<table>
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<tbody>
<tr class="odd">
<td colspan="55" rowspan="3"><p><strong>Public Health Service DEPARTMENT
OF HEALTH AND HUMAN SERVICES Food and Drug Administration</strong></p>
<p><strong>FOOD PROCESS FILING FOR LOW- ACID ASEPTIC
SYSTEMS</strong></p>
<p>(USE FDA BOOKLET TITLED "ASEPTIC PACKAGING SYSTEM SUPPLEMENT")</p>
<p><em>(TYPE OR PRINT ALL INFORMATION REQUESTED, IF AN ITEM DOES NOT
APPLY ENTER "NA". FILE ACIDIFIED ASEPTIC (pH 4.6 or BELOW) ON FORM
2541a)</em></p></td>
<td colspan="6" rowspan="3"><p>NOTE: No commercial processor shall</p>
<p>engage in the processing of low- acid</p>
<p>foods unless completed Forms FDA 2541</p>
<p>and FDA 2541c have been filed with the</p>
<p>Food and Drug Administration, 21 CFR</p>
<p>108.35 (c)( 1) and (2).</p></td>
<td colspan="7"><p id="form-approved-omb-no.-0910-0037"
class="heading">FORM APPROVED: OMB No. 0910-0037</p>
<p>EXPIRATION DATE: 6/30/08</p></td>
</tr>
<tr class="even">
<td colspan="7"><p id="fda-use-only" class="heading"><strong>FDA USE
ONLY</strong></p></td>
</tr>
<tr class="odd">
<td colspan="7"><p id="date-received-by-fda" class="heading">DATE
RECEIVED BY FDA</p>
<p>     </p></td>
</tr>
<tr class="even">
<td colspan="48"><strong>1.</strong> FCE</td>
<td colspan="2" rowspan="20"></td>
<td colspan="18"><strong>7.</strong> PRODUCT NAME, FORM OR STYLE, AND
PACKING MEDIUM</td>
</tr>
<tr class="odd">
<td colspan="48">     </td>
<td colspan="18" rowspan="3"><blockquote>
<p>     </p>
</blockquote></td>
</tr>
<tr class="even">
<td rowspan="8"><strong>2.</strong></td>
<td colspan="47">ESTABLISHMENT NAME</td>
</tr>
<tr class="odd">
<td colspan="47">     </td>
</tr>
<tr class="even">
<td colspan="47">ADDRESS <em>(No. and Street)</em></td>
<td colspan="18"><strong>8.</strong> NAMES OF STERILIZING SYSTEMS</td>
</tr>
<tr class="odd">
<td colspan="47">     </td>
<td colspan="2" rowspan="4"></td>
<td colspan="16">a. Product<sup>1</sup></td>
</tr>
<tr class="even">
<td colspan="27">CITY</td>
<td colspan="20">STATE</td>
<td colspan="16">     </td>
</tr>
<tr class="odd">
<td colspan="27">     </td>
<td colspan="20">     </td>
<td colspan="16">b. Packaging</td>
</tr>
<tr class="even">
<td colspan="11">ZIP CODE</td>
<td colspan="36">COUNTRY</td>
<td colspan="16">     </td>
</tr>
<tr class="odd">
<td colspan="11">     </td>
<td colspan="36">     </td>
<td colspan="18"><strong>9.</strong> PROCESS ORIGIN</td>
</tr>
<tr class="even">
<td colspan="48"><strong>3.</strong> SID</td>
