Low release and exposure exemption

Substances not on the Inventory or are not otherwise excluded or exempt are considered new and are subject to a premanufacture notice (PMN). Examples of exclusions would include mixtures, substances subject to another statute, impurities, by-products and nonisolated intermediates. Additional exemptions also include test marketing products, low volume products, polymer exemptions, LoREX (low release and exposure exemption), and R D substances. By statute, chemical manufacturers must notify the Agency at least 90 days before manufacturing a chemical substance that is not listed on the TSCA Chemical Substance Inventory. However, TSCA does not empower the US EPA to require routine testing of new chemicals to permit a valid evaluation of the potential risks. This has been a limitation in the overall effectiveness of the PMN process. Erequently, very little data accompanies the PMN (50% of submissions present no safety data and 90% have only an LD50 and an Ames test) however, the EPA must decide within 90 days if the submitted chemical will pose a health or environmental hazard. 

The PMN process is in many ways the heart of the entire TSCA regulatory program. PMNs, together with applications for exemptions from the PMN rules (the Test Marketing Exemption, Low Volume Exemption, and low release and exposure exemption (LoREX)) are the main way for the EPA to... 

Fed. Reg. 16336 (Mar. 29, 1995) Premanufacture Notification Exemption Revision of Exemption for Chemical Substances Manufactured in Small Quantities Low Release and Exposure Exemption Final Rule 60 FR 16336 LVE LoREX 3-29-95 64 Fed. Reg. 31987 (June 15, 1999) Recordkeeping Requirements for Low Volume Exemption and Low Release and Exposure Exemption Technical Correction 64 FR 31987 LoREX 6-15-99 67 Fed. Reg. 76282 (Dec. 11, 2002) Sustainable Futures—Voluntary Pilot Project Under the TSCA New Chemicals Program Notice 67 FR 76282 Sustainable 12-11-02... 

Additional substances qualify for exemptions from the PMN requirements. The EPA s PMN form is also used for certain exemption applications and other notifications. The exemption applications that must use the PMN form are the Low Volume Exemption and Low Release and Exposure Exemption. Use of the PMN form is optional for applying for a Test Marketing Exemption. 

Has the EPA issued a Low Release and Exposure (LoREX) exemption for any of the seller s products ... 

Records documenting compliance with all exemptions from PMN requirements that the seller relied upon. The buyer will need to apply for a new Test Marketing Exemption (TME) because the EPA does not consider TMEs to be transferable. The parties can assign Low Volume Exemptions (LVEs), Low Release and Exposure (LoREX) exemptions, and polymer exemptions, but must have the documentation to be able to comply. 

This Procedure applies to the low volume exemption (LVE) and to the low release and exposure (LoREX) exemption from the rules. Use of the PMN form to apply for LVEs and LoREX exemptions is mandatory. 

Polymer exemption LowVolume Exemption Low Release and Exposure—LoREX... 

When EPA updated the LVE regulations in 1995, it added a new exemption for chemicals with low environmental releases and low human exposures during their life cycles as part of its overall pollution prevention strategy. The principal focus of the LoREX exemption was on release and exposure, not on toxicity.The rationale for the exemption was to encourage companies to develop manufacturing, processing, use, and disposal techniques that minimize exposures from chemicals to people and the environment. To REX chemicals undergo a shortened thirty day review period and are not subject to user fees. 

If the manufacture and use of a substance is so well controlled that exposure will be minimal, the Low Releases and Low Exposures (LoREX) exemption may apply under 40 CFR 723.50. 

This document describes the procedure required to submit an application to the EPA to exempt a chemical substance from the requirements of the PMN rules because the substance will be manufactured or imported in annual quantities of less than ten thousand kilograms or has low environmental releases and low human exposure. The steps include gathering information to submit the application using the PMN form, and post-application steps to comply with the exemption requirements. 

In addition, the EPA has granted exemptions for small quantity manufacturers and importers under TSCA Section 5(h)(4) for persons who manufacture certain chemical substances in quantities of 10,000kg or less per year. Also, the amendment adds a new Section 5(h)(4) exemption category for certain chemical substances with low environmental releases and human exposure. This became effective on May 30, 1995, as well. 

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