Major Components of FDA’s Action Plan for Acrylamide Richard Canady, PhD DABT US Food and Drug Administration Center for Food Safety and Applied Nutrition Food Advisory Sub-Committee meeting December 4 and 5, 2002

Goal of this presentation Give the overall framework of the plan as an introduction to the detailed talks following

Overview of this presentation: Major components of the plan 1.Testing foods 2.Formation 3.Toxicology 4.Education 5.Meetings and collaborative projects

1. Testing foods: Methods development Develop and validate methods for analysis of acrylamide in food. Multiple methods for multiple needs FDA’s immediate need is developing occurrence and exposure data Future needs may include monitoring and enforcement

1. Testing foods: Goals and Approach for Occurrence Confirm occurrence in US foods Map the range of occurrence across foods to inform formation research and exposure sampling needs Describe variation across foods and within food types to inform formation research and exposure sampling needs

1. Testing foods: Goals for exposure assessment Determine exposure to acrylamide via food to use in risk characterization and to monitor changes in exposures over time (multiple evaluations)

1. Testing foods: Approach for exposure assessment Occurrence data to be used for exposure assessment FDA Total Diet Study FDA Exploratory Survey Other as appropriate Additional sampling Sample analyses by others Exposure will also be evaluated using biomarkers Collaboration with CDC National Health and Examination Survey (NHANES) Studies outside of NHANES

1.Testing foods: Sampling level Exploratory survey ~600 food samples planned for initial iteration (about one half done) More as needed Additional results (~4000) expected from other national governments and industry TDS samples ~1000 samples planned for FY03

Sampling design - Iterative process Decision needs and knowledge define sampling approach Current iteration is to define the scope of the problem Decision need is “where to sample” Knowledge builds with each set of results As scope is better understood, the decision needs and sampling will be defined by our risk management options

Scope definition endpoints Sample to diminishing return across foods Reasonably exhaustive coverage of food types Use knowledge of food chemistry and processing Ensure coverage of high consumption foods Sample to adequate definition of variability within foods Greater variability means more samples needed Formation knowledge will help define adequate sample size too

2. Acrylamide formation: Goals and approach Understand conditions leading to acrylamide formation in food and develop methods to prevent or reduce. Without incurring other risks? Process evaluation Time, temperature, methods Chemistry evaluation Ingredients, reactions Removal as well as formation

2. Acrylamide formation: Leveraging with consortia National Center for Food Safety and Technology (NCFST) and CFSAN are investigating: Mechanisms of acrylamide formation Processes for reducing formation FDA is working with the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) to foster Data needs discussions and data sharing relevant to formation mechanism and effects of processing Both consortia provide conduits to and participation with academic, other government, and industry research efforts

3. Toxicology: Goals and approach Examine the likelihood that adverse health effects are caused by exposure to acrylamide-containing foods. Identify data gaps regarding what effects might occur in humans Identify key factors affecting uncertainty about dose- response and what we can do to reduce the uncertainty Sponsor, coordinate, encourage, research and analysis to reduce uncertainty and fill data gaps

4. Education FDA will develop educational material to Inform and educate consumers and food industry about the potential risks of acrylamide in foods And, as knowledge is gained, provide options on how to reduce the risks FDA will solicit participation by stakeholders in the framing of the messages

5. Meetings and collaborative projects Worldwide interest and participation Collaboration and communication essential to getting the most done in the least time Data needs meetings WHO/FAO acrylamide food information network Interagency workgroups Consortia

5. Meetings and collaborative projects WHO/FAO consultation June 2002 Federal interagency roundtable, September 24, 2002 Workgroups forming for specific functions European Union Inter-laboratory collaborative analysis project Public meeting, September 30, 2002 JIFSAN workshop, October 28-30, 2002 WHO/FAO acrylamide-food information network by JIFSAN Emerging Issues in Neurotoxicology November 2002 Food Advisory Committee and subcommittee meetings Society for Risk Analysis December 2002 Germ Cell Mutagen Risk Assessment 2003 Codex Committee on Food Additives and Contaminants 2003 and 2004 JECFA meeting (tentative), early 2004

Summary Testing foods FDA exploratory survey and exposure assessment Formation Processing and chemistry pathways and interventions by FDA and consortia Toxicology Data gaps evaluation; sponsor and coordinate research Education Eat a balanced diet; Inform stakeholders as knowledge is gained and public health messages are determined Meetings and collaborative projects Worldwide effort, leveraging and collaboration essential to rapid progress