<table>
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<tbody>
<tr class="odd">
<td colspan="6"><p>Name(s) of Risk Team Members:</p>
<p>Richard Ferrieri, Carston Kroll</p></td>
<td colspan="3"><p>Point Value →</p>
<p>Parameter ↓</p></td>
<td colspan="10">1</td>
<td colspan="4">2</td>
<td colspan="2">3</td>
<td colspan="12">4</td>
<td colspan="5">5</td>
</tr>
<tr class="even">
<td colspan="6"><p>Job Title: Radiosynthesis of [11C]methamphetamine</p>
<p>Job Number or Job Identifier: DJ-JRA20A-Radiosynthesis</p></td>
<td colspan="3"><p>Frequency</p>
<p>(B)</p></td>
<td colspan="10"><u>&lt;</u>once/year</td>
<td colspan="4"><u>&lt;</u>once/month</td>
<td colspan="2"><u>&lt;</u>once/week</td>
<td colspan="12"><u>&lt;</u>once/shift</td>
<td colspan="5">&gt;once/shift</td>
</tr>
<tr class="odd">
<td colspan="6"><p>Job Description:</p>
<p>Use of radioactive [11C]methyl iodide in the synthesis of
[11C]methamphetamine</p></td>
<td colspan="3"><p>Severity</p>
<p>(C)</p></td>
<td colspan="10">First Aid Only</td>
<td colspan="4">Medical Treatment</td>
<td colspan="2">Lost Time</td>
<td colspan="12">Partial Disability</td>
<td colspan="5">Death or Permanent Disability</td>
</tr>
<tr class="even">
<td colspan="6"><p>Training and Procedures List: As defined in ESR
CO-11-7</p>
<p>RWP # CYC-2005-01Rev2.</p></td>
<td colspan="3" rowspan="2"><p>Likelihood</p>
<p>(D)</p></td>
<td colspan="10" rowspan="2">Extremely Unlikely</td>
<td colspan="4" rowspan="2">Unlikely</td>
<td colspan="2" rowspan="2">Possible</td>
<td colspan="12" rowspan="2">Probable</td>
<td colspan="5" rowspan="2">Multiple</td>
</tr>
<tr class="odd">
<td colspan="6"><p>Approved by: Diane Cabelli Date: 11/3/05 Rev. #:
0</p>
<p>R. Colichio 7/24/05</p></td>
</tr>
<tr class="even">
<td colspan="5"><p>Stressors (if applicable, please list all):</p>
<p>Critical timing for coordination of synthetic setup with arrival of
radioactive precursor into the lab.</p></td>
<td colspan="19">Reason for Revision (if applicable):</td>
<td colspan="18">Comments:</td>
</tr>
<tr class="odd">
<td colspan="8"></td>
<td colspan="13">Before Additional Controls</td>
<td colspan="7"></td>
<td colspan="13">After Additional Controls</td>
<td></td>
</tr>
<tr class="even">
<td colspan="2">Job Step / Task</td>
<td>Hazard</td>
<td colspan="4"><p>.</p>
<p>Control(s)</p></td>
<td><blockquote>
<p><strong>Stressors Y/N</strong></p>
</blockquote></td>
<td colspan="4"><blockquote>
<p><strong># of People A</strong></p>
</blockquote></td>
<td><blockquote>
<p><strong>Frequency B</strong></p>
<p><strong>A</strong></p>
</blockquote></td>
<td colspan="3"><blockquote>
<p><strong>Severity C</strong></p>
</blockquote></td>
<td><blockquote>
<p><strong>Likelihood D</strong></p>
</blockquote></td>
<td colspan="4"><blockquote>
<p><strong>Risk* AxBxCxD</strong></p>
</blockquote></td>
<td colspan="5">Control(s) Added to Reduce Risk</td>
<td colspan="2"><blockquote>
<p><strong>Stressors Y/N</strong></p>
</blockquote></td>
<td colspan="4"><blockquote>
<p><strong># of People A</strong></p>
</blockquote></td>
<td><blockquote>
<p><strong>Frequency B</strong></p>
</blockquote></td>
<td colspan="3"><blockquote>
<p><strong>Severity C</strong></p>
</blockquote></td>
<td colspan="2"><blockquote>
<p><strong>Likelihood D</strong></p>
</blockquote></td>
<td colspan="3"><blockquote>
<p><strong>Risk* AxBxCxD</strong></p>
</blockquote></td>
<td>% Risk Reduction</td>
</tr>
<tr class="odd">
<td colspan="2">Energize appropriate equipment in Capintec hot cell
(including, oil bath and stirrer, vacuum pump, bioscan detector, UV
detector).</td>
<td>Wall switches for individual components located on outside of cell
on panel. Electrical short if equipment failure occurs.</td>
<td colspan="4">All equipment is routinely inspected for frayed wiring
through Tier I inspections and internal lab inspections. All equipment
is fused at source and connected to breakered circuits.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>5</td>
<td colspan="3">1</td>
<td colspan="2">20</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Placement of glass reaction vessel and leak test using
argon gas flow.</td>
<td>Radiation exposure</td>
<td colspan="4">Vessel is tested to ensure gas tight seal at vessel and
fittings to valves. If test fails a new vessel is put into place. NO
activity is allowed into workspace until this step is performed
