U.S. Action Plan for AcrylamideActivities and Progress
Terry Troxell, Ph.D.and Lauren Posnick, Sc.D., U.S. FDA
March 16, 2003FAO/WHO Seminar on Acrylamide
in Food
Overview
• History and timetable
• The U.S. FDA Action Plan
• FDA data
History
• Swedish report, April 24, 2002
• Immediate worldwide attention
– Known neurotoxicant
– Potential carcinogen
– High levels, widespread in foods, formed
through traditional cooking practices
History
• Worldwide methods development and
testing efforts
– FDA/CFSAN method, June 20, 2002
• WHO/FAO consultation, June 25-27, 2002
History
• National and regional meetings on acrylamide• FDA
– Public meeting, September 2002
– Interagency research meeting, September 2002
– Food Advisory Committee Meetings in December 2002 and February 2003
• JIFSAN/NCFST October 2002 workshop
U.S. Response: Overview
• Developed method
• Tested a wide variety of foods
• Prepared exposure assessment
• Laid out plans for needed toxicology research
U.S. Response: Overview
• Conducting formation research and encouraging research by industry and academia
• Ultimate goal—a risk assessment incorporating new data that will provide scientific basis for appropriate risk management
Action Plan
• The Action Plan outlines FDA’s goals and planned actions on acrylamide in food over the next several years.
• FDA presented a Draft Action Plan at its September and December meetings.
• The plan was revised and presented to the Food Advisory Committee meeting in February.
Action Plan: Overall Goal
Through scientific investigation and risk management decision making, prevent and/or reduce potential risk of acrylamide in foods to the greatest extent feasible.
Action Plan: Major goals
• Develop rapid or inexpensive screening methods and validate confirmatory methods of analysis.
• Identify mechanisms responsible for the formation of acrylamide in foods and identify means to reduce acrylamide exposure.
Action Plan: Major goals
• Assess the dietary exposure of U.S. consumers to acrylamide by measuring acrylamide levels in various foods and estimating dietary exposure.
Action Plan: Major goals
• Characterize the potential risks and uncertainties associated with exposure to acrylamide in foods by assessing the available information, by expanding research into acrylamide toxicology to reduce uncertainty, and by performing a quantitative risk assessment with the new information.
Action Plan: Major goals
• Develop and foster public/private partnerships to gather scientific and technological information and data for assessing the human risk.
• Inform and educate consumers and processors about the potential risks associated with acrylamide throughout the assessment process and as knowledge is gained.
Action Plan: Major goals
• Provide all the essential elements for risk analysis, i.e., risk assessment, risk communication, and risk management.
Specific Action Areas
• Methodologies
• Research on Formation
• Measuring Exposure
• Toxicology and Health Effects
• Epidemiology
• Risk Assessment
• Meetings
• Inform and Educate the Public
• Further Actions
Action highlights
Measuring exposure
• Retail foods, gathered locally and nationally
• Total Diet Study foods
• Further testing as needed
• WHO/FAO Acrylamide Infonet data on U.S. consumers
Action highlights
Toxicology studies• Bioavailability
• Food versus water
• High-dose vs very low-dose exposures
• High-dose: P450 metabolism to carcinogen glycidamide
• Low dose: less glycidamide formed?
Action highlights
Toxicology studies• Adducts
• Hemoglobin adducts: biomarkers of exposure
• DNA adducts
Action highlights
Toxicology studies
• Chronic carcinogenicity studies (bioassay)
• Germ cell toxicity
• Neurotoxicity• Not cited as concern by WHO/FAO• More information useful
Action highlights
Epidemiology• Power available to detect small risks?• FDA will consider
• Occupational studies• Prospective cancer studies• Case-control cancer studies
Food survey progress
• About 400 food samples analyzed to date
• More than 35 different food types• More testing planned for future
Food survey progress
• Some foods have little or no acrylamide, such as infant formula, baby cereal, fish and chicken, and condensed and liquid milk.
• Other foods have acrylamide, but in variable amounts.
Examples of variability within selected food groups
ppb Acrylamide
0 200 400 600 800 1000 1200 1400
Fo
od
Ty
pe
s
Crackers
Cookies
Coffee
Cocoa
Chips
Chicken
Cereal
Bread
Baby Food
Almonds
Examples of variability within selected food groups
ppb Acrylamide
0 200 400 600 800 1000 1200 1400
Fo
od
Typ
e
Veg. canned
Soy Protein
Soup, Dried
Pretzels
Popcorn (Mw)
Peanut Butter
Fries (FF)
Fries (B)
Fish
Factors affecting acrylamide formation
• Food composition– Amino acids, sugars– pH – Moisture
• Processing conditions– Temperature– Time
Effect of temperature
Acrylamide levels in potato chips friedfor 4 minutes increased with frying
oil temperature.
160 °C 27 ppb
170 °C 70 ppb
180 °C326 ppb
Effect of time
Acrylamide levels in potato chips fried at 180 oC increased with frying time.
3.5 m12 ppb
4 m46 ppb
4.5 m227 ppb
5 m973 ppb
Consumer cooking and time
(4885 ppb)(1326 ppb)
(11 ppb)( 0 ppb)
Data summary
• FDA has measured acrylamide in a wide range of products.
• Acrylamide was detected in a variety of foods and at a variety of levels.
• In some foods, no acrylamide was detected.
Data summary
• FDA has found variability between food categories and within food categories, as well as between different brands.
• The variability in levels of acrylamide in similar foods suggests that there are ways to make products that will minimize acrylamide formation.
Consumer message
• FDA’s current dietary message for acrylamide is to: “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.”
• The FDA believes there are not enough scientific data to justify changing the message at this time.
Presentation summary
• Reviewed timetable of events leading up to development of FDA’s Action Plan for acrylamide in food.
• Reviewed goals and key action points in the Action Plan.
• Reviewed data from FDA’s survey of acrylamide levels in food and preliminary formation work.
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