<td colspan="2" rowspan="5"></td>
<td>No.</td>
<td colspan="12">Source for 8. a. and 8. b.</td>
<td colspan="3">Date <em>(mm/yyyy)</em></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2">-</td>
<td colspan="3"> </td>
<td colspan="2"> </td>
<td colspan="2">-</td>
<td colspan="5"> </td>
<td colspan="2"> </td>
<td colspan="3">/</td>
<td colspan="4"> </td>
<td colspan="3"> </td>
<td colspan="3"> </td>
<td colspan="11"></td>
<td rowspan="2">a.</td>
<td colspan="12" rowspan="2">     </td>
<td colspan="3" rowspan="2">     </td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="2">Y</td>
<td>Y</td>
<td colspan="2">Y</td>
<td>Y</td>
<td colspan="2"></td>
<td colspan="3">M</td>
<td colspan="2">M</td>
<td colspan="2"></td>
<td colspan="5">D</td>
<td colspan="2">D</td>
<td colspan="3"></td>
<td colspan="4">S</td>
<td colspan="3">S</td>
<td colspan="3">S</td>
<td colspan="11"></td>
</tr>
<tr class="odd">
<td colspan="16"><strong>4</strong>. NEW CANCELS REPLACES</td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td colspan="3">-</td>
<td colspan="3"> </td>
<td colspan="3"> </td>
<td>-</td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td>/</td>
<td> </td>
<td colspan="3"> </td>
<td> </td>
<td></td>
<td rowspan="2">b.</td>
<td colspan="12" rowspan="2">     </td>
<td colspan="3" rowspan="2">     </td>
</tr>
<tr class="even">
<td colspan="16"></td>
<td colspan="2">Y</td>
<td colspan="3">Y</td>
<td colspan="2">Y</td>
<td colspan="3">Y</td>
<td colspan="3"></td>
<td colspan="3">M</td>
<td colspan="3">M</td>
<td></td>
<td colspan="2">D</td>
<td colspan="3">D</td>
<td></td>
<td>S</td>
<td colspan="3">S</td>
<td>S</td>
<td></td>
</tr>
<tr class="odd">
<td colspan="16"><strong>5.</strong> SCHEDULED ALTERNATE FOR</td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td colspan="3">-</td>
<td colspan="3"> </td>
<td colspan="3"> </td>
<td>-</td>
<td colspan="2"> </td>
<td colspan="3"> </td>
<td>/</td>
<td> </td>
<td colspan="3"> </td>
<td> </td>
<td></td>
<td colspan="18"><strong>10.</strong> CONTAINER TYPE <em>(Check
one)</em></td>
</tr>
<tr class="even">
<td colspan="16"></td>
<td colspan="2">Y</td>
<td colspan="3">Y</td>
<td colspan="2">Y</td>
<td colspan="3">Y</td>
<td colspan="3"></td>
<td colspan="3">M</td>
<td colspan="3">M</td>
<td></td>
<td colspan="2">D</td>
<td colspan="3">D</td>
<td></td>
<td>S</td>
<td colspan="3">S</td>
<td>S</td>
<td></td>
<td colspan="18" rowspan="2"><p>a. Tinplate or b. Aluminum c. Glass d.
