Document ID: FDA-2007-N-0314-0053
Agency: fda
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-19T05:00Z

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<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:33.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58504</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:34.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:406.00pt;top:684.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.55pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:410.15pt;top:684.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">‘‘Consumption’’ is defined as the amount of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:692.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">substance produced in the United States, plus the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:700.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">amount imported into the United States, minus the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:708.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">amount exported to Parties to the Montreal Protocol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:716.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">(see section 601(6) of the Clean Air Act).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:406.00pt;top:725.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.55pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:410.15pt;top:725.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">Class I ozone depleting substances are listed at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:733.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">40 CFR part 82 subpart A, appendix A.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:60.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">where the synthesized or separated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:70.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">component is not stored prior to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">formulation. Typically, coatings include</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">products described by the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">North American Industry Classification</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">System (NAICS) codes, code 325510,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:120.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Paint and Coating Manufacturing, code</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:130.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">325520, Adhesive and Sealant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:140.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Manufacturing, and code 325910, Ink</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:150.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Manufacturing.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:162.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">* * * * *</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:177.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E6–16407 Filed 10–3–06; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:189.70pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 6560–50–P</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:215.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ENVIRONMENTAL PROTECTION</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:225.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">AGENCY</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:243.85pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">40 CFR Part 82</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:260.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[EPA–HQ–OAR–2006–0158; FRL–8227–4]</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:275.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">RIN 2060–AN29</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:293.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection of Stratospheric Ozone:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:303.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Allocation of Essential Use Allowances</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:313.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for Calendar Year 2006</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:329.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">AGENCY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:329.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Environmental Protection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:339.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agency (EPA).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:351.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ACTION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:78.05pt;top:351.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Final rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:368.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUMMARY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:87.65pt;top:368.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">With this action, EPA is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:378.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocating essential use allowances for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:388.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">import and production of class I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:398.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stratospheric ozone depleting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:408.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substances (ODSs) for calendar year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:418.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006. Essential use allowances enable a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:428.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">person to obtain controlled class I ODSs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:438.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">as part of an exemption from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:448.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory ban on the production and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:458.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">import of these chemicals that became</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:468.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effective as of January 1, 1996. EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:478.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocates essential use allowances for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:488.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exempted production or import of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:498.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">specific quantity of class I ODSs solely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:508.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for the designated essential purpose.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:518.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The allocations in this action total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:528.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1,002.40 metric tons (MT) of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:538.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">chlorofluorocarbons (CFCs) for use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:548.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">metered dose inhalers for 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:560.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:74.85pt;top:560.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Effective Date: This final rule is</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:570.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effective October 4, 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:582.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:95.25pt;top:582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA has established a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:592.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">docket for this action under Docket ID</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:602.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">No. EPA-HQ-OAR-2006–0158. All</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">documents in the docket are listed on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:622.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.regulations.gov">www.regulations.gov</a></FONT><FONT COLOR="000000"></FONT><FONT STYLE="font-size: 9.00pt"> </FONT></i><FONT STYLE="font-size: 9.00pt">Web site.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Although listed in the index, some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information is not publicly available,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">e.g., confidential business information</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or other information whose disclosure is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">restricted by statute. Certain other</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">material, such as copyrighted material,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is not placed on the Internet and will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">publicly available only in hard copy</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">form. Publicly available docket</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">materials are available either</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:732.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">electronically through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:60.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.regulations.gov">www.regulations.gov</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"> or in hard copy at</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:70.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Air Docket, EPA/DC, EPA West,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:80.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Room B102, 1301 Constitution Ave.,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:90.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">NW., Washington, DC. This Docket</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">facility is open from 8:30 a.m. to 4:30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">p.m., Monday through Friday, excluding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:120.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">legal holidays. The Public Reading</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:130.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Room is open from 8:30 a.m. to 4:30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:140.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">p.m., Monday through Friday, excluding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:150.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">legal holidays. The telephone number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:160.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for the Public Reading Room is (202)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:170.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">566</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.00pt;top:170.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–1744, and the telephone number for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:180.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Air Docket is (202) 566–1742.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:195.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">FOR FURTHER INFORMATION CONTACT</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:205.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Kirsten Cappel of the Office of Air and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:215.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Radiation, Stratospheric Protection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:225.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Division by regular mail at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:235.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Environmental Protection Agency, 1200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:245.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pennsylvania Avenue NW., (6205J)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:255.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Washington DC 20460; telephone</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:265.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number: 202–343–9556; fax number:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:275.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">202</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.00pt;top:275.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–343–2338; e-mail address:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:285.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">cappel.kirsten@epa.gov.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:302.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY INFORMATION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:317.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Table of Contents</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:329.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">I. Basis for Allocating Essential Use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:339.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Allowances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:348.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">A. What are essential use allowances?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:357.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">B. Under what authority does EPA allocate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:366.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">essential use allowances?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:375.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">C. What is the process for allocating</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:385.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">essential use allowances?</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:394.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">II. Response to Comments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:403.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">A. EPA Should Not Allocate Essential Use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:412.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Allowances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:421.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">B. The Proposed Level of Allocations Is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:431.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Incorrect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:440.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">C. Consideration of Stocks of CFCs in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:449.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Allocation of Essential Use Allowances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:458.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">D. Comments on the Rulemaking Process</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:467.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">and Timing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:477.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">E. EPA May Not Allocate Allowances to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:486.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Companies That Fail To Demonstrate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:495.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Research and Development of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:504.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Alternatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:513.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">F. Transition to Non-CFC Metered Dose</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:523.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Inhalers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:532.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">III. Allocation of Essential Use Allowances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:541.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">for Calendar Year 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:550.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">IV. Statutory and Executive Order Reviews</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:559.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">A. Executive Order 12866: Regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:569.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Planning and Review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:578.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">B. Paperwork Reduction Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:587.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">C. Regulatory Flexibility Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:596.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">D. Unfunded Mandates Reform Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:605.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">E. Executive Order 13132: Federalism</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:614.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">F. Executive Order 13175: Consultation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:623.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">and Coordination With Indian Tribal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:632.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Governments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:642.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">G. Executive Order 13045: Protection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:651.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Children From Environmental Health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:660.25pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Risks and Safety Risks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:669.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">H. Executive Order 13211: Actions That</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:678.45pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Significantly Affect Energy Supply,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:687.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Distribution, or Use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:696.65pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">I. National Technology Transfer and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:238.00pt;top:705.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Advancement Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:230.00pt;top:714.85pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">J. Congressional Review Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:723.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">V. Judicial Review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:733.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">VI. Effective Date of this Final Rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:60.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I. Basis for Allocating Essential Use</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:70.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Allowances</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:85.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">A. What are essential use allowances?</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:98.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Essential use allowances are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:108.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances to produce or import certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:118.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ozone-depleting substances (ODSs) in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:127.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the U.S. for purposes that have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:137.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">deemed ‘‘essential’’ by the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:147.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Government and by the Parties to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:157.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Montreal Protocol on Substances that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:167.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Deplete the Ozone Layer (Montreal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:177.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protocol).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:186.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Montreal Protocol is an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:196.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">international agreement aimed at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:206.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reducing and eliminating the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production and consumption</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:521.40pt;top:216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.85pt">1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:527.75pt;top:216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of ODSs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:226.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The elimination of production and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:236.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consumption of class I ODSs is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:246.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">accomplished through adherence to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:255.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">phaseout schedules for specific class I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:265.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ODSs, which include</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:424.50pt;top:265.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.85pt">2</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:275.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">chlorofluorocarbons (CFCs), halons,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:285.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">carbon tetrachloride, and methyl</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:295.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">chloroform. As of January 1, 1996,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:305.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production and import of most class I</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:315.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ODSs were phased out in developed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:325.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">countries, including the United States.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:334.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">However, the Montreal Protocol and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:344.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Clean Air Act provide exemptions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:354.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that allow for the continued import and/</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:364.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or production of class I ODSs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:374.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">specific uses. Under the Montreal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:383.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protocol, exemptions may be granted for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:393.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uses that are determined by the Parties</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:403.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to be ‘‘essential.’’ Decision IV/25, taken</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:413.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by the Parties to the Protocol in 1992,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:423.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">established criteria for determining</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:433.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">whether a specific use should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:443.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approved as essential, and set forth the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:453.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">international process for making</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:463.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determinations of essentiality. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:473.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">criteria for an essential use, as set forth</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:482.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in paragraph 1 of Decision IV/25, are the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:492.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">following:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:506.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">‘‘(a) That a use of a controlled substance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:515.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">should qualify as ‘essential’ only if:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:523.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(i) It is necessary for the health, safety or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:532.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">is critical for the functioning of society</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:541.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(encompassing cultural and intellectual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:550.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">aspects); and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:559.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(ii) There are no available technically and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:567.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">economically feasible alternatives or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:576.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">substitutes that are acceptable from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:585.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">standpoint of environment and health;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:594.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(b) That production and consumption, if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:603.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">any, of a controlled substance for essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:611.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">uses should be permitted only if:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:620.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(i) All economically feasible steps have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:629.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">been taken to minimize the essential use and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:638.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">any associated emission of the controlled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:647.15pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">substance; and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:655.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(ii) The controlled substance is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:664.75pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">available in sufficient quantity and quality</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00020</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:767.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:770.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:0.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background0.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:792.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:825.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58505</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:826.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:852.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">from existing stocks of banked or recycled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:861.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">controlled substances, also bearing in mind</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:870.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">the developing countries’ need for controlled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:879.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">substances.’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:893.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">B. Under what authority does EPA</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:903.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocate essential use allowances?</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:916.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Title VI of the Clean Air Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:926.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">implements the Montreal Protocol for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:936.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the United States. Section 604(d) of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:946.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Act authorizes EPA to allow the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:956.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of limited quantities of class</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:966.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I ODSs after the phaseout date for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:976.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">following essential uses:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:986.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(1) Methyl chloroform, ‘‘solely for use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:996.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in essential applications (such as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1006.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nondestructive testing for metal fatigue</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1016.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and corrosion of existing airplane</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1026.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">engines and airplane parts susceptible</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1036.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to metal fatigue) for which no safe and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1046.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effective substitute is available.’’ Under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1056.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Act, this exemption was available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1066.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only until January 1, 2005. Prior to that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1076.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">date, EPA issued methyl chloroform</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1086.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances to the U.S. Space Shuttle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1096.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Titan Rocket programs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1105.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(2) Medical devices (as defined in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1115.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 601(8) of the Act), ‘‘if such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1125.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">authorization is determined by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1135.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Commissioner [of the Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1145.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration], in consultation with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1155.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Administrator [of EPA] to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1165.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary for use in medical devices.’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1175.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA issues allowances to manufacturers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1185.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of metered dose inhalers (MDIs), which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1195.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">use CFCs as propellant for the treatment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1205.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of asthma and chronic obstructive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1215.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">pulmonary disease.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1224.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(3) Aviation safety, for which limited</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1234.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantities of halon-1211, halon-1301,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1244.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and halon-2402 may be produced ‘‘if the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1254.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administrator of the Federal Aviation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1264.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration, in consultation with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1274.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administrator [of EPA] determines that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1284.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">no safe and effective substitute has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1294.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">developed and that such authorization</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1304.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is necessary for aviation safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1314.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">purposes.’’ Neither EPA nor the Parties</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1324.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have ever granted a request for essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1334.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">use allowances for halon, because in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1344.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">most cases alternatives are available and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1354.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">because existing quantities of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1364.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substance are large enough to provide</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1374.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for any needs for which alternatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1384.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have not yet been developed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1394.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Parties to the Protocol, under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1404.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Decision XV/8, additionally allow a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1414.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">general exemption for laboratory and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1424.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">analytical uses through December 31,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1434.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2007. This exemption is reflected in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1444.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA’s regulations at 40 CFR part 82,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">subpart A. While the Act does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">specifically provide for this exemption,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA has determined that an allowance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for essential laboratory and analytical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uses is allowable under the Act as a </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">de</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">minimis exemption. The de minimis</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exemption is addressed in EPA’s final</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule of March 13, 2001 (66 FR 14760–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">14770). The Parties to the Protocol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:862.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">subsequently agreed (Decision XI/15)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:872.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that the general exemption does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:882.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">apply to the following uses: Testing of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:891.