Significant New Use Notices

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

X. Entities That Must Fiie Significant New Use Notices—SNUNs... 

A company produced a chemical substance regulated by a SNUR, for a significant new use as defined by the SNUR, without submitting a Significant New Use Notice to EPA. The substance was incorporated into a consumer use product. The company produced the chemical 9 times, with 3,000 pounds produced on each occasion. EPA discovered the violation. The company is charged with a failure to submit a Significant New Use Notice, level 1, major, per-day. 

The PMN form is also used for Significant New Use Notices (SNUNs), and for so-called mock PMNs, which are submissions in the context of enforcement proceedings. Note that requirements for the SNUNs are not the same as for PMNs., and are addressed in Procedure Number Reg. Aff. 7, Procedure for SNUNs. 

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. ... 

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. 

The distributor has notified the recipient that the recipient is engaging in an activity that is inconsistent with a personal protective equipment program set forth in a SNUR, and the distributor is aware of the lapse. In other words, the recipient is likely engaging in a significant new use. The distributor must submit that notice within 15 working days of the date it has knowledge of the activity. 

Section 5(a)(1) of TSCA states that no person may manufacture a new chemical substance, nor manufacture or process any chemical substance for a significant new use, unless such person submits to EPA at least 90 days before such manufacturing or processing, a PMN orSNUN notice. Person is defined by 40 CFR 720.3(x) to include any natural person, firm, company, corporation, joint-venture, partnership, sole proprietorship, association, or any other business entity, any state or political subdivision thereof, any municipality, any interstate body, and any department, agency or instrumentality of the Federal Government. ... 

As a result of the EPA interpretations, a buyer must file transfer notices with the EPA if it wants to continue to rely on its predecessor s EVE, LoREX exemption, or older polymer exemption that required EPA approval. A buyer must also notify the EPA if it is assuming the responsibilities of the seller under a 5(e) consent order. Buyers and sellers must also determine how they will manage any PMN that has not yet resulted in placing a substance on the Inventory. A purchaser will need to file a new SNUN if its use of a SNUR substance is a significant new use. 

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 ... 

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