1. Acrylamide testing at CFSAN Exploratory survey results Lauren M. Posnick, Sc.D. Public Meeting September 30, 2002

2. Outline Goals of exploratory testing program CFSAN method for acrylamide analysis Exploratory testing and overall sampling strategy Results of testing to date Summary

3. 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

4. CFSAN acrylamide method CFSAN method developed by Dr. Steven Musser and colleagues Liquid chromatography/tandem mass spectrometry method (LC/MS/MS) Method posted on CFSAN website June 20 and updated July 23

5. 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

6. 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

7. Overall sampling strategy for U.S. foods 3.Evaluate variability in foods 4.Evaluate exposure in Total Diet Study samples

8. Where we are now FDA is now partway through sampling strategy –Confirmation, breadth, mechanisms More than 150 food products About 500 analyses

9. 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)

10. 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

11. Keep in mind... We consider the data an initial set of data. We need to test more samples.

12. 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?

13. What the graphs will show Acrylamide on the vertical axis Categories on the horizontal axis Each point is an individual result. Sample graph 0 10 20 30 40 50 60 70 Acrylamide (ppb) Category A (4) Category B (3)

14. 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 0 10 20 30 40 50 60 70 Acrylamide (ppb) Category A (4) Category B (3)

15. What the graphs will show Detections below the LOQ of 10 ppb were graphed as 5. Non-detects were graphed as 0. Sample graph 0 10 20 30 40 50 60 70 Acrylamide (ppb) Category A (4) Category B (3)

16. 0 200 400 600 800 1000 1200 1400 Acrylamide (ppb) Acrylamide values by food category Breads/bakery (12) Protein foods (12) Infant formulas (12) Potato chips (16) Baby foods (23) French fries (16)

17. 0 200 400 600 800 1000 1200 Acrylamide (ppb) Acrylamide levels by food category Cereals (10) Oth. snacks (10) Grav./seas. (9) Nuts/butters (7) Crackers (7)

18. 0 200 400 600 800 1000 1200 Acrylamide (ppb) Acrylamide values by food category Chocolate (5) Cookies (4) Canned Veg. (5) Miscellaneous (5) Ground coffee (3)

19. Mechanistic research FDA is doing mechanistic research –Time –Temperature –Ingredients

20. 0 100 200 300 400 Acrylamide (ppb) Additional cooking has variable effects on acrylamide levels in purchased bread products No additional cooking Additional cooking

21. 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.

22. 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.