EPA Amends Small Manufacturer Definition under TSCA Section 8(a)

Posted on: June 1, 2020

by John J. Kowalski, CHMM

Factory worker in a hard hat using a laptop with an engineering software - Learn more about EPA Amends Small Manufacturer Definition under TSCA Section 8(a)On May 28, 2020, the U.S. Environmental Protection Agency (EPA) published a final rule to amend the definition of small manufacturer for reporting and recordkeeping requirements under Section 8(a) of the Toxic Substances Control Act (TSCA).  The final rule, which also includes a new definition for small government, is effective June 29, 2020.  This action is important because TSCA Section 8(a) generally excludes small manufacturers from reporting and recordkeeping requirements.

Under the final rule, small manufacturer means a manufacturer (including importer) that meets either of the following standards:

  • First standard. A manufacturer (including importer) of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $120 million. However, if the annual production or importation volume of a particular substance at any individual site owned or controlled by the manufacturer or importer is greater than 45,400 kilograms (100,000 lbs), the manufacturer (including importer) will not qualify as small for purposes of reporting on the production or importation of that substance at that site, unless the manufacturer (including importer) qualifies as small under paragraph (2) of this definition.
  • Second standard. A manufacturer (including importer) of a substance is small if its total annual sales, when combined with those of its parent company (if any), are less than $12 million, regardless of the quantity of substances produced or imported by that manufacturer (including importer).

Currently, the total annual sales thresholds are $40 million for the first standard and $4 million for the second standard.  The amended definition will impact the following TSCA Section 8(a) requirements:

  • Chemical-Specific Reporting and Recordkeeping rules codified at 40 CFR Part 704, unless individual rules specify otherwise;
  • Chemical Data Reporting (CDR) requirements codified at 40 CFR Part 711; and
  • Preliminary Assessment Information Reporting rules codified at 40 CFR Part 712.

But, at this time, it will impact the CDR requirements, for which the 2020 submission period is from June 1st to November 30th, more than the other TSCA Section 8(a) reporting rules codified at 40 CFR Parts 704 and 712.

At first glance, one might conclude that the amended definition would exclude many manufacturers that reported during previous CDR submission cycles.  But, the exclusion is negated with respect to any chemical substance that is the subject of a rule proposed or promulgated under TSCA Sections 4, 5(b)(4), or 6; that is the subject of an order in effect under TSCA Section 4 or 5(e); that is subject to a consent agreement under TSCA Section 4; or that is the subject of relief granted pursuant to a civil action under TSCA Section 5 or 7.  And, there are many such substances.  So, the practical effect may be much smaller.  Indeed, because of the proliferation of these so-called triggering actions, some manufacturers that never reported during previous CDR submission cycles may be subject to reporting in 2020.

Recommended Action Items

  • Review the final rule to determine its applicability to your situation; and,
  • Continue to watch this space, as we frequently post articles regarding significant new developments under TSCA.


Environmental Protection Agency.  “Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA) Section 8(a)”  Federal Register 85 (28 May 2020): 31986-31996.


United States, EPA, TSCA, CDR

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