Acrylamide testing at CFSANExploratory survey results

Lauren M. Posnick, Sc.D.

Public Meeting

September 30, 2002

Outline• Goals of exploratory testing program

• CFSAN method for acrylamide analysis

• Exploratory testing and overall sampling

strategy

• Results of testing to date

• Summary

Goals of exploratory acrylamide testing program

• Initial survey of levels of acrylamide in U.S. foods

• Identify the types of foods that need to be examined in the future

CFSAN acrylamide method

• CFSAN method developed byDr. Steven Musser and colleagues

• Liquid chromatography/tandem mass spectrometry method (LC/MS/MS)

• Method posted on CFSAN website June 20 and updated July 23

CFSAN acrylamide method

• Limit of quantitation (LOQ):– 10 parts per billion (ppb)

• Validation process ongoing– Single-lab validation being completed– Interlaboratory validations being planned– International proficiency testing study

• 33 international laboratories• FDA value within 3.5% of “assigned” value

How did we select samples:Overall Sampling Strategy

1. Starting point

– Foods identified previously

– Determine results for US foods

2. Expand sampling set based on:

– Wide breadth of foods

– Mechanistic insights

– Consumption rates

Overall sampling strategy for U.S. foods

3. Evaluate variability in foods

4. Evaluate exposure in Total Diet Study samples

Where we are now

• FDA is now partway through sampling strategy– Confirmation, breadth, mechanisms

• More than 150 food products

• About 500 analyses

Categories tested• Baby foods• Canned vegetables• Cereals• Chocolate products• Coffee• Cookies• Crackers• French fries

• Gravies and seasonings• Infant formulas• Miscellaneous• Nuts/nut butters• Potato chips• Protein foods

– Meat, Fish, Chicken, Soy• Snack foods (other)

Keep in mind . . .

• These data cover:– A limited number of food categories– A limited number of products in those

categories– A limited number of brands

• These data do not address:– Lot to lot variation– Unit to unit variation

Keep in mind . . .

• We consider the data an initial set of

data.

• We need to test more samples.

What’s in a level?

• Data on acrylamide levels alone do not indicate exposure or risk:

– How many grams of a food are in a serving?

– How much of this food do people eat?

What the graphs will show

• Acrylamide on the vertical axis

• Categories on the horizontal axis

• Each point is an individual result.

Sample graph

010203040506070

Acr

ylam

ide

(pp

b)

Categ

ory A

(4)

Categ

ory B

(3)

What the graphs will show• Some points will

overlap.• The number of

products is given after the category name.

• The categories are grouped on graphs by number of products tested.

Sample graph

010203040506070

Acr

ylam

ide

(pp

b)

Categ

ory A

(4)

Categ

ory B

(3)

What the graphs will show

• Detections below the LOQ of 10 ppb were graphed as 5.

• Non-detects were graphed as 0.

Sample graph

010203040506070

Acr

ylam

ide

(pp

b)

Categ

ory A

(4)

Categ

ory B

(3)

0

200

400

600

800

1000

1200

1400A

cryl

amid

e (p

pb

)

Acrylamide values by food category

Bread

s/ba

kery

(12)Pr

otei

n fo

ods

(12)In

fant

form

ulas

(12)Po

tato

chi

ps (1

6)

Baby

food

s (2

3)

Fren

ch fr

ies (1

6)

0

200

400

600

800

1000

1200A

cryl

amid

e (p

pb

)Acrylamide levels by food category

Cere

als (1

0)

Oth

. sna

cks (1

0)

Gra

v./sea

s. (9

)

Nut

s/bu

tter

s (7

)Cr

acke

rs (7

)

0

200

400

600

800

1000

1200A

cryl

amid

e (p

pb

)

Acrylamide values by food category

Choc

olat

e

(5) Co

okie

s (4

)

Cann

ed V

eg.

(5)

Misce

llane

ous

(5)

Groun

d co

ffee (3

)

Mechanistic research

• FDA is doing mechanistic research

– Time

– Temperature

– Ingredients

0

100

200

300

400

Acr

ylam

ide

(pp

b)

Additional cooking has variable effects on acrylamide levels in purchased bread products

No additionalcooking

Additionalcooking

Summary

• FDA has measured acrylamide levels in a broad range of products.

• Acrylamide was detected in a variety of foods and at a variety of levels. In some foods, no acrylamide was detected.

• We are finding variability between food categories, within food categories, and between different brands.

Conclusions

• We need to test more and different kinds of foods, as specified in the Action Plan.

• Research on mechanisms has begun.

• More mechanistic research is needed, as specified in the Action Plan.