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">oil and grease, and total petroleum</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:901.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">hydrocarbons in water; testing of tar in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:911.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">road-paving materials; and forensic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:921.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">finger-printing. EPA incorporated this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:931.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exemption at Appendix G to Subpart A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:941.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of 40 CFR part 82 on February 11, 2002</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:951.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(67 FR 6352).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:966.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">C. What is the process for allocating</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:976.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential use allowances?</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:989.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The procedure set out by Decision IV/</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:999.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">25 calls for individual Parties to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1009.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nominate essential uses and the total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1018.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">amount of ODSs needed for those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1028.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential uses on an annual basis. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1038.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protocol’s Technology and Economic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1048.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Assessment Panel (TEAP) evaluates the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1058.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nominated essential uses and makes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1068.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations to the Protocol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1078.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Parties. The Parties make the final</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1088.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">decisions on whether to approve a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1098.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Party’s essential use nomination at their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1108.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">annual meeting. This nomination cycle</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1117.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">occurs approximately two years before</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1127.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the year in which the allowances would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1137.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be in effect. The allowances allocated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1147.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">through this final rule were first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1157.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nominated by the United States in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1167.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">January 2004.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:1176.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">For MDIs, EPA requests information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1186.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from manufacturers about the number</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1196.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and type of MDIs they plan to produce,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1206.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">as well as the amount of CFCs necessary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for production. EPA then forwards the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1226.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information to the Food and Drug</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1236.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administration (FDA), which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1246.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determines the amount of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1256.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary for MDIs in the coming</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">calendar year. Based on FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1276.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination, EPA proposes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1286.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations to each eligible entity. Under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1296.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Act and the Protocol, EPA may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1306.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocate essential use allowances in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1316.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantities that together are below or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1326.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">equal to the total amount approved by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1336.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Parties. EPA will not allocate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1346.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential use allowances in amounts</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1356.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">higher than the total approved by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1366.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Parties. For 2006, the Parties authorized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1376.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the United States to allocate up to 1,100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1386.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">metric tons (MT) of CFCs for essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1396.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uses. In a notice of proposed rulemaking</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1406.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">published in the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 9.00pt">on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1416.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">April 11, 2006 (71 FR 18262), EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1426.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed to allocate 1,002.40 MT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1441.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">II. Response to Comments</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:1454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA received comments from ten</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entities on the proposed rule. Two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters, both members of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">general public, did not support an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exemption as a general matter, one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter indicated that his company</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">received too few allowances to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adequately protect patient safety, four</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:852.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters believed that EPA allocated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:862.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">more allowances than were necessary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:872.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">given the presence of stocks of CFCs in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:882.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the United States, one commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:891.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">indicated that the Agency should not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:901.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">increase one company’s allocations at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:911.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the expense of a second company and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:921.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should instead increase the total levels</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:931.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of allocations to accommodate any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:941.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">shortfalls. Lastly, one commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:951.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">believed that there is no downside to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:961.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocating the maximum number of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:971.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances possible because companies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:981.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only expend those allowances that they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:990.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">need. The comments are addressed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1000.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">more detail below.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1015.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">A. EPA Should Not Allocate Essential</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1025.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Use Allowances</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1038.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter wrote that non-CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1048.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs should be developed. This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1058.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter also expressed a belief that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1068.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a particular pharmaceutical company,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1078.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Schering-Plough, should not be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1088.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">permitted to produce CFC MDIs since</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1098.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs are banned. Additionally, this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1108.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter feels that asthma would not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1117.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be as serious a problem if the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1127.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Government stopped burning national</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1137.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">forests, parks, and wildlife areas.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1147.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Another commenter expressed the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1157.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">opinion that the 1,002.40 MT of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1167.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are not necessary for the manufacture of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1177.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs for the treatment of asthma and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1187.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">COPD. According to this commenter,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1197.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">skin cancer is not a suitable alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1207.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the lack of innovation by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1216.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">companies that want to use CFCs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1226.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Another commenter also did not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1236.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">believe that Schering-Plough should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1245.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">receive an essential use allocation. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1255.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter stated that the cornerstone</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1265.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the temporary essential use process is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1275.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that production of CFCs for MDIs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1285.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should be allowed only until companies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1295.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are able to develop and bring to market</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1305.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adequate non-CFC alternatives for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1315.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">patients. The commenter noted that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1325.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">TEAP has expressed a strong concern</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1335.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that ‘‘companies continue to request</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1345.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential use quantities for CFCs when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1355.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">they also manufacture HFA MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1365.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternatives for salbutamol,’’ and that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1375.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Schering Plough has had an approved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1385.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">non-CFC Albuterol MDI, Proventil(r), on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1395.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the market for a decade. Therefore, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1405.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter believes that no legal basis</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1415.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exists for allocating essential use CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1425.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to Schering-Plough.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1434.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA, in consultation with EPA, has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1444.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determined that 1,002.40 MT of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are necessary to meet the demand for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006 MDI manufacturing. As</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternatives become available, FDA will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be in a position to propose delisting of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential uses in a manner that is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">protective of patient safety. EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">appreciates the commenter’s interest in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the causes of asthma and reiterates that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00021</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:1559.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:1562.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:792.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background1.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:1584.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1617.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58506</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:1618.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1644.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA’s determination is made in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1654.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">accordance with protecting public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1664.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">health.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1673.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Delisting of CFC MDIs will proceed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1683.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">accordance with the 2002 FDA rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1693.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">establishing a mechanism for removing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1703.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential uses from the list in 21 CFR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1712.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2.125(e), published in the </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1722.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Register on July 24, 2002 (67 FR 48370)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1732.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(corrected at 67 FR 49396 and 67 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1742.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">58678). Delisting of albuterol CFC MDIs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1752.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is addressed specifically in the FDA rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1762.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">published in the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register </FONT></b><FONT STYLE="font-size: 9.00pt">on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1772.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">April 4, 2006 (70 FR 17168). Under this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1782.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule, CFC albuterol MDIs will no longer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1792.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be essential as of the end of 2008. In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1802.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">addition, FDA is in the process of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1811.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">examining the remaining essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1821.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">products to determine if and when they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1831.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">might no longer require an essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1841.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">designation. The U.S. is making</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1851.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substantial progress in the phasedown</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1861.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of exempted CFC production. For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1871.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">example, in 2005 the Agency allocated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1881.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">about 1,750 MT of CFCs while in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1891.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">action for 2006 the Agency is only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1901.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocating 1,002.40 MT of CFCs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:1910.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Schering-Plough manufactures a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1920.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">product which, as of 2006, is still</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1930.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential to the U.S. supply of albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1939.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs for treatment of asthma and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1949.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">COPD. With regard to the comment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1959.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regarding the TEAP 2005 Progress</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1969.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Report, while the TEAP did express</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1979.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">concerns ‘‘that companies continue to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1989.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">request essential use quantities for CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:1999.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">when they also manufacture [HFA] MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2009.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternatives for [albuterol],’’ it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2019.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">nevertheless recommended an essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2029.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">use exemption for the United States that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2038.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">included CFCs intended for Schering-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2048.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Plough, and this exemption was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2058.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approved by the Parties.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2073.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">B. The Proposed Level of Allocations is</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2083.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Incorrect</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:2096.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter stated that unless</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2106.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA increases the essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2116.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation for CFC propellants for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2126.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Armstrong Pharmaceuticals, the only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2136.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company with idle CFC albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2146.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production capacity, there will be a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2156.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">shortage of albuterol MDIs as early as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2166.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">June or July of 2006 because a European</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2176.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">firm, IVAX, is no longer providing some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2186.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">12 million units of albuterol inhalers to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2196.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the U.S. market. Therefore, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2206.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter requested that the 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential use allowances granted to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2226.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Armstrong be increased from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2236.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed 147.50 MT to 347.50 MT. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2246.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter noted that Medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2256.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Technical Options Committee (MTOC)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommended that 180 MT be added to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2276.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the U.S. allocations for 2006 if CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2286.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs were not imported from Europe in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2296.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006. A second commenter noted that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2306.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA proposed to allocate 1,002.40 MT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2316.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of CFCs for MDIs whereas the Parties to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1644.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Montreal Protocol authorized 1,100</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1654.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MT and suggested that the 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1664.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations could be raised to the upper</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1674.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">limit established in the Decision due to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1683.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the IVAX situation. This commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1693.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">indicated that because in the past MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1703.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">producers have only utilized the rights</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1713.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that they felt were critical to meet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1723.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">evolving supply/demand, there is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1733.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">limited risk associated with the full</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1743.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation of available rights and notes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1753.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that because excess CFCs will need to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1763.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">destroyed, essential use inventories will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1773.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">actually become a financial liability and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1782.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">producers will avoid overproduction of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1792.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC MDIs and excessive purchase of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1802.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC propellant.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:1811.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter believes that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1821.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agency does not fully understand the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1831.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">restrictions on the availability of stocks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1841.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of CFCs and that EPA’s inaccurate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1851.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">understanding of the matter led to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1861.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed allocations that are too low.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1871.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">They believe that misleading</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1881.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information in the May 2005 TEAP</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1891.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Progress Report on the availability for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1901.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the sale of GlaxoSmithKline (GSK)’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1910.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">excess pre-1996 CFC propellant has led</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1920.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA and EPA to assume that 605 MT of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1930.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">pre-1996 CFCs held by GSK would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1940.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available to all potential users even</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1950.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">though GSK will only sell these CFCs to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1960.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">four companies that do not have a need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1970.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for the material. The commenter also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1980.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">believes that in determining the size of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:1990.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Armstrong’s allocation, the Agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2000.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">assumed that Armstrong could obtain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2009.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">additional CFCs from Schering-Plough.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:2019.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Two commenters are of the opinion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2029.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that Armstrong Pharmaceuticals’ request</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2038.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for an additional 180 MT of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2048.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should be denied and recommended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2058.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that Armstrong not be granted any CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2068.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations, including the 147.50 MT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2078.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">granted in the proposed rulemaking.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2088.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Based on figures provided by Armstrong</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2098.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceuticals, the commenter claims</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2108.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that Armstrong Pharmaceuticals has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2118.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">more than enough CFCs to serve its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2128.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market share without receiving any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2137.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation for 2006. To support this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2147.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">claim, the commenter stated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2157.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Armstrong Pharmaceuticals may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2167.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacture as many as 6.4 million</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2177.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs in 2006, requiring 147 MT of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2187.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs, which can be met by their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2197.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stockpile of at least 195 MT of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2207.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(based on the difference between the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2217.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs needed to manufacture 3.29</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2227.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">million MDIs in 2005, and the amount</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2237.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of CFCs purchased by Armstrong in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2247.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2005).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:2256.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter indicated it believed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Armstrong Pharmaceuticals made</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2276.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">several inaccurate and misleading</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2286.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">statements during the April 21, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2296.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public hearing. These include the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2306.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company’s assertion, to support its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2316.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">request for an increased 2006 allocation,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1644.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that the European Community did not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1654.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocate any CFCs for the use in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1664.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of albuterol MDIs, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1674.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">therefore that 21.4 million imported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1683.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol MDIs were lost to the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1693.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market. According to the commenter,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1703.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">IVAX never supplied more than 14</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1713.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">million CFC MDIs to U.S. markets. In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1723.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">addition, the commenter also stated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1733.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in late 2005, the European Commission</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1743.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocated 180 MT of CFCs to IVAX for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1753.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of albuterol MDIs to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1763.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exported to the U.S. The commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1773.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">wished to correct Armstrong</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1782.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceuticals’ claim that the 605 MT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1792.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of GSK’s pre-1996 CFCs is only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1802.