With the 2020 reporting period under the Toxic Substances Control Act (TSCA) Chemical Data Reporting (CDR) rule rapidly approaching, the US Environmental Protection Agency (US EPA) has announced a number of key changes to the information that chemical manufacturers and importers must submit to the agency pursuant to the CDR rule. US EPA also announced that because of these changes the agency is giving companies more time this year to submit the information required by the CDR rule.
The CDR rule generally requires a chemical manufacturer (including an importer) to report to US EPA a wide range of production volume and use data for any substance that it has manufactured/imported in the amount of 25,000 lbs or more at any single site during any calendar year since the last principal reporting year (with certain exceptions). For the upcoming 2020 report, this means that a company must make a CDR submission to US EPA for any substance it manufactured/imported in the amount of 25,000 lbs or more during any of the calendar years 2016-2019. Moreover, a company must report the same information for any substance that it manufactured/imported in the amount of 2,500 lbs or more, if the substances is the subject of certain TSCA actions (e.g., certain orders and rules).
The reporting period for 2020 CDR submissions opens June 1, 2020. Normally, the deadline for submission of CDR reports is September 30, but US EPA has extended the deadline this year until November 30, to enable companies to become familiar with the new changes to the CDR reporting requirements, as well as various updates that the agency has made to the e-CDR web reporting tool in US EPA’s Central Data Exchange (CDX).
Limiting Confidential Business Information (CBI) Claims
Among the more significant changes to the CDR rule, US EPA has revised the requirements for asserting confidentiality claims for data submitted to the agency to align the CDR with the 2016 amendments to TSCA approved by Congress, including outlining when upfront substantiation for a CBI claim is required, updating the substantiation questions, and identifying data elements that cannot be claimed as confidential.
US EPA is requiring chemical manufacturers/importers to provide upfront substantiation for any CBI claims at the time that the CDR submission is made to US EPA (except for claims that are otherwise exempt from substantiation under TSCA). US EPA also is requiring companies to provide more information to substantiate a CBI claim. For example, a company must describe in more detail the substantial harmful effects that likely would result to its competitive position if the information in question is disclosed, “including but not limited to how a competitor could use such information and the causal relationship between the disclosure and the harmful effects.” US EPA also is seeking more information about whether (and where) information claimed to be CBI may already have been publicly disclosed elsewhere.
Further, US EPA is making clear that certain data cannot be claimed as confidential if the data constitute general descriptions of processes, functions, and uses, including information that customarily would be shared with the general public or within an industry or industry sector. These include data elements directly related to how the chemical is used or processed (i.e., the type of process or use, the industrial sector, and the industrial function); data directly related to how the chemical is used (i.e., the product category); whether the chemical is used in commercial or consumer products; whether the chemical is likely to be used in children’s products; and the function of the chemical in the consumer or commercial product.
US EPA also is barring CBI claims for certain processing and use data elements, such as percent production volume, number of sites, number of workers, and maximum concentration, because in US EPA’s view they do not fall within a TSCA exemption.
Requiring the Use of OECD Codes
US EPA has replaced certain processing and use codes in the CDR (relating to industrial function and commercial/consumer product use) with codes based on the Organization for Economic Cooperation and Development’s (OECD) functional use and product and article use codes, and has added a requirement to report the OECD-based functional use codes for consumer and commercial use information. US EPA is requiring that the OECD-based codes be used during the 2020 CDR submission period for the 20 chemical substances that have been designated by US EPA as a high priority for TSCA risk evaluations, but the use of the OECD-based codes will be voluntary for other substances this year. (During the 2024 CDR submission, however, US EPA will require that the OECD-based codes be used for all chemical substances.)
Information on Recycling
US EPA now is requiring that chemical manufacturers/importers report whether a substance is recycled or otherwise used for a commercial purpose, instead of being disposed of as a waste or included in a waste stream. Previously, companies identified whether a reportable chemical substance is “recycled, remanufactured, reprocessed, reused, or otherwise used for a commercial purpose” instead of being disposed of as a waste or included in a waste stream. US EPA has removed the terms “remanufactured, reprocessed, reused” from the CDR rule.
US EPA has added a voluntary reporting data element asking the percent total production volume (by weight) for a chemical substance that is a byproduct, to be provided in four ranges: 0 percent, greater than 0 but less than 50 percent, greater than or equal to 50 percent but less than 100 percent, or 100 percent.
US EPA also added two new exemptions from the CDR reporting requirement for byproducts.
First, US EPA has exempted certain specifically identified byproducts that are recycled on-site from two particular industries. Pursuant to the changes, Portland cement companies that manufacture the substance “Flue dust, portland cement” and manufacturers using the Kraft pulping process to manufacture “Sulfite liquors and Cooking liquors, spent” and “Carbonic acid calcium salt (1:1)” are exempted from reporting these byproduct substances when (i) the substances are recycled or otherwise used to manufacture another chemical substance within an enclosed system, within the same overall manufacturing process, and on the same site where the byproduct was originally manufactured, and (ii) the non-exempted portion of the byproduct substance or a different chemical substance that was manufactured from the byproduct or manufactured in the same overall manufacturing process is still reported under CDR. US EPA also has created a process by which parties may petition the agency to amend the list of exempted byproducts to add substances and processes that meet the criteria for the exemption.
Second, US EPA has exempted byproducts manufactured in certain equipment via processes that are not integral to the production process. According to US EPA, an integral process is “the portion of the manufacturing process that is chemically necessary or provides primary operational support for the production of the intended product.” Under the change to the CDR rule, certain associated processes that are not chemically required to produce the intended product would be considered non-integral. US EPA specifically exempted byproducts manufactured due to the use of pollution control equipment and boilers that generate heat or electricity on-site, when such equipment is not part of the main production process, but the agency also indicated that it will prepare a guidance document that addresses other types of facilities and processes that may qualify for the exemption.
Reporting Foreign Parent Company Identity
US EPA has added a requirement to report a foreign parent company in addition to reporting the highest-level U.S. parent company, when the ultimate parent company is located outside of the United States. Under the change, a company must report the highest-level parent company of the site’s ownership hierarchy. Companies must continue to report their highest-level US parent company, but also must report their highest-level foreign parent company if applicable.
US EPA revised the CDR rule to clarify several other reporting requirements as well, including, among others things: (i) requiring that the secondary submitter of a joint submission report the specific function of the chemical along with the percentage of the chemical in the imported product, and (ii) providing two reporting mechanisms by which co-manufacturers of a substance can separately report directly to US EPA within the e-CDR web reporting tool.