1. Implications of the Current State of Scientific Knowledge David W K Acheson, M.D. Center for Food Safety and Applied Nutrition U.S. Food and Drug Administration

2. Overview Current areas of scientific interest What do we know about the impact of current knowledge on health risks? Should the consumer message be altered based on the current state of knowledge?

3. Overall Goal Through scientific investigation and risk management decision making, prevent and/or reduce potential risk of acrylamide in foods to the greatest possible extent. Sub goal: Inform and educate consumers and processors about the potential risks throughout the assessment process and as knowledge is gained.

4. Consumers may have questions Will eating certain types of food cause cancer? What is safe to eat? Should I stop eating certain types of food? Should I be cooking foods differently? What should I be doing differently to protect myself and family?

5. Current consumer message Eat a balanced diet that heeds the advice in the dietary guidelines. Should this be any different based on current scientific knowledge?

6. Current areas of scientific interest Acrylamide formation –Ways to diminish formation Levels of acrylamide in food Dietary intake of various foods Exposure assessment Epidemiology –Impacts of exposure to acrylamide on human health

7. Implications Understanding formation, and developing mitigation strategies could lead to a reduction in levels. Key need is to understand the health implications of exposure from these levels.

8. Exposure assessment Based on the analyses to date a relatively small number of foods contribute the most to the total daily acrylamide exposure. Mean acrylamide exposure is in the range of 0.3- 0.5  g/kg/day.

9. Exposure assessment Wide range of exposure depending on diet. –Generally diets high in certain types of food (fries, chips, etc.) will have higher acrylamide intakes than diets of equivalent caloric intake that are lower in those types of foods. –100 calories of raw apple < acrylamide than 100 calories of “over baked” fries Does this level of acrylamide intake have an impact on health?

10. Understanding the risk from acrylamide in food to human health is a key need. Neurological consequences Effects on germ cells Role as a potential carcinogen

11. Evidence to indicate that the known levels of exposure to acrylamide in food are harmful to health. Animal studies –mg/kg range. Human dosing studies, single dose for kinetics –data not yet available Human epidemiological studies –Occupational exposure – no links with cancer –Exposure via food – one study

12. Human epidemiological studies Factors to consider: –Dose –Length of exposure –Age –Genetic susceptibility –Synergistic factors –Types of tumors

13. Human epidemiological study [British Journal of Cancer 2003; 88: 84-89] Purpose: To analyze data from a population-based control study in Sweden to investigate whether higher intake of certain food items with higher acrylamide content increases the risk of large bowel, bladder or kidney cancer.

14. Human epidemiological study [British Journal of Cancer 2003; 88: 84-89] 538 Controls 591 cases of large bowel cancer 263 cases of bladder cancer 133 cases of kidney cancer. Dietary consumption of certain foods in prior 5 years via questionnaire. Most “high-acrylamide” foods included in questions

15. Human epidemiological study [British Journal of Cancer 2003; 88: 84-89] Data stratified by acrylamide exposure into quartiles. Authors concluded: No positive association between dietary exposure to acrylamide and risks of bowel, bladder or kidney cancer.

16. Human epidemiological study [British Journal of Cancer 2003; 88: 84-89] BUT: Limited sample size Not all acrylamide containing foods captured Only looked at selected cancers

17. Current Implications Strength of the link between animal toxicity (mg/kg) with human exposure (  g/kg) Human data indicating that this level of exposure poses a significant health risk is lacking Consumptions of certain types of food will increase exposure to acrylamide What should the advice be to consumers?

18. Risk Management We do not want to create one problem by solving another. Maintaining objectivity and a balance is critical.

19. Consumer advice – follow dietary guidelines Choose a variety of grains daily, especially whole grains. Choose a variety of fruits and vegetables daily. Choose a diet that is low in saturated fat and cholesterol and moderate in total fat. Choose a diet moderate in sugars. Choose and prepare foods with less salt. Aim for a healthy weight. Be physically active each day.

20. Toward the future FDA will review the consumer message as new information is obtained during implementation of the action plan. –Methods to reduce levels By industry At home –Better understanding of the risk to human health