Significant New Use Rules—SNURs

See Chapter 4, Premanufacture Notifications, for a discussion of what constitutes processing. 

Like the PMN process, the significant new use notification process enables the EPA to evaluate the risks that may be presented by a new use of a substance and gives the EPA an opportunity to gather risk data and regulate the use if it may present unreasonable risks. 

The statutory standards for issuing a SNUR are quite flexible. The statute does not require EPA to make specific findings, and only requires that the EPA consider all relevant factors including volume, how use changes exposure, and handling methods, as set out in the excerpt of the statute quoted above. However, the SNUR regulations impose much more stringent requirements on the EPA before it can issue a SNUR. 

Under the SNUR regulations, the EPA either must make findings that justify issuance of an order under TSCA 5(e), or must determine that new uses may result in significant changes in human exposure or environmental releases, or that there is a concern about the health or environmental effects of the substance. The findings necessary for issuance of a 5(e) consent order are that there is insufficient iifformation to evaluate the effects of the substance on health and the environment The EPA must also find that either (i) without sufficient information to permit an evaluation of the substance s effects on health and the environment there may be an unreasonable risk to health or the environment, or (ii) the substance will be produced in substanticd 

The acronyms SNUR and SNUN are pronounced as if they were words instead of reading out the letters. 

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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. 

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. 

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... 

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... 

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. ... 

Step 3. The MRC must evaluate each proposed change to determine whether a new chemical substance required to be on the TSCA Inventory, or any other chemical inventories on which the product is listed, will be formed by the process change. The MRC must also evaluate whether a chemical substance subject to a Significant New Use Rule (SNUR) or any other restriction will be formed by or handled differently as a result of the process change. The Liaison must provide the MRC with information needed to complete such evaluation. 

As discussed in The Inventory Chapter, 5 of the Toxic Substances Control Act (TSCA) requires that all chemicals manufactured, processed, or used in the United States must be on a comprehensive list of chemicals maintained by the United States Environmental Protection Agency pursuant to 8(b) of TSCA, called the TSCA Inventory. New products and the production processes for manufacturing new products could result in the formation of new chemicals and intermediates not on the TSCA Inventory. New products and new intermediates may also be subject to Significant New Use Rules (SNURs) and other product restrictions under TSCA. The company must make certain new products and the processes for making them are adequately reviewed from a TSCA perspective. This procedure deals with the process steps for manufacturing or importing a new product that might have an impact on TSCA compliance. 

As discussed in the PMN Exclusions and Exemptions Chapter, 5(h)3 of the Toxic Substances Control Act (TSCA) exempts from TSCA 5(a) and (b) (the PMN and Significant New Use rules, respectively) small quantities of new chemicals or chemicals subject to a Significant New Use Rule (SNUR), if used solely for research and development (R D) purposes underspecified circumstances. R D substances are often sampled for outside testing to laboratories or to customers. If the product is not on the TSCA Inventory, or is the subject of a SNUR, the R D substance must be sampled in a way that meets the TSCA exemption requirements for research and development samples. TSCA s PMN rules apply to manufacturers and importers SNURs apply to processors as well as manufacturers and importers. 

If a chemical s manufacture, processing, distribution, use, or disposal would create unreasonable risks, the U.S. ERA, under the TSCA, can regulate it, ban it, or require additional testing. TSCA mandates the U.S. ERA to monitor and control the use of toxic substances by requiring the Agency to review the health and environmental effects of new chemicals [referred to as Premanufacturing Notice or PMN Section 5(a)(1) of TSCA] and chemicals already in commerce. The U.S. ERA also has Significant New Use Rules (SNUR) under Section 5(a)(2) ofTSCA which provides away for the U.S. ERA to restrict uses of a chemical substance already in commerce that are proposed for new uses. All of the solvents discussed are already commercially available, so a PMN would not apply some could be... 

Section 5 of TSCA requires a manufacturer or importer of a new chemical substance to notify the US EPA before beginning manufacture or importation. The agency reviews the premanufacture notice (PMN) and may require additional testing or restrict the conditions under which a chemical is manufactured or used through a Consent Order and potentially a Significant New Use Rule (SNUR). This regulatory process is so crucial to the life cycle of chemicals in the United States that it is worth a closer look. The subsections that follow describe these aspects of TSCA requirements for new chemicals ... 

US EPA. 2013. Consent Orders and Significant New Use Rules (SNURS). Web page... 

In the United States, CAS number 88-73-3, Benzene, l-chloro-2-nitro-, is listed on the Toxic Substances Control Act (TSCA) Non-Confidential Inventory with no Significant New Use Rule (SNUR) [38]. It has been designated as a High Production Volume (HPV) chemical [39]. In the European Union (EU), ONCB has been notified under REACH as an intermediate and as a chemical produced or imported at 100-1,000 tormes per armum. The REACH notifications refer to use as an intermediate in closed processes, and to use as a laboratory reagent [40]. In China, ONCB is listed on the Inventory of Existing Chemical Substances Produced or Imported in China (lESC) it is also listed in the Catalog of Hazardous Chemicals [41]. 

TSCA Significant New Use Rule (SNUR) None of the chemicals in this material have a SNUR under TSCA. 

Even if a substance is on the Inventory List, the EPA can issue a Significant New Use Rule (SNUR) for it when the agency deems that the material may pose a hazard to either human health or the environment. Under an SNUR, a manufaemrer or processor may be required to submit notice to the EPA for review at least 90 days prior to manufacture or use. 

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