Significant New Use Rule

EPA. 1992. Chemicals toxic chemical release reporting community right-to-know proposed significant new use rule. U.S. Environmental Protection Agency. Federal Register 57(174) 41020. 

Proposed significant new use rule (SNUR) n-Methanesulfony1-p-toluene sulfonamide. 

Under pressure from the EPA and others, the manufacturer of pentaBDE voluntarily moved to phase out production at the end of 2004. The EPA believed that it was important both to inform the substitution decisions that would inevitably result from this phase out, and to understand the potential for unintended consequences that could result. Alternatives were identified that could meet fire safety requirements but that did not pose the same level of concern as pentaBDE. This alternative assessment complemented EPA regulatory action, a significant new use rule ( SNUR ), that prevented future manufacture of pentaBDE without prior notification to the EPA, effectively a ban on the chemical. The results from the alternatives assessment were used by foam manufacturers to make real-time decisions on substitutions to alternative flame retardants. 

US Environmental Protection Agency (2000) Perfluorooctyl Sulfonates Proposed Significant New Use Rule. United States Environmental Protection Agency, Federal Register 65, No. 202, 62319-62333... 

The TSCA regulations are found in Title 40 of the Code of Federal Regulations (40 CFR), Parts 700-789. Probably the most important sections of TSCA to the plastics industry in general and the coloring of plastics in particular are Section 5 Premanufacture notification (PMN) and SNUR (Significant New Use Rules) Section... 

US Environmental Protection Agency. Perfluoroalkyl sulfonates, significant new use rule flnal rule and supplemental proposed rule. Fed. Regist., 61 11007-11013 (2002). 

As part of its premanufacture review, EPA can use Section 5(e), to require the submitter to develop data and to obtain hazards which the "new" chemical may pose, and can impose controls or restrictions on its nse. These requirements apply only to the company which submits the PMN. Once a chemical is added to the inventory, one may manufacture or use it without notifying EPA, without the same restrictions or controls. However, EPA can use its authority under Section 5 of TSCA to issue Significant New Use Rules (SNURS) which extend the limitations in Section 5(e) orders to other manufacturers, importers, and processors. This ensures that everyone is treated in essentially the same manner, and that the original PMN submitter is not put at a disadvantage compared to subsequent manufacturers, importers, and processors. 

The PMN approach also applies for known substances destined for a significant new use (Significant New Use Rule). If the substance is on the list and it is still destined for the use shown (no SNUR), the production/importation can take place. If the substance is not listed, the PMN process is followed. 

In addition, prior to importation of a chemical substance subject to TSCA into the United States, an importer of record must determine whether the substance is subject to a Significant New Use Rule issued under Section 5 of TSCA. Section 5 of TSCA authorizes EPA to designate use of a chemical substance as a significant new use , and require the submission of information to EPA prior to the chemical substance being manufactured (including imported) or processed for that use. 

A PMN must be made to the H A, under Section 5 of TSCA, 90 d before a new chemical substance is manufactured or imported into the USA. A new substance is one not on the Chemical Substances Inventory, which is the list of existing and previously-notified substances. A notification is also required for a new use of a listed substance which is subject to a Significant New Use Rule (SNUR). Notified substances are listed in the TSCA inventory only afto- being supplied and the mandatory Notice of Commencement of Manufacture or Import is filed with the EPA. Notified substances can be placed in the confidential section of the TSCA inventory, on justified request. Howev, potential suppliers can establish from the EPA whether the substance of concern is listed and hence is not notifiable by filing a bona fide intent to manufacture or import... 

The R8tD exemption from the premanufacture notification rule is addressed in Chapter 5. PMN Exclusions and Exemptions, and the exemption from Significant New Use Rules is addressed in Chapter 12, Significant New Use Rules. 

EPA has also issued Significant New Use Rules (SNURs) under TSCA covering at least four different nanoparticles, two of which were the subject of the 5(e) consent orders discussed above. In all of the SNURs... 

See Chapter 12, Significant New Use Rules for a discussion of procedures for the issuance of SNURs. 

E-mail from David E. Giamporcaro, Industry and Small Business Liaison, EPA to Listserv, Clarification of Applicability of Significant New Use Rules (July 28, 2009). 

There maybe significant limitations on a company s right to manufacture or import an existing chemical, as discussed in more detail in this chapter. Some of these limitations may be the result of a Significant New Use Rule, an order under Section 5(e), a consent order, or a product restriction under 6. 

Byproducts that have no commercial use, or that are commercially used by pubhc or private organizations only (i) to burn as a fuel, (ii) for disposal as a waste including landfilling and to enrich soil, or (iii) to extract components for commercial purposes are exempt from the PMN and significant new use rule (SNUR) requirements. ... 

The polymer exemption is an exemption from the premanufacture notice requirements and not an exemption from all of the many programs under the Toxic Substances Control Act. An exempt polymer is subject to all of the other TSCA programs, including (but not limited to) the substantial risk reporting in 8(e) of the statute, Significant New Use Rules, import certifications, and export notifications. 

Section 12(b) of TSCA requires exporters to notify the United States Environmental Protection Agency (EPA) before, or on the date of, export of certain chemical substances or mixtures. The covered chemical substances are those (i) for which data are required under 4 or 5(b), (ii) for which an order has been issued under 5, (iii) for which a rule has been proposed or issued under 5 or 6, or (iv) with respect to which an action is pending, or relief has been granted under 5 or 7. A significant new use rule is a rule under 5 and chemicals that are the subject of proposed or issued significant new use rules are subject to the 12(b) notification requirements. ... 

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