Chemical Data Reporting (CDR) Rule Revisions and Small Manufacturer Definition for TSCA 8(a)

23 April, 2019

How Could it Impact Me?

The proposed ammendments to the current CDR rule include:

1.    Changing requirements for confidential business information (CBI) claims.  Certain substantiation questions will be revised, others will be added, and all non-exempt claims of confidentiality must be substantiated at the time the information is submitted to USEPA.  Substantiation would not be required for (1) production volume and (2) supplier information associated with joint submissions, such as supplier identity and details of the full composition of a mixture.  A joint submission is started by a primary submitter (typically an importer) supported with information supplied by the secondary submitter (typically a non-domestic raw material supplier).  Non-exempt CBI claims are initially protected from disclosure for a period of 10 years from the date of submission.

2.    Replacing certain processing and use codes with codes based on the Organization for Economic Cooperation and Development (OECD) functional use and product and article use codes, and adding adding reporting of the OECD-based functional use codes for consumer and commercial uses.
 
3.    Adding the requirement to report the 6-digit North American Industry Classification System (NAICS) code that best describes the manufacturing activities conducted at the reporting site.

4.    Clarifying the requirement to indicate when a chemical is removed from the waste stream and recycled to eliminate the alternate terms  ‟remanufactured, reprocessed, reused or otherwise used”.

5.    Adding a requirement to identify the percent of the total production volume of a chemical substance that is a byproduct.  The Agency is asking for feedback regarding the rules on the specificity of this requirement, e.g., to require that the percentages for the percent byproduct be rounded to the nearest 10%, unless the percentage is less than 5% and the production volume attributable to that amount is greater ≥ 25,000 lbs where the rounding would be to the nearest 1%, or to simply round to the nearest 1% for all production.

6.    Requiring that the secondary submitter of a joint submission report the chemical specific function and the percentage of the chemical in the imported product.

7.    Adding a voluntary data element to provide a public contact who may be contacted by the general public with questions related to the publicly available information reported by the company.

8.    Modifying the definition of “parent company” and adding the 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.  The proposal includes  several hypothetical scenarios to assist in identifying the correct “parent company”.  It also proposes mandatory naming conventions for parent company names to assure consistency in reporting across sites.
9.    Simplifying the reporting process for co-manufacturers (aka ‟toll” or contract manufacturers) by enabling a multi-reporter process for reporters to separately report directly to USEPA.  To be considered a co-manufacturer two criteria must be met:
 

  • The chemical substance is manufactured (not imported) by the producing company exclusively for the contracting company and
  • The contracting company specifies the identity of the chemical substance, the total amount produced, and the basic technology for the plant process.

The Agency is proposing to change the reporting mechanism to be a multi-submitter process, similar to that used by importers, where the contracting company is the primary submitter and the producing company is the secondary submitter. This co-manufacture reporting procedure would enable the use of one Form U per site, because the contracting company indicates the producing company’s site without starting a separate Form U, and the producing company completes an independent report for any other non-co-manufactured chemicals in its own site report.  As with current reporting, both parties would remain legally liable for reporting the co-manufactured chemical.

10.    Adding exemptions for byproducts from two specifically identified processes (Portland cement manufacture and the Kraft pulping process) that are recycled in a site-limited, enclosed system.  Also,  byproducts that are manufactured as part of non-integral process, as in 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 (e.g. flue gas desulfurization,  selective catalytic reduction systems).  Anyone will be able to petition USEPA to amend the manufacturing process and related byproduct substance exempted list in the future.

Also, manufacturers of certain inorganic byproducts would have the option to combine and report multiple inorganic byproduct metal substances that would otherwise be reported individually into one or more specifically-listed categories citing the specific metal in the name ‟Metal and Metal Compounds“ that includes  the following metals: Sb, As, Ba, Be, Ca, Cr, Co, Cu, Pb, Mn, Hg, Mo, Ni, Se, Ag, Tl, and Va.  Exclusions apply (e.g., substances that are subject to certain TSCA actions, substances undergoing prioritization or risk evaluation under TSCA Section 6, etc.).  In the future USEPA may modify the metal categories list as more chemicals are evaluated as part of the existing chemical program.

The volume of the byproduct would be reported solely based on weight of the metal, not the entire compound (e.g., manufacture or import of 34,000 pounds of Copper chloride (CuCl2) (CASRN 7447-39-4) would be reported as 16,072 pounds of ‟Cu & Cu Compounds” .

CDR reporting for byproducts is one of the most complicated components of the CDR.  Specific guidance was published for the 2016 report and will hopefully be updated for 2020.

The Agency is also proposing a new definition for small manufacturers (including importers) subject to TSCA 8(a) reporting requirements.  This definition differs from the small business criteria used for other TSCA sections such as TSCA 5 reporting.  There are two standards:

  1. Total annual sales (when combined with a parent company, if applicable) is < $110 million.  However, if  the production or import volume at any individual site is > 100,000 lbs, the reporting entity would not qualify unless it meets standard 2
  2. Total annual sales (when combined with a parent company, if applicable) is < $11 million regarless of volume.

Sites that meet the small manufacturer requirements are exempt from the need to report either for the full site (based on the second standard) or for particular chemical substances (based on the first standard), unless the chemical substance is the subject of one of certain TSCA actions:

  • A rule proposed or promulgated under TSCA sections 4, 5(b)(4), or 6
  • An order in effect under TSCA section 5(e)
  • Is the subject of relief that has been granted under a civil action under TSCA sections 5 or 7

Bottom Line:

The next CDR report will not be due until 2020, but it is never too early to start compiling the required data.  And since it will encompass data from 2016-2019, we advise generating the data on an ongoing basis.  The proposed changes in this alert should be reviewed in detail to determine the potential effects on your organization. 

When the official version of the proposed rule is published in the Federal Register anyone may access the on-line docket to comment.

Contact Us:

knoell USA, LLC  will continue to follow TSCA developments and can provide your company with periodic TSCA updates to assist you in addressing  future regulatory requirements.  knoell USA can also provide assistance with your 2020 CDR obligations as well as a free consultation to talk through the ongoing issues and how they could affect your business.

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