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available to four companies that no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1812.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">longer require CFCs for MDIs. This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1822.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter states that these companies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1832.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">require CFCs for the production of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1842.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential MDIs. A second commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1852.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">indicated that GSK did not provide any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1862.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">misleading information concerning the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1872.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sale of its pre-1996 CFC supply. A third</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1881.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter indicated that her company</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1891.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">did have a need for, and purchased,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1901.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs from the GSK pre-1996 stockpile.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:1910.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA believes that the underlying</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1920.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">premise of the essential use exemption</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1930.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">program is to provide for the continued</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1940.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production and consumption of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1950.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needed to ensure patient safety. EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1960.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">concurs with the comment that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1970.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">historically, companies have only used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1980.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the allowances they needed and that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:1990.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of CFCs in excess of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2000.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">amount needed by a company would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2009.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">create a liability in that such material</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2019.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">would have to be destroyed or used by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2029.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">another essential use. However,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2039.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations are based on determinations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2049.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of medical necessity.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:2058.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Since the October 2005 determination</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2068.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by FDA, fewer albuterol CFC MDIs have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2078.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entered the market because IVAX</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2088.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stopped production. The market has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2098.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">also experienced an increase in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2108.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number of HFA MDIs. In making its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2118.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination on the amount of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2128.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that are medically necessary, FDA looks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2137.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">at factors such as the number of medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2147.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">device units required to meet patient</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2157.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">demand and the amount of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2167.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">already owned by MDI manufacturers.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2177.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA informs us that they have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2187.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">closely monitoring the albuterol supply</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2197.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in response to spot shortages,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2207.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">particularly of albuterol CFC MDIs, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2217.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">late winter and spring of 2006. Based on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2227.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">up-to-date information, there is an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2236.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adequate supply of albuterol MDIs to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2246.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meet patient needs in the U.S., as the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2256.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production capacity for the albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2266.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA MDIs has increased substantially</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2276.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the first half of 2006 and is expected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2286.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to continue to increase. While albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2296.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA MDI capacity is expected to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2306.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">continue to increase throughout 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2316.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and beyond, FDA has not determined a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00022</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:2351.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:2354.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:1584.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background2.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:2376.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:2409.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58507</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:2410.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2436.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reduction from the proposed allocations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2446.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for albuterol MDIs because the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2456.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">projections FDA has heard indicate that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2466.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">there will be a continuing need for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2475.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol CFC MDIs through all of 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2485.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA is also concerned that some of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2495.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">projections are not sufficiently reliable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2505.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to provide a basis for a determination</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2515.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that could result in shortages of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2525.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary drug, if expectations are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2535.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">met. Therefore, EPA is not altering the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2545.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed allocation of allowances in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2555.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this final rule to either increase</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2565.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations or decrease them.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:2574.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA was fully aware of the terms</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2584.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regarding the resale of the 605 MT of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2594.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs previously owned by GSK and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2603.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was provided with a copy of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2613.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">contract. EPA shared the terms of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2623.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">contract with FDA. Further, as EPA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2633.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stated previously, both agencies only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2643.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consider amounts of stocks owned by a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2653.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">given MDI manufacturer in determining</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2663.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the appropriate level of essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2673.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation. Therefore, stocks not owned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2683.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by an MDI manufacturer and future</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2693.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">potential commercial arrangements for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2702.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the sale of such stocks did not affect the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2712.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:2722.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In regard to concerns about the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2731.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">increased cost, see section II.F of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2741.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">preamble document on the transition to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2751.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC alternatives.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:2760.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter argued that EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2770.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should raise the total level of allocations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2780.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and pointed to the terms of sale of 605</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2790.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MT of GSK’s pre-1996 CFC inventory as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2800.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a reason to support such an action. This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2810.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter argues that the terms of sale</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2820.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have made it difficult to determine both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2830.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the level and distribution of CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2840.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations, which could cause concern</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2850.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">about how fluid the market may be at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2859.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">responding to patients’ needs. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2869.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter further points to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2879.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">potential that some producers involved</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2889.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the CFC-to-HFA propellant transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2899.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may choose to redirect their production</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2909.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">away from CFC-based products, while</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2919.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not releasing unutilized allocation rights</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2929.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to other producers for competitive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2939.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reasons, thus causing further restrictions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2949.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on availability of CFCs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:2958.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">As described above, EPA was fully</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2968.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">aware of the restrictions on the resale of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2978.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the 605 MT formerly owned by GSK. In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2988.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">light of the fact that none of that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:2998.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">material may be resold to the essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3008.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">use companies that manufacture singly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3018.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">moiety albuterol MDIs, the concerns of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3028.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the commenter regarding the difficulty</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3038.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of determining ‘‘both the level and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3048.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">distribution of CFC allocations’’ and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3058.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘how fluid the market may be at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3068.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">responding to patients’ needs’’ would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3078.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not apply to those companies that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3088.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">receiving exemptions to manufacture</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3098.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">single moiety albuterol MDIs because</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3108.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">these companies are not permitted to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2436.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">purchase any of the 605 MT to which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2446.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the commenter is referring. Further, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2456.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agency looks at holdings of CFCs stocks</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2466.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on a manufacturer-by-manufacturer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2475.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">basis. Only those quantities owned by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2485.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">an MDI manufacturer are assessed in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2495.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determining their overall allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2505.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needs. Thus, if the terms of resale on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2515.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">GSK material contributed to some</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2525.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">difficulties in the fluidity of the CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2535.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">propellant market, it should have no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2545.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">bearing on meeting patient demand for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2555.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs since these materials are excluded</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2565.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from the Agency’s assessment until they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2574.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are owned by an essential use company.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:2584.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The commenter’s second concern that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2594.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">companies that are transitioning to an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2603.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA-based alternative will not be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2613.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">inclined to sell or otherwise make their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2623.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances available to a company that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2633.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is still producing a product in a CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2643.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">format is immaterial. If a company is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2653.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">increasing production of its HFA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2663.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">product and decreasing its CFC product</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2673.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">at the same rate, there is no need for a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2683.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">second company to increase its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2693.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of CFC product since the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2702.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">total number of units on the market</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2712.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">remains the same and is sufficient to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2722.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">protect patient safety.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:2731.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter stated that EPA must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2741.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">fully consider how the CFC allocations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2751.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">will affect moieties for which there are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2761.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">no alternatives—i.e., that a too-generous</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2771.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation for CFC albuterol MDIs that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2781.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are being phased out could result in a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2791.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">backlash against the remaining essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2801.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">use products, some of which do not yet</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2811.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have alternatives. The commenter noted</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2821.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that the 2006 allocation is significantly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2830.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reduced from what EPA or the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2840.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Government requested from the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2850.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">international community, yet albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2860.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comprises the majority of the allocation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2870.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">To that end, the commenter encourages</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2880.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA to consider whether the allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2890.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the proposed rule takes into account</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2900.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the rapidly changing market for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2910.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol, noting that the allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2920.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">could be based on 6-to-12-month-old</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2929.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information, and asks the Agency to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2939.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ensure that the moieties that really need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2949.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs will have CFCs until they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2959.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approach the reformulation stage. A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2969.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">second commenter concurred with this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2979.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sentiment and expressed the opinion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2989.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that it is in the best interests of patients</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:2999.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and the environment if the availability</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3009.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of essential use CFCs is preserved for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3019.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the production of essential MDIs for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3028.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">which alternatives are not yet available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3038.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">but are under development. This second</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3048.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter stated that recent albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3058.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">shortages illustrate the potential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3068.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">disruption to patient care if medication</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3078.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is unavailable and further stated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3088.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this risk would be significantly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3098.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exacerbated in a situation where non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3108.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC alternatives were not available.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2436.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Therefore, the commenter recommends</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2446.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that, rather than allocate any volumes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2456.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for Schering-Plough and Armstrong</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2466.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceuticals, EPA hold those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2475.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">volumes for a possible emergency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2485.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation later in the year for those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2495.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">companies not manufacturing single-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2505.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">moiety albuterol MDIs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:2514.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA and FDA carefully consider the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2524.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements for all essential uses of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2534.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs, including those non-albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2544.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs that may continue to be essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2554.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uses beyond 2008. The domestic and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2564.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">international consideration of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2574.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essentiality of a product is technically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2584.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">based. Most of the 2006 allocation is for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2594.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol MDIs, consistent with both</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2603.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">domestic and international technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2613.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reviews. At the time of proposal of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2623.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006 essential use rule, EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2633.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">were not aware of any current market</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2643.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">conditions that would alter the CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2653.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements for 2006 essential uses.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2663.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Further, as described earlier in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2673.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">document, more recent information has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2683.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not indicated that there is a significant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2693.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">change in requirements for 2006. With</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2702.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the coming December 2008 ban on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2712.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sale of single moiety albuterol CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2722.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs, EPA and FDA anticipate that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2732.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">there may be a rapidly changing market</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2742.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that would affect the 2007 essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2752.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation. The Agencies will monitor</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2762.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the situation and make any adjustments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2772.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that are necessary in the 2007 proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2782.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and final rules.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:2791.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA considered and rejected the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2801.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter’s suggestion that EPA hold</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2811.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances proposed for Schering-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2821.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Plough and Armstrong Pharmaceuticals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2830.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">as an emergency reserve for non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2840.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol products. EPA received a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2850.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination from FDA as to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2860.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">volume of CFCs required for non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2870.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol products and FDA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2880.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">informed us that that those volumes,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2890.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">along with stocks held by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2900.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturers, are sufficient to protect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2910.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public health. Additional allowances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2920.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are not medically necessary. Since</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2929.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances expire on December 31,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2939.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006, any recommended ‘‘emergency’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2949.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances would have to be expended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2959.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by that date. As previously stated, there</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2969.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is no anticipated shortage of 2006 CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2979.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for non-albuterol uses. Lastly, comments</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2989.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">submitted by companies that have non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:2999.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol products also indicate that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3009.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">levels proposed by EPA are sufficient</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3019.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for their 2006 needs. Therefore, EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3029.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does not believe it is necessary to create</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3039.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">an emergency reserve for non-albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3049.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uses with 2006 allowances.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:3058.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter indicated that in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3068.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">granting allowances, EPA should not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3078.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">increase one company’s allocation at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3088.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">expense of a second company’s, but</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3098.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">instead any additional allocations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3108.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should come from the difference</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00023</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:3143.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:3146.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:2376.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background3.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3168.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3201.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58508</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:3202.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:52.00pt;top:3860.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.55pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:56.15pt;top:3860.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">See ‘‘1998 Report of the Aerosols, Sterilants,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3868.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">Miscellaneous Uses, and Carbon Tetrachloride</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3876.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">Technical Options Committee,’’ pp. 58–59.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:52.00pt;top:3885.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 4.55pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:56.15pt;top:3885.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">See ‘‘UNEP Technology and Economic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3893.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">Assessment Panel April 1998 Report’’ at p. 16, sec.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3901.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">1.2.4.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3228.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">between the amount authorized by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3238.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Parties, 1,100 MT, and the amount</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3248.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocated by the Agency, 1,002.40 MT.