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EPA Releases Final Rule Amending Small Manufacturer Definition for Reporting and Recordkeeping Requirements under TSCA Section 8(a)

Date: May 15, 2020

On May 11, 2020, the U.S. Environmental Protection Agency (EPA) released a pre-publication copy of the final rule “Small Manufacturer Definition Update for Reporting and Recordkeeping Requirements Under the Toxic Substances Control Act (TSCA) Section 8(a).” 

The rule revises the definition of small manufacturer (and importer) - the new definition will apply to TSCA section 8(a) reporting obligations, including the 2020 Chemical Data Reporting (CDR) rule.  As discussed below, EPA is adjusting the sales standard levels for inflation from $40 million to $120 million under its first size standard and from $4 million to $12 million under its second size standard. EPA believes that the amended definition will eliminate CDR reporting entirely for 127 sites and the need to report at least one chemical for additional 173 sites.

With certain exceptions, TSCA section 8(a) reporting requirements generally exclude small manufacturers and processors. EPA had established the general section 8(a) small manufacturer definition in 1988, but under the Frank Lautenberg Chemical Safety for the 21st Century Act (LCSA), enacted on June 22, 2016, within 180 days of enactment EPA was required to consult with the U.S. Small Business Administration to review the adequacy of standards for determining whether manufacturers and processor qualify as “small” manufacturers and processors. Based on this review, EPA decided that revisions to the standards were appropriate. 

The final rule the size standards definition for small manufacturers under TSCA section 8(a) reporting as follows:

  • First standard:  EPA increased the annual sales threshold based on inflation from $40 million to $120 million. Thus, under the final rule a manufacturer/importer is considered “small” if its total annual sales (when combined with its parent company) are less than $120 million. 
      • However, if the annual production or importation volume of a substance at any individual site owned or controlled by the manufacturer/importer is greater than 100,000 pounds, the manufacturer/importer will not qualify as “small” for purposes of reporting on the production or importation of that substance at that site..
  • Second standard:  EPA increased the annual sales threshold based on inflation from $4 million to $12 million. Thus, under the final rule a manufacturer/importer is considered “small” if its total annual sales (when combined with the parent company) are less than $12 million, regardless of the quantity of substances manufactured or imported.

An otherwise reportable substance that is manufactured at or imported by a site must be reported. However, if the substance is subject to a proposed or final TSCA section 4 test rule; a TSCA section 4 test order; a proposed or final rule under section 5(b)(4) (concern list); a proposed or final section 6 rule; a section 5(e) order; or if relief has been granted under a section 5 or 7 civil action.

EPA also added a definition for small governments in order to reduce reporting their burdens under the CDR. The final rule defines a small government as a “government of a city, county, town, township, village, school district, or special district with a population of less than 50,000. State and tribal governments are not considered small governments.”

EPA also made a technical correction to the small manufacturer reference for hexafluoropropylene oxide and a proposed update to the current small manufacturer definition in the section 8(a) Preliminary Assessment Information Rule (PAIR).

For more information, please visit EPA’s website at: https://www.epa.gov/chemical-data-reporting/prepublication-version-final-rule-tsca-chemical-data-reporting-revisions-and.