revised action plan food advisory committee meeting
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Revised Action Plan Food Advisory Committee Meeting. Terry C. Troxell, Ph.D. Lauren M. Posnick, Sc.D. FDA February 24-25, 2002. Finalization of the Action Plan. The Draft Action Plan has been revised based on input from the public and Subcommittee meetings - PowerPoint PPT PresentationTRANSCRIPT
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Revised Action Plan Food Advisory Committee
Meeting
Terry C. Troxell, Ph.D.Lauren M. Posnick, Sc.D.
FDAFebruary 24-25, 2002
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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
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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
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Major Changes
• Reorganized structure• New sections on exposure
assessment, epidemiology, and risk assessment
• More details and updated information
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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.
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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.
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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.
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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.
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Major Goals Outlined in Action Plan V
•Provide all the essential elements for risk analysis, i.e., risk assessment, risk communication, and risk management.
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Actions by Section
• Methodologies• Research on
Formation• Measuring
Exposure• Toxicology and
Health Effects
• Epidemiology• Risk
Assessment• Meetings• Inform and
Educate the Public
• Further Actions
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Methodologies
• Method publication on Web
• Peer validation for AOAC publication
• Screening alternatives
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New in Methodologies
• New update posted
• AOAC validation
• LC/UV alternative
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Research on Formation
• Investigate formation and reduction at NCFST
• Interact with academia and industry to encourage outside research
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New in Research on Formation
• NCFST to investigate home cooking
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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
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Measuring Exposure II
• Exposure assessment– Exposure modeled from acrylamide
levels and intake data, using probabilistic methodology
–Updates as needed, incorporating new data
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New in Measuring Exposure
• More details on testing plans
• New section on exposure assessment process, including info on modeling and databases
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Toxicology and Health Effects
• New toxicology work will provide more information for risk assessment
• Animal toxicology and human toxicology
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Animal Toxicology
•Short-term studies at NCTR•Bioavailability in food•Range of DNA and protein adducts
•Adduct formation in rodents
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Animal Toxicology II
–NTP studies at NCTR•Rodent carcinogenicity bioassay•Subchronic and mechanistic studies•Develop mechanistic, toxicokinetic, and biomarker data
•Physiological-based pharmacokinetic modeling
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Animal Toxicology III
•Neurodevelopmental effects (NCTR)
•Mechanistic research on germ cell toxicity and neurotoxicity (NIEHS)
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Human Toxicology andHealth Effects
•Rodent-human adduct correlations (NCTR and NCEH)
•Diet-related adducts in humans (FDA and NCEH)
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Human Toxicology andHealth Effects II
•Potential outside sources
•NHANES general population study
•NIOSH worker study
•Acrylamide manufacturer toxicokinetics study
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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
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Epidemiology
• Gathering epidemiology information–Cross-cutting toxicology -
epidemiology studies– Exploring feasibility of
prospective studies–Relevant literature studies
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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
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Risk Assessment
• Characterize potential risk of acrylamide in food– Include uncertainty analysis
• Key toxicology data needs: bioavailability, biomarkers,
metabolism, and toxicokinetics
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Risk Assessment II
• Revise when significant developments materially change the assessment
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New in Risk Assessment
• New section
• Outlines the goals, data needs, and expected output of the risk assessment
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Meetings
• Participate in and/or convene meetings, as appropriate
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Inform and Educate the Public I
• Commitment to communicate with public–Meetings–Website postings–FDA Consumer, Jan/Feb 2003
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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
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New in Inform and Educate the Public
• Previous consumer messages section expanded
• Summary of risk communication to date
• Participation of outside organizations
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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.
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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.
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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