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3258.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This commenter also stated that it is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3267.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">satisfied with its proposed 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3277.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation and that it represents the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3287.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">minimum amount required to meet the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3297.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market demand for the commenter’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3307.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">product. A second commenter indicated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3317.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">satisfaction with its proposed allocation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:3326.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In this action, EPA is not changing the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3336.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006 allocations to individual</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3346.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">companies, or in total, from the amounts</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3356.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3371.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">C. Consideration of Stocks of CFCs in</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3381.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Allocation of Essential Use</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3390.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Allowances</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:3404.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter urged EPA to clarify</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3414.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that ‘‘operational supply’’ encompasses</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3423.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not only the amount of CFCs needed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3433.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meet MDI demand for a particular year,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3443.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">but also a ‘‘safety stock.’’ This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3453.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter believes a stock of up to 12</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3463.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">months of forward demand is prudent,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3473.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">given that there is now a single supplier</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3483.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the U.S. and a long lead time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3493.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">associated with revalidating an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3503.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">interrupted plant, and that this is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3513.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consistent with the view of the Aerosols</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3522.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Miscellaneous Uses Technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3532.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Options Committee (ATOC) expert</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3542.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">panel. The commenter states that this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:70.50pt;top:3542.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.85pt">3</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3552.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">view has also been adopted by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3562.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">TEAP, which recommended to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3572.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Parties that companies be permitted to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">maintain a one-year safety stock of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3592.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:69.00pt;top:3592.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 5.85pt">4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:3601.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In addition, this commenter suggests</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3611.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that EPA take into account blend</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3621.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements and only count stock</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3631.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">blended in the needed proportion when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3641.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">calculating the safety stock limit. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3650.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter notes that the pre-1996</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3660.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stockpile recently made available by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3670.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">GlaxoSmithKline comprises only CFC–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3680.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">11 and CFC–12, but to the extent that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3690.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the commenter’s company sources its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3700.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needs from that stock, it will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3710.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">unusable if it is not supplemented by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3720.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC–114. This commenter also believes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3730.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that EPA should take into account a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3740.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company’s need to maintain a safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3749.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stock for each of its foreign affiliates, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3759.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">no excess supply is maintained at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3769.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">European production sites or certain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3779.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">other affiliates. The commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3789.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">explained that the European</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3799.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Commission takes into account a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3809.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company’s global supply when</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3819.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determining allocations, forcing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3829.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">companies to maintain an operational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:3839.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supply for their European facilities as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3228.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">well as their U.S. facilities. This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3238.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">situation also results in the expenditure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3248.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of two allowances for each metric ton of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3258.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs transferred from U.S. to European</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3267.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">facilities.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:3277.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This commenter notes that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3287.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">conversion of safety stock to ‘‘just in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3296.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">time’’ supply will be made as the end</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3306.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">date for the company’s transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3316.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">becomes clearer. Given the cost of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3326.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">destruction and the ‘‘point of sale’’ ban</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3336.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that will render the company’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3346.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stockpiles of no use when its CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3356.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">products are deemed non-essential, this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3366.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter states that it has every</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3376.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">incentive to avoid excess stockpiles.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:3385.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In assessing the amount of new CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3395.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production required to satisfy 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3405.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential uses, EPA and FDA applied</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3415.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the terms of Decision XVII/5 including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3424.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provisions on stocks of CFCs that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3434.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">indicate Parties should allocate such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3444.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that manufacturers of MDIs maintain no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3454.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">more than a one-year operational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3464.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supply. FDA’s current practice is to first</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3474.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">calculate the quantity of CFCs that a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer needs for MDIs in the year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3494.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in question and then subtract from that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3504.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantity any CFC stocks owned by that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3514.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDI manufacturer exceeding a one-year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3523.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operational supply. The remainder, if a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3533.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">positive number, is the quantity of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3543.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">newly produced or imported CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3553.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needed by that manufacturer. Consistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3563.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with the language of Decision XVII/5,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3573.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA has informed EPA that it considers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3583.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the quantity of CFCs owned by each</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3593.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer, rather than the total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3603.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supplies owned by all entities. EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3613.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does not read Decision XVII/5 as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3623.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">endorsing a safety stock in excess of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3633.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">one-year operational supply specifically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3643.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">mentioned in the Decision.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:3652.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA’s proposed allocation did not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3662.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">take the blend of CFCs into account in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3672.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determining the size of a manufacturer’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3682.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stocks and the ensuing amount of new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3692.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs required. EPA does not currently</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3702.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collect data on the specific CFCs that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3712.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comprise the stocks owned by the MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3722.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer. EPA agrees that it would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3732.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be reasonable to take into account the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3742.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">type of CFC needed for MDI production</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3752.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">if EPA had such data.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:3761.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Two commenters indicated that in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3771.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determining a company’s pre-allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3781.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘operational supply,’’ EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3791.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should count all stocks owned or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3801.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">controlled by a company, including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3811.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stocks at its production facility, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3821.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transit, on order, or stored off-site.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:3831.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA evaluated stocks owned by an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3841.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDI manufacturer, regardless of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3851.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">physical location of the material, in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3861.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">making its determination.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:3870.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Two commenters stated that in order</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3880.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to effectively implement Decision XVII/</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3890.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">5, FDA and EPA should evaluate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:3900.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">level of stockpiles held by companies as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3228.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the end of 2005, or as of January</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3238.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006. In determining how much a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3248.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company needs to maintain a ‘‘one-year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3258.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operational supply,’’ EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3267.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should consider how much a company</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3277.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needs to serve markets during the year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3287.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and maintain a reasonable safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3297.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reserve. The starting point for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3307.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determining this amount could be the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3317.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">amount of CFCs a company used in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3327.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">previous year, which could be modified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3337.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">based on the company’s circumstances.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3347.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">They further state that EPA should only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3357.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocate CFCs to a company if the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3366.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company’s one-year operational supply</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3376.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">need is greater than its pre-allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3386.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operational supply. The commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3396.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">defines ‘‘operational supply need’’ as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3406.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the amount the company needs to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3416.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘serve its markets during the current</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3426.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year’’ plus a reasonable safety reserve,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3436.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not to exceed 12 months. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3446.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter defines ‘‘pre-allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3456.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operational supply’’ as all stocks owned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3465.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or controlled by a company.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3475.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Additionally, with regard to the safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3485.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">net, a 12-month level would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3495.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">excessive for products with an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3505.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">established phaseout date and where the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3515.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market is transitioning to non-CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3525.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">products. According to one of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3535.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters, the </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">U.S. Reporting</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3545.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Accounting Framework reported that</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3555.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1,911 MT of CFCs were ‘‘on hand’’ at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3564.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the end of 2005. With the addition of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3574.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1,000 MT of pre-phase out CFCs (398.6</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3584.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MT reported by the U.S. Accounting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3594.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Framework and 605 MT made available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3604.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by GSK), the commenter asserts that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3614.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">almost three times more than the 1,171</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3624.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MT of CFCs used in 2005 were available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3634.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for use in MDIs as of the end of 2005.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:3643.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">A third commenter indicated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3653.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowable operational supply should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3663.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determined based on the average carried</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3673.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">over the course of a year, as opposed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3683.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year-end supply, which may appear</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3692.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">excessive given the fact that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3702.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of CFCs–11 and –12 occur</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3712.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only during August and this commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3722.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">receives a full year’s supply at that time.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:3731.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">With regard to the first two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3741.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters’ concern on the timing for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3751.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA’s determination, the Agency refers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3761.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">readers to section II.D of this preamble</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3771.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on the essential use process. EPA and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3781.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA do not concur with the commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3791.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that a safety net of 12 months is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3801.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">excessive for those products where the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3811.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market is transitioning. EPA notes that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3820.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the product in question (albuterol CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3830.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDI) is not set to be phased out until</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3840.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">December 31, 2008. Given that the final</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3850.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transition date is more than a year away,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3860.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">it still makes sense to factor in a ‘‘one-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3870.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year operational supply’’ at this time.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3880.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA believes this comment may be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3890.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">more pertinent to 2007 and 2008, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:3900.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">last years of the transition.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00024</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:3935.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:3938.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:3168.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background4.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:3960.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:3993.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58509</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:3994.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:4020.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">As stated above, FDA first calculates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4030.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the quantity of CFCs that a manufacturer</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4040.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needs for MDIs in the year in question</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4050.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and then subtracts from that quantity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4060.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">any CFC stocks owned by that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4070.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer in excess of a one-year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4080.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operational supply. FDA evaluates data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4090.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provided to EPA before and during the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4100.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rulemaking process which may include</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4110.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stocks data collected midyear, as was</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4120.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the case for the 2006 rulemaking. Those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4130.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stocks include all materials owned by a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4140.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer. Consistent with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4150.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">language of Decision XVII/5, FDA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4160.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">informed EPA that it considers the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4170.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantity of CFCs owned by each MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4180.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer, rather than the total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4190.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supplies owned by all entities. EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4200.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notes that some the stocks one of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4210.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters points to in the U.S.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4220.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Accounting Framework are not owned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4230.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by MDI manufacturers. EPA reminds</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4240.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters that the U.S. Accounting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4250.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Framework captures data at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4260.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">aggregate level but that allowance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4270.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation determinations are company-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4280.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">specific.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:4291.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In determining what authorization of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4301.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">new production is ‘‘necessary for use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4311.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">medical devices’’ under section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4321.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">604(d)(2) of the CAA, FDA calculates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4331.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the quantity of CFCs needed to produce</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4341.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">an adequate supply of medical devices</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4351.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for use by patients, or other end users,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4361.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the relevant year. FDA does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4371.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consider the increase of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4381.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer’s year-end stock of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4391.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to be ‘‘necessary’’ for purposes of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4401.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 604(d)(2). FDA has informed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4411.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA that, in accordance with this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4421.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reading of section 604(d)(2) of the CAA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4431.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA will not make a determination that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4441.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">any newly produced CFCs are needed,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4451.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">if the resulting allocation would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4461.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reasonably be expected to result in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4471.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDI manufacturer having a larger stock</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4481.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of CFCs at the end of a relevant year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4491.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">than it had at the beginning of that year.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4501.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA has provided the following</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4511.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">examples of its current method of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4521.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">arriving at a determination of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4531.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantities of CFCs needed for a given</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4541.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:4549.30pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.15pt;top:4551.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Manufacturer A will have 100 MT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4561.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of CFCs in stocks at the beginning of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4571.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year. 50 MT are required to produce the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4581.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs needed in that year. FDA would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4591.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determine that no additional CFCs are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4601.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needed because Manufacturer A will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4611.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have a one-year supply of CFCs in stock</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4621.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">at the end of the year.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:4629.90pt;z-index:3;"><FONT FACE ="Symbol" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">•</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:63.15pt;top:4632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Manufacturer B will have 100 MT</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of CFCs in stocks at the beginning of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year. 150 MT are required to produce</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the MDIs needed in that year. FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">would determine that Manufacturer B’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation should only be 150 MT, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determinations made by FDA are not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4020.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">intended to increase stocks of CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4030.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">through the allocation process.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:4039.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Both examples assume that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4049.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary quantities of CFC-containing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4059.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs remain constant. FDA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4069.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">informed EPA that as the manufacture,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4079.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and capacity for manufacture, of non-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4088.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ODS alternatives, including albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4098.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA MDIs, increases, it takes those</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4108.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">increases into consideration in making</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4118.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">its determination under section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4128.