1. Chemical Risk Assessment & Exposure Monitoring Quantitative Risk Assessment Revision December 2010 - Information provided subject to the 'Conditions for Sharing Materials and Advice' -

2. 2 Objective n At the end of this training session you will know: –What & when exposure monitoring in required. –Where to sample. –How long to monitor for. –How & when to use the Brief and Scala method for adjusting to different shift patterns when monitoring. –What the appropriate standards to compare against are

3. 3 Exposure Monitoring Plan As a result of the QEA, Exposure Monitoring Priorities are established, that include: n All areas/tasks that require sampling. –The type of sampling to be conducted u Personal exposure sampling during activity –Full Shift if appropriate –Task (partial shift) u STEL if applicable u General area u Wipe samples if applicable –Sampling frequency - based on Exposure Severity Rating

4. 4 Exposure Monitoring Plans n Basline sampling plan is –A schedule outlining the industrial hygiene sampling surveys to be performed, according to the qualitative exposure assessment. n Periodic sampling plan is –A schedule outlining the on-going sampling surveys to be performed, based on sampling results obtained in the baseline survey, and the possible health effects from exposure to the agent. n These sampling plans determine what needs to be monitored and when.

5. 5 Exposure Monitoring priorities Following the QEA the SEG/ Job titles /activities are risk ranked and the monitoring priorities are determined based on the severity of the risk ranking: Priority Monitor Extreme ASAP - begin engineering controls immediately High sample next - within 3 months Medium sample next - ideally within 3-6 months Low No need to sample Except if : PBOEL 3B or 4 Acute toxicants Known Human carcinogens ideally sample within 12 months. Remark December 2010: The approach described in this slide is no longer applied in J&J at this time and must be considered to be an example only

6. 6 Monitoring following modifications / changes n When changes or modifications are made to the process that could adversely affect employee exposure levels:  Monitoring should be conducted prior to restart n If this is not possible monitoring must be completed within 30 days of restart.

7. 7 Example sampling Plan: Chemical Production Geel Processes Available Sampling methods IH critical activities PBOEL/API Current status baseline sampling Reference IH reports

8. 8 Personal monitoring n When carying out personal monitoring to determine exposures the following criteria should be met: –Random selection of employees with each SEG to be sampled –Personal sampling should be conducted outside of respiratory protective equipment. –Personal sampling should be conducted for an eight-hour shift or the entire period of time the employee has exposure to the agent. –Sampling results for periods of time less than an eight-hour shift should be reported both for the period of time sampled as well as the 8-hour time-weighted average.

9. 9 Area Samples n General Area sampling may be used to supplement personal sampling but should not be used as a substitute for personal sampling without justification. n General Area sampling can also be used to verify effectiveness of engineering controls or as “diagnostic” sampling to determine the point where a contaminant is released from a process or piece of equipment.

10. 10 Personal Monitoring n Sampling results for periods of time greater than an eight-hour shift should be compared to an adjusted OEL, using the Brief and Scala model. n Short-term sampling should be conducted when the agent has a “ceiling” or “short-term exposure limit.” n When the effects of different agents are additive, the combined effect of the agents should be calculated.

11. 11 BRIEF AND SCALA MODEL n Repeated exposures during longer workdays may, in some cases, stress the bodies detoxification mechanisms. n In a 12-hour workday: –The period of exposure to toxicants is 50% greater than in the standard 8-hour workday, –The period of recovery between exposures is shortened by 25%, or from 16 to 12 hours. n The Brief & Scala reduction method is used to provide a reduction factor for OELs when exposures exceed 8 hours.

12. BRIEF AND SCALA MODEL calculations The reduction factor (RF) is calculated as follows: Where, S = hours per standard shift (8-hour shift) h = hours worked per day for extended shift R = recovery period, in hours, standard shift (R = 24 -8 = 16) RF = Exposure Limit Reduction Factor THUS, FOR A 12-HOUR WORKSHIFT

13. 13 Multiple samples 8-hr TWA 7+ hour sample, or Calculate the employee's 8-hr TWA using the following formula: If multiple samples were collected for the same analyte, from the same employee, for different tasks, the 8-hr TWA is calculated using the following formula:

14. 14 Additive effects n If employees are exposed during the same shift to several compounds that have similar toxicological effects, exposures are considered to be "additive"; and exposure should be calculated using the following formula: n If the equation results in > 1, the exposure limit for the mixture has been exceeded.

15. 15 Short Term Exposure Limit (STEL) n The airborne concentration of substance that should not be exceeded during any 15-minute portion of a shift. n Sample time should be 15 minutes, if task is longer collect several samples. n STEL cannot be exceeded more than 3 times in one day. n There should be at least 60 minutes between successive exposures in this range

16. 16 Ceiling Limit (C)  The airborne concentration of substance that should not be exceeded at any time during the shift.

17. 17 Excursion Limit n Excursion Limit – apply to those TLV-TWAs that do not have a STEL. n EL can be exceeded no more than 30 minutes per shift. n EL = 3 times the TLV-TWA, provided the TLV-TWA is not exceeded. n Exposure can never exceed 5 times the TLV-TWA

18. 18 Statistical Requirements n Statistical tools should be applied to determine 95% confidence of sample results when data set is sufficient. n To achieve 95% confidence 6 samples should be collected at each unit operation. Remark December 2010: Using the Bayesian tool, we are happy with at least 3 samples

19. 19 Exposure limits n Applicable OELs to consider prior to sampling –8-hr TWA u -(ACGIH TLV, J&J OEL, local OEL - which ever is lower) –STEL - 15 minute TWA –Ceiling Limit –Excursion Limit n Exposure monitoring results are to be compared to the applicable limit to ensure employee exposures are controlled. n Where exposure exceeds the OEL appropriate management action plans need to be developed to bring activity within control.

20. 20 Recap n The QEA results in the EMP which outlines the areas/tasks that require sampling. –The type of sampling to be conducted u Personal exposure sampling –Full Shift if or –Task (partial shift) u STEL if applicable u General area u Wipe samples if applicable –Sampling frequency - based on Exposure Severity Rating –Personal sampling to be carried out outside of RPE. n Brief and Scala calculation is used when shift patterns vary form an 8hr shift. n Additive effects to be considered n Exposure monitoring results are to be compared to the applicable limit to ensure employee exposures are controlled, if exceeded a corrective action plan is needed.