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.EPA raised the production-volume basic reporting threshold from 10,000 pounds per year per chemical substance to 25,000 pounds per year, per chemical. For the reporting of processing and use information, the threshold now is 300,000 pounds or greater per year.
Exposure-related information.EPA is requiring manufacturers to report, in ranges: (1) the number of workers "reasonably likely to be exposed" to the chemical at the manufacturing site; (2) the physical form(s) in which the chemical substance is sent off-site; (3) the percentage of total reported production volume associated with each physical form; and (4) the maximum concentration of the chemical substance at the time it leaves the submitter's manufacturing site or, if the chemical substance is site-limited, the maximum concentration at the time it is reacted on-site to produce a different chemical substance.
"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.EPA is requiring producers of chemical substances with production volumes of 300,000 pounds or more per year to report exposure-related information about the processing and use of each reportable chemical substance at sites that receive the reportable chemical substance from the submitter site directly or indirectly. Manufacturers of these "larger-production-volume" substances are required to report:
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.Submitters must report up to 10 categories that best describe the commercial and consumer products in which the reportable chemical substance is used.*
Revocation of full exemption for inorganic chemical substances.EPA revoked the full exemption from IUR reporting for inorganic chemical substances and is phasing in reporting for these substances. For the 2006 submission period, the agency is requiring partial reporting for these substances. This means inorganic substances will not be subject to the reporting of processing and use information. Eventually, manufacturers of inorganic substances will be subject to full reporting, including processing and use information, to the extent they manufacture 300,000 pounds or more of an inorganic chemical substance at a site in a reporting year.
Amendment to chemicals termed "petroleum process streams."EPA created a partial reporting exemption for certain chemical substances termed petroleum process streams. These streams include the multi-component complex chemical substances listed by Chemical Abstract Service (CAS) number in the text of Section 710.46(b)(1). These chemicals are not subject to the reporting of processing and use information.
Partial exemption for low-current-interest chemicals.EPA listed chemical substances currently of "low interest" in IUR amendment processing and use information; the agency created for these chemicals a partial exemption from IUR processing and use information.
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.EPA exempted from IUR reporting certain forms of natural gas, identified by CAS number under Section 710.46(a)(4).
More specific plant site reporting.EPA is requiring the submission of more specific information for each plant site reporting under the IUR. For example, the name of a person who will serve as a technical contact is required, as is a Dunn and Bradstreet number and related information.
Change to a calendar year reporting basis.EPA changed the reporting period from a corporate fiscal-year basis to a calendar-year basis.
Production volume ranges may be claimed confidential.EPA is authorizing submitters to claim their production range as confidential business information (CBI), in addition to the existing requirement that submitters report a specific production volume number and the CBI status of that specific number.
Upfront CBI substantiation.EPA is requiring plant site confidentiality claims be substantiated at the time they are made.
Record retention.EPA extended the record retention period requirement from four years to five years. The agency intends, in a subsequent rulemaking, to extend the record retention program to six years.
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 LBERGESON@lawbc.com. The views expressed herein are solely those of the author.