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">604(d)(2) of the CAA, and will continue</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4138.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to do so. EPA agrees that FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4148.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approach to determining the necessary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4158.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantity of newly produced or imported</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4168.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs for the manufacture of essential</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4178.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs is reasonable, appropriate, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4187.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consistent with relevant provisions of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4197.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Parties’ Decisions, the Montreal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4207.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protocol, and the CAA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4222.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">D. Comments on the Rulemaking</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4232.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Process and Timing</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:4245.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Three commenters expressed the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4255.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">opinion that EPA has not adequately</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4265.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supported its proposed essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4275.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations for 2006 because EPA could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4285.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not have adequately taken into account</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4295.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Decision XVII/5 given the timing of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4305.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed rule. Since Decision XVII/5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4314.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was adopted on December 16, 2005 at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4324.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the 17th MOP, FDA’s October 12, 2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4334.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations to EPA could not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4344.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have taken this Decision into account.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4354.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">While two draft decisions were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4364.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">forwarded to the 17th MOP, neither</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4374.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">decision was adopted in full by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4384.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MOP, and there is no way FDA could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4394.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have known which decision would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4404.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adopted. Therefore, when FDA made its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4413.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommended allocation to EPA, it</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4423.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">could not have taken Decision XVII/5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4433.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">into account. One of the commenters</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4443.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stated that, under this Decision, EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4453.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and FDA are required to factor in any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4463.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">final shipments of CFCs from the now-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4473.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">closed Weert CFC manufacturing plant.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:4482.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA and FDA were aware of Decision</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4492.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">XVII/5 at the time of publication of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4502.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposal, and nothing in that decision</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4512.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">required a change to the October 2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4522.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA determination. Decision XVII/5(2)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4532.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">says: ‘‘That Parties * * * shall take into</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4542.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">account pre- and post-1996 stocks of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4552.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">controlled substances as described in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4562.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">paragraph 1(b) of decision IV/25, such</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4572.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that no more than a one-year operational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supply is maintained by that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4592.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer.’’ This language is not in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4602.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">conflict with language in Decision XVI/</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">12 from the previous year which states</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4622.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that Parties ‘‘should give due</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consideration to existing stocks * * * of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">banked or recycled controlled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substances as described in paragraph</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1(b) of decision IV/25, with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">objective of maintaining no more than</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">one year’s operational supply.’’ FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination did pre-date Decision</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4020.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">XVII/5, however, it is consistent with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4030.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Decision XVII/5 as well as Decision</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4040.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">XVI/12. Decision XVII/5 contains two</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4050.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">details that Decision XVI/12 did not: It</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4059.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">refers to stocks at the MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4069.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturing level and clarifies that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4079.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">both pre- and post-1996 stocks should</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4089.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be taken into account. FDA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4099.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">informed EPA that in making their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4109.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination they took both pre-1996</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4119.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and post-1996 stocks at the MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4129.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturing level into account. Even</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4139.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">at the time Decision XVI/12 was taken,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4149.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the U.S. Government articulated to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4158.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Parties that the U.S. believed the terms</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4168.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on stocks in the Decision would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4178.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">applied at the individual company</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4188.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">level. The more recent Decision</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4198.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">indicated other Parties’ concurrence</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4208.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with this approach by specifically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4218.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including the phrase ‘‘by that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4228.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturer.’’ Thus, the decision taken</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4238.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in December 2005 did not have a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4248.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substantive impact on FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4257.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination made in October 2005.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:4267.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Four commenters expressed the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4277.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">opinion that EPA did not adequately</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4286.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">support its proposed essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4296.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations for 2006 because EPA based</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4306.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the proposed 2006 allocations on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4316.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">outdated information. The commenters</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4326.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stated that FDA provided its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4336.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination to EPA on October 12,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4346.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2005, prior to several significant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4356.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">developments. Two of these</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4366.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters believe that EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4376.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should take into account increases in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4385.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA manufacturing, as well as the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4395.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uptake of HFA products that began in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4405.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">January 2006 and that has increased</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4415.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from 3 percent to 10 percent of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4425.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">overall albuterol market. One</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4435.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter stated that EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4445.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should also consider the albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4455.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">shortages that occurred in early 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:4464.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">We understand concerns raised by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters that given the 2008 ban on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4484.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the sale of albuterol CFC MDIs, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4494.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market may be rapidly shifting and a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4504.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">snapshot of data six to twelve months</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4513.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">prior to an allocation may not represent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4523.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">actual essential needs. In response, EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4533.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notes that the purpose of a comment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4543.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">period is to bring new information and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4553.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">opinions to the Agency’s attention and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4563.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that EPA does look at data that comes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4573.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to us during the comment period.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:4583.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">While the Agency makes every</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4593.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reasonable effort to use best available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4603.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">data, it is also reasonable to create a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4613.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">process for data gathering and establish</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4623.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a cut off for new information. For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4633.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">example, it would be impossible for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4643.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA to review and consider new data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4653.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that comes to us the day a rule is signed.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:4662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Although there is an established</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">process for gathering information, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agency does make every reasonable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effort to use newer data when feasible.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00025</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:4727.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:4730.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:3960.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background5.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:4752.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4785.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58510</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:4786.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4812.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">For example, EPA does evaluate new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4822.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information that comes to the Agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4832.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">during the comment period. In the April</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4842.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">11, 2006, proposed rule, the Agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4851.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stated ‘‘[t]he amounts listed in this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4861.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposal are subject to additional</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4871.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">review by EPA and FDA if new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4881.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information demonstrates that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4891.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed allocations are either too high</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4901.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or too low.’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:4910.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">On the specific matter of revising the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4920.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations in this rule based on more</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4930.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recent stock data, the Agency has data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4940.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on stock holdings as of the end of 2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4950.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and mid-2006 which is more recent data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4960.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">than was available at the time of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4970.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">publication of the proposed rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4979.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">However, these data do not indicate that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4989.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the October 2005 FDA determination</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:4999.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should be revised. Information on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5009.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">individual stock holdings is in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5019.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">confidential portion of the docket for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5029.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this rulemaking.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:5038.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter stated that EPA based</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5048.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">its proposed 2006 CFC essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5058.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations on information on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5068.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number of MDI units produced during</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5078.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2004 and anticipated to be produced</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5088.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">during 2005, which was obtained from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5098.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC MDI manufacturers via CAA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5107.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 114 letters. The commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5117.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notes that actual 2005 information is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5127.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">now available both from companies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5137.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">themselves via section 114 requests and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5147.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from public sources such as IMS data.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5157.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The commenter also believes that FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5167.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommendations to EPA regarding the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5177.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006 essential use allocations were</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5187.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">based on outdated and insufficient</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5197.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information. The commenter notes that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5206.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">since FDA’s recommended allocation</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5216.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">levels were sent to EPA in a letter dated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5226.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">October 12, 2005, FDA did not have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5236.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">complete 2005 production data at hand</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5246.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on which to base its conclusions.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5256.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Further, any data that FDA used</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regarding stockpiles prior to the end of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5276.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the calendar year would have been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5286.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">incomplete, since manufacturers</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5296.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">replenished their CFC stockpiles from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5305.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">October through December 2005.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:5315.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The commenter stated that EPA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5325.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reliance on outdated data is not in line</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5334.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with the well-established administrative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5344.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">law principle that ‘‘an agency must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5354.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">examine relevant data’’ in making its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5364.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determinations and that failure to do</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5374.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this ‘‘either is arbitrary decision making</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5384.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or at least prevents a court from finding</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5394.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">it non-arbitrary.’’ With respect to EPA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5404.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed 2006 allocations, according to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5414.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the commenter, the most pertinent data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5424.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">are from 2005, and the use of 2004 data</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5434.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">cannot be justified. Thus, based on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5444.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">administrative law standards, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter believes that EPA will have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">acted in an arbitrary and capricious</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">fashion by not using more recent and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">relevant data. The commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4812.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommends, therefore, that EPA send</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4822.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">new Section 114 letters to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4832.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturers requesting current</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4842.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information and that FDA use this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4851.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information to prepare a new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4861.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination of recommended</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4871.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations for 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:4880.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA uses a well-established</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4890.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rulemaking process which includes a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4900.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">timeline for collection of data,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4910.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">development of a proposed rule,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4920.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consideration of comments, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4930.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">issuance of a final rule. As stated above,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4940.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA agrees that the Agency should use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4950.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">best available data but notes that a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4960.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reasonable cut off for new information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4970.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">is required in any process. Therefore,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4979.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">best available data in this circumstance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4989.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">may be the information available as of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:4999.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the development of the proposal, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5009.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supplemented by public comments and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5019.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information generated by regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5029.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reporting requirements in time for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5039.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consideration during the development</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5049.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the final rule. For the past ten years</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5059.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the essential use program, the Agency</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5069.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">has based proposed allocations largely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5078.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on data obtained during the year prior</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5088.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the allocation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:5098.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA does evaluate new information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5107.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that comes to the Agency during the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5117.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comment period and through periodic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5127.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reports from regulated entities. New</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5137.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information on stock holdings and HFA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5147.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDI market penetration has been made</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5157.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available to EPA and FDA and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5167.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">October 2005 FDA determination is still</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5177.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">appropriate given this new information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5187.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Agency further notes that it placed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5197.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the 2005 accounting framework (which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5206.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">includes actual use data for 2005) in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5216.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">public docket for this proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5226.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rulemaking and relied on it in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5236.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">developing the rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:5245.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In the October 2005 letter to EPA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5255.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA stated that its determination of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5265.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">amount of CFCs necessary for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5275.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production of essential MDIs is lower</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5285.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">than the total amount requested by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5295.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturers, and in reaching this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5305.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">estimate, FDA took into account the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5315.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturers’ production of MDIs that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5325.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">used CFCs as a propellant in 2004, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5335.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturers’ estimated production in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5345.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2005 and 2006, the manufacturers’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5355.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">current stockpile levels, and the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5365.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">presence on the market of two albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5375.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs that do not use CFCs. The letter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5385.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">also informed EPA that FDA based its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5395.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determination for 2006 on an estimate of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5405.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the quantity of MDIs using CFCs as a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5415.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">propellant that would be necessary for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5425.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturers to maintain a 12-month</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5435.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">stockpile, consistent with paragraph 3 of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5445.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Decision XVI/12.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:5454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In making allocations, government</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">experts examine projected MDI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturing demand for the year in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">question. One important element in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4812.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">arriving at an estimate of projected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4822.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">demand is to examine information on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4832.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">past demand and production. If EPA or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4842.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA were to see use data in 2005 that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4851.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was a significant departure from use in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4861.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the preceding years, such data would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4871.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of interest to the agencies and could</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4881.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">lead to a different conclusion. There</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4891.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was no 2005 data provided to the EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4901.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that indicate a rapid change in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4911.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">marketplace beyond the amounts offset</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4921.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">by the IVAX production shortfall and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4931.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">therefore no need for FDA to revise its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4941.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">October 2005 determination.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:4950.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter noted that EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4960.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed the amount recommended by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4970.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA without revisions. This commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4979.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">urged EPA to revise FDA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4989.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommended allocations to take into</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:4999.