EPA Issues Proposed IUR Modifications Rule
On August 13, 2010, the U.S. Environmental Protection Agency (EPA) proposed its Inventory Update Reporting (IUR) Modifications Rule. 75 Fed. Reg. 49655. As highlighted below, the proposal includes important changes to the IUR reporting obligations that will have a significant impact on industry. These include, among others, requiring process and use information for substances over 25,000 pounds, requiring electronic submission of IUR reports; replacing the “readily obtainable” reporting threshold with “reasonably ascertainable” for process and use information; and requiring submission of production volume information for all years in between reporting periods. EPA intends to issue a final rule in time for the next reporting period, which is scheduled for June 1-September 30, 2011. EPA also requests comment on a number of areas which could point the way for significant additional changes to the IUR reporting scheme, including increasing the scope of reporting and expanding the reporting universe to include processors. More information is available online. Comments must be received on or before October 12, 2010.
The IUR rule requires manufacturers, including importers, of certain chemical substances listed on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory to report information about the manufacturing (including import), processing, and use of those chemical substances. According to EPA, manufacturers (including importers) of chemical substances and mixtures listed on the TSCA Inventory in volumes of 25,000 pounds or more at a site during the principal reporting year (i.e., calendar year 2010) may be affected by the proposed Rule. Potentially affected entities may include, but are not limited to, chemical manufacturers and importers, as well as chemical users and processors who may manufacture a byproduct chemical substance. Certain chemicals, such as naturally occurring substances, microorganisms, polymers, certain forms of natural gas, and water, are exempt from the IUR unless they are subject to another TSCA rule. In addition, certain chemicals are partially exempt, and manufacturers of such chemicals are required to report only identification and manufacturing information for those chemicals. EPA lists the partially exempt chemicals at 40 C.F.R. Section 711.6(b). The 2011 submission period, during which 2010 manufacturing, processing, use, and 2006-2009 production volume information would be reported, is scheduled to occur from June 1-September 30, 2011.
According to EPA, its proposed amendments would provide improved information to identify better and, where appropriate, “take steps to manage risks associated with chemical substances.” EPA states that it is proposing to modify the IUR rule to meet four primary goals:
- Better align the information collected with EPA’s overall information needs;
- Increase its ability to provide effectively public access to the information;
- Obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory; and
- Improve the usefulness of the information reported.
The proposed rulemaking includes the following proposed changes.
Reporting Information to EPA
- Require use of the electronic reporting software and the Internet to submit all IUR information;
- Require reporting of production volume for all years since the previous principal reporting year (i.e., 2005), rather than just the principal reporting year;
- Require upfront substantiation of certain data elements when the information is claimed as confidential business information (CBI) and limitations on information elements subject to CBI protection;
- Require process and use information under the reporting standard of “known to or reasonably ascertainable by” in lieu of the current reporting standard of “readily obtainable”;
- After the 2011 submission period, require reporting for any substance that meets or exceeded the 25,000-pound threshold in any calendar year since the last principal reporting year; and
- Return the reporting frequency from every five years to every four years.
- Require the reporting of certain manufacturing data elements, including:
- Whether an imported chemical is physically at the reporting site;
- The volume of the chemical substance directly exported and not domestically processed or used; and
- Whether a manufactured chemical, such as a byproduct, is being recycled, remanufactured, reprocessed, reused, or reworked.
- Whether an imported chemical is physically at the reporting site;
Processing and Use-related Information
- Lower the 300,000 pound threshold for processing and use information to 25,000 pounds thereby requiring all reporters of non-excluded substances to report information in all parts of the IUR Form U;
- Revise the list of industrial function categories for the reporting of processing and use information and replacing the five-digit North American Industrial Classification System (NAICS) codes with 48 Industrial Sectors (IS) (EPA worked with Canadian authorities to develop these changes), and requiring that entries of “other” include a written description of the use;
- Require reporting to distinguish between consumer and commercial product categories, or to indicate if both are relevant;
- Revise and expand the consumer and commercial product category codes for the reporting of consumer and commercial use information (these were also developed with Canadian authorities), including requiring an explanation when the “other” product category is selected; and
- Require reporting on number of commercial workers potentially exposed to the reported substance.
Other Proposed Changes
- Eliminate the 25,000-pound threshold for certain chemical substances that are the subject of particular promulgated TSCA rules and/or orders and to require manufacturers (including importers) of such chemicals to report under the IUR rule, regardless of the production volume; EPA requests comments on whether this change should be applied to proposed such rules and/or orders, and whether a de minimus volume threshold should be set;
- Eliminate IUR reporting exemption eligibility for substances subject to an enforceable consent agreement to conduct testing;
- Changes to definitions to address reporting difficulties related to portable manufacturing, toll manufacturers, and similar situations; and
- Responding to questions and issues that have arisen concerning byproduct reporting; EPA has developed and requests comments on draft guidance for such reporting.
Possible Future Changes
EPA raises for comment a number of additional possible changes or future approaches, including:
- Changing the 2011 submission period to another period later in 2011;
- Revising or eliminating reporting exemptions;
- Revising or eliminating the 25,000 pound reporting threshold, possibly to 10,000 pounds;
- Changing the IUR reporting requirements to parallel more closely the exposure reporting required on new chemicals via the Premanufacture Notification to allow more quantitative assessment of exposure, and asking whether such more detailed information might be collected through the IUR, a new reporting mechanism under TSCA Section 8(a), or through the use of TSCA Section 11(c) subpoena authority; and
- Expanding the reporting universe to include processors.
The proposed changes to the IUR should go a long way to resolving the issues and information limitations encountered by EPA in applying and attempting to use the information reported in the 2006 IUR. The proposed shifts to limit CBI claims and require substantiation are not unexpected given the changes which have already occurred in EPA’s approach to CBI under the Obama Administration. At the same time, it is clear that the proposed changes would substantially increase the industry’s reporting obligations and burden. Perhaps the most interesting and significant discussion is that concerning possible future changes to exposure information reporting that, if implemented, would represent a sea change in the scope and extent of reporting.