FDA Action Plan for Acrylamide in Food: Update on Activities

1
FDA Action Plan for Acrylamide in Food Update
on Activities

• Lauren Posnick Robin, Sc.D.
• FDA/CFSAN
• 2005 Toxicology Forum Summer Meeting
• July 11, 2005

2
Background

• First report, Sweden, April 2002
• Neurotoxicant and potential human carcinogen
• Found in a wide range of foods, including dietary
  staples
• Formed through traditional cooking methods
• During food processing and at home
• From nutrients in food (asparagine and reducing
  sugars)

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FDA Action Plan for Acrylamide in Food

• Draft Action Plan for Acrylamide, September 2002
• Revised version, Food Advisory Committee,
  February 2003
• Final scheduled revision, March 2004
• Acrylamide information page http//www.cfsan.fda.
  gov/lrd/pestadd.htmlacrylamide

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Specific Action Areas

• Methodologies
• Research on Formation
• Measuring Exposure
• Toxicology and Health Effects

• Epidemiology
• Risk Assessment
• Meetings
• Inform and Educate the Public
• Further Actions

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Methodologies

• LC/MS/MS method posted on CFSAN website in June
  2002 updated July 2002 and February 2003
• FDA published studies on acrylamide measurement
  methodology and on acrylamide measurement in
  coffee samples in 2003 and 2004.
• Steven Musser, John Roach, Martha Gay, Dennis
  Andrzejewski, David Nortrup

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Methodologies

• Goal Evaluate screening methodologies for more
  rapid or less expensive detection of acrylamide
  in the food supply.
• HPLC/fluorescence method
• HPLC 2-step post column reaction fluorescence
  detection of substituted isoindole
• LOD 10 ppb
• Mixed success in foods matrix dependent
• Need to identify internal standard
• May be useful for small producers to monitor
  processes
• Greg Noonan, Tim Begley, Charles Warner, Greg
  Diachenko

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Research on Formation

• FDA/NCFST Effects of Consumer Food Preparation
  on Acrylamide Formation
• Lauren S. Jackson, Fadwa Al-Taher, Joe Jablonski
• Project objectives
• Study the effects of cooking conditions (e.g.
  time and temperature) on acrylamide formation in
  a variety of consumer-prepared foods
• Measure the degree of correlation between degree
  of browning and acrylamide levels in a variety of
  foods
• Identify methods for reducing acrylamide
  formation in home-prepared food

8
Research on Formation

• Selected major findings
• Toasting
• Dark toasting resulted in low to moderate
  acrylamide formation in most breads.
• Light toasting results in little increase in
  acrylamide formation.
• Scraping toast to remove browned surface reduces
  acrylamide levels.

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Research on Formation
10
Research on Formation
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Research on Formation

• Selected Findings
• French Fries
• Acrylamide levels increased with increasing
  frying times and temperatures.
• Acrylamide levels increased with degree of
  browning.
• Brown color, as measured by L and a values,
  correlated highly with acrylamide levels.

262 ppb
76 ppb
45 ppb
515 ppb
866 ppb
1512 ppb
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Research on Formation

• Selected major findings
• French fries
• Rinsing/soaking fresh-cut fries before frying
  (e.g., in NaCl, vinegar, lemon juice) reduced
  acrylamide.
• Potato storage from 6 - 8 C increased acrylamide
  formation in fries storage at room temperature
  decreased acrylamide formation.
• Frying oil type and reuse did not affect
  acrylamide formation.

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Research on Formation

• Selected major findings
• Browning
• Degree of browning can be used as an indicator of
  acrylamide formation during cooking or
  processing.
• Cooking foods to the same degree of doneness as
  indicated by the degree of browning may result in
  similar levels of acrylamide formation.

