Food Safety Management System in the U'S'

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Food Safety Management System in the U.S.

• Drs. Carol Kramer-LeBlanc and Sylvana Li
• Foreign Agricultural Service
• U.S. Department of Agriculture

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U.S. Food Safety System

• Legal foundation U.S. Constitution
• Three branches of U.S. government carry out three
  functions
• Legislative (U.S. Congress, States) branch enacts
  laws
• Administrative (USDA, FDA, EPA, State Depts of
  Ag.) branch implements laws
• Judicial branch hears court cases

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U.S. Food Safety Principles

• Foods must be safe wholesome to be marketed
• Regulatory decision making regarding safe food
  should be science-based
• Government has enforcement authority
• Process, manufacturers, distributors, importers
  and others in the food marketing chain must
  comply with laws and are liable if they dont
• Regulatory process is transparent and accessible
  to public

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U.S. Laws Implementing Regulations on Food
Safety

• Federal Food, Drug Cosmetic Act (FFDCA) - Food
  Drug Administration (FDA)
• Federal Meat Inspection Act (FMIA) - USDA
• Poultry Products Inspection Act (PPIA) - USDA
• Egg Products Inspection Act (PPIA) - USDA
• Food Quality Protection Act (FQPA) - U.S.
  Environmental Protection Agency (USEPA)
• Public Health Services Act

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U.S. Laws Procedural Statutes

• Administrative Procedures Act (requirements for
  rule-making)
• Federal Advisory Committee Act (balanced advisory
  group)
• Freedom of Information Act (publics right to
  access information from agencies)

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Characteristics of U.S. Rule Making

• US food safety programs aspire to be risk-based
• Regulations science-based
• Regulatory process transparent
• Stakeholder input encouraged through notice and
  comment rule making
• Also,
• Advisory committees
• Public meeting

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Administrative Branch Agencies Their Major
Responsibilities Regulatory

• Department of Health Human Services (DHHS),
  especially the FDA - Responsibility for most
  foods, especially processed
• USDA, especially the Food Safety Inspection
  Service (FSIS) - Responsibility for meat, egg
  poultry products
• and USDA, Animal Plant Health Inspection
  Service (APHIS) - Responsibility for animal and
  plant health
• USEPA - Responsibility for pesticide registration
  and animal drugs

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Administrative Branch Agencies Their Major
Responsibilities Monitoring Research

• DHHS, Centers for Disease Control and Prevention
  (CDC) Public health monitoring, epidemiology
• DHHS, National Institutes of Health (NIH)
  research
• USDA, Agricultural Research Service (ARS)
  research
• USDA, Cooperative State Research Education and
  Extension Service (CSREES) research, education,
  extension outreach
• USDA, Economic Research Service (ERS)
  regulatory impact analysis, costs of food-borne
  illness

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Administrative Branch Agencies Their Major
Responsibilities Monitoring Research, contd

• USDA, Agricultural Marketing Service (AMS)
• Economic grades standards (not safety)
• National Organics standards
• USDA, Grain Inspection, Packers and Stockyard
  Administration (GIPSA)
• Grain and livestock marketing (not safety)
• Department of Commerce, National Marine Fisheries
  Service (NMFS)
• Seafood marketing

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U.S. Government International Activities

• USDA, Foreign Agricultural Service (FAS),
  International Cooperation Development (ICD)
• Collaborative research, technical assistance,
  training
• USDA, FAS, International Trade Policy (ITP)
• International trade negotiations
• USDA, Codex Office
• Works with Codex Alimentarius Commission and
  member countries
• Office of the U.S. Trade Representative
• International trade negotiations
• U.S. Department of State
• Foreign policy

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Major Categories of Food Safety Hazards

• Pathogenic microorganisms
• Pesticide residues
• Animal drug residues
• Irradiation
• Myco toxins
• Heavy metals other chemical contaminants
• Illegal food additives

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U.S. Approach Precaution

• Risk analysis
• Risk assessment
• - Hazard ID
• - Hazard characterization
• - Exposure assessment

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U.S. Approach Precaution, contd

• Risk management
• e.g. - HAACP (Hazard Analysis and Critical
  Control Point)
• Risk communication
• Precaution - pre market approval

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• Thanks