On June 19, 2014, the U.S. Environmental Protection Agency (EPA) issued a direct final rule exempting manufacturers of three chemical substances from certain reporting-process-and-use information requirements under the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) rule for those compounds. This column discusses the rule and the potential value of public petitioning.
Under TSCA Section 8(a), manufacturers (including importers) of chemicals listed on the TSCA Inventory are required to submit certain information regularly to the EPA. Previously referred to as the Inventory Update Reporting (IUR) rule, the requirements are now known as the CDR rule. The CDR rule enables the EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures listed on the TSCA Inventory. This includes current information on chemical substance production volumes, manufacturing sites, and how the chemical substances are used.
The information helps the EPA determine whether people or the environment are potentially exposed to the reported chemical substances. The information also is reviewed by third-parties, including competitors and detractors of chemicals generally. The EPA also relies upon the information for purposes of informing its priorities for additional regulatory scrutiny and new rulemaking opportunities. The EPA publishes submitted CDR data that are not considered confidential business information and the data are widely available and used for multiple regulatory purposes.
Under the CDR rule, the EPA maintains a list of “partially exempt chemicals” for which the CDR processing and use information is of “low current interest” under 40 C.F.R. Section 711.6(b)(2)(iv). Manufacturers of these listed chemical substances are exempt from reporting the processing and use information otherwise required by 40 C.F.R. Section 711.15(b)(4). Chemical substances are included on this list only if the EPA has determined that there is low current interest in the processing and use information for that substance.
The EPA may amend the list of partially exempt chemicals on its own initiative or in response to a petition submitted by the public requesting that a chemical be added to or removed from the partial exemption. The latter is the case with regard to the three chemicals at issue here — 1,3-propanediol (CAS No. 504-63-2); oils, palm kernel (CAS No. 8023-79-8); and bentonite, acid-leached (CAS No. 70131-50-9) were included in a petition submitted by the Corn Refiners Association, the Institute of Shortening and Edible Oils, and the National Oilseed Processors Association. The chemicals have food use applications that are already regulated by the U.S. Food and Drug Administration. The three chemicals also are used to make a variety of preparations, including cosmetics, adhesives, finger paints and water treatment compounds.
The EPA determined these three chemicals should be included on the list of chemical substances partially exempt from reporting additional information under the CDR rule based on its determination that the substances are of low current interest with respect to CDR processing and use information. The EPA reached this conclusion after considering the risk of adverse human health or environmental effects, information needs for CDR processing and use information, and the availability of other sources of comparable processing and use information.
PETITION PAYS OFF
Preparing a petition such as the one approved here is never easy, but the rewards derived from the EPA’s approval are significant. Assuming the direct final rule is not opposed, which is unlikely, these three chemicals will be added to the list of partially exempt chemicals for which diminished reporting will apply. The manufacturers will not need to deal with time-consuming regulatory reporting obligations, thereby saving time and money, and the substances can properly be referred to as chemicals that are of low interest to the EPA for CDR reporting purposes. This classification also may have marketing appeal in certain business sectors.
The next CDR reporting cycle is 2016. Persons interested in submitting a petition have until June 2015 to submit one in time to be considered before the next reporting cycle. Interested parties may wish to consider whether chemical substances for which reporting is otherwise required are amenable to partial reporting because the EPA could consider them of low current interest for CDR rule purposes.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on conventional, biobased, and nanoscale chemical industry issues. She served as chair of the American Bar Association Section of Environment, Energy, and Resources (2005-2006).