TSCA Update - Chemical Data Reporting (CDR) rule revisions

25 March, 2020

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.

Details

CBI claims: Upfront Substantiation and General Eligibility

Amended CBI provisions require substantiation at the time of submission for all confidentiality claims except the following exempt information:

  1. Production volume (volume domestically manufactured in 2019, volume imported in 2019, and the total production volume for each of the three years 2016 through 2018) is exempt.
     
  2. In joint submissions, information from the primary submitter as to the supplier identity, chemical substance name (trade name) and details of the full composition of a mixture is exempt.  Information submitted by the secondary submitter is not, including all confidentiality claims for the data elements that it submits directly to EPA (its company name and location, a technical contact, trade name, chemical identity(ies), and percentage of each chemical substance in the composition of the substance or mixture represented by the trade name). Except for the percentage composition information, which is generally exempt from substantiation, all other reported data elements are subject to substantiation at the time the information is submitted.


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

  • Eligible - Percent production volume, maximum concentration, number of workers
  • Ineligible - Type of process or use, industrial sector, industrial function


Consumer and Commercial use data elements

  • Eligible - Percent production volume, maximum concentration, number of commercial workers
  • Ineligible – Product category, used in commercial or consumer products, likely to be used in children’s products, chemical function

Processing and Use Codes

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. 

In addition:

  • This requirement will be codified in the Code of Federal Regulations (CFR) rather than being included in CDR guidance. The current 35 industrial function codes have been replaced by 117 OECD-based function codes, and the current 33 consumer/commercial product categories have been replaced by 96 OECD-based product categories.
  • Not all of the OECD harmonized codes are adopted as individual CDR function codes because some are for functional uses not regulated by TSCA. Codes associated with non-TSCA uses (e.g., FIFRA and FDA regulated uses) will be folded into the overarching “non-TSCA use” code.
  • For the 2020 CDR use of the OECD-based codes will be required only for the 20 chemical substances designated in 2019 by EPA as a high priority for risk evaluation. Use will be voluntary for all other substances. For the 2024 CDR OECD-based codes will be required for all chemical substances.

Site of Manufacture: North American Industry Classification System (NAICS) Codes

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.

Recycling

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.

Byproducts

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.

  • It is burn it as a fuel
  • It is disposed of it as a waste, including in a landfill or for enriching soil
  • Inventory listed chemical substances are extracted from it for commercial purposes


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:

  • 0
  • 0 > x < 50
  • 50 > x < 100
  • 100


There are also two new exemptions associated with specific byproducts:

1. Specifically-listed byproducts that are recycled in a site limited, enclosed system.

  • Portland cement manufacturers that manufacture “Flue dust, portland cement” (CASRN 68475-76-3)
  • Manufacturers using the Kraft pulping process to manufacture Sulfite liquors and Cooking liquors, spent (CASRN 66071-92-9)
  • Carbonic acid calcium salt (1:1) (CASRN 471-34-1)

 
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.

Joint Submissions: Chemical-specific Function of Imported Mixtures

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.

Parent Company Identity

Requirement Added

  • When the ultimate parent company is located outside of the U.S, a requirement to report the foreign parent company in addition to reporting the highest-level U.S. parent company.
  • For parent company names the requirement to report the legal name(s) and to follow a specified naming convention. Details of the naming convention will be provided in the CDR Instructions for Reporting.


Requirement Replaced

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.

Co-Manufacture (Toll or Contract Manufacture)

The term “toll manufacturer” is replaced with the term “producing company”.  Two methods for reporting are available:

  1. The contracting company (primary submitter) initiates a co-manufacture report that prompts the producing company (secondary submitter) to report. The contracting company identifies the chemical substance and the producing company. The contracting company is responsible for completing the volume manufactured and the processing and use-related sections. The producing company will then have the information needed to complete its portion of the co-manufacturer report, which includes the manufacturing-related data elements, including the production volume. Each party will complete its part of the co-manufacturer joint report as part of its overall CDR submission and will not have access to the information submitted by the other party.
     
  2. This reporting methodology requires the contracting and producing company to enter into a written agreement to work together to complete the report. The producing company (instead of the contracting company) initiates the report including the exposure information from the manufacturing site. The producing company would then coordinate with the contracting company to obtain the additional information needed to complete the submission. Although the producing company submits the report, both parties are legally liable for the information provided in the report.


Consistent with the past CDR rule, only a domestically produced chemical substance can be the subject of a co-manufacturing report.

Business Units: 
Elizabeth Dederick, Ph.D. Vice President, Industrial Chemicals and Biocides
+1 610 558 3001 Ext. 102 +1 610 558 6025 send mail