satisfactorily</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Preparing cryogen bath (acetonitrile and dry ice)</td>
<td>Skin burn</td>
<td colspan="4">Wear PPE during preparation (latex gloves)</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">2</td>
<td colspan="2">8</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Prepare substrate solution and inject formulation into
reaction vessel</td>
<td><h1
id="contact-of-amphetamine-with-skin-when-preparing-stock-solution-of-reagent-needle-prick.">Contact
of amphetamine with skin when preparing stock solution of reagent,
needle prick.</h1></td>
<td colspan="4">Wear PPE (latex gloves) when working with controlled
substances. Use short 22 gauge needles that don’t flex when puncturing
vessel septum. Keep syringe capped until ready to dispense
reagents.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">2</td>
<td colspan="2">8</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Charge vacuum trap and rotary evaporator traps with dry
ice.</td>
<td><h1 id="skin-burn">Skin burn</h1></td>
<td colspan="4">Ensure hot cell blower is operating using Kim Wipe
tissue test at opening. Wear PPE (latex gloves). Traps are located in a
fume hood so there is no risk of asphyxiation for CO<sub>2</sub>.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Place appropriate glass collectors into Capintec dose
monitoring chamber.</td>
<td>Leakage of radioactive liquid--contamination</td>
<td colspan="4">Ensure all Teflon tubing is intact and attached to
appropriate glass ports on collectors. Ensure collection value is
properly positioned.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Place round bottom flask onto end of rotary evaporator
and position over hot water bath.</td>
<td>Cut skin</td>
<td colspan="4">Care in placement or else could crack ground-glass
fitting at flask neck and cut skin. Inspect flask neck for cracks prior
to use.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>2</td>
<td colspan="3">2</td>
<td colspan="2">16</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Ensure valves are all configured to receive [11C]methyl
iodide precursor.</td>
<td>Radiation exposure</td>
<td colspan="4">The way the system is designed there is no chance of
leakage of radioactive gas to the outside world. However, if valves are
not configured in the correct orientation to receive the precursor then
the run is lost and the precursor will be vented to collection balloons
in back vault. While this is not a contamination issue, personnel will
still be needlessly exposed to radioactivity.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Coordinated with cyclotron operator to unload
11CO<sub>2</sub> from target into GE MeI box.</td>
<td>None</td>
<td colspan="4">These processes are all remotely controlled and
automated.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Cool reaction vessel during transfer of [11C]methyl
iodide from GE box to hot cell.</td>
<td>Radiation exposure</td>
<td colspan="4">If the substrate solution is not cooled the precursor
will not effectively trap. Radioactivity will pass through the hot cell
and be vented to collection balloons located at remote vault. Still
personnel can be exposed needlessly to radioactivity if this is not
carried out.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Seal vessel and heat contents in oil bath</td>
<td>Radiation exposure</td>
<td colspan="4">Remote operation of valves.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Displace contents of vessel into HPLC injector and
inject.</td>
<td>Radiation exposure, chance of pinching hands/fingers in sliding lead
doors of hot cell</td>
<td colspan="4">This step requires opening the hot cell door sufficient
placing the lead glass portion between chemist and source to minimize
radiation exposure. Injection valve is manually operated inside
dispersible zone. Proper PPE using gauntlets and double latex gloves
minimizes contamination risk. Whole body shielding minimized dose to
critical organs. Caution in moving heavy lead doors as fingers could get
caught.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>3</td>
<td colspan="3">2</td>
<td colspan="2">24</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Collect product cut from HPLC and evaporate
solvent.</td>
<td>Radiation exposure, chance of pinching hands/fingers in sliding lead
doors of hot cell</td>
<td colspan="4">This step requires opening the hot cell door sufficient
