LoREX exemption

The original plus two dupKcate complete copies of all paper submissions, including attachments and enclosures, must be filed with a PMN or SNUR no duphcate copies are required if the filing is for a TME, EVE, or LoREX exemption. If any information is claimed as confidential then a full set with the confidential information sanitized or blanked out, must also be submitted. Everything has to be in Enghsh except for reports in the open scientific Uterature. ... 

If the PMN form is submitted because the submitter is applying for an LVE or LoREX exemption then the person who signs the form also takes personal responsibility for these additional certification statements ... 

The Focus Meeting is when the EPA makes its determinations on TMEs, LVEs, and LoREX exemption applications. 

The United States Environmental Protection Agency (EPA) has authority under the statute to grant additional exemptions under TSCA 5(h)(4) if the manufacture, processing, distribution in commerce, use or disposal of a substance will not present an unreasonable risk of injury to health or the environment. Several exemptions have been promulgated under this authority, including the polymer exemption, the LVE and LoREX exemptions, and the Polaroid exemption. 

If a manufacturer, importer, or processor wants to use surplus R D material for a non-R D purpose, it may file a PMN, a Low Volume Exemption or a LoREX exemption application. Interestingly, the substance will not be put on the Inventory unless it is manufactured or imported subsequently for a non-exempt purpose because no Notice of Commencement (NOC) can be filed for a batch that was manufactured for R D purposes. ... 

TSCA 12(b) 15 U.S.C. 261 fib). It is unUkely that a substance subject to a TME, LVE, or LoREX exemption would be subject to a test rule to trigger these export notification requirements. The TME is time Umited, so it is likely such an exemption would expire prior to the issuance of any test rule, and with respect to chemicals marketed under an LVE or LoREX exemption, the EPA retains significant authority to revoke those exemptions, which is a quicker route to imposing restrictions than rulemaking. 

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. 

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. ... 

The review period for a LoREX exemption ends thirty days after receipt of the notice by the TSCA Document Control Officer. EPA will acknowledge the receipt of the notice and will indicate in that letter the date the review period begins. If EPA has taken no action during the thirty day review period, the manufacturer may begin to manufactme the new chemical substance at the end of that review period. If EPA determines that the chemical substance is ineligible for a LoREX exemption, EPA will notify the manufacturer. The manufacturer may at any time during the review... 

Some of the more significant requirements of the LoREX exemption deal with notifications to customers about product restrictions and the obhga-tions of the manufacturer in the event it learns a customer is not adhering to those restrictions. Manufacturers must notify processors and industrial users that the chemical can be used only for the particular uses and under the... 

Both the low volume exemption (EVE) and the LoREX exemption have mandatory requirements to submit to the EPA test data which indicates that the substance may not qualify for the exemption. Such test data must be submitted within 15 working days. Therefore, a submittal made under this... 

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

If the EPA has not issued a LoREX exemption for a chemical substance that is being manufactured, but is not on the Inventory, the seller may be in violation of TSCA, and the buyer may be at risk for penalties and business disruptions if it continues manufacturing that product. 

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. 

Similarly, when a substance is the subject of an EVE or LoREX exemption from the premanufacture notification requirements of TSCA 5, the ERA will allow the exemption to be transferred to the buyer, but if the seller will continue to manufacture the substance it may not want to transfer it. Even if the seller does choose to transfer the exemption to the buyer, it will have... 

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. 

In all other cases, where the seller and buyer agree to transfer a 5(e) consent order, an LVE, a LoREX exemption or an older polymer exemption, the parties should use the forms provided by the EPA for that purpose. ... 

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. 

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. 

This Procedure does not apply to research and development substances that are made, imported, or handled solely by laboratories or facilities in compliance with either Procedure Number Pilot Plant. 11, Qualifying for the R D Exemption at Pilot Plants, or Procedure Number Lab. 11, Qualifying for the R D Exemption at Laboratories. Note that LVEs and LoREX exemptions are not exemptions from Significant New Use Rules. 

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

Step 3. If the decision in Step 2 is to proceed with fifing an application for an LVE or LoREX exemption, the MRC shall gather information sufficient to describe the substance s chemical identity, physicochemical properties, manufacturing, processing and use information, test data, other data, and optional pollution prevention information. The MRC shall request information from the Product Manager, Production Manager, suppliers in the case of LVE or LoREX substances to be imported, suppliers and manufacturers of precursors and in-house or external chemists as necessary to conclusively determine... 

The complete set shall be retained in the corporate archives for five years after the company ceases to manufacture or import the LVE or LoREX substance in rehance on the LVE or LoREX exemption. 

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. 

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 ... 

Does not reflect restrictions implicit in certain exemptions such as the LoREX exemption (81 substances, 1979-2013). 

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