Significant New Use of Existing

Section 5 deals with the notification to EPA of new substances or significant new uses of existing chemicals. Table 2 outlines the information requirements of this section. The Premanufacturing Notice (PMN) requirement of the act, as required under section 5(a)(1)(A), went into effect, as mandated by Congress, 30 days after the TSCA inventory was published, according to Section 8(b). Since taking effect on July 1, 1979, over 1250 PMN s have been submitted. This activity has been one of the top agency priorities. 

Section 5 of TSCA regulates the manufacture or import a new chemical substance for commercial purposes. Under this section, EPA requires notice before manufacture or importation of nonexempt substances. They then evaluate whether the chemical substance poses a threat to human health or the environment. This notice is called a PMN and must be submitted at least 90 days prior to the activity.34 Manufacturers must also submit information on significant new uses of existing chemicals to EPA for its review. After its review of the PMN or Significant New Use information, EPA may limit, restrict, or prohibit the manufacture, use, distribution, or disposal of the chemical substance. 

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... 

For example, Section 4 of the Act authorizes EPA to promulgate rules which require the testing of particular substances or mixtures. Under Section 4(a), one of the criteria for promulgating such rules is whether the chemical may present an unreasonable risk of injury to health or the environment. Under Section 5 of the Act, companies must notify EPA 90 days before they intend to manufacture a new chemical substance or manufacture or process an existing chemical substance for a significant new use. Under Section 5(e)(1), upon receiving that notice, EPA may require further postponements in manufacture or processing if it determines that, without the development of additional information, the chemical in question may present an unreasonable risk of injury to health or the environment. ... 

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. 

TSCA (Section 5) also provides EPA with the authority to regulate and control the introduction of new chemicals either through manufacture or import, or the processing of an existing chemical for a significant new use. Such manufacturers and importers must file a Premanufacture Notification (PMN) 90 days before producing or importing the chemical. Once a PMN is filed, EPA assesses the information and determines if the chemical poses an unreasonable risk of injury to health or the environment. An additional 90 days may be re-... 

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]. 

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