Low volume exemption

This exemption is person-specific, but contains no time limitations — i.e. a manufacturer may qualify for the exemption and thus avoid the PMN requirements indefinitely, so long as the company does not market more than one tonne annually.(14). This low volume exemption is contingent upon the manufacturer providing a limited notice to each Member State in which the substance is marketed, and complying "with any conditions imposed by those authorities" in the various Member States. 

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... 

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. ... 

The EPA receives very few MCANs each year. In 2007 it received three MCANs covering eight microorganisms, and just one TERA." Only 43 intergeneric microorganisms have been added to the Inventory through the MCAN process." In contrast, in the 18 months covering 2007 and the first half of 2008, 1071 PMNs and 630 applications for low volume exemptions from the PMN requirements were filed."... 

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... 

B). The exemptions that incorporate this reference to PMNs and not SNURs are the polymer exemption, low volume exemption, LoREX, and the instant photo and peel-apart film exemption. The practical effect of not having these exemptions apply to the SNUR program is that companies cannot file for or rely on one of these exemptions to avoid the restrictions in a SNUR. 

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. 

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. 

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. 

Third, the submission must be a full PMN, as opposed to an abbreviated exemption notice. Notices for test market exemptions, low volume exemptions or... 

Low Volume Exemption (EVE) may apply if 10,000 kilograms or less of the substance will be manufactured or imported each year under the requirements at 40 CFR 723.50. 

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