Exemption Application

Manufacturers must submit an application at least 45 days before beginning manufacture of the chemical substance for test marketing that contains the following informationP  

EPA must pubHsh a notice in the Federal Register both when it receives an application for a TME and when that application has been granted or denied. The review period for a TME is 45 days. However, unhke with PMN, LoREX, and EVE filings, EPA takes the position that the manufacturer cannot begin to manufacture at the end of the review period unless EPA has made an affirmative finding that the test marketing will not present any unreasonable risk of injury to health or the environment.  

The regulations do not impose on TME applicants the requirement to use the PMN form, as is specifically required by regulation for both the EVE and EoREX exemptions. TMEs are specifically excused from those notification requirements. The regulation governing use of the PMN form says it is only applicable to companies required to submit a notice. The EPA, however, in some of its literature and through the EPA TSCA hotUne, does tell submitters to use that form. In other older Hterature, EPA takes the opposite position. The EPA prenotice submission office does concede that there is no statutory authority to require submitters to submit notices using the PMN form and that it is not required to be used, but does suggest that the use of the 

48 Fed. Reg. 21721, 21725 (May 13. 1983) EPA Draft Instruction Manual for Reporting Under the TSCA 5 New Chemicals Program. 6-7 (2003) [hereinafter PMN Instruction Manual], available through http //www.epa.gov/oppt/newchems/. 

30(d) states that chemicals that are distributed in commerce pursuant to a TME under 40 C.F.R. 720.38 are not subject to the PMN notification requirements. See also, PMN Instruction Manual. 21-22. 

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To encourage industry participation in this voluntary pilot project, the Agency has provided regulatory flexibility in the form of certain expedited reviews of PMNs. For purposes of this voluntary pilot project, EPA implemented a program leading to the opportunity for simultaneous submissions of Test Market Exemption applications and PMNs on chemical substances for which the submitter demonstrates the application and use of the P2 Framework or other scientifically acceptable hazard and exposure... 

Class III transitional devices, i.e., devices considered to be a new drug or antibiotic drug before May 28, 1976, and new devices are automatically classified into Class III by statute and require premarket approval by FDA before they may be commercially distributed. Applicants may either submit a PMA or PDP, or they may petition FDA to reclassify the devices into Class I or II. Clinical studies in support of a PMA, PDP, or a reclassification petition are subject to the Investigational Device Exemption application. 

IND Investigational New Drug Exemption application for FDA approval to carry out new drug trials in humans requires animal data... 

SECTION 1. APPLICANT IDENTIFICATION - Intormalion must be typed or printed in the blocks provided to help reduce data entry errors. A physical address is required in address line 1 a pest office box or corrtinuetiort of address may be entered In address line 2. Fee exempt applicant must list the address of the fee exempt institution. The email address and point of contact are new data items that are in the process of OM6 approval and will soon be mandatory. They are requested in order to facilitate communicalton or as required by inler agency data sharing requii emenis. Applicant must enter a valid tax identificaiion number (TIN). 

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

Fed. Reg. 76282 (Dec. 11. 2002). This Federal Register notice states that the PMN form must be used for TMEs, and that [i]f EPA has not taken action to deny the exemption application, under section 5(h)(1) for TMEs. .. the notice submitter may manufacture or import the new chemical substance when the respective review period for those notices expires (i.e., day 45 for TME...). W. at 76284-85. This is not consistent with statements EPA has made elsewhere about TMEs. For a discussion of TMEs see Chapter 5, PMN Exclusions and Exemptions. 

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. ... 

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. 

Copies of all records supporting the site change notification, including exposure determinations and environmental release calculations, shall be maintained in the file with the original exemption application. 

Exemption Application — An individual, motor carrier, or other entity responsible for the operation of a commercial motor vehicle may apply for an exemption. 

The New Roads and Street Works Act 1991 stipulates circumstances under which certain excavation contractors, defined as utilities and other undertakers, must give notice of their planned works. Emergency, urgent and some minor works are excluded from this duty. It also requires that contractors keep up-to-date records of the location of their apparatus and make them available, free of charge, for inspection at all reasonable hours. The exemptions applicable to the Act do not affect contractor liability under the HSW Act. 

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