EPA Issues Proposed TSCA IUR Modifications Rule
On August 13, 2010, the Environmental Protection Agency (EPA) published a notice in the Federal Register, proposing to modify the Inventory Update Reporting (IUR) rule. For readers less familiar with the IUR, this is a rule established under section 8(a) of the Toxic Substances Control Act (TSCA). It enables EPA to collect, and then make public, critical information on the manufacture (including import), processing, and use of certain chemicals listed on the TSCA Chemical Substances Inventory. This includes current information on volumes of chemical production, manufacturing facility data, and how the chemicals are used. EPA uses this information to help identify and, when necessary, manage potential risks that some chemicals may pose to human health or the environment.
The proposed rule includes a number of important changes that will impact industry. Among these include: requiring electronic reporting; increasing the reporting frequency; requiring process and use information for substances over 25,000 pounds; changing the method for determining whether the reporting threshold has been exceeded; replacing the “readily obtainable” reporting threshold with “reasonably ascertainable” for processing and use information; and requiring submission of production volume information for all years in between reporting periods.
EPA intends to issue the final rule in advance of, and have it apply to, the 2011 submissions. That submission period runs from June 1, 2011 through September 30, 2011. Reporting companies are closely monitoring this development to ensure compliance with the requirements EPA ultimately adopts. Comments must be received on or before October 12, 2010.
EPA states that it is modifying the rule to meet four primary goals:
- To tailor the information collected to better meet the Agency’s overall information needs;
- To increase its ability to effectively provide 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.
The changes the Agency is proposing to meet these goals are discussed in further detail below.
I. General Reporting Changes
- The reporting frequency would be increased. Reporting would return to its previous four-year cycle, making the first post-2011 submission due in 2015. EPA also requested comment on whether to require a different reporting frequency.
- The method would change for determining whether a report was required.
- In general, an IUR report would be required for any post-2011 submission whenever a non-exempt chemical is manufactured or imported in volumes of 25,000 lbs. or more at any single site owned or controlled by the manufacturer in any calendar year since the last principal reporting year.
- EPA also requested comment on whether alternative methods would provide an equally accurate picture of chemical production, and whether more frequent reporting on a limited set of chemicals would be more appropriate.
- However, the 25,000 lb. threshold would eliminated for reporting on chemicals subject to a rule promulgated pursuant to TSCA sections 5(a)(2), 5(b)(4) or (6), subject to a TSCA section 5(e) or section 5(f) order, or that is the subject of relief granted in a civil action under TSCA sections 5 or 7. EPA also requested comment on whether chemicals included in a proposedrule under sections 5(a)(2), 5(b)(4), or 6 should be part of this group as well, and whether a de minimus reporting threshold should set for the group.
- EPA also requested comment on changing the applicability threshold from 25,000 lbs. to 10,000 lbs.
- Electronic reporting, using reporting software and the internet, would be required for preparation and submission of all IUR information. Paper reporting and submitting reports as files on electronic media (e.g., CD-ROM) would no longer be allowed.
- The requirements concerning assertion of claims of confidential business information (CBI) and EPA’s response to such claims would be changed.
- EPA would release publicly chemical identity information without notice to the reporting company for those chemicals already on the public portion of the TSCA Inventory.
- Substantiation would need to be provided up front for processing and use information; otherwise, the Agency would not consider the information confidential and would make it publicly available without notice to the reporting company.
- EPA would disallow confidentiality claims for processing and use data elements identified as not “known to or reasonably ascertainable.”
- EPA would consider the name and site identity to be separate items, requiring separate claims and substantiation for each.
II. Reporting of Manufacturing Information
- More manufacturing (and importing) data elements would reported, such as:
- The name of the ultimate domestic parent company, making the IUR report consistent with the Toxic Release Inventory (TRI) reporting requirements under section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA);
- The current Chemical Abstracts (CA) Index Name, as used to list the chemical substance on the TSCA Inventory, would be required as part of the chemical identity;
- Production volume for each year since the previous principal reporting year (i.e., 2005), rather than just the principal reporting year;
- The production volume of a manufactured (including imported) chemical used at the reporting site;
- Whether an imported chemical is physically at the reporting site;
- The production volume of the chemical 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.
III. Reporting of Processing and Use Information
- The threshold would change for reporting processing and use information. The current 300,000 lb. threshold would be eliminated. Companies submitting Parts I and II of Form U would also complete Part III. EPA also requested comments on whether stakeholders disagree and believe that there should be a threshold for this information.
- The standard for reporting would be changed from reporting of all information “readily obtainable” to the “known to or reasonably ascertainable to the submitter” standard that applies to the other information reported on Form U.
- The list of industrial function categories for the reporting of processing and use information would be revised and the five-digit North American Industrial Classification System (NAICS) codes would be replaced with 48 Industrial Sectors (IS), and entries of “other” would be required to include a written description of the use.
- Reporting on consumer and commercial product categories would be changed.
- Companies would have to distinguish between consumer and commercial product categories, or indicate if both are relevant.
- The consumer and commercial product categories would be revised and expanded for consumer and commercial use information, and an explanation would be necessary with the “other” product category is selected.
- Reporting on the number of commercial workers potentially exposed to the chemical would be required.
- EPA requested comments on potentially changing the IUR reporting requirements in the future to parallel exposure reporting required on new chemicals via the pre-manufacture notification (PMN), thereby allowing more quantitative exposure assessment, and whether such 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.
- EPA also requested comments on whether processors should be subject to future exposure-related reporting.
IV. Other Proposed Changes
- Definitions would be adopted or revised to address toll manufacturing, portable manufacturing, and other past reporting challenges. Among these include:
- “Manufacture” would be revised to include production under a toll arrangement and the manufacturing entity and the entity contracting for such service would both be defined as the “manufacturer” and thus, responsible for filing an IUR, although only one report need be filed.
- “Site” would be revised to address toll manufacturing, portable manufacturing, and importation. Specifically, the new definition would make the place of production under a toll agreement the “site” for purposes of IUR reporting. The distribution center would be designated as the “site” for manufacture in portable manufacturing units. Lastly, the location of an importer’s headquarters in the United States, the location of an operating unit in the United States, or, if neither of those locations exists, the address of the agent in the United States authorized to accept service of process would be designated as the “site.”
- Several chemicals would receive expanded exemptions and others would be deemed ineligible for exemptions:
- Manufactured water, water from petroleum streams, and the three polymers that are currently partially exempt from the IUR requirements would be completely exempted; and
- Chemicals for which an enforceable consent agreement (ECA) to conduct testing has been made would be ineligible.
- Responding to questions and issues that have arisen concerning byproduct reporting; EPA developed and requests comments on draft guidance for such reporting.
V. Concluding Thoughts
EPA’s proposed changes move the Agency closer to meeting its stated goals. They should help resolve many of the difficulties it encountered using the information received in the last IUR reporting cycle. The limitations and requirements on the protection of CBI are not surprising given the Agency’s stated interest in expanding public access to information on chemicals. Nonetheless, it is clear that the proposed changes will increase industry’s reporting burden and place more confidential business information at greater risk of public disclosure.