Exemptions from SNUR Requirements

Many of the exemptions from PMN requirements are applicable to SNURs, but because SNURs cover processors the SNUR rules are adapted to cover processing when required. A person who has received a test marketing exemption for a significant new use ° or has been granted an exemption under TSCA 5(h) (5)is exempt from SNUR requirements. A person who manufactures, imports, or processes a SNUR substance solely for research and development or as an impurity or as a byproduct that is burned as a fuel, disposed of as waste, or from which other substances are extracted for commercial purposes is exempt from SNUR requirements. An importer or processor who imports or processes the substance as part of an article is exempt from the SNUR requirements, but a manufacturer of an article is not. A person who manufactures, imports, or processes a SNUR substance solely for export is exempt from filing a SNUN so long as the substance is labeled as 

This exception from the requirement to file a SNUN only applies to processors. Manufacturers and importers have an obligation to identify their chemicals and determine if SNURs apply. 

49 Fed. Reg. 35011, 35012 (Sept. 5, 1984). The language of the applicable regulation has been changed since the date of this Federal Register notice and as a result the EPA s statements in the preamble may not be binding on the EPA. 

For the test marketing exemption to apply to SNURs, a company that is subject to a SNUR must be able to file a test marketing exemption to avoid the restrictions in the SNUR. See the discussion infra concerning the application of the LVE, LoREX and polymer exemptions to SNURs. 

This rarely used provision of the TSCA statute provides that the EPA may grant exemptions from the PMN and SNUN requirements for  

---

Entitles That Must File Significant New Use Notices—SNUNs 428 Exemptions from SNUR Requirements 431... 

The R D exemption from SNUR requirements is different from the PMN R D exemption in several respects. The most significant difference is that SNURs apply to noncommercial research laboratories, which are otherwise exempt from the PMN requirements. The SNUR regulations do not have any counterpart to the PMN regulations at 40 C.F.R. 720.30(i) which exempts noncommercial research conducted in laboratories by academic, government, or independent not-for-profit research organizations (e.g., universities, colleges, teaching hospitals, and research institutes). ... 

Marketing Exemption from PMN and SNUR Requirements 724 Procedure Number Reg. Aff. 4, Procedure for LVE and LoREX Exemptions from PMN Requirements 730... 

Step 5. If the substance is not on the Inventory, the MRC shall determine if the substance is excluded from the definition of chemical substance because it is a pesticide, a food, a nuclear material, or any other substance excluded from TSCA s scope. The MRC shall also determine if the substance is eHgible for an exemption from the PMN requirements because it is to be made for test marketing, in low volumes, is an exempt polymer, or any other type of substance eHgible for an exemption. If the substance is excluded or qualifies for an exemption, no PMN is required see Procedure Number Reg. Aff. 3, Procedure for the Test Marketing Exemption from PMN and SNUR Requirements, Procedure Number Reg. Aff. 4, Procedure for EVE and LoREX Exemptions from PMN Requirements. 

Articles are not listed on the TSCA Inventory, and no PMN is required for an article.Articles are not exempted from TSCA programs other than the PMN, Inventory and part of the SNUR programs. An article is defined as ... 

PMNs are only required for substances that are manufactured or imported for commercial purposes, which is defined in the regulations to mean to import, produce, or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer or importer. Any amount of manufacture or import, no matter how small, can be for a commercial purpose if it is for commercial distribution, test marketing, product research and development, or use as an intermediate. Byproducts and impurities that have no commercial value are made or imported for a commercial purpose if they are made with or present in a product with commercial value that was made or imported for a commercial advantage," " although they may qualify for exemptions from PMN and SNUR requirements. 

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 statute also exempts R D substances from SNURs. The R D exemption for SNURs is very similar to the R D exemption from the Inventory and PMN rules. However, unless the context is clear otherwise, this discussion only relates to the R D exemption from the Inventory and PMN requirements. 

The R D exemption is only an exemption from the PMN, Inventory, and SNUR requirements of TSCA. R D substances are subject to the substantial risk reporting requirements of TSCA 8(e), any restrictions that may be issued under 4 or 6, import certifications, export notifications, and all other TSCA programs. 

TSCA 5(h)(l) authorizes EPA to exempt from PMN and SNURs chemical substances that will be used for test marketing purposes. Unlike the other exemptions discussed infra requiring EPA prior approval, the holder of a TME has a limited time to conduct the test marketing. TME chemicals undergo a shortened 45 day review period and are not subject to user fees. 

Several of the exemptions from the PMN requirements do not apply on their face to SNURs because they state they are exemptions from certain of the premanufacture notice requirements of section 5(a)(1)(A) of the Toxic Substances Control Act, and that is a reference to the premanufacture notification program only. The SNUR program is authorized in TSCA 5(a)(1)... 

All other requirements of the R D exemption from the PMN program apply to SNURs. 

This document describes the procedure required to submit an application to the EPA to exempt a chemical substance from the requirements of the PMN and SNUR rules because the substance will be manufactured or imported for test marketing purposes only. The steps include gathering information to submit the application using the PMN form, and post-approval steps to comply with the exemption requirements. 

This procedure should be followed when the Manager of Regulatory Compliance (MRC) has determined that a substance (a) that any person in the Company intends to manufacture or import is not on the TSCA Inventory, or that a substance that any person intends to manufacture, import, or process is subject to a SNUR, and (b) may qualify for a TME exemption from the PMN and SNUR requirements. 

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. 

It covers manufacture of the substance by the pilot plant, and use of substances manufactured at other facilities. This Procedure also applies to certain laboratories that are required to evaluate the risks associated with R D substances to qualify for the R D exemption from the PMN and SNUR requirements. ... 

---