On Feb 8, 2024, the U.S. Environmental Protection Agency (EPA) announced its final rule on revising the Toxic Substances Control Act (TSCA) fee. The revised fees will be effective 60 days after the 2024 final rule is published in the Federal Register.
Earlier on Jan 1, 2022, EPA has adjusted TSCA fees. Consistent with the formula in the final rule, fees have been increased by the inflation rate, calculated to be 18.9% and ensuring the fair distribution of fees. In any scenario where all manufacturers of the chemical substance are independently undergoing the EPA-initiated risk evaluation do not form a single consortium, the EPA would take the following steps to allocate fees:
- Count the total number of manufacturers;
- Divide the total fee amount by the total number of manufacturers to generate a base fee;
- Provide all small businesses who are either not associated with a consortium, or associated with an all-small business consortium, with an 80% discount from the base fee;
- Recalculate the remaining costs after deducting the small business discount and reallocate the costs according to the manufacturer's production volume;
- Reallocate 80% of the remaining fee evenly across manufacturers in the top 20% of production volume; and
- Reallocate the remaining fee evenly across the remaining manufacturers.
The revised fees for large businesses:
Fee Category | From Jan 1, 2022 | From Apr 9, 2024 |
TSCA Section 4 | ||
Test order | $11,650 | $25,000 |
Test rule | $35,080 | $50,000 |
Enforceable Consent Agreement (ECA) | $27,110 | $50,000 |
TSCA Section 5 | ||
Premanufacture Notice (PMN)/ Significant New Use Notice (SNUN)/ Microbial Commercial Activity Notice (MCAN) | $19,020 | $37,000 |
Low Releases and Low Exposures (LoREX) exemption/ Low Volume Exemption (LVE)/ Test Marketing Exemption (TME)/ Tier II exemption/ TSCA Environmental Release Application (TERA) / Film Articles | $5,590 | $10,870 |
TSCA Section 6 | ||
EPA-initiated risk evaluation | $1,605,000 | $4,287,000 |
Manufacturer-requested risk evaluation on a chemical included in the Work Plan |
50% of total actual costs with a $1,490,000 initial payment |
Two payments of $1,414,924, with the final invoice to recover 50% of actual costs |
Manufacturer-requested risk evaluation on a chemical not included in the Work Plan |
100% of total actual costs with a $2,970,000 initial payment |
Two payments of $2,829,847, with the final invoice to recover 100% of actual costs |
The revised fees for small businesses:
Fee Category | From Jan 1, 2022 | From Apr 9, 2024 |
TSCA Section 4 | ||
Test order | $2,320 | $5,000 |
Test rule | $7,020 | $50,000 |
Enforceable Consent Agreement (ECA) | $5,470 | $50,000 |
TSCA Section 5 | ||
Premanufacture Notice(PMN)/ Significant New Use Notice(SNUN)/ Microbial Commercial Activity Notice(MCAN) | $3,330 | $6,480 |
Low Releases and Low Exposures (LoREX) exemption/ Low Volume Exemption (LVE)/ Test Marketing Exemption (TME)/ Tier II exemption/ TSCA Environmental Release Application (TERA) / Film Articles | $1,120 | $2,180 |
TSCA Section 6 | ||
EPA-initiated risk evaluation | $320,000 | $857,000 |
Manufacturer-requested risk evaluation on a chemical included in the Work Plan |
50% of total actual costs with a $1,490,000 initial payment |
Two payments of $1,414,924, with the final invoice to recover 50% of actual costs |
Manufacturer-requested risk evaluation on a chemical not included in the Work Plan |
100% of total actual costs with a $2,970,000 initial payment |
Two payments of $2,829,847, with the final invoice to recover 100% of actual costs |
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