On Jan. 7, 2003, the U.S. Environmental Protection Agency (EPA) issued its long-awaited amendments to the Toxic Substances Control Act (TSCA) Section 8(a) Inventory Update Rule (IUR). The news is mixed. On the bad news side, completing IUR Form U will be significantly more complicated in the next IUR reporting period. Certain exposure-related information will be required for chemical substances covered by the IUR, and inorganic chemical substances now are subject to IUR reporting because EPA decided to revoke the full exemption from IUR reporting for these substances. On the good news side, however, EPA raised production-volume basic reporting thresholds for chemical substances, as well as the thresholds for reporting of processing and use information. Entities that historically have prepared IUR Form U will notice many other changes of significance. Similarly, new submitters that now must report because of the rule's expanded scope ," including inorganic chemical substances, among other changes ," will be challenged by the new reporting obligations. Key reporting changes Basic reporting thresholds. Exposure-related information. "Reasonably likely to be exposed" means an exposure to a chemical substance which, under foreseeable conditions of manufacture, processing, distribution in commerce or use of the chemical is more likely to occur than not to occur. Exposure information for chemicals with production volumes greater than 300,000 pounds. The type of industrial processing or use operation(s) at each site, including downstream sites. The five-digit NAICS codes that best describe the industrial activities during the processing or use operation. The industrial function of each chemical substance during the processing or use operation for each NAICS code reported. The percentage of the submitter's production volume used in each industrial function category. The number of sites at which the various processing or use operations occur. The number of workers reasonably likely to be exposed to the chemical substance in each processing or use operation. The commercial and consumer use categories of the reportable chemical substance. An indication of the presence of the reportable chemical substance in or on consumer products intended for use by children (defined to include children 14 years or younger). The percentage of the submitter's production volume associated with each commercial and consumer product category. The maximum concentration of the reportable chemical substance in each commercial and consumer product category. Revocation of full exemption for inorganic chemical substances. Amendment to chemicals termed "petroleum process streams." Partial exemption for low-current-interest chemicals. Significantly, EPA provided a new process under Section 710.46(b)(2) that enables any person to request the agency to amend the list of substances for which a partial exemption applies. Under the list revision process described in the final rule, EPA will provide a written response to requests within 120 days of request receipt. Factors EPA will review in considering requests include: Whether the chemical qualifies or has qualified in past IUR collections for the reporting of the information described in Section 710.52(c)(4). The substance's chemical and physical properties or potential for persistence, bioaccumulation and (adverse) health or environmental effects (considered independently or together). The information needs of EPA, other federal agencies, tribes, states and local governments, as well as the public. The availability of other complementary risk screening information. The availability of comparable processing and use information. Whether the potential risks of the chemical substance are adequately managed by EPA or another agency or authority. EPA reportedly is preparing a standard operating procedure (SOP) for the list exemption process. The SOP will outline the steps defining the process and provide guidance to exemption request submitters. Full exemption for certain forms of natural gas. More specific plant site reporting. Change to a calendar year reporting basis. Production volume ranges may be claimed confidential. Upfront CBI substantiation. Record retention. Future actions EPA notes in its final rule that it expects to take action on a number of other related IUR matters. Next month's column takes a look at these future actions, as well as their implications. 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.