Other <em>(Specify below and</em></p>
<p>Steel Can Can <em>in item 22 if necessary)</em></p></td>
</tr>
<tr class="odd">
<td colspan="48"><strong>6.</strong> SUP SID</td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2"> </td>
<td> </td>
<td colspan="2">-</td>
<td colspan="3"> </td>
<td colspan="2"> </td>
<td colspan="2">-</td>
<td colspan="5"> </td>
<td colspan="2"> </td>
<td colspan="3">/</td>
<td colspan="4"> </td>
<td colspan="3"> </td>
<td colspan="3"> </td>
<td colspan="11"></td>
<td colspan="14"></td>
<td colspan="3">     </td>
<td></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="2">Y</td>
<td>Y</td>
<td colspan="2">Y</td>
<td>Y</td>
<td colspan="2"></td>
<td colspan="3">M</td>
<td colspan="2">M</td>
<td colspan="2"></td>
<td colspan="5">D</td>
<td colspan="2">D</td>
<td colspan="3"></td>
<td colspan="4">S</td>
<td colspan="3">S</td>
<td colspan="3">S</td>
<td colspan="11"></td>
<td colspan="14"></td>
<td colspan="3"></td>
<td></td>
</tr>
<tr class="even">
<td colspan="3" rowspan="2"><p><strong>11.</strong> MAXIMUM</p>
<p>WATER</p>
<p>ACTIVITY <sup>2</sup></p></td>
<td colspan="6"><strong>12.</strong> pH</td>
<td colspan="49"><strong>13.</strong> MAXIMUM CONSISTENCY OR VISCOSITY
IN CENTIPOISES OR APPROPRIATE UNITS</td>
<td colspan="4" rowspan="2"><p><strong>14.</strong> SPECIFIC</p>
<p>GRAVITY</p>
<p>AT 77<u>+</u>2<sup>o</sup> F</p></td>
<td colspan="4" rowspan="2"><p><strong>15.</strong> INSIDE DIAME-</p>
<p>TER OF HOLDING</p>
<p>TUBE <em>(Inches)</em></p></td>
<td colspan="2" rowspan="2"><p><strong>16.</strong> HOLDING</p>
<p>TUBE LENGTH</p>
<p><em>(Inches)</em></p></td>
</tr>
<tr class="odd">
<td colspan="3">Normal</td>
<td colspan="3">Max.<sup>3</sup></td>
<td colspan="11"><p>Value at</p>
<p>77<u>+</u>2<sup>o</sup> F</p></td>
<td colspan="10"><p>Value at</p>
<p>Other Temp</p></td>
<td colspan="9"><p>Other</p>
<p>Temp (<sup>o</sup>F)</p></td>
<td colspan="10">Units</td>
<td colspan="7">Method Name</td>
<td colspan="2"><p>Viscosity</p>
<p>Characteristic</p></td>
</tr>
<tr class="even">
<td colspan="3">0.     </td>
<td colspan="3">    .  </td>
<td colspan="3">    .  </td>
<td colspan="11">    .  </td>
<td colspan="10">    .  </td>
<td colspan="9">     </td>
<td colspan="10">     </td>
<td colspan="7">     </td>
<td colspan="2">N P D </td>
<td colspan="4">     </td>
<td colspan="4">     </td>
<td colspan="2">     </td>
</tr>
<tr class="odd">
<td colspan="9"><p><strong>17.</strong> OTHER CRITICAL CONTROL</p>
<p>FACTORS <em>(Check all that apply)</em></p></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td colspan="19"><p><strong>18.</strong> CONTAINER DIMENSIONS</p>
<p>(Inches and Sixteenths)</p></td>
<td colspan="24"><strong>19.</strong> SCHEDULED PROCESS</td>
<td colspan="3"><strong>20.</strong> MAXIMUM</td>
<td colspan="3"><strong>21.</strong> THRUPUT</td>
<td colspan="5"><strong>FOOTNOTES</strong></td>
</tr>
<tr class="even">
<td colspan="9" rowspan="7"><p>61 Percent Solids</p>
<p>62 Ratio of Solids to Liquids</p>
<p>63 Syrup Strength</p>
<p>68 Method of Preparation</p>
<p>70 Formulation</p>
<p>71 Rehydration <em>(specify method</em></p>
<p><em>in 22)</em></p>
<p>72 Particulates <em>(specify maxi-</em></p>
<p><em>mum size in 22)</em></p>
<p>73 Other <em>(specify in 22)</em></p></td>
<td colspan="2"></td>
<td colspan="3">No.</td>
<td colspan="5"><p>Diameter or</p>
<p>Length</p></td>
<td colspan="6"><p>Height or</p>
<p>Width</p></td>
<td colspan="8">Height</td>
<td colspan="7"><p>Minimum</p>
<p>Initial <sup>4</sup></p>
<p>Temp (<sup>o</sup>F)</p></td>
<td colspan="4">Time (sec)</td>
<td colspan="7">Temp (<sup>o</sup>F)</td>
<td colspan="3"><p>Least</p>
<p>Sterilizing</p>
<p>Value (F<sub>o</sub>)<sup>5</sup></p></td>
<td colspan="3"><p>Flow</p>
<p>Correction</p>
<p>Factor</p></td>
<td colspan="3"><p>FOOD FLOW</p>
<p>RATE</p>
<p>(gal / min)</p></td>
<td colspan="3"><p>(containers /</p>
<p>minute)</p></td>
<td colspan="5" rowspan="7"><p>1 For steam injection, enter volume
increase and thermal expansion factors in 22.</p>
<p>2 If reduced water activity is used as</p>
<p>an adjunct to the process, spec-</p>
<p>ify the maximum water activity.</p>
<p>3 Where acidification is followed for</p>
<p>normally low- acid fruits, vege-</p>
<p>tables or vegetable products for</p>