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">account more recent stocks data in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5009.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determining the 2006 allocations. In a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5019.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">similar context, the commenter also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5029.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">states that EPA and FDA did not apply</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5039.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the terms of Decision XVII/5 at the time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5049.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of allocation. The commenter notes that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5059.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protocol decisions are part of Protocol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5069.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">law and are also U.S. law for purposes</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5078.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of essential use allocations.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:5088.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The commenter’s paraphrase of CAA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5098.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 604(d)(2) reverses the EPA and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5107.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA roles. The statute says that EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5117.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘shall authorize,’’ to the extent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5127.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consistent with the Montreal Protocol, if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5137.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA, in consultation with EPA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5147.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determines such authorization to be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5157.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary. Thus, FDA plays the primary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5167.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">role in the determination, although</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5177.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consultation must (and does) occur.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5187.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pursuant to the statutory language, EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5197.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does evaluate whether the essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5206.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances are consistent with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5216.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Montreal Protocol prior to issuing a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5226.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed or final rule. The allowances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5236.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">contained in this final rule are fully</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5246.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consistent with the Protocol and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5256.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Decisions of the Parties. In addition, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">explained above, EPA concurs with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5276.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA’s interpretation and application of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5286.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the phrase ‘‘one-year operational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5296.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supply’’ as used in Decision XVII/5. In</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5305.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regard to the legal status of decisions of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5315.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Parties, EPA refers readers to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5325.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recent DC Circuit opinion in </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">NRDC </FONT></i><FONT STYLE="font-size: 9.00pt">v.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5335.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA, D.C. Cir. No. 04–1438 (August 29,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5345.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006), as well as to the discussion of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5355.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">matter in EPA’s ‘‘Supplemental Brief for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5365.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Respondent,’’ filed in that same</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5375.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">case. These documents are available in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5385.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the docket for this action.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:5394.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter noted that neither</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5404.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA nor EPA has explained how they</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5414.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">propose to define and implement the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5424.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">key terms in Decision XVII/5. According</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5434.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the commenter, the lack of definitions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5444.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the proposed rulemaking is not only</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">counter to EPA’s obligation to provide</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notice and opportunity for the public to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comment, but also means that each</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company will apply its own definition.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00026</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:5519.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:5522.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:4752.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background6.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:5544.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:5577.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58511</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:5578.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5604.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The commenter asserted that EPA’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5614.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">failure to define terms in the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5625.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule is not in line with well-established</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5635.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements for notice and comment</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5645.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">under the Administrative Procedures</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5656.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Act. The commenter also stated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5666.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">there is no record in the docket to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5677.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">support EPA’s claim in the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5687.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule that it has ‘‘confirmed with FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5697.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that this determination is consistent</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5708.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with Decision XVII/5 * * *’’ and that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5718.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">neither agency has provided any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5729.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information on the methodology used to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5739.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determine that the allocations were in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5749.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">conformity with the Decision.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:5763.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">In reaching its determination, FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5773.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">used the plain meaning of the phrase</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5783.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘one-year operational supply.’’ A</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5794.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company’s ‘‘one-year operational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5804.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supply’’ is the amount needed to supply</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5815.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that company’s manufacturing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5825.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operations for one year. One commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5835.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provided a helpful refinement of this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5846.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">concept by pointing out that its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5856.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operations require a blend of CFCs –11,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5867.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–12, and –114, and that the presence of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5877.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only one or two of these compounds</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5887.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">does not constitute an operational</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5898.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">supply. This comment suggests that the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5908.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">use of the phrase in the proposed rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5919.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was sufficiently clear to put commenters</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5929.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on notice of FDA’s interpretation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5939.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Because the Agency used the plain</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5950.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meaning of the words ‘‘one-year</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5960.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">operational supply’’ there was no need</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5971.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to propose a definition for public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:5981.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">comment.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:5994.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter urged EPA to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6005.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consider making essential use allowance</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6015.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations earlier in the year in order to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6025.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">minimize the logistical challenges posed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6036.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in manufacturing essential MDIs. Since</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6046.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC–114 is produced throughout the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6057.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year, this commenter could make use of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6067.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">its allowances if they were awarded</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6077.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sooner. A second commenter noted that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6088.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the domestic ruling on essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6098.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances for 2006 has been delayed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6109.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">due to extended consideration in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6119.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Montreal Protocol negotiation. As a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6129.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">result, the commenter stated the opinion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6140.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that it is essential that domestic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6150.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">implementation occur at the earliest</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6161.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">date to allow for production planning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6171.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and execution to meet this year’s CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6181.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDI producer needs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:6195.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA makes every effort to allocate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6205.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances in a timely manner but is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6215.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">affected by factors beyond its control,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6226.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including the timing of Decisions and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6236.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the length of the regulatory process</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6247.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">itself. A final decision for 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6257.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocations was only taken in December</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6267.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2005.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5604.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">E. EPA May Not Allocate Allowances to</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5614.35pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Companies That Fail To Demonstrate</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5624.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Research and Development of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5634.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Alternatives</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:5647.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter stated that EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5657.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should not allocate essential use CFCs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5667.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to companies that have not fully</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5677.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">complied with Decision VIII/10 by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5687.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">clearly establishing that they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5697.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">undertaking efforts to develop non-CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5707.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternatives. The commenter does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5717.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">believe that Armstrong Pharmaceuticals’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5727.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">research and development program is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5737.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adequate to achieve results by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5747.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">December 31, 2008 phaseout deadline.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5757.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">To that end, the commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5767.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommends that EPA use its section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5777.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">114 authority to investigate the resource</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5787.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commitment and level of effort of any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5797.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">research and development effort by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5807.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Armstrong Pharmaceuticals. Unless EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5817.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and FDA conclude that Armstrong’s</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5827.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">research and development program has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5837.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a realistic chance of success by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5847.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">December 31, 2008, this commenter</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5857.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">believes that Armstrong should be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5867.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">denied an essential use exemption in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5877.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006 on this basis.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:5887.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Agency agrees that companies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5897.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">should undertake research efforts to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5907.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">demonstrate a commitment to eliminate</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5917.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the need for an exemption, but disagrees</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5927.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with the premise that such efforts must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5937.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be completed by December 31, 2008.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5947.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Finally, EPA refers readers to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5957.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">extensive discussion on this matter in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5967.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the 2005 final allocation rule (70 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5977.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">49838</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:247.00pt;top:5977.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–9) and to a 2002 </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal Register</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5987.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notice that addresses this topic (67 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:5997.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">6355).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6012.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">F. Transition to Non-CFC Metered Dose</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6022.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Inhalers</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:6036.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Two commenters expressed concern</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6046.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that the allocations may have negative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6056.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effects on the transition to non-CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6066.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs. One of these commenters</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6076.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recommended that EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6086.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consider how CFC allocations at this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6096.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">end stage might affect transition at the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6106.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">patient level. According to this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6116.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter, the proposed allocations for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6126.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006 could result in a transition period</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6136.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">as long as 30 months in which both CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6146.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and HFA albuterol have a substantial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6156.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">market share. Both commenters stated</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6166.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that a mixed market of CFC and HFA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6176.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs could have negative health effects</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6186.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on patients. For example, physicians</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6196.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">might not know which product their</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6206.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">patients are using and patients also may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">be confused, which could result in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6226.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adverse health outcomes (</FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">e.g.</FONT></i><FONT STYLE="font-size: 9.00pt">, since</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6236.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA inhalers may feel different than the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6246.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC one, patients may overuse the HFA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6256.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">device). Both commenters also believe</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that mixed signals from EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6276.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">about albuterol and new HFA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5604.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">technology could cause confusion and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5614.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uncertainty. As a result, one of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5624.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters believes there could be a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5634.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">backlash against the MDI transition, if</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5643.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not about ozone layer protection in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5653.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">general. In light of these factors, one</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5663.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter expressed the opinion that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5673.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the 2006 allocations should send a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5683.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">message consistent with what has been</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5693.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">occurring in the market place.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5703.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Therefore, the commenter urged EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5713.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and FDA to reevaluate the proposed</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5723.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocation of 700 MT for CFC albuterol</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5733.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">MDIs (including 147.7 MT allocated to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5742.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">one company, which according to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5752.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenter is more than twice that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5762.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">company’s one-year operational supply)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5772.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">so that those allocations do not impede</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5782.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the transition to non-CFC MDIs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:5791.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Another commenter stated that a near-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5801.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">term, achievable transition date in 2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5811.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or early 2006 would have sent a strong</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5821.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">message to manufacturers, the medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5831.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">community, and patients, providing a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5841.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">catalyst for the planning needed to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5851.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transition to non-CFC MDIs. In addition,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5861.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">given the albuterol shortages reported in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5870.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">early 2006, this commenter stated that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5880.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the continued and expanded availability</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5890.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of HFA MDIs is critical to ensuring that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5900.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">additional shortages do not occur and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5910.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that the transition is as seamless as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5920.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">possible for patients.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:5929.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Both commenters urged EPA and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5939.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to use the allocation tool to promote a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5949.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">smooth transition during the end stage</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5959.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the albuterol transition, in which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5969.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">HFA manufacturers are completing the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5979.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">scale-up of their production capacity.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5989.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One commenter expressed the opinion</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:5998.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that facilitating an orderly and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6008.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transparent transition is consistent with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6018.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA’s authority and affirmative legal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6028.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">responsibility under the Clean Air Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6038.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to implement the Montreal Protocol.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6048.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The commenters state that by limiting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6058.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFCs to only those uses that are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6068.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary, EPA and FDA would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6078.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">enhance the likelihood of a smooth</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6088.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">transition in several ways, which</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6097.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">include sending a signal that the U.S. is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6107.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">serious about facilitating a transition</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6117.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">away from CFC MDIs; reinforcing the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6127.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">idea that the transition offers positive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6137.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">opportunities for patients and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6147.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">physicians to improve medical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6157.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">outcomes; introducing further certainty</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6167.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">about when HFA MDI supplies will be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6177.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adequate; and preventing the market</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6187.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">from sliding back into CFC albuterol, as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6197.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this would engender confusion and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6207.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">risks to patient health.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:6216.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA previously conducted an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6226.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">extensive regulatory process to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6236.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determine when albuterol MDIs would</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6246.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">no longer be considered essential uses,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6256.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">evaluating the factors raised by the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6266.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">commenters above. FDA concluded in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6276.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that rulemaking that albuterol CFC MDIs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00027</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:6311.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:6314.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:5544.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background7.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:6336.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6369.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58512</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:6370.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6396.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">would no longer be essential at the end</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6406.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of 2008. As of 2006, however, CFC</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6416.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">albuterol MDIs continue to appear on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6426.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FDA’s list of essential MDIs and FDA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6436.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">has determined that limited production</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6446.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of new CFCs is necessary to protect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6456.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">patient safety in 2006. Despite the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6466.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">continued need for CFC albuterol MDIs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6476.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA would note that the transition to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6396.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFC-free albuterol MDIs is well</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6406.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">underway and the number of HFA MDIs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6416.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on the market today is evidence of that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6426.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">fact.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6441.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">III. Allocation of Essential Use</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6451.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Allowances for Calendar Year 2006</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:6466.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">With this action, EPA is allocating</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6476.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential use allowances for calendar</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6396.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">year 2006 to the entities listed in Table</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6406.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1. These allowances are for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6417.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production or import of the specified</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6427.