EPA Proposes Significant New UseRules Under TSCA for MultipleChemical Substances
Significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) have recently been proposed by the Environmental Protection Agency (EPA) for a group of chemicals that are the subject of premanufacture notices. Here we present a brief overview of SNURs and look at the corresponding substances for which the SNURs have been proposed.
Significant New Use Rules
SNURs are used to require notice to the EPA before chemicals (substances or mixtures) can be used in new ways that might yield concerns. If the EPA determines that a chemical's use constitutes a “significant new use”, relevant parties must then provide the Agency with at least 90 days’ notice (significant new use notice) before manufacturing, importing, or processing of the substance takes place for any activity related to that use. The EPA is required to assess associated risks, make a decision on the notice, and take actions deemed necessary (e.g., mitigating possible risks that may be detected in the process).
Objectives of Proposed SNURs
The principal objectives underlying the proposed SNURs are to:
- Allow for the identification of any manufacturing, processing, use, distribution in commerce, or disposal not conforming to TSCA Order-imposed restrictions as significant new uses
- Allow for significant new use notice data evaluation prior to the submitter’s manufacture or processing of a particular substance for its significant new use
- Allow for the determination that an unreasonable risk is not likely to be presented by manufacture or processing, or take required regulatory steps prior to the occurrence of the significant new use
The chemical substances for which significant new use rules were recently proposed are displayed in the table below.
|Quaternary ammonium salt of polyisobutene succinic acid|
|2-Propenoic acid, 2-alkyl-, 2-(dialkylamino)alkyl ester, polymer with alpha-(2-alkyl-1-oxo-2-alken-1-yl)-omega-methoxypoly(oxy-1,2-alkanediyl)|
|Alkanedioic acid, polymer with cycloalkyl dimethanol, alkyl and cycloalkyl diisocyanates, dimethyl-alkanediol, dihydroxyalkanoic acid methylenebis[isocyanatocyclohexane, hydroxyethyl acrylate- and polyalkyl glycol monoalkyl ether blocked|
|Poly(oxy-1,4-butanediyl), alpha-hydro-omega-hydroxy-, polymer with 1,1′-methylenebis[4-isocyanatobenzene),caprolactam-blocked|
|Tall oil pitch, fraction, sterol-low|
|Carboxylic acid, reaction products with metal hydroxide, inorganic dioxide and metal|
|Multi-walled carbon nanotubes; closed; 4.4-12.8 nm diameter; bundle length 10.6-211.1 µm|
|Multi-walled carbon nanotubes; closed; 5.1-11.6 nm diameter; bundle length 1.9-552.0 µm|
|Multi-walled carbon nanotubes; closed; 7.9-14.2 nm diameter; bundle length 9.4-106.4 µm|
|Multi-walled carbon nanotubes; closed; 17.0-34.7 nm diameter; globular shape|
|2-Propenoic acid, 2-methyl, 2-(dimethylamino)ethyl ester, polymers with 2-(C16-18-acylamino)ethyl acrylate and hydroxyalkyl acrylate, acetates (salts)|
|Organic acid ester, polymer with aliphatic diols and 1,1′-methylenebis[4-isocyanatobenzene]|
|4,4-Methylenebis (2,6-dimethyl phenol) polymer with 2-(chloromethyl)oxirane, 1,4-benzene diol, 2-methyl-2-propenoic acid, mixed alkyl substituted 2-methyl 2-propenoate, and ethyl 2-propenoate, reaction products with 2-(dimethylamino) ethanol|
|Phenol, methylethylidene, polymer chloromethyl epoxide and methylethylidene bis-oxy, bis-amine|
|Amine, methylethylidene bis(oxy)|
|Carbamic acid, N-[3-(trialkoxysilyl)propyl]-, C,C′-[2,2,4(or 2,4,4)-trimethyl-1,6-hexanediyl] ester|
|Arylfurandione, [bis(trihaloalkyl)alkylidene]bis-, polymer with alkanediamine|
|Phosphonic acid, dimethyl ester, reaction products with alkyl-alkyl-alkanediol and alkanediol|
|Heteromonocycle, polymer, substituted aliphatic carbamate, [2-[(1-oxo-2-propen-1-yl)oxy]alkyl]ester|
|Alkanes, C4-8-branched and linear|
Source: Environmental Protection Agency
For individuals planning to manufacture or process any of the aforementioned chemical substances for an activity noted as a significant new use, the SNURs require that a notification be made to the EPA three months prior to the activity beginning. Once notified, the Agency begins its assessment of the substance’s use, subject to its use conditions. No manufacturing or processing is permitted until the Agency’s review has finished and a corresponding decision has been made.
Accessing Additional Information
More information regarding the recently proposed SNURs, may be found by reviewing Federal Register citation 87 FR 65548.