On Tuesday, March 17, 2020 USEPA released a pre-publication notice of its final revisions to the Chemical Data Reporting (CDR) Rule (“TSCA Chemical Data Reporting Revisions under TSCA Section 8(a)”). This action follows the changes proposed in 2019 that were the subject of an earlier knoell alert. Several of the revisions proposed in April, 2019 are not included in the final rule, but changes to Confidential Business Information (CBI) claims, co-manufacturer reporting, and byproducts bear scrutiny. The 2020 submission period has been extended and is now June 1 to November 30, 2020.
While additional changes are not anticipated, a pre-publication notice it is not the official version of the document and does not represent an Agency determination or policy. On Tuesday, March 31, 2020, EPA will host a webinar to provide an overview of the 2020 CDR requirements and a walk through of the draft e-CDRweb reporting tool.
Amended CBI provisions require substantiation at the time of submission for all confidentiality claims except the following exempt information:
Note that exempt data may still be subject to substantiation and CBI review under certain circumstances determined by the Agency.
General CBI Protection Eligibility
Industrial processing and use data elements
Consumer and Commercial use data elements
The current industrial function and commercial/consumer product use codes will be replaced with codes based on Organization for Economic Cooperation and Development’s (OECD) function, product, and article use categories. It is now also mandatory to report the function of the chemical in commercial and consumer products.
Submitters are directed to report the 6-digit NAICS code that best describes the manufacturing activities conducted at the reporting site. In cases where identifying a single NAICS code may be difficult (e.g., for companies that consolidate imports for multiple sites at a single corporate site) reporters may indicate up to three NAICS codes that best represent the majority of activities associated with the intended use of the chemical substances.
The question regarding whether a chemical is removed from a waste stream and recycled, remanufactured, reprocessed, or reused now asks submitters to simply indicate whether a chemical is removed a the waste stream and recycled.
Under TSCA a byproduct is:
“A chemical substance that is produced without a separate commercial intent during the manufacture, processing, use, or disposal of another chemical substance(s) or mixture(s); because it is part of the manufacture of a chemical product for a commercial purpose, it is considered to be produced for the purpose of obtaining a commercial advantage and is therefore itself considered manufactured for a commercial purpose.”
EPA is not requiring the reporting of the byproducts within the intended product, which frequently are referred to by industry as contaminants or impurities, but rather the byproducts that are manufactured and then separated from the intended product. These byproducts are already required to be reported separately unless the production volume is under the reporting threshold or the byproduct is covered by another exemption, e.g.
For 2020 there is a new voluntary reporting element for the weight percent of total intended product production volume that is a byproduct within four ranges:
There are also two new exemptions associated with specific byproducts:
1. Specifically-listed byproducts that are recycled in a site limited, enclosed system.
There is a process to petition the Agency for additions to the list of exempted manufacturing processes and related byproduct substances.
2. Byproducts manufactured in pollution control and boiler equipment when that equipment is non-integral to the primary manufacturing process. An integral portion of the manufacturing process is chemically necessary or provides primary operational support for the production of the intended product. For the purposes of this exemption, certain associated processes that are not chemically required to produce the intended product would be considered non-integral, e.g., those required due to other regulations or needed to generate heat or electricity on-site.
A joint submission is most typically used when a substance or a mixture is imported and the supplier does not provide to the importer the specific chemical identity of the substance or substances that comprise the mixture. The secondary submitter of a joint submission, typically a non-US supplier, is required to report the chemical-specific function along with the already-required information on chemical composition of the imported product or mixture.
The definition of U.S. parent company is replaced with a new definition for “highest-level parent company”. Under the new definition, highest-level parent company means the highest-level company(s) of the site’s ownership hierarchy as of the date of the submission during which data are being reported. The highest-level U.S. parent company is located within the United States, while the highest-level foreign parent company is located outside the United States.
In some situations, the highest-level parent company is outside of the United States. Since sites must, when applicable, also identify the highest-level worldwide parent company, the requirement includes reporting the foreign parent company in addition to their highest-level U.S. parent company, if applicable.
The term “toll manufacturer” is replaced with the term “producing company”. Two methods for reporting are available:
Consistent with the past CDR rule, only a domestically produced chemical substance can be the subject of a co-manufacturing report.