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EPA Issues Direct Final Rule on SNURs for 29 Chemicals

On July 10, 2017, the U.S. Environmental Protection Agency (EPA) issued a prepublication version of a direct final rule, Significant New Use Rule on Certain Chemical Substances, noting the  issuance of  significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 29 chemical substances that were the subject of premanufacture notices (PMN) and subject to consent orders under TSCA Section 5(e).  These are the first rules with consent orders negotiated under new TSCA.  Persons who intend to manufacture or process any of the chemicals for an activity that is designated as a significant new use (SNU) by this rule must notify EPA at least 90 days before commencing that activity, and the notification will initiate EPA’s evaluation of the intended use within the applicable review period.  Further, “[p]ersons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.”  EPA will be accepting comments on these SNURs; comments will be due 30 days after publication in the Federal Register.  If comment deemed adverse is submitted after the rules are published in the Federal Register as to any of the 29 chemical substances, EPA will withdraw the rule and propose it for comment.  Comment will be due 30 days after publication.

EPA states it is issuing these SNURs for specific chemical substances which have undergone premanufacture review because it wants to achieve the following objectives with regard to the SNUs designated in this rule:

  1. EPA will receive notice of any person's intent to manufacture or process a TSCA Inventory listed chemical substance for the described significant new use before that activity begins;

  2. EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use;

  3. EPA will be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs; and

  4. EPA will ensure that all manufacturers and processors of the same chemical substance that is subject to a TSCA Section 5(e) consent order are subject to similar requirements.

The 29 chemicals are:

  • PMN Number: P-15-310; Chemical name: 1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters;

  • PMN Numbers:  P-15-487, P-15-488, P-15-489, P-15-490, and P-15-491; Chemical names: Multi-walled carbon nanotubes (generic);

  • PMN Number:  P-16-165; Chemical name: Propanoic acid, iron (2+) salt (2:1);

  • PMN Numbers:  P-16-255, P-16-256, P-16-257, P-16-258, and P-16-259; Chemical names:  1-Butanaminium, N,N,N-tributyl-, carbonic acid (1:1) (P-16-255), 1-Butanaminium, N,N,N-tributyl-, methyl carbonate (1:1) (P-16-256), 1-Butanaminium,N,N,N-tributyl-, ethyl carbonate (1:1) (P-16-257), 1-Butanaminium, N,N,N-tributyl-,propyl carbonate (1:1) (P-16-258), 1-Butanaminium, N,N,N-tributyl-, and 1-methylethyl carbonate (1:1) (P-16-259); CAS numbers: 17351-62-1(P-16-255), 56294-05-2(P-16-256), 478796-04-2(P-16-257), 1338579-13-7(P-16-258), and 1803407-49-9(P-16-259);

  • PMN Number:  P-16-284; Chemical name:  Anilino substituted bis-triazinyl derivative of 4,4'-diaminostilbene-2,2'- disulfonic acid, mixed amine sodium salt (generic);

  • PMN Numbers:  P-16-309 and P-16-310; Chemical names:  12-Hydroxystearic acid, reaction products with alkylene diamine and alkanoic acid (generic);

  • PMN Number:  P-16-315; Chemical name:  Alkyldiene, polymer, hydroxy terminated alkoxysilylalkylcarbamate (generic);

  • PMN Number:  P-16-323; Chemical name: Alkylaldehyde, reaction products with substituted carbomonocyclesubstituted heteromonocycle-alkylene glycol bis[[[[substituted(oxoneoalkyl)oxy]alkyl] amino]alkyl] ether polymer and alkyl substituted alkanediamine, acetate salts (generic);

  • PMN Numbers:  P-16-330 and P-16-331; Chemical names:  Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[4-isocyanatobenzene] (P-16-330) and Hydroxy functional triglyceride polymer with glycerol mono-ester and 1,1'-methylenebis[isocyanatobenzene] (P-16-331) (generic);

  • PMN Number:  P-16-360; Chemical name:  Poly(oxy-1,2-ethanediyl),.alpha.-(1-oxodocosyl)-.omega.-[(1- oxodocosyl)oxy]-;

  • PMN Number:  P-16-361;  Chemical name: Pulp, cellulose, reaction products with lignin;

  • PMN Numbers:  P-16-365 and P-16-367; Chemical names:  Alkyl carbonate, polymer with, substituted alkanes and substituted heteromonocycle, substituted alkyl acrylate-blocked (generic) (P-16-365) and substituted heteromonocycle, polymer with substituted alkane and ethoxylated alkane, substituted heteromonocycle substituted alkyl ester-blocked (generic) (P-16-367);

  • PMN Number:  P-16-369; Chemical name:  Substituted heteromonocycle, telomer with substituted carbomonocycles, substituted alkyl ester (generic);

  • PMN Number:  P-16-387;  Chemical name:  Aliphatic polycarboxylic acid, polymer with alicyclic polyhydric alcohol and polyoxyalkylene (generic);

  • PMN Number:  P-16-455; Chemical name:  Sodium tungsten oxide;

  • PMN Number:  P-16-503; Chemical name:  Fatty acids, tall-oil, polymers with alkanoic acid, substituted carbomonocycle, alkyl peroxide-initiated (generic); and

  • PMN Number:  P-16-591; Chemical name:  Alkyl bisphenol (generic).

©2017 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Margaret Graham, Environmental Science and Policy Paralegal, Bergeson Campbell Law firm
Paralegal

Margaret R. Graham (Maggie), a paralegal with Bergeson & Campbell, P.C. (B&C®), holds a Masters degree in Environmental Science and Policy, and has over a decade of paralegal experience, including eight years focused in federal regulatory law.  Her understanding of environmental policy and the administrative and legislative process involved in regulatory compliance makes her an invaluable resource to B&C staff and clients, who rely on her research, project management, and writing and editing skills to complete efficiently briefs, pleadings, and other documents.

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