application of this standard. A quick review suggests that there may be more subtle changes to the standard that warrant close scrutiny.
Are Any Chemicals Exempt from Reporting?
According to EPA's fact sheet, the following chemicals are exempt from reporting:
Certain chemicals -- naturally occurring substances, microorganisms, polymers, certain forms of natural gas, and water -- are exempt unless they are subject to another TSCA rule. In addition, certain chemicals are partially exempt, and manufacturers of such chemicals are required only to report identification and manufacturing information for those chemicals. The partially exempt chemicals are listed in the CDR regulations at 40 C.F.R. Section 711.6(b).
Chemical substances that are the subject of an enforceable consent agreement are no longer exempt from reporting.
Are There Changes That Will Be Phased in for the 2016 CDR?
According to EPA, it is delaying implementing certain requirements until the 2016 submission period. For the 2016 CDR:
Will EPA Provide Reporting Instructions?
EPA will conduct a webinar on September 23, 2011, to demonstrate e-CDRweb. According to EPA, those interested will be able to test the tool during the following week. The test version will not be usable for 2012 submissions. More information is available online.
EPA will also provide guidance materials with reporting instructions, questions and answers, and case studies prior to the start of the submission period. EPA states that it has placed two documents that provide detailed instructions for reporting chemical information, including the requirements for reporting byproduct chemicals, in the docket (EPA-HQ-OPPT-2009-0187) for the final CDR Rule, which is available online.
The final CDR Rule represents an important step that will greatly increase EPA's understanding of the volumes, uses, and exposures of chemicals, beginning with the 2012 reporting and increasing with the changes that will take place in the 2016 reporting. The final CDR Rule is only modestly changed from the proposal, although some of the changes are important and contribute to the workability and somewhat reduced burden of the final set of requirements. In particular, EPA has decided to:
Also, in the proposed rule EPA had raised a number of potentially far-reaching issues for comment and has decided not to proceed down these paths. These include, among others:
Some of the language in the final CDR Rule will need close scrutiny to understand fully its effect and to consider its legal provenance. In particular we draw attention to the discussion on the byproducts reporting requirement and CBI substantiation, including what seems to be a conflated misreading of the statute to apply criminal sanctions against submitters if there are "knowing and willful" false statements made regarding confidentiality claims.
Finally it is interesting that EPA recurrently cites its experience applying the 2006 IUR data under the Chemical Assessment and Management Program (ChAMP), but redolent of political correctness, cannot bring itself to state "ChAMP" in the preamble (yet comfortably cites the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation repeatedly).
Regardless, it is clear from the discussion in the rule that the experiences gained under ChAMP in applying the IUR data were key to the shape and form of this final CDR Rule. It is regrettable that EPA cannot bring itself to recognize the contributions made by ChAMP under the Bush Administration to the current rulemaking. Nevertheless, based on the discussion in the preamble concerning the use of the CDR data, it is evident that EPA will apply these data in much the same way that ChAMP did, to prepare screening level or prioritization assessments. Thanks to the experience gained in ChAMP, EPA will find itself with more of the information it needs to do the assessments.