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.