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Measuring Exposure

• Goal Determine exposure of U.S. consumers to
  acrylamide from food
• In June 2005, FDA released new data on acrylamide
  levels in food
• Four hundred samples from FDAs Total Diet Study
  (TDS) for FY04
• Almost 500 targeted samples (through
  JIFSAN-Covance contract)
• Samples now total over 2100
• Many foods from restaurants/take-out stores
  Asian, Hispanic, and Southern cuisines
• 54 new infant formula samplesno detectable
  acrylamide

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Measuring Exposure

• Laboratory analysis
• CFSAN analytical staff
• Kansas City Marvin Hopper, Ron Luchtefeld, Pat
  Wisor
• Covance
• Exposure assessment
• Michael DiNovi and Donna R. Howard
• Update
• Based on CSFII 1994-1996, 1998 intake survey
• For ages 2

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Top 20 Foods by Mean Acrylamide Intake
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Top Eight Foods by AcrylamidePer Portion
Portion Sizes From 21 CFR 101.12, Table 2
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Exposure Summary

• Original crude estimates, 2002
• 0.7 µg/kg-bw-d
• 0.3-0.8 µg/kg-bw-d
• First FDA model, 2003
• 0.4 µg/kg-bw-d
• Updated FDA model, 2004
• 0.4 µg/kg-bw-d
• Updated FDA model, 2005
• 0.4 µg/kg-bw-d

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Toxicology

• FDAs National Center for Toxicological Research
  is carrying out a comprehensive suite of
  toxicology studies on acrylamide and glycidamide.
• Hemoglobin and DNA adducts
• Toxicokinetics
• In vivo mutagenicity
• Carcinogenicity bioassays
• Neurotoxicity

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Toxicology

• At least nine studies from NCTR published or in
  press since 2002 on acrylamide toxicology
• Data used in recent assessment by the Joint
  Expert Committee on Food Additives and
  Contaminants (JECFA)
• Ultimately, data will be used in FDA risk
  assessment

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Epidemiology

• CDC/NCEH monitoring acrylamide- and glycidamide
  hemoglobin adducts in NHANES
• CDC/NCEH hemoglobin adduct/feeding study
• NCTR may participate in expanded study to relate
  Hb adducts to DNA adducts
• Review of epidemiology studies for JIFSAN, JECFA,
  CCFAC

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Meetings

• Goal Participate in/convene meetings to gather
  public and expert input and foster coordination
  of efforts
• Public meeting, September 2002
• Food Advisory Committee/Subcommittee, December
  2002 and March 2003
• Interagency meetings, September 2002, February
  2004
• JIFSAN Acrylamide Workshops, October 2003, April
  2004

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Meetings

• 64th JECFA, February 2005
• FDA experts participated
• U.S. toxicology and exposure assessment data
  incorporated
• JECFA concluded that acrylamide may be a human
  health concern based on Margin of Exposure (MOE).

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Meetings

• JECFA recommendations consistent with FDA
  approach to acrylamide
• Reevaluate when ongoing carcinogenicity and
  long-term neurotoxicity studies are available
• Continue work on toxicology modeling
• Continue appropriate efforts to reduce acrylamide
  concentrations in food and
• Encourage accumulation of scientific data on
  acrylamide in foods in developing countries.

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Meetings

• 37th Meeting, Codex Committee on Food Additives
  and Contaminants (CCFAC), April 2005
• US (FDA) co-lead with UK on Discussion Paper on
  Acrylamide
• Initial version presented in 2004, revised
  version presented in 2005
• Formation and mitigation section
• Third version planned for 2006 meeting, to
  include outline of Code of Practice

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Inform and Educate the Public

• Sharing information through meetings, web
  postings, FDA Consumer article
• Dietary message Eat a balanced diet, choosing a
  variety of foods that are low in trans fat and
  saturated fat, and rich in high-fiber grains,
  fruits, and vegetables.
• Advice must be carefully constructed to avoid
  greater risks, such as undercooking or neglecting
  important dietary staples.
• FDA is considering developing consumer/retail
  information on ways to reduce exposure.

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Next Steps

• Continue toxicology research, including PB/PK
  model
• Currently collecting and analyzing Total Diet
  Study (TDS) samples for FY05
• For FYO6 and beyond, monitor one TDS market
  basket on a rotating basis
• Consumer information
• CCFAC Discussion Paper
• Publish methodology, mitigation studies