Last month's column detailed a rulemaking that finalized amendments to the U.S. Environmental Protection Agency's (EPA) Toxic Substance Control Act (TSCA) Section 8(a) Inventory Update Rule (IUR). This month's column takes a look at additional rule-related actions the agency said it expects to take in the future, as well as the implications of these changes for chemical facilities.
Standard operating procedure (SOP) for obtaining partial exemptions.EPA intends to issue an SOP/guidance document providing additional details about how to add chemical substances to the list of substances for which a partial exemption applies.
Guidance on completing Form "U."EPA is preparing a guidance document with specific reporting instructions to assist in completing Form U. The agency also intends to conduct workshops to help IUR submitters understand the new reporting requirements. EPA said it would seek comment on the revised Form U before issuing it in final for users in 2006.
Change in reporting frequency.The agency states in the final rule that it intends, in a separate action, to change the reporting frequency after the first reporting year under the IUR amendments, or 2005, with submission to EPA in 2006, from every four years to every five years thereafter. EPA also would change the record-keeping period accordingly, from five years to six years. EPA said it would make this change as part of an interagency review under Executive Order 12866 to reduce the potential reporting burden related to compliance with the amendments to the IUR.
The final amendments to the IUR drive home the importance of having certain exposure information pertinent to chemical substances. Producers will need more detailed information pertinent to workplace exposures, and producers meeting the greater-than-300,000-pound-per-year (per chemical substance) threshold will need specific processing and use information. Exactly what will be required under the rule and how submitters will discharge these new reporting obligations are not yet clear.
EPA said it has three primary reasons for seeking such information. First, it wants to tailor a chemical substance's reporting requirements to more closely match EPA's information needs. Second, it wants to obtain new and updated information relating to potential exposures to a subset of chemical substances listed on the TSCA Inventory. Last, it wishes to improve the utility of the information reported.
EPA notes in the preamble that data presently available to the agency are "generally inadequate for risk screening purposes," and receipt of the new information compelled under the IUR amendments will "enable EPA to more selectively conduct initial risk screening on a subset of the chemical substances with its purview." These data will ," in combination with other EPA initiatives such as the High Production Volume (HPV) Challenge Program and Voluntary Children's Chemical Evaluation Program (VCCEP) ," allow the agency to prioritize its TSCA Section 4 rulemaking and enforceable consent agreement better. At one level, this justification is compelling and could make a judicial challenge to the rule somewhat difficult to win.
IUR submitters plainly will need to prepare early for the next IUR reporting cycle because information not necessarily in their hands will be required to be reported for chemical substances that have been reported routinely in prior IUR reporting periods. Although the deadline for these reporting obligations is years away, care nonetheless will need to be taken on a plan to satisfy these new reporting obligations, particularly as they relate to exposure data requirements, and to identify and characterize new chemical substances that previously were exempt from IUR reporting.
Additionally, CBI claims will need to be considered carefully and substantiated at the time a claim is asserted. Upfront substantiation requires thought and a clear understanding of the types of information meeting the definition of CBI under the controlling rules.
EPA's new process for adding chemical substances to the list of partially exempt chemicals offers important opportunities for manufacturers and others. EPA must receive requests no later than January 1 of the year before the reporting period in question. Although the next reporting period is some time away, care should be taken now to understand the exemption process.
Review of ," and comment on ," the forthcoming SOP EPA reportedly intends to circulate are well advised. Chemical manufacturers and others understandably will wish to make application for as many chemical substances as possible to minimize reporting obligations.
Bergeson is a founding shareholder of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm concentrating on industrial and agricultural chemical, medical device and diagnostic product approval and regulation; product defense; and associated business issues. Contact her at [email protected]. The views expressed herein are solely those of the author.