<p>the purpose of thermal proces-</p>
<p>sing, specify the maximum</p>
<p>finished product equilibrium pH.</p>
<p>4 If a critical factor is in the process.</p>
<p>5 Or equivalent scientific basis of</p>
<p>process adequacy.</p></td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="3"><strong>1</strong></td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="8">     </td>
<td colspan="7">     </td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="3"><strong>2</strong></td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="8">     </td>
<td colspan="7">     </td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="3"><strong>3</strong></td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="8">     </td>
<td colspan="7">     </td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="3"><strong>4</strong></td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="8">     </td>
<td colspan="7">     </td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
</tr>
<tr class="odd">
<td colspan="2"></td>
<td colspan="3"><strong>5</strong></td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="8">     </td>
<td colspan="7">     </td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
</tr>
<tr class="even">
<td colspan="2"></td>
<td colspan="3"><strong>6</strong></td>
<td colspan="5">     </td>
<td colspan="6">     </td>
<td colspan="8">     </td>
<td colspan="7">     </td>
<td colspan="4">     </td>
<td colspan="7">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
<td colspan="3">     </td>
</tr>
<tr class="odd">
<td colspan="45" rowspan="5"><p><strong>22.</strong> COMMENTS</p>
<p>     </p></td>
<td colspan="23"><strong>AUTHORIZED COMPANY REPRESENTATIVE</strong></td>
</tr>
<tr class="even">
<td colspan="14">NAME <em>(Type or Print)</em></td>
<td colspan="9">TITLE</td>
</tr>
<tr class="odd">
<td colspan="14">     </td>
<td colspan="9">     </td>
</tr>
<tr class="even">
<td colspan="14">SIGNATURE</td>
<td colspan="4">DATE</td>
<td colspan="5">PHONE NO.</td>
</tr>
<tr class="odd">
<td colspan="14"></td>
<td colspan="4">     </td>
<td colspan="5">     </td>
</tr>
</tbody>
</table>

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|          | **Public reporting burden for this collection   |         |
|          | of information** is estimated to average .75    |         |
|          | hours per\                                      |         |
|          | response, including the time for reviewing      |         |
|          | instructions, searching existing data sources,  |         |
|          | gathering and\                                  |         |
|          | maintaining the data needed, and completing and |         |
|          | reviewing the collection of information. Send   |         |
|          | comments\                                       |         |
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|          | aspect of this collection of information,       |         |
|          | including suggestions\                          |         |
|          | for reducing this burden to:                    |         |
|          |                                                 |         |
|          | > Food and Drug Administration                  |         |
|          | >                                               |         |
|          | > LACF Registration Coordinator (HFS- 618)      |         |
|          | >                                               |         |
|          | > Center for Food Safety & Applied Nutrition    |         |
|          | >                                               |         |
|          | > 5100 Paint Branch Parkway                     |         |
|          | >                                               |         |
|          | > College Park, MD 20740                        |         |
|          |                                                 |         |
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|          | person is not required to respond to, a         |         |
|          | collection of\                                  |         |
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|          | valid OMB control number.*                      |         |
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