Revised Action Plan Food Advisory Committee

Meeting

Terry C. Troxell, Ph.D.Lauren M. Posnick, Sc.D.

FDAFebruary 24-25, 2002

Finalization of the Action Plan

• The Draft Action Plan has been revised based on input from the public and Subcommittee meetings

• Today we are seeking input that will assist FDA in finalizing the Action Plan

Outline of Today’s Talk

• Summarize key changes in the Plan

• Review Major Goals of the Plan

• Walk through the Action sections

• Highlight changes section by section

Major Changes

• Reorganized structure• New sections on exposure

assessment, epidemiology, and risk assessment

• More details and updated information

Major Goals Outlined in Action Plan

• 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.

Major Goals Outlined in Action Plan II

• Assess the dietary exposure of U.S. consumers to acrylamide by measuring acrylamide levels in various foods and estimating dietary exposure.

Major Goals Outlined in Action Plan III

• 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.

Major Goals Outlined in Action Plan IV

• 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.

Major Goals Outlined in Action Plan V

•Provide all the essential elements for risk analysis, i.e., risk assessment, risk communication, and risk management.

Actions by Section

• Methodologies• Research on

Formation• Measuring

Exposure• Toxicology and

Health Effects

• Epidemiology• Risk

Assessment• Meetings• Inform and

Educate the Public

• Further Actions

Methodologies

• Method publication on Web

• Peer validation for AOAC publication

• Screening alternatives

New in Methodologies

• New update posted

• AOAC validation

• LC/UV alternative

Research on Formation

• Investigate formation and reduction at NCFST

• Interact with academia and industry to encourage outside research

New in Research on Formation

• NCFST to investigate home cooking

Measuring Exposure

• Testing foods– Locally collected foods, nationally

collected foods, TDS–CFSAN, ORA, and contract

laboratory– Further testing (FY04 and on)

based on initial findings and statistical consultation

Measuring Exposure II

• Exposure assessment– Exposure modeled from acrylamide

levels and intake data, using probabilistic methodology

–Updates as needed, incorporating new data

New in Measuring Exposure

• More details on testing plans

• New section on exposure assessment process, including info on modeling and databases

Toxicology and Health Effects

• New toxicology work will provide more information for risk assessment

• Animal toxicology and human toxicology

Animal Toxicology

•Short-term studies at NCTR•Bioavailability in food•Range of DNA and protein adducts

•Adduct formation in rodents

Animal Toxicology II

–NTP studies at NCTR•Rodent carcinogenicity bioassay•Subchronic and mechanistic studies•Develop mechanistic, toxicokinetic, and biomarker data

•Physiological-based pharmacokinetic modeling

Animal Toxicology III

•Neurodevelopmental effects (NCTR)

•Mechanistic research on germ cell toxicity and neurotoxicity (NIEHS)

Human Toxicology andHealth Effects

•Rodent-human adduct correlations (NCTR and NCEH)

•Diet-related adducts in humans (FDA and NCEH)

Human Toxicology andHealth Effects II

•Potential outside sources

•NHANES general population study

•NIOSH worker study

•Acrylamide manufacturer toxicokinetics study

New in Toxicology

•New study areas, including neurotoxicity, germ cell toxicity, and industry toxicokinetics

•PBPK, dose-response elements discussed

•More details on NTP studies, including chronic carcinogenicity

Epidemiology

• Gathering epidemiology information–Cross-cutting toxicology -

epidemiology studies– Exploring feasibility of

prospective studies–Relevant literature studies

New in Epidemiology

• Epidemiology section new

• Explains how epidemiological data could benefit FDA work on acrylamide

• A number of studies and collaborations are under consideration

Risk Assessment

• Characterize potential risk of acrylamide in food– Include uncertainty analysis

• Key toxicology data needs: bioavailability, biomarkers,

metabolism, and toxicokinetics

Risk Assessment II

• Revise when significant developments materially change the assessment

New in Risk Assessment

• New section

• Outlines the goals, data needs, and expected output of the risk assessment

Meetings

• Participate in and/or convene meetings, as appropriate

Inform and Educate the Public I

• Commitment to communicate with public–Meetings–Website postings–FDA Consumer, Jan/Feb 2003

Inform and Educate the Public II

• Dietary message: 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

• FDA may recruit diet and nutrition organizations to help spread messages

New in Inform and Educate the Public

• Previous consumer messages section expanded

• Summary of risk communication to date

• Participation of outside organizations

Further Actions I

• Develop and revise regulatory options as additional knowledge is gained on acrylamide in food.

• Encourage industry to adopt feasible, practical, and safe processes that are successful at reducing acrylamide, as needed.

Further Actions II

• Develop and revise consumer messages about dietary choices and cooking, as additional knowledge is gained to assist consumers in making informed choices.

• Any adjustments in messages would be made as dictated by the totality of the science.

Conclusion

• Action Plan outlines goals and planned actions

• Revised to reflect comments and new info

• Reorganized, new sections, more details

• FDA is seeking input to assist in finalizing the plan