Chemicals, Regulatory Developments

TSCA Definition of Small Manufacturer Broadened by EPA

Stating that compliance with the reporting requirements of Section 8(a) of the Toxic Substances Control Act (TSCA) places a particular burden on small businesses, the EPA has finalized a new definition of small manufacturer to include more entities. TSCA Section 8(a) generally excludes small manufacturers and processors of chemical substances from the reporting and recordkeeping requirements in Section 8(a).

Chemical manufacturing facility

Dmitry Kalinovsky /

“Smaller manufacturers tend to have fewer administrative personnel and less capability for data compilation and recordkeeping than larger manufacturers,” states the EPA.

The revised definition primarily affects reporting under the 2016 Chemical Data Reporting (CDR) rule, although reporting under other TSCA provisions is also affected. Also, the definition applies only to manufacturers (which include importers).

Reporting requirements for chemical processors are not addressed in the action. The EPA says that if it sees the need to change the definition of small processors, it will do so in another rulemaking.

When the Exclusion Does Not Apply

Elimination from reporting under TSCA does not apply to all manufacturers defined as small. TSCA Section 8(a)(3)(A)(ii) authorizes the Agency to require TSCA Section 8(a) reporting and recordkeeping from small manufacturers and processors 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.

In addition, the revised size standard does not apply if a different standard is identified in the regulatory text of a particular TSCA Section 8(a) rule. TSCA Section 8(a) rules with different definitions than the current small manufacturer definition at 40 CFR 704.3 are the nanoscale rule at 40 CFR 704.20; certain chemical-specific rules at 40 CFR 704.43 (chlorinated naphthalenes) and 40 CFR 704.102 (hexachloronorbornadiene); and the Preliminary Assessment Information Rule (PAIR) at 40 CFR 712.

Sales and Production Volume

The revised definition comprises two standards:

  1. First standard. A manufacturer (including an 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 import 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 pounds), 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 standard (2) of the definition.
  2. Second standard. A manufacturer (including an 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).

Eliminated Reports

The Agency estimates that the updated definition will eliminate reporting entirely for 127 industry sites that reported under the 2016 CDR and will reduce reporting by eliminating the need to report at least one chemical for an additional 173 industry sites that reported under the 2016 CDR. Overall, 1,248 chemical reports from industry sites will no longer be submitted under the CDR. This adds up to a reduction of 2 percent of sites, an overall reduction of 3 percent of chemical reports, and a reduction of 0.09 percent of total volume reported.

The EPA is also finalizing a definition for small government. The Agency estimates that 33 government sites report under the CDR in a 4-year cycle. Under the added definition, reporting will be eliminated entirely for four government sites with an associated six chemical reports.

The final rule is effective 30 days after its publication in the Federal Register. In April 2020, the EPA extended the submission deadline for 2020 CDR reports from September 30, 2020, to November 30, 2020.

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