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EPA Direct Rule Establishes Significant New Use Rules for 25 Chemicals

The Environmental Protection Agency has issued a direct final rule that promulgates significant new use rules (SNURs) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for 25 chemical substances which were the subject of premanufacture notices (PMNs).

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Rule Effective Nov 19 Unless Adverse Comments Received by Oct 20

The direct final rule is effective November 19, 2010.1 However, if EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments on one or more of the SNURs before October 20, 2010, it will withdraw the relevant sections of this direct final rule and issue a proposed SNUR for that chemical substance(s), providing a 30 day period for public comment.

Importers of Substances for a SNUR Activity Must Notify EPA Before Import

TSCA requires persons who intend to manufacture, import, or process any of these 25 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before beginning that activity. In addition, importers of chemicals subject to SNURs must comply with certain recordkeeping and information submission requirements such as certifying compliance with these SNUR requirements.

SNUR Activity Evaluated After Notification, EPA Can Prohibit or Limit Activity

The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.

25 Substances Subject to Significant New Use Rules

EPA is establishing significant new use and recordkeeping requirements for the following 25 chemical substances in 40 CFR part 721, subpart E:

1. Cobalt lithium manganese nickel oxide (CAS number: 182442-95-1)

2. Benzoic acid, 4-chloro-2- [(substituted)azo]-, strontium salt (1:1) (generic -- CAS not available)

3. Phosphonium, tetrabutyl-, hydroxide (1:1) (CAS number: 14518-69-5)

4. Aryloxyacrylate (generic -- CAS not available)

5. Formaldehyde, polymer with 1,3-benzenediol and 1,1′- methylenebis [isocyanatobenzene] (CAS number: 1067881-45-1)

6. 4-Cyclohexene-1,2-dicarboxylic acid, 1,2-bis(2-oxiranylmethyl) ester (CAS number: 21544-03-6)

7. 1,3-Cyclohexanedimethanamine, N1,N3-bis(2-methylpropylidene)- (CAS number: 173904-11-5)

8. Amines, di-C11-14-isoalkyl, C13-rich (CAS number: 1005516-89-1)

9. Epoxy terminated, hydrolyzed trialkoxysilane and glycidyl ether of phenol-formaldehyde resin (generic -- CAS not available)

10. Soybean oil, epoxidized, reaction products with diethanolamine (CAS number: 1002761--12--7)

11. Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates (CAS number: 84962--05--0)

12. 1,2-Ethanediol, reaction products with epichlorohydrin (CAS number: 705265--31--2)

13. Polyether polyester copolymer phosphate (generic -- CAS not available)

14. Poly(oxyalkylenediyl), .alpha.-substituted carbomonocycle-.omega.-substituted carbomonocycle (generic -- CAS not available)

15. Benzenepropanol,.beta.-methyl-. (CAS number: 7384--80--7)

16. 2-Propenoic acid, 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexyl ester (CAS number: 903876--45--9)

17. Branched and linear alcohols (generic -- CAS not available)

18. 2-Propenoic acid, 2-methyl-, C12-15-branched and linear alkyl esters, telomers with alkyl 2-[[(alkylthio)thioxomethyl]thio]-2-alkanoate, aminoalkyl methacrylate and alkyl methacrylate, tert-Bu 2-ethylhexanoperoxoate-initiated (generic -- CAS not available)

19. Butanamide,N-[substituted phenyl]-[(alkoxynitrophenyl)diazenyl]-3-oxo- (generic -- CAS not available)

20. Phosphoric acid, polymer with cycloaliphatic diglycidyl ether, alkylethers (generic-- CAS not available)

21. 3-Nonen-1-ol, 1-acetate, (3Z)-. (CAS number: 13049--88--2)

22. Styrenyl surface treated manganese ferrite (generic-- CAS not available)

23. Styrenyl surface treated manganese ferrite with acrylic ester polymer (generic-- CAS not available)

24. Diglycidylaniline (generic-- CAS not available)

25. Quino[2,3-b] acridine-7,14-dione, 2,9-dichloro-5,12-dihydro [4-[[2-(sulfooxy) ethyl] substituted] phenyl]-, sodium salt (1:1) (generic-- CAS not available)

(EPA provides the following information for each chemical substance: (i) PMN number; (ii) chemical name (generic name, if the specific name is claimed as CBI); (iii) CAS number (if assigned for nonconfidential chemical identities); (iv) basis for the TSCA section 5(e) consent order or, for non-section 5(e) SNURs, the basis for the SNUR (i.e., SNURs without TSCA section 5(e) consent orders); (v) toxicity concerns; (vi) tests recommended by EPA to provide sufficient information to evaluate the chemical substance; (vii) the assigned CFR citation; and (viii) the activities designated as significant new uses.)

One Substance Also Subject to “Risk Based” Consent Order

This rule includes one substance (cobalt lithium manganese nickel oxide) that is also subject to a ‘‘risk-based’’ consent order under TSCA section 5(e)(1)(A)(ii)(I) where EPA determined that activities associated with the PMN substance may present unreasonable risk to human health and the environment. (See notice for details.)

For the remaining 24 substances, EPA did not find that the use scenario described in the PMN triggered the determinations set forth under TSCA section 5(e). However, EPA does believe that certain changes from the use scenario described in the PMN could result in increased exposures, thereby constituting a ‘‘significant new use.’’

1For purposes of judicial review, the direct final rule will be considered promulgated at 1 p.m. on October 4, 2010.

Kenneth Moss (technical information)(202) 564-9232
TSCA Hotline (general information)(202) 554-1404

(D/N EPA--HQ--OPPT--2009--922, FR Pub 09/20/10)