Release and Exposure Exemption—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. 

---

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... 

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. 

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... 

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... 

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. 

To be eligible to apply for a LoREX exemption, a manufacturer must meet stringent exposure and environmental release requirements. Ehgibility does not depend on production quantity. ... 

Below certain levels of exposure, the TSCA program presumes that risk is likely to be limited. Table 3.2 illustrates that general philosophy, as does the LoREX exemption, which provides the first of the three benchmarks for acceptable exposures. Federal regulations specify the LoREX criteria at 40 CFR 723.50(2). Paraphrased, exposure to releases of a new chemical substance during its manufacture and use are generally considered to be negligible when there would be ... 

---