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Public Health Impacts of Substances Detected at Low Levels in Food:
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A Workable Approach to Risk Management Decisions
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<= b>Richard Lane
<= b>Unilever
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<= b>JIFSAN Workshop
<= b>June 4-6, 2007
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2
Impetus for Creating a Tool
R= 26;There are more and more low-level detections of substances in foods
&= #8211;Many lead to recalls or other product actions
R= 26;Many detected substances are poorly characterized from a toxicological perspective
–Lack of knowledge may lead to misallocation of resources and inappropriate responses
&#= 8226;Fear of the presence and assumed hazard of the substance, not from any health risk
•
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Impetus for Creating a Tool
R= 26;There are a number of papers in the literature explaining = how to address low-level exposures. 
R= 26;There are accepted regulatory approaches in place that deal with some low-level exposures. 
&= #8211;Threshold of Regulation
&= #8211;Action Levels, Tolerances
– <= /div>
R= 26;Some low-level detections result in problems while similar ones do not.  Something is not connecting…
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Impetus for Creating a Tool
&#= 8226;The future does not look much better
&= #8211;Chemists will continue to find smaller amounts in more foods
–Animal testing is under pressure, so less toxicology data will be generated
&= #8211;Resources for analysis and action will remain limited
&= #8211;Pressure to act quickly will continue to increase
• <= /div>
̶= 6;We need to find a way to avoid chasing after each “discovery&#= 8221; of a low level of a substance as if it is a problem.
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Technical Committee on Food & Chemical Safety<= /span>
R= 26;Saw the need to expand the understanding that most low-level exposures are not significant public health issues in order to cover mo= re substances being found in food, and do it in such a way that is reasonably simple understand and can be generally accepted.  
&#= 8211;Transparent and widely accepted concept and common process
&= #8226;To bridge the gap between science and actions
&= #8226;To give credibility to safety determinations based on exposure
&= #8211;Not intended to create something completely new
&= #8226;Based on peer-reviewed science and methods in the open literature
–
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Technical Committee on Food & Chemical Safety<= /span>
&#= 8226;Preparing a draft paper outlining such an approach.=  
&#= 8211;Not unlike the work done by ILSI Europe (Barlow et al., 2001;  Kroes et al., 2004), but recommend a simpler method.  =
&= #8211;Still under construction
&= #8211;Once finalized, the approach will be reviewed and published
R= 26;Plan to disseminate the approach broadly with the help of GMA, IFIC, and others.  =
= 211;Want a common view that the TTC can be used in many situations of low-level exposure
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Technical Committee on Food & Chemical Safety&= #8217;s Findings
R= 26;There is a rich literature supporting the threshold of = toxicological concern (TTC) as a sound scientific concept and this can be a useful approach to prudently handle low-level exposures.
&= #8211;Reviewed 20 or so papers
&= #8226;All stress its inherent conservatism
&#= 8226;In particular, Kroes et al. (2004) very thoroughly compile the current thinking about TTC
&#= 8211;Found nothing refuting the concept, the methods used, or the levels determined. 
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Threshold of Toxicological = Concern
&#= 8226;A 500-year-old concept
&= #8211;Paracelsus (c. 1508)
&#= 8226;A 50-year quest to apply it broadly
&#= 8211;First mentioned by Ben Oser on behalf of the IOM’s FPC (1958) <= /div>
&#= 8211;Many approaches using different toxicology data and (publications fr= om 1967-2007)
&= #8211;FDA’s Threshold of Regulation (1995)
&= #8211;JECFA for flavoring substances (1997)
&= #8211;ILSI Europe workshops (1999, 2003)
&= #8211;British Toxicology Society annual congress (2007)
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