EPA Promulgates Direct Final SNURs under TSCA for Seventeen Chemicals

TSCA:

On June 24, 2010, EPA promulgated significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 17 chemical substances that were the subject of premanufacture notices (PMNs), the type of notice submitted prior to manufacturing or importing a “new chemical” for commercial purposes.  The Federal Register notice announcing the SNURs can be found at 75 Fed. Reg. 35977.

Two of the substances are subject to ‘‘risk-based’’ consent orders under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the substances may present unreasonable risks to human health or the environment.  The SNURs for these two substances are based on and consistent with the provisions in the underlying consent orders.  The 5(e) SNURs designate as a ‘‘significant new use’’ the absence of the protective measures required in the corresponding consent orders.

The other 15 substances are not subject to consent orders under section 5(e).  EPA did not find that the use scenarios described in their PMNs triggered the determinations set forth under TSCA section 5(e).  Nonetheless, the Agency concluded that certain changes from the use scenarios could result in increased exposures potentially causing adverse human health or environmental effects, or both, and thereby would constitute ‘‘significant new uses.’’

The Agency used its direct final rulemaking procedure to promulgate the SNURs, which means the rules will become effective on August 23, 2010, if EPA does not receive by July 26, 2010, written adverse or critical comments, or notice of intent to submit such comments.  In that instance, EPA would withdraw the SNUR for the substance(s) for which it received comments or notices, and instead it would issue a proposed SNUR and provide a 30-day public comment period.

A short overview of each substance, and the next steps some companies will likely consider, are set out below.

Overview of the Chemicals Affected

Persons who intend to manufacture, import, or process any of these 17 substances for an activity that is designated as a significant new use are required to notify EPA at least 90 days before commencing that activity. The required notification will give EPA the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

Each substance is listed below – typically with a generic name to protect Confidential Business Information (CBI) – along with the Code of Federal Regulations (CFR) citation to its respective SNUR, the PMN number, and the use(s) identified in its PMN.

  • Aliphatic triamine (generic). CAS number not available.  PMN Number P–02–996.  Will be used as a monomer for polymers with amide or imide links; a crosslinker for epoxy type coatings, adhesives and sealants; a crosslinker for epoxy type composites; a monomer for urea and urethane urea polymers used in coatings; a chemical intermediate for functional chemicals: amides, imides; a chemical intermediate for functional chemicals: isocyanates, salts; and a chemical intermediate for functional chemicals: cyclic amines, etc..  SNUR to be codified at 40 CFR § 721.10184.

  • 1,2-Propanediol, 3-(diethylamino)-, polymers with 5-isocyanato-1- (isocyanatomethyl)-1,3,3-trimethylcyclohexane, propylene glycol and reduced Me esters of reduced polymd. oxidized tetrafluoroethylene, 2-ethyl-1-hexanol-blocked, acetates (salts). CAS number: 328389–90–8.  PMN Number P–03–106.  Will be used as a surface treatment agent.  SNUR to be codified at 40 CFR § 721.10185.

  • Ethylhexyl oxetane (generic). CAS number not available.  PMN P–04–132.  Will be used as an additive for industrial applications.  SNUR to be codified at 40 CFR § 721.10186.

  • 4-Morpholinepropanamine, N-(1,3-dimethylbutylidene)-. CAS No. 1003863–30–6.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10187.

  • Fatty acids, tall-oil, reaction products with 4-methyl-2-pentanone and aliphatic polyamine (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10188.

  • Fatty acids, tall-oil, reaction products with (butoxymethyl) oxirane formaldehyde-phenol polymer glycidyl ether, morpholinepropanamine, propylene glycol diamine and aliphatic polyamine, N-(1,3 -dimethylbutylidene) derivs (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10189.

  • Formaldehyde, polymer with aliphatic diamine and phenol, reaction products with 4-methyl-2-pentanone (generic). CAS number not available.  PMN P–05–186.  Will be used as a curing agent for epoxy coating systems.  SNUR to be codified at 40 CFR § 721.10190.

  • Amides, coco, N-[3-(dibutylamino)propyl]. CAS No. 851544–20–2.  PMN P–06–262.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10191.

  • Amides, coco, N-[3-(dibutylamino)propyl], acrylates. CAS No. 851545–09–0.  PMN P–06–263.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10192.

  • 1-Butanaminium, N-(3-aminopropyl)-N-butyl-N-(2-carboxyethyl)-,N-coco acyl derivs., inner salts. CAS No. 851545–17–0.   PMN P–06–263.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10193.

  • Dialkylcocoamidoalkylpropionate (generic). CAS number not available.  PMN P–06–264.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10194.

  • Dialkylcornoilamidoalkylamine (generic). CAS number not available.  PMN P–06–265.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10195.

  • Dialkylcornoilamidoacrylate (generic). CAS number not available.  PMN P–06–266.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10196.

  • Dialkycornoilamidoalkylbetaine (generic). CAS number not available.  PMN P–06–266.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10197.

  • Dialkylcornoilamidopropionate (generic). CAS number not available.  PMN P–06–267.  Will be used as an intermediate for hydrate inhibitor in oil and gas production.  SNUR to be codified at 40 CFR § 721.10198.

  • Substituted aliphatic amine (generic). CAS number not available.  PMN P–06–702.  Will be used as a polymer curative.  SNUR to be codified at 40 CFR § 721.10199.

  • Benzenacetonitrile, cyclohexylidene-alkyl substituted (generic). CAS number not available. PMN P–09–75.  Will be used as a component of odorant compositions for highly dispersive applications..  SNUR to be codified at 40 CFR § 721.10200.

Next Steps

First, many companies are probably determining whether they currently manufacture, import, or process any of these substances, or have plans to do so in the future.   If so, they may be assessing whether and how these rules would affect their business and deciding whether to submit comments to EPA by the deadline noted above.

Second, companies that import any of these substances are likely confirming that they are prepared to make the necessary import certifications.  TSCA section 13 (15 U.S.C. 2612) requires importers to certify that each shipment of a chemical substance complies with all applicable rules and orders under TSCA.  Importers of chemical substances subject to a final SNUR must certify their compliance with the SNUR requirements.  The import certification requirements are set out in the regulations at 19 CFR 12.118 – 12.127, and 127.28 (the corresponding EPA policy is codified at 40 CFR part 707, subpart B).

Lastly, companies may also be confirming that they are prepared to make the necessary export certifications.  In general, any person who exports or intends to export a chemical substance that is the subject of a proposed or final SNUR is subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and the regulations at 40 CFR part 707, subpart D. The export notification requirements apply even when a company does not manufacture, import, or process the substance in a manner restricted by the SNUR.  The notification requirement applies regardless of whether the company is required to take any action under the SNUR.