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">quantity of class I controlled substances</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6437.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">solely for the specified essential use.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:158.20pt;top:6493.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">T</FONT><FONT STYLE="font-size: 8.19pt">ABLE </FONT><FONT STYLE="font-size: 10.00pt">1.—E</FONT><FONT STYLE="font-size: 8.19pt">SSENTIAL </FONT><FONT STYLE="font-size: 10.00pt">U</FONT><FONT STYLE="font-size: 8.19pt">SE </FONT><FONT STYLE="font-size: 10.00pt">A</FONT><FONT STYLE="font-size: 8.19pt">LLOWANCES FOR </FONT><FONT STYLE="font-size: 10.00pt">C</FONT><FONT STYLE="font-size: 8.19pt">ALENDAR </FONT><FONT STYLE="font-size: 10.00pt">Y</FONT><FONT STYLE="font-size: 8.19pt">EAR </FONT><FONT STYLE="font-size: 10.00pt">2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:178.40pt;top:6518.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Company Chemical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:514.95pt;top:6514.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">2006 Quantity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:517.60pt;top:6522.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(metric tons)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:84.35pt;top:6539.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:6557.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Armstrong Pharmaceuticals .........................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:354.35pt;top:6557.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 .............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.55pt;top:6557.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">147.50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:6566.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Boehringer Ingelheim Pharmaceuticals .......................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:354.35pt;top:6566.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 .............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.55pt;top:6566.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">116.50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:6575.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Inyx (Aventis) ................................................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:354.35pt;top:6575.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 .............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.50pt;top:6575.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">106.40</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:6584.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Schering-Plough Corporation .......................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:354.35pt;top:6584.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 .............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.55pt;top:6584.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">556.00</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:6593.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">3M Pharmaceuticals .....................................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:354.35pt;top:6593.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 .............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:551.45pt;top:6593.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">0.00</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:6602.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Wyeth ...........................................................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:354.35pt;top:6602.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 .............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:547.00pt;top:6602.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">76.00</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6634.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">IV. Statutory and Executive Order</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6644.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Reviews</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6658.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">A. Executive Order 12866: Regulatory</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6668.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Planning and Review</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:6682.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Under Executive Order 12866 (58 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6691.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">51735, October 4, 1993), this action is a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6701.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘significant regulatory action’’ because</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6711.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">it raises novel legal or policy issues.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6721.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Accordingly, EPA submitted this action</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6731.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to the Office of Management and Budget</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6741.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(OMB) for review under Executive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6751.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Order 12866 and any changes made in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6761.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">response to OMB recommendations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6771.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have been documented in the docket for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6781.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this action.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:6790.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA prepared an analysis of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6800.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">potential costs and benefits related to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6810.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this action. This analysis is contained in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6820.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Agency’s Regulatory Impact</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6830.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Analysis (RIA) for the entire Title VI</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6840.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">phaseout program (U.S. Environmental</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6850.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Protection Agency, ‘‘Regulatory Impact</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6860.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Analysis: Compliance with Section 604</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6870.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the Clean Air Act for the Phaseout of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6880.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Ozone Depleting Chemicals,’’ July</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6890.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1992). A copy of the analysis is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6900.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available in the docket for this action</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6910.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and the analysis is briefly summarized</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6920.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">here. The RIA examined the projected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6930.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">economic costs of a complete phaseout</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6940.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of consumption of ozone-depleting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6950.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substances, as well as the projected</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6960.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">benefits of phased reductions in total</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6970.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">emissions of CFCs and other ozone-</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6980.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">depleting substances, including</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:6990.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">essential use CFCs used for metered</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7000.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">dose inhalers.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7015.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">B. Paperwork Reduction Act</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7028.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This action does not impose any new</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7038.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information collection burden. The</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7048.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recordkeeping and reporting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7058.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements included in this action are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7068.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">already included in an existing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6634.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information collection burden and this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6644.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">action does not make any changes that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6654.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">would affect the burden. However, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6664.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Office of Management and Budget</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6674.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(OMB) has previously approved the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6684.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information collection requirements</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6694.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">contained in the existing regulations at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6704.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">40 CFR 82.8(a) under the provisions of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6714.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Paperwork Reduction Act, 44 U.S.C.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6724.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">3501 </FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">et seq. </FONT></i><FONT STYLE="font-size: 9.00pt">and has assigned OMB</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6734.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">control number 2060–0170, EPA ICR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6744.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number 1432.25. A copy of the OMB</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6754.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">approved Information Collection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6764.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Request (ICR) may be obtained from</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6774.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Susan Auby, Collection Strategies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6784.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Division; U.S. Environmental Protection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6794.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agency (2822T); 1200 Pennsylvania</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6804.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Ave., NW., Washington, DC 20460 or by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6814.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">calling (202) 566–1672.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:6826.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Burden means the total time, effort, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6836.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">financial resources expended by persons</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6846.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to generate, maintain, retain, or disclose</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6856.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or provide information to or for a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6866.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal agency. This includes the time</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6876.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">needed to review instructions; develop,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6886.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">acquire, install, and utilize technology</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6896.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and systems for the purposes of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6906.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">collecting, validating, and verifying</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6916.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information, processing and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6926.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">maintaining information, and disclosing</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6936.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and providing information; adjust the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6946.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">existing ways to comply with any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6956.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">previously applicable instructions and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6966.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements; train personnel to be able</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6976.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to respond to a collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6986.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information; search data sources;</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:6996.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">complete and review the collection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7006.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">information; and transmit or otherwise</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7016.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">disclose the information.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:7028.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">An agency may not conduct or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7038.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sponsor, and a person is not required to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7048.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">respond to a collection of information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7058.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">unless it displays a currently valid OMB</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7068.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">control number. The OMB control</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6634.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">numbers for EPA’s regulations in 40</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6644.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">CFR are listed in 40 CFR part 9.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6658.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">C. Regulatory Flexibility Act</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:6672.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA has determined that it is not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6682.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">necessary to prepare a regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6691.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">flexibility analysis in connection with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6701.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">today’s final rule. EPA has also</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6711.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determined that this rule will not have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6721.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a significant economic impact on a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6731.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substantial number of small entities. For</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6741.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">purposes of assessing the impact of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6751.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">today’s final rule on small entities,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6761.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">small entities are defined as: (1)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6771.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pharmaceutical preparations</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6781.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">manufacturing businesses (NAICS code</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6790.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">325412) that have less than 750</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6800.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">employees; (2) a small governmental</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6810.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">jurisdiction that is a government of a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6820.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">city, county, town, school district or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6830.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">special district with a population of less</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6840.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">than 50,000; and (3) a small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6850.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">organization that is any not-for-profit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6860.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">enterprise that is independently owned</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6870.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and operated and is not dominant in its</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6880.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">field.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:6889.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">After considering the economic</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6899.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">impacts of today’s final rule on small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6909.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entities, EPA has concluded that this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6918.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">action will not have a significant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6928.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">economic impact on a substantial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6938.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number of small entities. In determining</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6948.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">whether a rule has a significant</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6958.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">economic impact on a substantial</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6968.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">number of small entities, the impact of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6978.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">concern is any significant </FONT></FONT><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adverse</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6988.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">economic impact on small entities,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:6998.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">since the primary purpose of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7008.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory flexibility analyses is to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7018.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">identify and address regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7028.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternatives ‘‘which minimize any</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7038.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">significant economic impact of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7048.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposed rule on small entities.’’ 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7058.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">U.S.C. Sections 603 and 604. Thus, an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7068.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">agency may conclude that a rule will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00028</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:7103.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:7106.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:6336.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background8.png"></span>
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<SPAN STYLE="color:#000000;position:absolute;left:536.40pt;top:7161.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58513</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:7162.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7188.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not have a significant economic impact</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7198.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on a substantial number of small entities</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7208.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">if the rule relieves regulatory burden, or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7218.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">otherwise has a positive economic effect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7227.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on all of the small entities subject to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7237.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule. This rule provides an otherwise</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7247.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">unavailable benefit to those companies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7257.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that are receiving essential use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7267.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allowances. We have therefore</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7277.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">concluded that this final rule will</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7287.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">relieve regulatory burden for all small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7297.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entities.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7312.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">D. Unfunded Mandates Reform Act</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7325.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Title II of the Unfunded Mandates</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7335.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Reform Act of 1995 (UMRA), Public</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7345.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Law 104–4, establishes requirements for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7354.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal agencies to assess the effects of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7364.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">their regulatory actions on State, local,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7374.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and tribal governments and the private</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7384.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">sector. Under section 202 of the UMRA,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7394.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA generally must prepare a written</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7404.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">statement, including a cost-benefit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7414.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">analysis, for proposed and final rules</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7424.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">with ‘‘Federal mandates’’ that may</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7434.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">result in expenditures to State, local,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7444.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and tribal governments, in the aggregate,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7453.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or to the private sector, of $100 million</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7463.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or more in any one year.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7473.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Before promulgating an EPA rule for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7482.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">which a written statement is needed,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7492.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 205 of the UMRA generally</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7502.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requires EPA to identify and consider a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7512.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">reasonable number of regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7522.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternatives and adopt the least costly,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7532.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">most cost-effective, or least burdensome</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7542.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">alternative that achieves the objectives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7552.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the rule. The provisions of section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7562.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">205 do not apply when they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7572.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">inconsistent with applicable law.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7581.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Moreover, section 205 allows EPA to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7591.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adopt an alternative other than the least</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7601.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">costly, most cost-effective, or least</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7611.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">burdensome alternative, if the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7621.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administrator publishes with the final</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7631.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule an explanation why that alternative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7641.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">was not adopted.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7651.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Before EPA establishes any regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7661.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requirements that may significantly or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7671.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">uniquely affect small governments,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7681.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">including tribal governments, it must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7691.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have developed a small government</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7701.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">agency plan under section 203 of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7711.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">UMRA. The plan must provide for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7721.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">notifying potentially affected small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7731.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">governments, enabling officials of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7741.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">affected small governments to have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7751.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">meaningful and timely input in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7761.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">development of EPA regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7771.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">proposals with significant Federal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7781.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">intergovernmental mandates, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7791.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">informing, educating, and advising</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7801.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">small governments on compliance with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7811.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the regulatory requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:7820.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Today’s rule contains no Federal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7830.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">mandates (under the regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7840.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provisions of Title II of the UMRA) for</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7850.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">State, local, or tribal governments or the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7860.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">private sector, since it merely provides</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7188.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exemptions from the 1996 phaseout of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7198.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">class I ODSs. Similarly, EPA has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7208.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">determined that this rule contains no</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7218.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory requirements that might</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7227.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">significantly or uniquely affect small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7237.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">governments, because this rule merely</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7247.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">allocates essential use exemptions to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7257.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">entities as an exemption to the ban on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7267.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production and import of class I ODSs.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7282.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">E. Executive Order 13132: Federalism</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:7295.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Executive Order 13132, entitled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7305.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Federalism’’ (64 FR 43255, August 10,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7315.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1999), requires EPA to develop an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7325.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">accountable process to ensure</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7335.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘meaningful and timely input by State</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7345.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and local officials in the development of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7355.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory policies that have federalism</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7365.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">implications.’’ ‘‘Policies that have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7375.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">federalism implications’’ is defined in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7385.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Executive Order to include</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7395.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulations that have ‘‘substantial direct</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7405.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effects on the States, on the relationship</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7415.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">between the national government and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7425.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the States, or on the distribution of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7435.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">power and responsibilities among the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7445.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">various levels of government.’’</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:7454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This final rule does not have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">federalism implications. It will not have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">substantial direct effects on the States,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on the relationship between the national</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">government and the States, or on the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">distribution of power and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">responsibilities among the various</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7524.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">levels of government, as specified in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7534.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Executive Order 13132. Thus, Executive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7544.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Order 13132 does not apply to this rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7559.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">F. Executive Order 13175: Consultation</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7569.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and Coordination With Indian Tribal</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7579.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Governments</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:7592.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Executive Order 13175, entitled</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7602.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘Consultation and Coordination with</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Indian Tribal Governments’’ (65 FR</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7622.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">67249, November 9, 2000), requires EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">to develop an accountable process to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ensure ‘‘meaningful and timely input by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">tribal officials in the development of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">regulatory policies that have tribal</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">implications.’’ This final rule does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">have tribal implications, as specified in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Executive Order 13175. Today’s rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">affects only the companies that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requested essential use allowances.