placing the lead glass portion between chemist and source to minimize
radiation exposure. Valves are located just within dispersible zone to
carry out this task. Proper PPE using gauntlets and double latex gloves
minimizes contamination risk. Whole body shielding minimized dose to
critical organs. Caution in moving heavy lead doors as fingers could get
caught.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>3</td>
<td colspan="3">2</td>
<td colspan="2">24</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Remove round bottom flask from rotary evaporator and
reformulate tracer with saline.</td>
<td>Radiation exposure, chance of pinching hands/fingers in sliding lead
doors of hot cell</td>
<td colspan="4">This step requires opening the hot cell door sufficient
placing the lead glass portion between chemist and source to minimize
radiation exposure. Proper PPE using gauntlets and double latex gloves
minimizes contamination risk. Whole body shielding minimized dose to
critical organs. Caution in moving heavy lead doors as fingers could get
caught.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>3</td>
<td colspan="3">2</td>
<td colspan="2">24</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Millipore filtration of radioactive formulation</td>
<td>Radiation exposure, chance of pinching hands/fingers in sliding lead
doors of hot cell. Potential for needle prick when removing Millipore
filters from MIV. Chemical hazards are not significant due to the minute
amounts of substrate and solvent used for ultra-micro scale
syntheses.</td>
<td colspan="4">This step requires opening the hot cell door sufficient
placing the lead glass portion between chemist and source to minimize
radiation exposure. Proper PPE using gauntlets and double latex gloves
minimizes contamination risk. Whole body shielding minimized dose to
critical organs. Caution in moving heavy lead doors as fingers could get
caught. Remove filters and needle attachments by grasping firmly just
below the filter on the plastic part of the needle.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>3</td>
<td colspan="3">2</td>
<td colspan="2">24</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="2">Quality assurance testing of radiotracer. Small aliquot
of tracer removed and placed in small shielded vial for follow up
radioanalytical tests (including radio TLC and radio HPLC)</td>
<td>Radiation exposure, chance of pinching hands/fingers in sliding lead
doors of hot cell. Shielded lead container with QC sample is taken to
dispersible bench for final workup. Chance of dropping lead container.
Chances of contamination.</td>
<td colspan="4">Ensure tops to lead container are properly affixed
before it is transferred to another dispersible zone. Be alert to trip
hazards when working around the lab space (ex. risers in front of hot
cells). Don fresh PPE when moving source to other zones for work up.
Frisk frequently to avoid spread of contamination. Rinse contaminated
HPLC injection syringes with the needle portion submerged under solvent.
The lead container is not heavy and does not present a risk of bone
fracture if it contacts foot on dropping.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>2</td>
<td colspan="3">3</td>
<td colspan="2">24</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="odd">
<td colspan="2">Transfer multi injection vial to transfer lead pig for
shipping to PET facility.</td>
<td>Radiation exposure, contamination.</td>
<td colspan="4">Wear proper PPE and frisk after procedures to avoid
spread of contamination.</td>
<td>N</td>
<td colspan="3">1</td>
<td colspan="3">4</td>
<td>1</td>
<td colspan="3">1</td>
<td colspan="2">4</td>
<td colspan="7"></td>
<td colspan="2"></td>
<td colspan="2"></td>
<td colspan="3"></td>
<td></td>
<td colspan="4"></td>
<td></td>
<td colspan="2"></td>
</tr>
<tr class="even">
<td colspan="42"><p>Further Description of Controls Added to Reduce
Risk:</p>
<p>See above</p></td>
</tr>
<tr class="odd">
<td>*Risk: 12</td>
<td colspan="3">0 to 20</td>
<td colspan="6">21 to 40</td>
<td colspan="12">41-60</td>
<td colspan="8">61 to 80</td>
<td colspan="12">81 or greater</td>
</tr>
<tr class="even">
<td>negligible</td>
<td colspan="3">Negligible</td>
<td colspan="6">Acceptable</td>
<td colspan="12">Moderate</td>
<td colspan="8">Substantial</td>
<td colspan="12">Intolerable</td>
</tr>
</tbody>
</table>