Dietary Supplements Joint Committee Meeting May 20, 2007
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Transcript of Dietary Supplements Joint Committee Meeting May 20, 2007
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Dietary SupplementsJoint Committee
Meeting
May 20, 2007
Recommended Changes to Pass/Fail Criteria for Metal Contaminants
Clif McLellanDirector of Toxicology Services
NSF International
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Presentation Outline
• Review ballot submitted to change pass/fail criteria for cadmium, chromium and lead Background of current criteria and reason for change
– How were proposed criteria derived?– How are values calculated?– Current vs proposed levels– Impact of change for certified products
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Background of current criteria and reason for change
• The current pass/fail criteria were originally established in 2003. The criteria were chosen because;– it was felt that using international criteria would better reflect the
international focus of this program. – No data were available indicating the level of metal
contaminants that would be expected.
• Since 2003, the program has developed more as a North American Standard and it is now believed that the basis of the pass/fail criteria should be more reflective of North American Standards and be based on health effects endpoints whenever possible.
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How were proposed criteria derived (cadmium, chromium and lead)?
• A review was performed to determine the best human health risk assessment available for cadmium, chromium and lead.
• For cadmium and chromium the U.S. EPA risk assessments were determined to be the most current and used state-of-the art risk assessment procedures.
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How were proposed criteria set (Lead)?
• Since there is no current safe level set for lead an alternate approach was required which met the following criteria;– as low as was achievable based on current
test results– be more protective of sensitive sub
populations (children and pregnant women).
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How are the criteria calculated based on daily safe levels?
Finished Product
Criteria
Rfd (mg metal /kg-bw-day) * 60 kg-bw * RSC
--- mg metal / day
RSC = Relative Source Contribution = 0.1 (10% of daily acceptable level).
Lab evaluation
Lab result (mg metal / g product) * maximum recommended daily dose (g product / day)
---- mg metal /day
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How are the criteria calculated based on daily safe levels?
Raw Ingredient
Criteria
Rfd (mg metal /kg-bw-day) * 60 kg-bw * RSC * 1/AUL * Unit conversion
--- ug metal / g ingredient --- ppm
RSC = Relative Source Contribution = 0.1 (10% of daily acceptable level)
AUL = Assumed Use Level = 1000 mg ingredient
Unit Conversion = 106 ug metal / 1g metal
* Raw ingredients can be evaluated based upon a use level recommended by manufacturer
Lab evaluation
Lab result (ug metal / g ingredient) ---- ppm
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What other levels have been established (units - ug/day)?Cadmium Chromium VI Lead
CA-Prop 65 Repro 4.1 - 0.5
CA-Prop 65 Cancer - - 15
Canada NHPD 5.4 17.4 17.4
NSF Current 6 20 20
NSF Proposed 4.1 Commerce
(6)
20 0.5 and 15
US ATSDR 12 - - no threshold
US FDA- Shellfish 55 - 6, 25 and 75
EU-Foodstuff 60 - 214
WHO/JECFA 60 - 214 Adult
35 Child (10kg)
EPA - IRIS 60 40
based on Cr VI
- no threshold
FDA- Bottled Water
–Based on 2L
5 200 based on total chrome
10
EPA Water
– Based on 2L
5 200 based on total chrome
30
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Raw Materials - Current vs Proposed Levels
5.3.1.1 Raw materials – Current
Raw materials shall not contain undeclared metals in amounts greater than the following:
– cadmium content shall not exceed 0.3 ppm;– chromium (VI) content shall not exceed 2 ppm;– lead content shall not exceed 10 ppm; and
5.3.1.1 Raw materials – Proposed
Raw materials shall not contain undeclared inorganic metals in amounts greater than the following:
– cadmium content shall not exceed 4.1 ppm;– chromium (VI) content shall not exceed 20 ppm;– lead content shall not exceed 15 ppm; and
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Finished Products - Current vs Proposed Levels
5.3.1.2 Finished products – Current Finished products shall not contain undeclared metals at rates of intake greater than the following:
– cadmium content shall not exceed 0.006 mg/d;– chromium (VI) content shall not exceed 0.02 mg/d;– lead content shall not exceed 0.02 mg/d;
5.3.1.2 Finished products - ProposedFinished products shall not contain undeclared inorganic metals at rates of intake greater than the
following:
– cadmium content shall not exceed 0.0041 mg/d;– chromium (VI) content shall not exceed 0.02 mg/d;– lead content in products marketed for children or women shall not exceed 0.0005 mg/d; – lead content in all other products shall not exceed 0.015 mg/d; and
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Requested Action?
Ballot proposed levels for adoption to Dietary Supplement Standard for inorganic
cadmium, chromium VI and lead
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Basis for Current Criteria
ContaminantFinished Product Basis -
Level (mg/day)Raw Ingredient Basis -
Level (ppm)
Cadmium
Joint FAO/WHO Expert Committee on Food Additives Provisional Tolerated Weekly Intake for cadmium - 0.006 mg/day.
WHO Monographs on Selected medicinal plants - 0.3 ppm.
Chromium VI EPA Reference Dose - 0.02 mg/day. EPA Reference Dose - 2 ppm chromium w as derived.
Lead
Joint FAO/WHO Expert Committee on Food Additives Provisional Tolerated Weekly Intake for Lead - 0.02 mg/day.
WHO Monographs on Selected Medicinal Plants - 10 ppm.
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Relative Source Contribution
• Definition: A factor that is used to proportion the total acceptable level of a contaminant for a single source of exposure.
• If a proportion of the acceptable level for a contaminant is not considered, the compounding of exposure from various sources would result in an unacceptable daily exposure.
• Sources of exposure to consider: oral, dermal or inhalation.– For oral exposure consideration would be for water, food (various types)
and supplements.
• Example default source contributions are food (80%) and water (20%) when air sources are known to be minimal or insignificant.
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Source Contribution - How could you determine a source contribution for dietary supplements for a contaminant as a
proportion of total daily exposure?
• Weight? – Example: 2 g DS / 3 kg food +2 kg water = 0.04 %
• Volume? – Same result.
• Base it on exposure levels, when known?– Subtract each known source of exposure from the “safe” level.
» Safe level – oral – dermal – inhalation
Limitations: would you use averages? 90, 95, 99 percentile? Which population(s)? Are data available? The “safe” level for heavy metals is either “0” or very low.
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Source Contribution – Why did we use 10% ?
• Most risk values are good to one significant figure (chromium, cadmium and mercury) and 10% of the daily total would result in a numerically insignificant exposure.
• Other established source contributions are 80% food and 20% water, and we felt that dietary supplements should contribute less than the amount allowed for food and water while at the same time not be too restrictive.
• Contaminant levels should be set so they provide protection based on human
health endpoints.