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Thus, Executive Order 13175 does not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7732.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">apply to this rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7747.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">G. Executive Order 13045: Protection of</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7757.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Children From Environmental Health</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7767.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Risks and Safety Risks</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:7780.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Executive Order 13045, ‘‘Protection of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7790.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Children from Environmental Health</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7800.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">risks and Safety Risks’’ (62 FR 19885,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7810.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">April 23, 1997), applies to any rule that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7820.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(1) is determined to be ‘‘economically</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7830.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">significant’’ as defined under Executive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7840.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Order 12866, and (2) concerns an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7850.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">environmental health and safety risk</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7860.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that EPA has reason to believe may have</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7188.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a disproportionate effect on children. If</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7198.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the regulatory action meets both criteria,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7208.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Agency must evaluate the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7218.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">environmental health or safety effects of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7227.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the planned rule on children, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7237.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">explain why the planned regulation is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7247.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">preferable to other potentially effective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7257.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and reasonably feasible alternatives</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7267.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">considered by the Agency. EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7277.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">interprets Executive Order 13045 as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7287.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">applying only to those regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7297.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">actions that are based on health or safety</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7307.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">risks, such that the analysis required</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7317.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">under section 5–501 of the Order has</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7326.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the potential to influence the regulation.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7336.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This rule is not subject to Executive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7346.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Order 13045 because it implements the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7356.60pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">phaseout schedule and exemptions</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7366.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">established by Congress in Title VI of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7376.40pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Clean Air Act.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7391.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">H. Executive Order 13211: Actions That</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7401.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Significantly Affect Energy Supply,</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7411.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Distribution, or Use</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:7424.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This rule is not subject to Executive</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7434.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Order 13211, Actions Concerning</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7444.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Regulations That Significantly Affect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7454.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Energy Supply, Distribution, or Use (66</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7464.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">FR 28355, May 22, 2001) because it is</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7474.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not likely to have a significant adverse</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7484.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">effect on the supply, distribution, or use</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7494.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of energy. The rule affects only the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7504.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">pharmaceutical companies that</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7514.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requested essential use allowances.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7529.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I. National Technology Transfer and</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7539.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Advancement Act</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:7552.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Section 12(d) of the National</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7562.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Technology Transfer and Advancement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7572.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Act of 1995 (‘‘NTTAA), Public Law No.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">104</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:414.00pt;top:7582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">–113, section 12(d) (15 U.S.C. 272</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7592.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">note) directs EPA to use voluntary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7602.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consensus standards in this regulatory</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">activities unless to do so would be</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7622.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">inconsistent with applicable law or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">otherwise impractical. Voluntary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consensus standards are technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">standards (</FONT></FONT><FONT COLOR="000000"><i><FONT STYLE="font-size: 9.00pt">e.g.</FONT></i><FONT STYLE="font-size: 9.00pt">, materials specifications,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7662.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">test methods, sampling procedures, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7672.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">business practices) that are developed or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7682.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">adopted by voluntary consensus</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7692.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">standards bodies. The NTTAA directs</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7702.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA to provide Congress, through OMB,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7712.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">explanations when the Agency decides</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7722.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">not to use available and applicable</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7732.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">voluntary consensus standards. This</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7742.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">final rule does not involve technical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7752.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">standards. Therefore, EPA did not</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7762.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consider the use of any voluntary</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7772.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consensus standards.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7787.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">J. Congressional Review Act</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:7800.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Congressional Review Act, 5</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7810.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">U.S.C. 801 et seq., as added by the Small</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7820.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Business Regulatory Enforcement</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7830.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Fairness Act of 1996, generally provides</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7840.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">that before a rule may take effect, the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7850.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">agency promulgating the rule must</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7860.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">submit a rule report, which includes a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00029</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:7895.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:22.00pt;top:7898.40pt;z-index:3;"></SPAN>
<span style="color:#000000;background-color:#ffffff;position:absolute;left:0.00pt;top:7128.00pt;z-index:-1;"><img style="width:612pt;height:792pt;" src="outputfile-288234952.htm_files\outputfile-288234952_background9.png"></span>
<SPAN STYLE="position:absolute;left:71.76pt;top:7920.00pt"> </SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7953.80pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 11.00pt">58514</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:97.50pt;top:7954.55pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">Federal Register/Vol. 71, No. 192 /Wednesday, October 4, 2006 /Rules and Regulations</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7980.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">copy of the rule, to each House of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:7990.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Congress and to the Comptroller General</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8001.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">of the United States. Therefore, EPA</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8011.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">will submit a report containing this rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8021.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">and other required information to the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8032.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">U.S. Senate, the U.S. House of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8042.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Representatives, and the Comptroller</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8053.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">General of the United States prior to</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8063.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">publication of the rule in the </FONT></FONT><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8073.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Register. This rule is not a ‘‘major rule’’</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8084.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">as defined by 5 U.S.C. 804(2). This rule</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8094.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">will be effective October 4, 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8110.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">V. Judicial Review</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:54.00pt;top:8127.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Under section 307(b)(1) of the Act,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8138.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA finds that these regulations are of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8148.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">national applicability. Accordingly,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8158.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">judicial review of the action is available</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8169.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">only by the filing of a petition for review</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8179.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">in the United States Court of Appeals</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8190.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">for the District of Columbia Circuit</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8200.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">within sixty days of publication of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8210.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">action in the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register</FONT></b><FONT STYLE="font-size: 9.00pt">. Under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8221.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 307(b)(2), the requirements of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8231.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this rule may not be challenged later in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8242.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">judicial proceedings brought to enforce</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8252.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">those requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:7980.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">VI. Effective Date of This Final Rule</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:231.00pt;top:7997.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Section 553(d) of the Administrative</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8007.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Procedures Act (APA) generally</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8018.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">provides that rules may not take effect</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8028.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">earlier than 30 days after they are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8039.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">published in the </FONT></FONT><FONT COLOR="000000"><b><FONT STYLE="font-size: 9.00pt">Federal Register</FONT></b><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8049.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Today’s final rule is issued under</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8059.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">section 307(d) of the CAA, which states,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8070.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">‘‘The provisions of section 553 through</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8080.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">557 * * * of Title 5 shall not, except as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8091.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">expressly provided in this subsection,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8101.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">apply to actions to which this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8111.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">subsection applies.’’ Thus, section</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8122.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">553(d) of the APA does not apply to this</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8132.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">rule. EPA nevertheless is acting</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8143.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">consistently with the policies</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8153.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">underlying APA section 553(d) in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8163.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">making this rule effective October 4,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8174.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2006. APA section 553(d) provides an</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8184.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">exception for any action that grants or</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8195.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recognizes an exemption or relieves a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8205.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">restriction. Because today’s action</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8215.90pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">grants an exemption to the phaseout of</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8226.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">production and consumption of CFCs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8236.70pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA is making this action effective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8247.10pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">immediately to ensure continued</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8257.50pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">availability of CFCs for medical devices.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:7980.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">List of Subjects in 40 CFR Part 82</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:7994.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Environmental protection,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8004.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Administrative practice and procedure,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8014.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Air pollution control, Chemicals,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8024.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Exports, Imports, Reporting and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8034.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">recordkeeping requirements.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:8048.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Dated: September 27, 2006.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8059.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Stephen L. Johnson,</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8070.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Administrator.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8083.25pt;z-index:3;"><FONT FACE ="Amyuni Symbols" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">ٱ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.35pt;top:8082.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">40 CFR part 82 is amended as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8100.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">PART 82—PROTECTION OF</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8110.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">STRATOSPHERIC OZONE</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8127.25pt;z-index:3;"><FONT FACE ="Amyuni Symbols" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">ٱ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.35pt;top:8126.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">1. The authority citation for part 82</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8136.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">continues to read as follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.00pt;top:8150.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Authority: 42 U.S.C. 7414, 7601,7671–</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8159.05pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">7671q.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8176.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Subpart A—Production and</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8186.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Consumption Controls</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8205.25pt;z-index:3;"><FONT FACE ="Amyuni Symbols" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 7.00pt">ٱ</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:407.35pt;top:8204.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2. Section 82.8 is amended by revising</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8214.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the table in paragraph (a) to read as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8224.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">follows:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8241.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">§82.8</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:428.35pt;top:8241.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Grants of essential use allowances</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8250.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">and critical use allowances.</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:8261.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(a) * * *</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:159.60pt;top:8278.80pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 10.00pt">T</FONT><FONT STYLE="font-size: 8.19pt">ABLE </FONT><FONT STYLE="font-size: 10.00pt">I.—E</FONT><FONT STYLE="font-size: 8.19pt">SSENTIAL </FONT><FONT STYLE="font-size: 10.00pt">U</FONT><FONT STYLE="font-size: 8.19pt">SE </FONT><FONT STYLE="font-size: 10.00pt">A</FONT><FONT STYLE="font-size: 8.19pt">LLOWANCES FOR </FONT><FONT STYLE="font-size: 10.00pt">C</FONT><FONT STYLE="font-size: 8.19pt">ALENDAR </FONT><FONT STYLE="font-size: 10.00pt">Y</FONT><FONT STYLE="font-size: 8.19pt">EAR </FONT><FONT STYLE="font-size: 10.00pt">2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:177.20pt;top:8303.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Company Chemical</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:512.70pt;top:8299.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">2006 Quantity</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:515.40pt;top:8307.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(metric tons)</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:84.35pt;top:8324.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">(i) Metered Dose Inhalers (for oral inhalation) for Treatment of Asthma and Chronic Obstructive Pulmonary Disease</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:8342.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Armstrong Pharmaceuticals ........................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:351.90pt;top:8342.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 ............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.55pt;top:8342.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">147 .50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:8351.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Boehringer Ingelheim Pharmaceuticals ......................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:351.90pt;top:8351.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 ............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.55pt;top:8351.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">116 .50</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:8360.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Inyx (Aventis) ..............................................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:351.90pt;top:8360.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 ............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.50pt;top:8360.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">106 .4</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:8369.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Schering-Plough Corporation ......................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:351.90pt;top:8369.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 ............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:542.55pt;top:8369.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">556 .00</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:8378.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">3M Pharmaceuticals ....................................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:351.90pt;top:8378.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 ............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:551.45pt;top:8378.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">0 .0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.30pt;top:8387.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">Wyeth ..........................................................................................................................</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:351.90pt;top:8387.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">CFC–11 or CFC–12 or CFC–114 ............</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:547.00pt;top:8387.05pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">76 .0</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8419.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">* * * * *</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8433.95pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[FR Doc. E6–16372 Filed 10–3–06; 8:45 am]</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8446.60pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 6.00pt">BILLING CODE 6560–50–P</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8472.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">ENVIRONMENTAL PROTECTION</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8482.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">AGENCY</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8500.75pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">40 CFR Part 180</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8519.95pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 8.00pt">[EPA–HQ–OPP–2006–0670; FRL–8092–7]</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8537.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Flumetsulam; Pesticide Tolerance</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8553.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">AGENCY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:81.25pt;top:8553.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Environmental Protection</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8563.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Agency (EPA).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8575.25pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ACTION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:78.05pt;top:8575.00pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Final rule.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8592.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUMMARY</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:87.65pt;top:8592.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This regulation establishes a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8602.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">tolerance for residues of flumetsulam in</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">or on beans (dry). Dow AgroSciences</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8622.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">LLC requested this tolerance under the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Federal Food, Drug, and Cosmetic Act</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(FFDCA), as amended by the Food</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:45.00pt;top:8652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Quality Protection Act of 1996 (FQPA).</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8419.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">DATES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:251.85pt;top:8419.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">This regulation is effective</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8429.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">October 4, 2006. Objections and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8439.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">requests for hearings must be received</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8449.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">on or before December 4, 2006, and</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8459.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">must be filed in accordance with the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8469.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">instructions provided in 40 CFR part</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8479.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">178 (see also Unit I.C. of the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8489.45pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY INFORMATION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">)</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:342.65pt;top:8489.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8502.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">ADDRESSES</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:272.25pt;top:8502.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">EPA has established a</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8512.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">docket for this action under docket</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8522.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">identification (ID) number EPA–HQ–</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8532.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">OPP–2006–0670. All documents in the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8542.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">docket are listed in the index for the</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8552.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">docket. Although listed in the index,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8562.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">some information is not publicly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8572.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available, e.g., Confidential Business</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Information (CBI) or other information</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8592.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">whose disclosure is restricted by statute.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8602.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Certain other material, such as</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">copyrighted material, is not placed on</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8622.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">the Internet and will be publicly</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8632.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available only in hard copy form.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Publicly available docket materials are</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:222.00pt;top:8652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available in the electronic docket at</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8419.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt"><a href="http://www.regulations.gov,">http://www.regulations.gov</a></FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">, or, if only</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8429.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">available in hard copy, at the OPP</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8439.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Regulatory Public Docket in Rm. S-4400,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8449.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">One Potomac Yard (South Building),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8459.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">2777 S. Crystal Drive, Arlington, VA.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8469.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">The Docket Facility is open from 8:30</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8479.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">a.m. to 4 p.m., Monday through Friday,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8489.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">excluding legal holidays. The Docket</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8499.20pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">telephone number is (703) 305–5805.</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8512.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">FOR FURTHER INFORMATION CONTACT</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:547.45pt;top:8512.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Phil</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8522.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Errico, Registration Division (7505P),</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8532.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Office of Pesticide Programs,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8542.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Environmental Protection Agency, 1200</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8552.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">Pennsylvania Ave., NW., Washington,</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8562.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">DC 20460–0001; telephone number:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8572.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">(703) 305–6663; e-mail address:</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8582.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">errico.philip@epa.gov.</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8597.55pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 7.44pt">SUPPLEMENTARY INFORMATION</FONT></FONT><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">:</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8612.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><b><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">I. General Information</FONT></FONT></b></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8627.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><i><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">A. Does this Action Apply to Me?</FONT></FONT></i></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:408.00pt;top:8642.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">You may be potentially affected by</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:399.00pt;top:8652.30pt;z-index:3;"><FONT FACE ="Melior" style = "font-size: 12.00pt"><FONT COLOR="000000"><FONT STYLE="font-size: 9.00pt">this action if you are an agricultural</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:25.00pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">VerDate Aug<31>2005</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:100.30pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">14:25 Oct 03, 2006</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:162.60pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Jkt 211001</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:201.40pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">PO 00000</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:237.65pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Frm 00030</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:276.10pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Fmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:310.55pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">Sfmt 4700</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:347.15pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">E:\FR\FM\04OCR1.SGM</FONT></FONT></FONT></SPAN>
<SPAN STYLE="color:#000000;position:absolute;left:425.65pt;top:8687.35pt;z-index:3;"><FONT FACE ="Arial" style = "font-size: 12.00pt"><FONT COLOR="ffffff"><FONT STYLE="font-size: 6.50pt">04OCR1</FONT></FONT></FONT></SPAN>
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