Allen Rudman, Ph.D.
Acting Director
Senior Science and Policy Staff
Office of Food Additive Safety, CFSAN
June 14, 2012
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Food Additives
◦ Exposure is intentional
◦ Exposure can usually be controlled
◦ Approval contingent on adequate information from
manufacturer
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Contaminants
◦ Exposure is normally unintentional
◦ Exposure is usually difficult to control
◦ Limits may be set using available information
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1. Oversee Total Dietary Survey Program
2. Oversee Toxic Elements Program
3. Provide dietary exposure and
consumption estimates
4. Perform health assessments and risk
assessments on chemical hazards
5. Develop scientific guidance
6. Represent CFSAN at public, regulatory,
and international meetings
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One of the oldest programs in FDA - 1961
Monitors for radioactive contamination,
pesticide residues, industrial chemicals, and
toxic elements.
Foods are prepared as they would be
consumed
Revised periodically (about every 10 years) to
reflect changing dietary patterns
Each food composite is analyzed for:
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Pesticide residues (>300)
Industrial chemicals (PCBs, perchlorate)
Radionuclides (13)
Elements (4 toxic, 14 nutrient)
Dioxin (since 1999); acrylamide (2003-06);
furan (since 2004)
Analytes:
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Pesticides
◦ organochlorine, organophosphorus, N-methylcarbamates, chlorophenoxy
acids, pyrethroids, organosulfur, EBDCs and ethylenethiourea, substituted,
benomyl, carbendazim, and thiabendazole
Industrial Chemicals
◦ Polychlorinated biphenyls, volatile organic compounds
Elements
◦ Arsenic, cadmium, calcium, copper, iron, iodine, lead, magnesium,
mercury, nickel, phosphorus, potassium, selenium, sodium, zinc
Radionuclides
◦ Americium-241, barium-140, cesium-134, cobolt-60, iodine-131,
lanthanum-140, potassium-40, radium-226, ruthenium-103, strontium90, thorium-232
100
90
Lead (µg/day)
80
70
60
50
40
30
20
10
0
TDS revision
TDS revision
2 yr
6 yr
10 yr
14-16 Male
25-30 Male
Year
25-30 Female
7
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Codex Committee on Contaminants in
Foods (CCCF)
 to support FDA’s position on
international food standards
Joint FAO/WHO Expert Committee on Food
Additives (JECFA)
 for conducting international food
safety/risk assessments for
contaminants
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Objectives of the program are:
 To generate information on the concentration
of toxic elements in selected foods
 To estimate dietary exposure of those
elements, particularly for sensitive
populations
 To identify the major dietary sources of those
contaminants
 Aid CFSAN in directing its efforts to reduce
those levels
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TEP monitors foods of current interest
Updated routinely
Major dietary sources of certain toxic elements.
◦ Exposure to lead from certain candies
◦ Led FDA to propose guidance on recommended
maximum levels for lead in candy.
◦ Exposure to toxic elements that have been found
to accumulate in certain aquatic organisms.
Monitor levels of specified toxic elements in
specific foods
Estimate dietary exposure to these contaminants
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TEP is overseen by the Chemical Hazard
Assessment Group (CHAT) in OFS in collaboration
with the other Divisions and Offices
It covers both imported and domestic foods
◦ Appx. 450-500 each
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Includes foods such as seasonings, flour,
mushrooms, onions, bakery goods, candy, fruits,
juices and various types of seafoods
Provides expertise in the evaluation of toxic
chemicals in foods for The Joint Food and
Agriculture Organization of the United Nations
(FAO)/World Health Organization (WHO) Expert
Committee on Food Additives (JECFA)
Contaminants Examined
 Elements
◦ Arsenic, Cadmium, Lead, Mercury
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Mycotoxins
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Chlorinated Hydrocarbons
◦ Aflatoxin, Dioxynivalenol, Fumonisin, Patulin,
Zearalenone
◦ Dioxins, PCBs
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Heat-Generated Toxicants
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Naturally Occurring Toxicants
◦ Acrylamide, PAHs
◦ Cyanide, Methanol, Saxitoxins
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Essential part of Chemical Hazard
Assessment
Provides consumption estimates need for
health hazard and risk assessments
Ability to supply consumption estimates by
age ranges and various other attributes
Analyses using CSFII or NHANES data
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Dietary intake = analyte concentrations x
amount of food consumed
Where:
 Concentrations based on analytical results
 Consumption amounts based on:
◦ TDS diets
◦ Proprietary software
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Evaluation of potential health hazards present
in food
Response to chemical issues as they arise
(e.g. oil spills)
Samples often analyzed by ORA
Contaminants are not limited
Makes recommendations on whether foods
are adulterated or would pose a health
concern
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Dose-response modeling and health hazard
assessments for major contaminants
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Dose response modeling of mercury in fish
Dose response modeling of arsenic in apple juice
Arsenic contamination levels in various foods
Lead levels in various foods
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Development of Limits and Action Levels
◦ Pear Juice Limit of Concern (LOC)
◦ Apple Juice Action Level – ongoing
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Collaboration with WHO and FAO on reports
and evaluations concerned with contaminants
in food.
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Representative on NCTR/NTP TSSRC Interagency
Committee
Book chapter contribution Risk assessment on
Mercury, Encyclopedia of Food Safety (FOSA),
2012 (In press).
Toxicology monograph on Arsenic, Safety
evaluation of certain contaminants in food. WHO
Food Additives Series No. 63, 2011.
Toxicology monograph on Lead, Safety
evaluation of certain food additives and
contaminants. WHO Food Additives Series No. 64,
2011.
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Sue Anne Assimon
Clark Carrington
Katie Egan
Kiros Hailemariam
Clarence Murray
Parviz Rabbani
Shyy Hwa “Shirley” Tao
Janet Zang
Nega Beru