Bioterrorism Act

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Bioterrorism Act

• Recordkeeping Regulations
• Application to Unsaleables
• (July 2005)
• Deborah R. White
• Vice President
• Associate General Counsel
• Food Marketing Institute

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Bioterrorism Act

• Persons who handle food must maintain records of
  the immediate previous sources and immediate
  subsequent recipients of the food
• FDA has ability to access those records under
  some circumstances
• Looks simple, right??

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Records Maintenance

• Proposal
• Detailed requirements
• Name of truck driver
• Lot code tracking
• Cost estimates from members
• Short implementation period
• Members very concerned
• Store tours for FDA officials
• Congressional letters
• Meetings with OMB
• Conferences with HHS officials

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Records Maintenance

• Final rule more reasonable
• FDA does not intend to require the
  reconfiguration of business operations
• Longer implementation period
• No lot code tracking for retail/distribution
• Est. savings to industry
• 9.2 million per year per distribution center
• 14,000 per year per store
• BUT still challenging

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Who must keep records?

• With some exceptions, applies to persons who
  conduct any of the following activities M ? I
  with food
• Manufacture -- Distribute
• Process -- Receive
• Pack -- Hold
• Transport -- Import

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Who doesnt have to?

• Exceptions to recordkeeping mandate
• Farms
• Restaurants
• Prepare and sell food directly to consumers for
  immediate consumption
• At least 90
• Applies to food prepared and sold for immediate
  consumption in retail stores
• Exploring application to delis, etc.
• Franchise operations

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Who else?

• Partial exclusions from maintenance but not
  access
• Non-profits
• Charitable entity that prepares and serves food
  directly to consumers
• Food banks, soup kitchens, food delivery services
• Must meet standards for 501(c)(3)
• Small retailers
• 10 or fewer FTEs per location

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Who else?

• Partial exclusions from maintenance but not
  access or prohibited act
• Persons who manufacture, etc, food-contact
  substances other than finished container
• Persons who manufacture, etc, food must provide
  access to records on non-food-contact packaging

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Whats food??

• Articles used for food or drink by man or other
  animals
• Examples
• Fruits and vegetables
• Fish and seafood
• Dairy and shell eggs
• Baked goods, candy, snack foods
• Canned and frozen foods

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Whats food??

• More Examples
• Beverages
• Including infant formula, alcoholic beverages,
  and bottled water
• Dietary supplements
• But not HBC generally
• Animal feed and pet food
• Even some food-contact packaging materials
• Sold to consumer with food
• But not pots, pans, baby bottles, water filters,
  etc

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Whats NOT food??

• Food under the exclusive jurisdiction of the U.S.
  Department of Agriculture is NOT covered
• Examples
• Meat
• Poultry
• Egg products

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What information?

• Records to identify immediate previous sources
  and immediate subsequent recipients of food to
  address credible threats of serious adverse
  health consequences or death

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Non-transporters/Transporters

• FDA further characterizes recordkeepers and
  sources/recipients as either
• Non-transporters OR
• Person who owns food or who holds, manufactures,
  processes, packs, imports, receives or
  distributes food for purposes other than
  transportation
• Transporters
• Person who has possession, custody or control of
  food in US for sole purpose of transportation

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IPS/ISR Basics

• Previous source/subsequent recipient
• Name/address/phone number
• Fax/email, if available
• Type of food (brand specific variety)
• Quantity type of packaging (e.g., 12 oz
  bottles)
• Date received
• Transporter
• Lot code numbers, if you manufacture, process or
  pack food
• To the extent the information exists
• Also for recipient records
• Specific source of ingredients in final food
  products
• Reasonably available

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Some exceptions to identifying ISRs

• Household consumers
• NO retailer as Big Brother
• Store level samples
• Non-profits
• Stand in shoes of consumer
• Vertical integration
• Entities within corporate bubble

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Business ISRs

• Retailers ARE responsible for identifying
  business ISRs to the extent the information is
  reasonably available
• Information is reasonably available if you have
  a system in place to capture the information.
  FDA does not intend to require the
  reconfiguration of business operations
• Response to Comment 38 69 Fed. Reg. at 71575
• Ex. Club card store, such as Costco

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One retail companys view
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Unsaleables!

• Routes for unsaleables to leave retail
• Food banks or soup kitchens
• But already know these are exempt as consumers
• Reclamation centers
• Salvage operations
• Farms (waste)

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Farms as ISRs

• Example
• Waste tossed in large bin
• Picked up by farmers sold or donated
• Primary issue is adequate description of food
• Will continue to work with FDA

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Reclamation Centers as ISRs

• Examples
• Products tossed in banana carton and transported
  to reclamation center
• Issues
• Ownership of reclamation center
• Who transports and how? Through cross-dock?
• What exactly was sent and when is that known?

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Reclamation Centers as ISRs

• FDAs Position
• Need to maintain ISR record
• Name
• Adequate description of food
• Quantity and packaging
• Date released
• Transporter
• Primary issue timing

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Salvage as ISR

• Example
• Pallet of dents and dings sold to salvager as
  is
• FDA concern
• Product diverted to consumers through smaller
  retailers or other outlets
• At this point, regulations would require tracking
  of individual products out of retail/DC (and
  onward through chain)

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How specific must records involving third party
contractors be?

• Examples
• Freight broker who determines truck driver
• Dairy cooperative sourcing milk from multiple
  farms
• FDA will accept identity of broker

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How do you handle records involving cross-docks?

• Example
• Manufacturer ships food to ABC warehouse
• ABC warehouse trucks transport food to XYZ
  cross-dock
• XYZ cross-dock connects food to other food
  products that are then shipped to Independent
  Retailer
• Cross-dock essentially a transporter
• Indep. Retailer ABCs ISR

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Degree of Specificity

• How closely do you need to be able to tie a
  particular food item to a specific record?
• Use information reasonably available standard
  (ex. flour silos)
• FDA will seek guidance/input from source of
  records

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What format?

• Records must be created at time food is received
  or released unless information already contained
  in existing records
• Any format acceptable
• Information does not have to be in single record

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How long must you keep records?

• Based on food perishability
• 60 days 6 months ? 1 year
• 6 months ? 2 years
• Animal feed/pet food ? 1 year

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How quickly must you be able to produce records?

• As soon as possible, but no longer than 24 hours.

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Where must records be kept?

• Onsite or at a reasonably accessible location
• Consider in conjunction with records
  retrieval standard

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When may FDA inspect these records?

• Access
• If FDA has a reasonable belief that the food is
  adulterated and presents a threat of serious
  adverse health consequences or death to humans or
  animals
• Carefully negotiated NOT mislabeling
• Already in effect
• Does FDA have authority to conduct routine
  inspections?

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What standards apply to FDAs access authority?

• Limits
• Written notice, credentials
• Reasonable time, manner
• No recipes or financial, personnel or sales data
• Implement provisions to protect against release

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What are the consequences?

• Prohibited acts
• Failure to establish or maintain records
• Refuse access to or verification or copying of
  any required records
• Failure to make records available

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Records Implementation

• Regulation effective
• December 9, 2005
• Staggered implementation for smaller businesses
  (consider entire company)
• 11 ? 499 FTEs June 9, 2006
• 10 or less FTEs December 11, 2006

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Records Implementation

• Must keep records as of relevant effective date
  and forward
• Example.
• Receive eggs, milk, butter to make cakes prior to
  December 9, 2005
• Bake and sell cakes after December 9, 2005
• Must keep records of ISR of cakes, but not IPS of
  ingredients

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Questions...

• Contact Info
• Deborah White
• dwhite_at_fmi.org202 220 0614